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  • Xiong Yaqun, Qi Fei, Guo Yan, Zeng Liu
    Adverse Drug Reactions Journal. 2025, 27(9): 574-576. https://doi.org/10.3760/cma.j.cn114015-20250309-00128
    A 2-month-old female infant developed fever for 2 days and diarrhea for 1 day. Laboratory tests showed that white blood cell count was 18.8×109/L, neutrophil count was 8.3×109/L, C-reactive protein was 88.8 mg/L, procalcitonin was 35.9 μg/L, alanine aminotransferase (ALT) was 150 U/L, and aspartate aminotransferase (AST) was 121 U/L. Infectious fever and diarrhea were diagnosed. After 3 days of treatment with ceftriaxone, the diarrhea was improved, but there was still fever. Ceftriaxone was replaced by meropenem (20 mg/kg by intravenous infusion, once per 8 hours). Three days later, the infant′s ALT, AST and white blood cell count returned to normal, but she still experienced recurrent fever (up to 39.0 ℃) and mental fatigue, which was considered to be intracranial infection. The dose of meropenem was doubled (40 mg/kg by intravenous infusion, once per 8 hours), and 3 days later, the infant′s body temperature was normal, but mild yellowish skin occurred, with ALT 1 442 U/L, AST 2 868 U/L, direct bilirubin 20.0 μmol/L, and total bile acid (TBA) 90 μmol/L. Acute liver injury caused by meropenem was considered, the drug was replaced by ceftazidime, and liver-protective treatments such as glutathione and ademetionine were given. After 9 days, the infant′s ALT was 140 U/L, AST was 116 U/L, TBA was 46.3 μmol/L, and yellowish skin disappeared. Two weeks later, her liver function indexes basically returned to normal.

  • Ma Qing, Fu Jing, Chen Wei, Wang Weijun, Cao Kun, Huang Huiying
    Adverse Drug Reactions Journal. 2025, 27(9): 570-573. https://doi.org/10.3760/cma.j.cn114015-20240816-00732
    An 85-year-old male patient received immunotherapy with toripalimab (240 mg by intravenous infusion on day 1, 21 days as one treatment cycle). After one week of the first medication, the patient experienced fatigue, poor appetite, weight loss, gradually developed mild ptosis of the right eyelid, shortness of breath and palpitations after activity, which were progressively aggravated. The patient also developed unclear speech, choking on water, and difficulty breathing. Laboratory tests showed alanine aminotransferase (ALT) 93 U/L, aspartate aminotransferase (AST) 171 U/L, creatine kinase (CK) 2 982 U/L, creatine kinase isoenzyme (CK-MB) 110 U/L, lactate dehydrogenase (LDH) 603 U/L, and high-sensitivity troponin T (hs-cTnT) 243 ng/L. All indicators of thyroid function were abnormal. Based on results of the laboratory tests, neurophysiological examination, and electrocardiogram examination, combined with the patient′s clinical symptoms, immune-mediated hepatitis of grade 2, immune-mediated myocarditis of grade 3, myasthenia gravis of grade 3, immune-mediated myositis of grade 2, and thyroid dysfunction of grade 1 were diagnosed, which was considered to be induced by toripalimab. Toripalimab was stopped. After treatments with glucocorticoids, liver-protective drugs, and symptomatic treatments, above-mentioned indicators showed a downward trend. After 27 days of treatments, the patient′s clinical symptoms were improved significantly. Laboratory tests showed ALT 123 U/L, AST 68 U/L, CK 116 U/L, CK-MB 42 U/L, LDH 305 U/L. The thyroid function indicators were all normal. After 57 days of treatments, above symptoms in the patient basically disappeared, and laboratory indicators tended to be normal.

  • Zhang Li‘na, Feng Hui, Li Jinfeng
    Adverse Drug Reactions Journal. 2025, 27(9): 568-570. https://doi.org/10.3760/cma.j.cn114015-20240724-00629
    A 54 year-old male patient with lung adenocarcinoma received immunotherapy with camrelizumab (200 mg by intravenous infusion on day 1, with 21 days as one cycle) after operation. After 3 cycles of treatment, the patient developed fever, vomiting, urinary and fecal incontinence, unconsciousness, no response to verbal stimuli, and limb tremors. Cerebrospinal fluid test showed a positive Pandy test, with total protein of 1 173 mg/L and immunoglobulin G of 113 mg/L. Laboratory and imaging examinations excluded intracranial infection, brain metastasis, and metabolic encephalopathy, and the immune-related encephalitis due to camrelizumab was considered. Camrelizumab was stopped and methylprednisolone sodium succinate was given. Ten days later, the patient′s aforementioned symptoms disappeared.

  • Li Juan, Yang Guohan, Zhang Hong, Zhou Huanhuan, Hou Min, Xu Chengying, Luo Xiaofeng, Xing Haiyan
    Adverse Drug Reactions Journal. 2025, 27(9): 559-567. https://doi.org/10.3760/cma.j.cn114015-20240830-00021
    Objective To formulate the audit standards of Chinese patent medicine prescriptions, and provide reference for rational prescriptions of Chinese patent medicine. Methods A three-level evidence system for prescription review of Chinese patent medicine was established according to the national regulatory documents, drug labels, relevant guidelines, and expert consensuses. The catalog of Chinese patent medicines in Army Medical Center of the People′s Liberation Army was integrated and classified, preliminary review criteria including indications, drug selection, usage and dosage, and combination drugs was established and submitted to clinical experts of traditional Chinese medicine for review and revision, and finally the prescription review standard was confirmed. Results The Chinese patent medicine catalog of the Medical Center contained 218 drugs, which were divided into 23 kinds according to efficacy and 17 kinds according to dosage forms. The prescription review standards of Chinese patent medicine were as follows. (1) Indications: both traditional Chinese medicine and Western medicine diagnosis were required. (2) Drug selection: 37 kinds of Chinese patent medicines were marked as forbidden for pregnant women in the labels, and 16 kinds were not marked but contained forbidden ingredients; 4 kinds were marked with caution for patients with liver dysfunction, and 24 kinds were not marked but contained ingredients with caution; 2 kinds of Chinese patent medicines were marked with caution for patients with renal insufficiency, and 9 kinds were not marked but contained ingredients with caution. (3) Usage and dosage: the usage and dosage rules of Chinese patent medicines for children, the elderly and patients with liver and kidney dysfunction were formulated. (4) Combined medication: 5 and 21 kinds of Chinese patent medicines were marked as "highly toxic" and "toxic" in the labels, respectively, 11 kinds of Chinese patent medicines contained incompatible ingredients of “Shibafan”(eighteen antagonisms) and "Shijiuwei (nineteen incompatibilities), and a new review scale for repeated use of Chinese patent medicine was developed. Conclusions Based on the existing evidence-based medicine, the evidence system of prescription review of Chinese patent medicine is established, the prescription review standards of Chinese patent medicine prescription based on the pharmaceutical interaction mode is formulated and constructed.

  • Shu Yang, Chen Yunwen, Yuan Xiyue, Qi Jia
    Adverse Drug Reactions Journal. 2025, 27(9): 552-558. https://doi.org/10.3760/cma.j.cn114015-20240731-00666
    Objective To analyze the occurrence and risk factors of moderate-to-severe pain after elective endoscopic variceal ligation (EVL). Methods This was a single-center case-control study. The research subjects were selected from inpatients with liver cirrhosis who received elective EVL in the Department of Gastroenterology of Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from April 2015 to June 2022. Based on the medical records and nursing documents, the general information of the patients, operation records of EVL, laboratory tests and abdominal ultrasound examination results, dose of octreotide and occurrence of very early postoperative gastrointestinal bleeding, pain assessment records, etc. were collected; the preoperative liver function and the severity of gastroesophageal varices (GOV) in the patients were evaluated accordingly. The patients were divided into low (0.3 mg/12 h) and high (0.6 mg/12 h) dose groups according to the octreotide dosage, and the incidence of very early postoperative gastrointestinal bleeding in the 2 groups was compared. The patients were divided into 2 groups based on whether moderate-to-severe pain occurred after the operation. The clinical characteristics in the patients of the 2 groups were compared, and the independent risk factors of moderate-to-severe pain after the operation were analyzed by the multivariate logistic regression model. Results A total of 252 patients were included in this study, 6 of which developed very early gastrointestinal bleeding after elective EVL with an incidence of 2.4%. There was no statistically significant difference in the incidence of very early bleeding between the low-dose and high-dose octreotide groups [2.5% (3/122) vs. 2.3% (3/130), P=1.000]. Moderate-to-severe pain occurred in 61 patients after elective EVL with an incidence of 24.2%. Compared with patients without moderate-to-severe pain, the proportions of females, and those with severe GOV, undergoing EVL for the first time, and using high-dose octreotide were relatively high in patients with moderate-to-severe pain, and the differences were statistically significant (all P<0.05). Multivariate logistic regression analysis showed that being female[odds ratio (OR)=2.603, 95% confidence interval (CI): 1.377-4.923, P=0.003], with severe GOV (OR=2.436, 95%CI: 1.098-5.405, P=0.029), using high-dose octreotide (OR=2.205, 95%CI: 1.162-4.184, P=0.016), and undergoing EVL for the first time (OR=2.070, 95%CI: 1.072-3.998, P=0.030) were independent risk factors for moderate-to-severe pain after EVL. Conclusions The efficacy of octreotide at doses 0.3 and 0.6 mg/12 h was similar in preventing very early postoperative gastrointestinal bleeding after elective EVL. Females and patients with severe GOV, using high-dose octreotide, and undergoing EVL for the first time had a higher risk of moderate-to-severe pain after surgery. It is recommended to optimize the octreotide treatment plan to reduce the occurrence of moderate-to-severe pain after elective EVL.

  • Li Danni, Ding Wenwen, Liu Xiaona, Wei Pingping, Zhang Lei, Liang Hui
    Adverse Drug Reactions Journal. 2025, 27(9): 545-551. https://doi.org/10.3760/cma.j.cn114015-20250220-00084
    Objective To analyze the safety profile of blinatumomab in children with B-cell acute lymphoblastic leukemia (ALL). Methods Demographic and clinical data of 33 pediatric B-cell ALL patients treated with blinatumomab in the Women and Children′s Hospital, Qingdao University from January 2022 to November 2024 were retrospectively collected. Demographic data included gender and age, while clinical data comprised leukemia risk stratification, minimal residual disease (MRD) status before blinatumomab use, treatment duration (14 day or 28 day courses), and safety outcomes included drug-related fever, cytokine release syndrome (CRS), tachycardia, blood pressure abnormalities, elevated transaminases, immune effector cell-associated neurotoxicity syndrome (ICANS), oral mucositis, rash, and infections. Patients were stratified by CRS occurrence and transaminase elevation for comparative analysis of demographic/clinical characteristics. Results A total of 33 children with B-cell type ALL who received blinatumomab treatment were included. Among them, 21 were male and 12 were female; the age was 5.2 (4.7, 7.0) years, ranging from 1.7 to 10.0 years. Risk stratification included low (2 cases), intermediate (23 cases), and high (8 cases) risk. Pre-treatment MRD was negative in 16 and positive in 17 patients. Eight patients received a 14 day blinatumomab course, while 25 cases received a 28 day course. The overall adverse events (AEs) rate was 81.8% (27/33). Among the 27 patients who experienced AEs, there were 5 cases (18.5%) of severe adverse events (all grade 3). The specific adverse events that occurred in the 33 patients included drug-related fever in 21 cases (63.6%) [including 16 cases (48.5%) of CRS], elevated transaminases in 10 cases (30.3%), infectious symptoms in 5 cases (15.2%), rash in 4 cases (12.1%), tachycardia in 3 cases (9.1%), ICANS in 2 cases (6.1%), and oral mucositis in 1 case (3.0%). No statistically significant differences were observed in gender, age, risk stratification, pretreatment MRD status, and treatment duration between the CRS and non-CRS groups, transaminase-elevated and normal groups (all P>0.05). Conclusions In pediatric B-cell ALL, the most common AEs related to blinatumomab are CRS and elevated transaminases, but most reactions are mild, with rapid recovery and favorable tolerability.
  • Xu Lin, Miao Min, Zhang Yanlan, Song Rui, Wang Caiying
    Adverse Drug Reactions Journal. 2025, 27(9): 537-544. https://doi.org/10.3760/cma.j.cn114015-20250219-00079
    Objective To systematically evaluate the efficacy and safety of nirsevimab in preventing respiratory syncytial virus (RSV) infection in infants. Methods Randomized controlled trials (RCTs) of nirsevimab in the prevention of RSV infection in newborns and infants (≤ 2 years old) were collected by searching relevant databases at home and abroad (up to February 12, 2025). Subjects in the trial group received a single dose injection of nirsevimab, while those in the control group received placebo or no interventions, with an observation period of ≥150 days. The efficacy outcome indicators included the incidence of acute lower respiratory tract infections (LRTI), RSV-associated hospital visits, RSV-associated hospitalization, and severe RSV infection events. The safety outcome indicators were the occurrence of adverse events (AEs) after injection of nirsevimab. Quality of methodology was evaluated using bias risk assessment tool of Cochrane collaboration networks. Meta-analysis was performed using RevMan 5.4 software. The effect sizes  were relative risk (RR) and its 95% confidence interval (CI). Results A total of 4 RCTs and 11 051 subjects were entered in the analysis, including 6 032 subjects in the trial group and 5 019 in the control group. The results of meta-analysis showed that compared with the control group, the incidences of acute LRTI [4.94% (298/6 032) vs. 5.70% (286/5 019), RR=0.57, 95%CI: 0.41-0.81], RSV-associated hospital visits [1.85% (37/1 995) vs. 7.11% (71/998), RR=0.26, 95%CI: 0.18-0.38], RSV -associated hospitalization [0.31% (19/6 032) vs. 1.75% (88/5 019), RR=0.17, 95%CI: 0.07-0.43], and severe RSV infection events [0.10% (5/5 038) vs. 1.52% (69/4 523), RR=0.07, 95%CI: 0.03-0.17] in the trial group were significantly lower, and the differences were statistically significant (all P<0.001). The differences in incidences of AEs, grade ≥3 AEs, AEs of great concern, and death events in the 2 groups during the observation period were not significant (all P>0.05), and no nirsevimab-related death events occurred. Conclusion Nirsevimab is effective in preventing RSV infection in infants and has a good safety profile.

  • Guo Jin, Zhao Peng, Liu Chunrong, Liao Mingyu, Chen Jingwen, Wu Jianru Ren Yan, Rong Biao, Qi Huanyang, Chen Moliang, Sun Xin, Tan Jing, Xiong Yiquan
    Adverse Drug Reactions Journal. 2025, 27(9): 530-536. https://doi.org/10.3760/cma.j.cn114015-20250303-00111
    Objective To explore the association between the use of tetracyclines during pregnancy and congenital malformations, with the aim of providing evidence -based guidance for the rational use of antibiotics during pregnancy. Methods Data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) and the Canada Vigilance Adverse Reaction (CVAR) database from January 2015 to September 2024 were collected. Five methods including Tree -based scan statistic (TreeScan), proportional reporting ratio (PRR), reporting odds ratio (ROR), the UK Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard, and the Bayesian confidence propagation neural network (BCPNN) were used to detect signals of risk for congenital malformations in offspring following maternal use of tetracyclines during pregnancy. A signal that met the threshold criteria of all above 5 methods was considered as a risk signal. Based on population-based cohort of the drug exposures and adverse pregnancy outcomes (DEEP) data from January 2013 to December 2021 in Xiamen City, propensity score matching (PSM) -based Poisson regression was applied to evaluate the association between the first -trimester tetracyclines exposure and congenital malformations in offspring. Adjusted relative risk (aRR) and its 95% confidence interval (CI) were calculated. Sensitivity analysis was conducted to validate the reliability of the results. Results A total of 304 098 reports of adverse events during pregnancy were obtained from the FAERS and CVAR databases. Among them, 5 028 reports were related to tetracyclines, including 1 026 reports of congenital malformations in offspring, involving congenital malformations of musculoskeletal system, other digestive system, and other congenital malformations. Signal detection results suggested that tetracyclines may be a risk signal for above congenital malformations in offspring. The DEEP data included 411 936 pregnant women. After PSM, 240 pregnant women exposed to tetracyclines were included. The results showed no significant association between the first-trimester tetracyclines exposure and congenital malformations in offspring (aRR=0.75, 95%CI: 0.26-2.17), sensitivity analysis also showed no correlation. Conclusions Data mining from the FAERS and CVAR databases suggests a potential association between tetracyclines use during pregnancy and congenital malformations in offspring. However, the DEEP data study shows no significant correlation.

  • Wei Ran, Zhou Ying
    Adverse Drug Reactions Journal. 2025, 27(9): 525-529. https://doi.org/10.3760/cma.j.cn114015-20250801-00408
     The theme of World Patient Safety Day 2025 is "Safe care for every newborn and every child", and the slogan is "Patient safety from the start!", highlighting the importance of safe care for children. Medication safety for children is the core aspect. Around this theme, the article systematically discusses the key issues that affect the medication safety of newborns and children, including the risk of fetal drug exposure in early life, prevention of medication errors and adverse drug reactions in children in medical institutions, accidental drug poisoning and treatment compliance challenges in children at home. It also deeply analyzes the medication risks arising from the physiological characteristics of children, as well as the progress and shortcomings of current policies and monitoring systems. Finally, this article proposes multidimensional systematic optimization strategies such as strengthening the monitoring and early warning, deepening the professional education, promoting the tool research and development, and improving the policy frameworks, in order to assist the systematic improvement of children′s medication safety practices in China.

  • Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, Section of Clinical Toxicology of Chinese Society of Toxicology, Editorial Committee of Adverse Drug Reactions Journal
    Adverse Drug Reactions Journal. 2025, 27(9): 513-524. https://doi.org/10.3760/cma.j.cn114015-20250302-00109
    Hyperthyroidism combined with abnormal liver function is a tricky problem in clinical diagnosis and treatment, which mainly includes hyperthyroidism-related liver injury, liver injury caused by antithyroid drugs (ATD), and other liver diseases associated with hyperthyroidism. Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, Section of Clinical Toxicology of Chinese Society of Toxicology, and the Editorial Committee of Adverse Drug Reactions Journal organized relevant experts majoring in endocrinology, hepatology, and clinical pharmacy to jointly discuss and formulate this consensus based on a systematic review of relevant research progress at home and abroad, combined with the actual clinical situation in China. This consensus systematically expounds the epidemiology, pathogenesis, clinical characteristics, diagnosis and differential diagnosis, monitoring and treatment of hyperthyroidism with liver dysfunction, and puts forward recommendations for diagnosis and treatment, aiming to help clinicians make reasonable decisions in the prevention, diagnosis and treatment of hyperthyroidism combined with abnormal liver function, and improve the level of clinical diagnosis and treatment.

  • Chen Guoxiang, Feng Youfan, Hao Jianshu, Zhang Qike, Sun Yanqing
    Adverse Drug Reactions Journal. 2025, 27(8): 510-512. https://doi.org/10.3760/cma.j.cn114015-20241021-00103
    A 40-year-old male patient was treated orally with carbamazepine 0.1 g once daily for epilepsy. Twenty days later, the patient developed fever without obvious cause (highest body temperature 39.0 ℃), which showed no improvement after treatments with ribavirin and ibuprofen. Eleven days later, splenomegaly occurred, and serum ferritin was elevated (1 188.18 μg/L). Etiological testing showed positive influenza virus A/B antibody but negative nucleic acid; tests of Epstein-Barr virus, cytomegalovirus, novel coronavirus, respiratory syncytial virus, adenovirus, human rhinovirus, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Leishmania donovani, Brucella, and Toxoplasma gondii all showed negative results. Blood culture and autoantibody profile were both negative. Anti-infective treatments with ceftizoxime, levofloxacin, ganciclovir, and oseltamivir were successively given. Oseltamivir was later changed to peramivir. Eight days later, the patient′s body temperature fluctuated between 38.4 ℃ and 38.6 ℃. Fibrinogen decreased to 1.49 g/L, serum ferritin increased to 1 218.91 μg/L, and soluble CD25 increased to 3 814 kU/L. Bone marrow smear showed hemophagocytosis. Secondary hemophagocytic lymphohistiocytosis was diagnosed, which was considered to be caused by carbamazepine. Carbamazepine and the aforementioned anti-infective drugs were discontinued, and intravenous infusion of dexamethasone 15 mg once daily was administered. The patient′s body temperature decreased to 37.5 ℃. Six days later, intravenous infusion of etoposide 100 mg once was added. The next day, the patient no longer had fever, and laboratory indicators showed significant improvement. The patient′s laboratory indicators returned to normal in re-examination 3 months later.
  • Zhang Jing, Zhang Xinyi
    Adverse Drug Reactions Journal. 2025, 27(8): 507-509. https://doi.org/10.3760/cma.j.cn114015-20240711-00539
    A 59-year-old male patient with lung squamous cell carcinoma received chemotherapy combined with tislelizumab 200 mg by intravenous infusion on day 1, with 21 days as 1 cycle. On the 10th day after 12 cycles of intermittent treatments, the patient developed rashes all over the skin, with local blisters and partial ulceration, especially at the ends of the limbs. The patient was diagnosed as having erythema multiforme and considered to be related to tislelizumab. Chemotherapy was stopped and tislelizumab was discontinued. Intravenously infusion of methylprednisolone 80 mg once daily and symptomatic treatments such as topical cream to the skin lesion were given. After 14 days of treatments, the rashes were subsided obviously, and some blisters scabbed. Methylprednisolone was changed to prednisone tablets 60 mg orally once daily, which was gradually reduced until withdrawal more than 3 months later. The patient′s skin rashes and blisters were subsided, leaving pigmentation at the site of skin rupture on the limbs. Since then, the patient did not  receive immunotherapy, and did not have any adverse skin reactions.
  • Guang Jiejie, Zhu Zhonghua
    Adverse Drug Reactions Journal. 2025, 27(8): 505-507. https://doi.org/10.3760/cma.j.cn 114015-20241015-00092
    A 39-year-old male patient with ankylosing spondylitis received adalimumab 40 mg subcutaneously every 2 weeks plus sulfasalazine enteric-coated tablets 0.75 g orally twice daily. Two weeks after the therapy initiation, he received his second adalimumab injection and discontinued sulfasalazine because of skin rashes. Meanwhile, cetirizine 10 mg once daily was given as anti-allergic treatment for 3 days. Six days later, he developed fever and persistent holocranial dull pain. The next day the headache worsened, with one episode of vomiting gastric contents. Cranial magnetic resonance imaging revealed findings consistent with infectious leptomeningeal lesions, and cerebrospinal fluid analysis suggested intracranial infection. Empirical anti-infection therapy with ceftriaxone and ganciclovir, as well as intracranial pressure reduction therapy with 20% mannitol was initiated. Two days later, next-generation sequencing of cerebrospinal fluid identified Neisseria meningitidis as the highly probable pathogen. The therapy regimen was adjusted to ceftriaxone, acyclovir and dexamethasone. After 12 days of treatments, the patient achieved full clinical recovery from meningitis.
  • Peng Longxi, Li Zhengxiang, Yuan Hengjie
    Adverse Drug Reactions Journal. 2025, 27(8): 502-504. https://doi.org/10.3760/cma.j.cn114015-20241206-00185
    A 12-year-old male child with severe pneumonia received anti-infection therapy with cefoperazone sodium and sulbactam sodium (3 g by intravenous infusion, once every 8 hours) and minocycline (100 mg twice daily orally). After 8 days, the child experienced severe headache, accompanied by blurred vision and nausea. The head magnetic resonance imaging and 4 hour video electroencephalogram showed no abnormalities in the child. Cerebrospinal fluid pressure measured by lumbar puncture was 220 mmH2O, and cerebrospinal fluid biochemistry and routine examination showed no abnormalities. After excluding intracranial infection, toxic encephalopathy, intracranial hemorrhage, and space-occupying lesions, it was considered that the increase of intracranial pressure was caused by minocycline. After discontinuing minocycline and administering symptomatic treatments such as mannitol, nonsteroidal anti-inflammatory drugs for 3 days, his headache was relieved. At 1 week and 1 month follow-up, no abnormal symptoms such as headache recurred in the child.
  • Dou Wei, Liu Xin, Zuo Wei, Yu Jiaxin, Wu Jiayu, Zhang Bo
    Adverse Drug Reactions Journal. 2025, 27(8): 495-501. https://doi.org/10.3760/cma.j.cn114015-20241124-00164
    Objective To understand the application situation and role of prescription sequence symmetry analysis (PSSA) in pharmacovigilance. Methods The relevant databases at home and abroad were searched (up to April 30, 2024), and the original articles using PSSA as the research method were collected. The basic information of the literature (first author, publication year, country, etc.), the purpose and main content of the study, the index drugs as well as the marker drugs or medical diagnoses involved in the adverse drug reactions (ADRs) were extracted. Descriptive statistical analysis was carried out. Results A total of 66 articles were included in the analysis. The first article was published in 1996, the number of articles published in recent years has increased significantly, and those published after 2016 accounted for 68.2% (45/66). The top 3 countries in terms of published literature quantity were the United States, Denmark, and Japan. The index drugs most commonly studied were those for the cardiovascular system and the neuropsychiatric system, in 18 and 14 articles respectively. The drugs studied in 3 or more papers were hypolipidemic drugs, antihypertensive drugs, antipsychotics, antiepileptics, proton pump inhibitors, hypoglycemic drugs and anticoagulants. The targeted ADRs/diseases most studied were those about the neuropsy- chiatric system (in 13 studies), followed by those about the endocrine and metabolic system (in 12 studies). The research objective in 47 articles was to explore the association between index drugs and ADRs/diseases through PSSA. Finally, the associations between 21 ADRs and index drugs were identified in 24 articles, of which 9 were new ADRs not recorded in drug instructions; benefits or potential preventive and therapeutic effects of index drugs on certain diseases were found in 7 studies. Ten studies were conducted to explore ADR information of specific drugs or detect suspicious drugs that cause specific ADRs, and some correlation signals between drugs and ADRs that previously unknown were detected. Nine studies evaluated the prescribing cascades, including the use of antitussive drugs after ACEI, the prescribing cascades related to drug-induced lower urinary tract symptoms and edema, the prescription cascades of statins, and the prescribing cascade relic. Conclusion PSSA is a useful method for identifying potential prescribing cascades and mining ADR signals using medical prescription databases, especially suitable for the safety monitoring of long-term medication for chronic diseases and the signal detection of ADR that causal relationships are difficult to determine.
  • Yang Ruomeng, Wang Lifang, Du Wei, Jia Shouqian, Feng Rundong
    Adverse Drug Reactions Journal. 2025, 27(8): 486-494. https://doi.org/10.3760/cma.j.cn114015-20241125-00167
    Objective To analyze the safety of pigments and inks commonly used in food and drug packaging materials. Methods The acute oral toxicity, skin irritation, and eye irritation tests in 4 different batches of pigment samples (YP-001 to YP-008) and one kind of ink (YP-009) were investigated by animal experiments. Median lethal dose (LD50), body weight, and stimulation intensity were used as detection indicators. The test sample with LD50>5 000 mg/kg was judged as practically non-toxicity, the test sample with skin irritation intensity of 0-<0.50 points and eye irritation intensity of 0-3 points were judged as no irritation. Bacterial reverse mutation test, in vitro mammalian chromosome aberration test, and mammalian erythrocyte micronucleus test were carried out on oil paint (YP-007). The number of revertant colonies, chromosome aberration rate, and erythrocyte micronucleus rate were used as the detection indexes. If the number of revertant colonies in each dose group in the test sample was less than 2 times of that in the blank control group, the chromosome aberration rate and erythrocyte micronucleus rate were not statistically significant compared with the negative control group, the test sample was judged to be negative. Results The acute oral toxicity test showed that the weight of mice in different test groups was not reduced, and the LD50 was more than 5 000 mg/kg, so the samples were judged to be practically non-toxic, no irritation to skin and eyes of rabbits. The bacterial reverse mutation test showed that the results in 5 different dose groups and 5 repeated dose groups of oil paint test samples were all negative. The in vitro mammalian chromosome aberration test showed that the results in 3 dose groups of oil paint test samples (5.0, 2.5 and 1.25 mg/ml) were all negative. The mammalian erythrocyte micronucleus test showed that the results in 3 dose groups of oil paint test samples (10.0, 5.0 and 2.5 mg/kg) were all negative. Conclusions The test samples of 4 different batches of pigments and one kind of ink are practically non-toxic and free of skin and eye irritation. The oil paint (YP-007) has no genotoxicity and potential carcinogenicity in vivo and in vitro.
  • Gao Wenwen, Guo Lubo, Xie Yanjun, Zhang Qiuhong, Li Xia, Yin Yanhui
    Adverse Drug Reactions Journal. 2025, 27(8): 479-485. https://doi.org/10.3760/cma.j.cn114015-20240711-00553
    Objective To investigate the occurrence and characteristics of adverse reactions of Xuesaitong preparations, mine its coagulation disorders/bleeding risk signals, and provide references for its safe and rational use in clinic. Methods The reports of adverse drug reactions (ADR) caused by Xuesaitong preparations from August 2003 to August 2023 in the database of Shandong Provincial Center of Adverse Drug Reaction Monitoring were collected. ADR were counted and classified using the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities 26.1. Three methods, namely the reporting odds ratio (ROR), the proportional reporting ratio (PRR), and the comprehensive standard method of the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom, were used to detect the risk signals of coagulation disorders/bleeding in using Xuesaitong preparations. Results A total of 17 015 reports of ADR related to Xuesaitong preparations were collected, involving 9 dosage forms, in which injection dosage form accounted for 95.50% (16 250/17 015). The median age of the patients was 62 years, 44.87% of the cases were 45-64 years and 42.90% of them were 65 years and above. There were 2 217 cases of severe ADR reports, accounting for 13.03% (2 217/17 015). A total of 18 SOCs were involved, the top 3 were skin and subcutaneous tissue diseases, systemic diseases and drug administration site reactions, and neurological diseases. A total of 54 PTs were not recorded in the instructions, among which 34 were severe. Ninety-three cases about coagulation disorders/bleeding (98 times) were reported, the top 3 PTs were hematuria [24.49% (24/98)], purpura [11.22% (11/98)], and epistaxis [10.20% (10/98)]. Seven dosage forms of Xuesaitong preparations were involved, the top 3 were Xuesaitong for injection (freeze-dried) (48 cases, accounting for 51.61%), Xuesaitong injection (29 cases, accounting for 31.18%), and Xuesaitong tablets (8 cases, accounting for 8.60%). Among 93 reports of coagulation disorders/bleeding, there were 23 severe cases, accounting for 24.73%, which was significantly higher than that in other reports (12.97%), and the difference was statistically significant (P<0.001). Sixteen PTs about coagulation disorders/bleeding were not recorded in the instructions, among which 9 were severe. The proportion of cases with onset time longer than 7 days in ADRs about coagulation disorders/bleeding was higher than that in other ADRs [22.58%(21/93) vs. 7.43%(1 258/16 922), P<0.001]. The risk signals of coagulation disorders/bleeding were mined for Xuesaitong for injection (freeze-dried), Xuesaitong injection, Xuesaitong tablets, and Xuesaitong capsules, and the risk signal density of Xuesaitong tablets was the strongest. Conclusions The ADRs of Xuesaitong preparations involve multiple systems and organs. Among them, Xuesaitong for injection (freeze-dried), Xuesaitong injection, Xuesaitong tablets, and Xuesaitong capsules have a strong association with coagulation disorders/bleeding risks, and the proportion of severe cases is relatively high. However, the relevant risk warning information is not included in the drug instructions of some manufacturers. Medication monitoring needs to be strengthened and timely intervention should be carried out in clinic.
  • Zhao Jinxia, Xie Yanjun, Jing Shen′ao, Zhang Ying, Sun Nannan, Li Xia, Han Yi
    Adverse Drug Reactions Journal. 2025, 27(8): 472-478. https://doi.org/10.3760/cma.j.cn114015-20241122-00161
    Objective To detect adverse reaction risk signals of triazole antifungal agents and provide evidences for their safe use in clinic. Methods Adverse reaction/event reports with fluconazole, itraconazole, voriconazole, posaconazole, or isavuconazonium as the primary suspect drug were collected from the data in National Adverse Drug Reaction Monitoring System of China reported by Shandong Province from January 2004 to June 2024 and the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the second quarter of 2023. Adverse reaction/event terms were standardized using the preferred term (PT) and system organ class in Medical Dictionary for Regulatory Activities 24.0. Risk signals were detected using the reporting odds ratio (ROR) method and the Bayesian confidence propagation neural network (BCPNN) algorithm. A PT was defined as an adverse reaction risk signal if the number of reports was ≥3, the lower limit of the 95% confidence interval (CI) for ROR was >2, and the lower limit of the 95%CI for the information component (IC) was >0. Descriptive statistical analysis was performed. Results A total of 3 988 reports with the above 5 antifungal drugs as the primary suspect drug were collected from data in National Adverse Drug Reaction Monitoring System of China reported by Shandong Province, 822 (20.6%) of which were serious cases. Voriconazole, fluconazole, itraconazole, posaconazole, and isavuconazonium was the primary suspect drug in 1 852, 1 395, 703, 27, and 11 cases among the 3 988 reports, and in 591 (31.9%), 149 (10.7%), 59 (8.4%), 18 (66.7%), and 5 (5/11) serious cases among the 822 serious case reports, respectively. A total of 20 066 reports with the above 5 drugs as the primary suspect drug were collected in FAERS database, 9 635 (48.0%) of which were serious cases. Voriconazole, fluconazole, itraconazole, posaconazole, and isavuconazonium was the primary suspect drug in 7 758, 6 180, 2 869, 1 796, and 1 463 cases among the 20 066 reports, and in 4 295 (55.4%), 2 806 (45.4%), 1 191 (41.5%), 828 (46.1%), and 515 (35.2%) serious cases among the 9 635 serious case reports, respectively. Based on the data reported by Shandong Province and in FAERS database, 18 and 207 risk signals of  adverse reaction not mentioned in the labels were identified, respectively, and 5 of them were identified in both databases, including fluconazole-induced renal impairment and voriconazole-induced oliguria, delirium, psychiatric disorders, and rhabdomyolysis. In the data reported by Shandong Province and in FAERS database, 13 and 189 reports of muscle-related disorders (rhabdomyolysis, myopathy, and myositis) were identified respectively, involving voriconazole (in 8 and 62 cases), itraconazole (in 4 and 74 cases), and flucona- zole (in 1 and 53 cases). Conclusions Renal impairment induced by fluconazole and oliguria, delirium, psychiatric disorders, and rhabdomyolysis induced by voriconazole are risk signals of adverse reaction not mentioned in the labels for triazole antifungal agents. Voriconazole, itraconazole, and fluconazole may also cause muscle-related disorders, warranting vigilance in clinical practice.
  • Zhang Xiaotong, Liu Biqing, Xing Xiaoxuan, Wang Zhizhou, Wang Ke, Zhuang Wei, Zhang Lan, Dong Xianzhe
    Adverse Drug Reactions Journal. 2025, 27(8): 465-471. https://doi.org/10.3760/cma.j.cn114015-20240715-00576
    Objective To evaluate potentially inappropriate medication (PIM) in hospitalized elderly patients with bacterial pneumonia, and explore its influencing factors. Methods It was a singlecenter cross-sectional study. The study focused on elderly patients with bacterial pneumonia who were admitted to Xuanwu Hospital, Capital Medical University from January 2018 to November 2022. Patients′ gender, age, weight, length of hospital stay, diagnosis at admission, physical examination, diagnosis at discharge, comorbidities, medications, and laboratory test results were extracted from hospital information system and electronic medical records. Medication use of patients included in the analysis during their hospitalization were evaluated according to the classification of PIMs in the 5 lists of the Beer′s criteria of American Geriatrics Society. Based on whether PIM occurred, the patients were divided into with PIM group and without PIM group. The clinical features between the 2 groups were compared and the influencing factors of PIM were analyzed using multivariable logistic regression. Results A total of 2 720 patients were included, in which 1 734 (63.75%) were male. The median age was 78 (70, 85) years and their ages ranged from 65 to 103 years. The number of drugs used per patient was 14 (10, 18) kinds, ranging from 1 to 57 kinds. The length of hospital stay was 12 (9, 17) days, ranging from 1 to 162 days. Charlson comorbidity index (CCI) was 6 (5, 8) points. Among the 2 720 patients, 1 894 (69.63%) experienced PIM, with a total of 6 166 cases of PIM. The top 3 drugs ranked by the number of PIM occurrence were antiplatelet agents (1 357 cases), benzodiazapine receptor agonists (956 cases), and antipsychotics (884 cases). The comparison of clinical characteristics between the 2 groups showed that differences in age, CCI, length of hospital stay, and number of medications between with PIM and without PIM patients were statistically significant (all P<0.001). Multivariable logistic regression results showed that CCI, length of hospital stay, and number of medications were independent influencing factors for PIM. The risk increased by 8% and 1% with one point increase in CCI and one day extension in length of hospital stay [odds ratio (OR)=1.08, 95% confidence interval (CI): 1.04-1.13, P<0.001; OR=1.01, 95%CI: 1.00-1.03, P=0.03]. PIM risk of patients with more than 15 concurrent medications had a 22.16 times higher PIM risk than those with less than 5 concurrent medications (OR=22.16, 95%CI: 14.15-34.72, P<0.001). Conclusions Hospitalized eldery patients with bacterial pneumonia who have more severe comorbidities, longer hospital stay, and multiple concomitant medications are at a higher risk of PIM occurrence. Rational medication use among these patients should be paid attention to in clinical practice.
  • Gao Yunling, Lin Lanxin, Yang Qingming, Chen Xiaohong
    Adverse Drug Reactions Journal. 2025, 27(8): 458-464. https://doi.org/10.3760/cma.j.cn114015-20250417-00207
    Objective To investigate off-label drug use and the incidence of adverse events (AE) in patients with nontuberculous mycobacterial (NTM) pulmonary disease, and to provide reference in standardization of off-label drug use in this population. Methods The medical records of NTM pulmonary disease patients in our hospital from January to December 2024 were retrieved based on the presence of "nontuberculous mycobacteria" in the diagnosis. The demographic characteristics of patients (gender, age), underlying diseases, identified NTM species, details of off-label prescribing (clinical medication indications and the name, duration and frequency of drugs), and the AE occurrence were collected. The utilization rate, AE incidence, and off-label use rate of the anti-NTM drugs were calculated. Results A total of 259 patients with NTM pulmonary disease were included in the analysis, including 125 males and 134 females, aged (61±11) years with a range of 20-83 years; 243 patients (93.8%) were complicated with underlying diseases, 99 cases (38.2%) of which had 2 or more underlying diseases. Among the 259 patients, the top 3 pathogenic bacteria in the sputum and bronchoalveolar lavage fluid were Mycobacterium intracellulare (126 cases, 48.6%), Mycobacterium abscessus (50 cases, 19.3%), and Mycobacterium avium (30 cases, 11.6%); 16 patients (6.2%) were co-infected with 2 strains. All of the 259 patients were treated with a combination therapy of 4 drugs without discontinuation at least 1 year after the negative sputum culture. All 259 patients had off-label drug use, mainly including off-label indication [98.8%(256/259)] and prolonged treatment duration(100%). Among the 259 patients, 17 kinds of off-label drugs were involved, and the top 5 in terms of usage frequency were ethambutol (182 cases, 70.3%), amikacin (141 cases, 54.4%), azithromycin (140 cases, 54.1%), clari- thromycin (135 cases, 52.1%), and rifabutin (106 cases, 40.9%). The overall AE incidence was 37.5% (97/259), mainly including gastrointestinal reactions [17.4% (45/259)], skin pruritus [12.0% (31/259)], and abnormal liver function [9.7% (25/259)]. The incidences of severe AE and AE involving 2 or more systems were 5.0% (13/259) and 17.4% (45/259), respectively. Conclusions Off-label drug use is prevalent in patients with NTM pulmonary disease, mainly characterized by off-label indications and prolonged treatment duration. A variety of drugs are involved, among which ethambutol, amikacin, macrolides, and rifabutin are the most common. The types of AE reported are all common, mainly including gastrointestinal reactions, allergic reactions, and abnormal liver function, with a low proportion of severe AE. However, off-label use carries inherent risks, it is necessary to strengthen therapeutic drug monitoring and management during the treatment of NTM pulmonary disease.
  • Bai Xiangrong, Zhang Qingxia, Wang Yuqin, Jiang Ling, Ma Manling, Hai Xin, Huang Pinfang, Zhang Yi, Liu Taotao, Yan Suying, Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, Adverse Drug Reactions Journal Agency
    Adverse Drug Reactions Journal. 2025, 27(8): 449-457. https://doi.org/10.3760/cma.j.cn114015-20250522-00281
    In 2024, a total of 27 309 cases of medication error (ME) from 484 hospitals in 27 provincial administrative regions were collected in the National Monitoring Network for Clinical Safe Medication. Among them, 279 (1.02%) were classified as grade A, 22 081 (80.86%) as grade B, 4 268 (15.63%) as grade C, 472 (1.73%) as grade D, 96 (0.35%) as grade E, 105 (0.38%) as grade F, 6 (0.02%) as grade H, and 2 (<0.01%) as grade I; no MEs of grade G occurred. Among the 27 030 patients involved in MEs of grade B to I, 15 124 (55.95%) were male and 11 906 (44.05%) were female; their ages were from 1 day to 104 years; 3 369 (12.46%) were children (<18 years old), 12 113 (44.81%) were young and middle-aged adults (≥18 to <60 years old), and 11 548 (42.72%) were elderly (≥60 years old). The top 3 contents of ME were wrong drug class (5 347 cases, 19.13%), wrong dosage (4 913 cases, 17.58%), and wrong administration frequency (3 429 cases, 12.27%). Among the 27 030 grade B-I MEs, the main person who triggered the event were physicians (18 703 cases, 69.19%) and pharmacists (6 343 cases, 23.47%). These MEs mainly occurred in clinics (11 009 cases, 40.73%), in hospital wards (7 393 cases, 27.35%), and in pharmacies (6 219 cases, 23.27%). The main persons who discovered the MEs were pharmacists (21 021 cases, 74.14%). The top 3 factors causing ME were lack of related pharmacologic knowledge (8 716 cases, 26.49%), tiredness (5 755 cases, 17.49%), and inexperienced skills (4 505 cases, 13.69%). A total of 209 patients were involved in severe MEs (grade E-I), including 133 (63.64%) males and 76 (36.36%) females, aged from 21 months to 94 years, of which 42 (20.10%) were children, 75 (35.88%) were young and middle-aged adults, and 92 (44.02%) were elderly. The top 3 diseases diagnosed in severe MEs were drug poisoning (41 cases, 19.62%), diabetes (34 cases, 16.27%), and hypertension (14 cases, 6.70%); the main person who triggered the MEs were patients and their families (135 cases, 64.59%); the MEs occurred mainly in patients′ houses (116 cases, 55.50%). Drug poisoning was mainly related to accidental ingestion by children, and MEs in patients with diabetes and hypertension were often related to issues on patient compliance. Based on the data of MEs in 2024, it was proposed to establish a better medication safety culture and improve the ME reporting situation in China, pay attention to the risks of misusing external drugs for internal use, children′s accidental ingestion and insulin-related MEs, strengthen the prevention of MEs related to look-alike sound-alike drugs, pay attention to the post administration management and the compliance education of home care for patients with chronic diseases, so as to improve the medication safety of patients in China.
  • Wang Rongchun, Li Na, Tian Jia, Zeng Xiangbo
    Adverse Drug Reactions Journal. 2025, 27(7): 443-445. https://doi.org/10.3760/cma.j.cn114015-20240926-00062
    A 62-year-old female patient underwent medical thoracoscopic pleural biopsy for undiagnosed pleural effusion. Preoperative vital signs in the patient were stable, with no cardiovascular, cerebrovascular or neurological underlying diseases. During the procedure, midazolam 2 mg (0.045 mg/kg) and fentanyl 150 μg (3.3 μg/kg) were administered by intravenous injection for sedation and analgesia. Two minutes later, the patient developed respiratory depression, and her oxygen saturation decreased to 42%. Immediate jaw thrust maneuver followed by bag-valve-mask ventilation was initiated, and the spontaneous respiration resumed and oxygen saturation recovered (>90%) after 2 minutes, allowing successful biopsy of a pleural nodule. The patient was fully conscious in the immediate postoperative period, with normal ability of communication and mobility. However, at 6 hours postoperatively, she developed anterograde and retrograde amnesia, disorientation, sensation disorders, nausea, and retching. Cranial magnetic resonance imaging revealed no significant abnormalities. These symptoms were considered to be related to transient higher cortical dysfunction induced by the sedative and analgesic agents. Given supportive treatments including fluid administration, the symptoms were gradually improved at 8 hours postoperatively, and resolved completely by 11 hours postoperatively.
  • Deng Xu, Dai Yan, Li Tingting, Gao Yun, Dai Tiantian, Ge Mingqin, Wang Shilong
    Adverse Drug Reactions Journal. 2025, 27(7): 440-442. https://doi.org/10.3760/cma.j.cn114015-20240410-00240
    A 57-year-old female patient with small cell lung cancer was treated with serplulimab (100 mg by intravenous infusion on the first day, 21 days as a cycle). After the 10th cycle of treatment, the patient suddenly presented drowsiness, shortness of breath, dry mouth, nausea, vomiting, fatigue and other symptoms. Laboratory tests showed fasting blood glucose 38.9 mmol/L, glycosylated hemoglobin 7.9%, serum C peptide 0.2 μg/L, pH value 7.05, anion gap 31 mmol/L, anti-islet cell antibody 36 kU/L, anti-glutamic acid decarboxylase antibody 131 kU/L, urine ketone body (+++). The patient was diagnosed with fulminant type 1 diabetic ketoacidosis, which was considered to be related to serplulimab. The drug was stopped, and insulin, rehydration, correction of acid-base imbalance, and other treatments were given. After 3 days, the patient′s consciousness returned to normal. After 12 days, her breathing was stable, dry mouth, nausea, vomiting and other symptoms were relieved. Laboratory tests showed random blood glucose 13.6 mmol/L, pH value 7.44, anion gap 6 mmol/L, and urine ketone body negative. After 26 days, her random blood glucose was controlled at 10.0-12.0 mmol/L.
  • Zhang Tingting, Dang Xiaohong, Lei Caiqin, Wang Yan
    Adverse Drug Reactions Journal. 2025, 27(7): 438-440. https://doi.org/10.3760/cma.j.cn114015-20241010-00083
    A 57-year-old male patient with ulcerative colitis for more than 8 years was treated with mesalazine sustained-release granules 0.5 g thrice daily orally in the early stages of the disease, and the patient′s condition was improved. Chest CT scan showed no abnormalities in both lungs. The patient stopped taking the medication intermittently due to the remission of the condition over the course of 8 years, and due to the recurrence and worsening of symptoms, the dosage of mesalazine sustained-release granules was increased 3 times to 1 g orally, 4 times a day. At the first time, the patient experienced skin itching after taking increased dose of mesalazine for 2 days, which relieved after stopping the medication for 3 days. Afterwards, the dosage was reduced to 0.5 g thrice daily orally, and the patient′s skin itching did not recur. At the second time, the patient experienced skin itching on the trunk and limbs, chest tightness, and coughing 1 week after taking increased dose of mesalazine for 2 days, which relieved after stopping the medication for 2 days. At the third time, the patient experienced skin itching, chest tightness, and cough after taking increased dose of mesalazine for 1 day, which relieved after stopping the medication for 1 day. Laboratory tests showed no abnormalities in blood routine and C-reactive protein. High resolution CT scan of the chest revealed patchy ground glass opacities in both lungs, linear opacities in the lower lobes of both lungs, and cystic translucent opacities in the pleura of both lungs. Allergic pneumonia caused by mesalazine was considered.

  • Ma Jingyue, Zheng Xin, Wang Huiping
    Adverse Drug Reactions Journal. 2025, 27(7): 435-437. https://doi.org/10.3760/cma.j.cn114015-20240929-00066
    A 67-year-old female patient with erythrodermic psoriasis showed no significant improvement in rash after 2 weeks of treatments with acitretin, ebastine, etc., with the psoriasis area and severity index (PASI) score of 72 points (the highest value). Secukinumab 300 mg once a week was given by subcutaneous injection, which was changed to 300 mg once a month after 5 weeks of medication. After 5 weeks of treatment(medication 5 times), the patient′s PASI improvement rate was 75%, but the patient developed alopecia areata and her eyebrows fall off. After 6 months of treatment, the PASI improvement rate was 100%, but the patient developed alopecia totalis and her eyebrows completely disappeared. During the 9 month follow-up, the patient did not stop taking medication or received hair loss treatment. No psoriasis rash recurred and her hair loss was not improved.

  • Guo Aihua, Guo Ciren, Sun Yang
    Adverse Drug Reactions Journal. 2025, 27(7): 428-434. https://doi.org/10.3760/cma.j.cn114015-20241008-00079
     Immune checkpoint inhibitors (ICIs) have made great progress in the field of oncology, becoming one of the indispensable therapeutic approaches. However, the hyperprogressive disease (HPD) following treatment, observed in a few patients, has raised widespread clinical concern due to its association with rapid disease deterioration. Despite the extensive researches on HPD in recent years, its definition, underlying mechanisms, predictive methods, and management strategies remain unclear. The indications of ICIs in gynecologic cancer were approved relatively later, and there were few reports and studies on HPD after immunotherapy. This article reviews the incidence, influencing factors, mechanisms, differentiation from pseudoprogression, prevention and management of HPD caused by ICIs and its occurrence in gynecologic cancer, in order to promote the research on HPD after ICIs treatment in gynecological malignant tumors, and provide reference and help for the safe application of ICIs in gynecological malignant tumors.

  • Sun-Li Chaoyue, Man Chunxia, Yan Suying, Liu Hua, Wang Guanchun, Xie Qing
    Adverse Drug Reactions Journal. 2025, 27(7): 422-427. https://doi.org/10.3760/cma.j.cn114015-20240814-00719
    Objective To analyze the current situation and hotspots of medication literacy research at home and abroad, and provide references for medication literacy research in China. Methods The literature related to medication literacy in the Web of Science Core Collection Database, Scopus and China National Knowledge Infrastructure Database were retrieved (up to May 31, 2024). The CiteSpace software was used to analyze the number of published papers, countries, institutions, journals, authors and keywords, etc. Results A total of 604 literature were included (361 in Chinese and 243 in English). The litera- ture related to medication literacy were first seen in 2000, and the number grew slowly, which showed rapid growth after 2016, and reached a peak in 2023. The country with the largest number of published English literature was China (69 articles), followed by the United States (66 articles). The literature from the United States were cited 3 623 times, and those from China were cited 2 523 times. Central South University and the Third Xiangya Hospital of Central South University were tied for the first place in terms of the number of published articles as institutions (both 15 articles). The top 5 institutions in terms of the number of Chinese publications were Xiangya Third Hospital of Central South University, Central South University, Yanbian University, Affiliated Hospital of Yanbian University, and Tianjin Chest Hospital. The discipline with the largest number of published English literature was pharmacology/pharmacy (107 articles), followed by public environmental occupational health (88 articles) and general internal medicine (39 articles); the discipline with the largest number of Chinese published articles was clinical medicine (124 articles), followed by research on medical and health policies and regulations (56 articles), and medical education and marginal medical disciplines (34 articles). Keyword cluster analysis showed that the top 3 keywords in the English literature were medication errors, health education, and community pharmacy, while those in the Chinese literature were health literacy, self-management, and health education. Conclusions Research on medication literacy has rapidly developed in recent years. China and the United States are the main countries for research related to medication literacy. Health education and medication errors are the mainstream of the research. Future research can focus on personalized assessment and intervention measures of medication literacy, so as to develop high-quality assessment tools for medication literacy.

  • Lai Yanlan, Li Lianghao, Pan Min, Li Yufeng
    Adverse Drug Reactions Journal. 2025, 27(7): 415-421. https://doi.org/10.3760/cma.j.cn114015-20240830-00024
    Objective To systematically evaluate the risks of osteonecrosis of the jaw induced by bone-modifying agents (BMAs) in breast cancer patients with bone metastasis. Methods Randomized controlled trials (RCTs) of BMAs in the treatment of breast cancer bone metastasis, in which osteonecrosis of the jaw were evaluated as one of adverse outcome indicators, were collected by searching relevant databases at home and abroad (up to June 25, 2024). Cochrane risk of bias tool was used to evaluate the quality of the included studies. R software (version 4.2.3) was used to conduct Bayesian network meta-analysis, drawing the network evidence plot, the league map of pairwise comparison, and the surface under the cumulative ranking curve for the risks of osteonecrosis of the jaw induced by BMAs in breast cancer patients with bone metastasis, and ranking the risks of osteonecrosis of the jaw caused by different BMAs. The effect sizes of osteonecrosis of the jaw were expressed by hazard risk (HR) and its 95% confidence interval (CI). Results A total of 12 RCTs were included in the analysis, involving 26 047 patients. BMAs were used in 18 503 patients, including zoledronic acid (in 6 202 patients), ibandronate (in 4 817 patients), clodronate (in 3 897 patients), and denosumab (in 3 587 patients); 7 544 patients were treated with placebo or not be intervened.  Among 26 047 patients, 272 occurred osteonecrosis of the jaw. The incidence of osteonecrosis of the jaw was 1.44% (267/18 503) in BMA treated patients and 0.07% (5/7 544) in placebo/non-intervention patients, respectively. The results of the network meta-analysis showed that the HR (95%CI) of osteonecrosis of the jaw caused by denosumab, zoledronic acid, ibandronate and clodronate in breast cancer patients with bone metastases were 18.12 (10.03-35.75), 11.42 (6.03-22.86), 5.92 (2.78-13.22) and 2.73 (0.99-7.20), respectively, compared with the patients in the placebo or non-intervention group. Compared with zoledronic acid or denosumab, ibandronate and clodronate had lower risks of inducing osteonecrosis of the jaw. There was no statistically significant difference in the risk of inducing osteonecrosis of the jaw by denosumab and zoledronic acid. Conclusions Denosumab and zoledronic acid have a higher risk of inducing osteonecrosis of the jaw. Among BMAs, clodronate and ibandronate should be preferred in treatment of breast cancer patients with bone metastasis who have risk factors of osteonecrosis of the jaw.

  • Kang Ye, Li Yingrui, Zhang Xiao
    Adverse Drug Reactions Journal. 2025, 27(7): 409-414. https://doi.org/10.3760/cma.j.cn114015-20240831-00028
    Objective To mine the drugs that may cause capillary leak syndrome (CLS), and evaluate the risk of CLS, and provide reference for safe and rational use of drugs in clinic. Methods Adverse event (AE) reports with the preferred term "capillary leak syndrome" from the 1st quarter of 2004 to the 4th quarter of 2023 were collected by searching US Food and Drug Administration Adverse Event Reporting System (FEARS) database. Reporting odds radio (ROR) method and proportional reporting ratio (PRR) method were used to mine the AE risk signals. Drugs with report number ≥3, lower limit of the 95% confidence interval (CI) of ROR value >1, PRR ≥2, χ2 ≥4 were grouped and classified according to the Anatomical Therapeutic Chemical Classification (ATC) system. The top 20 drugs in ROR values were selected, and a risk assessment for drugs potentially causing CLS was performed by reviewing drug labels, adverse reaction datasets, and relevant literature. Results A total of 1 033 AE reports related to CLS were collected, involving 558 primary suspected drugs associated with CLS. The top 5 types of drugs that the most commonly causing CLS were antineoplastic and immunomodulating agents, systemic hormonal preparations, anti-infectives for systemic uses, cardiovascular system, and alimentary tract and metabolism. The risk assessment results showed that 13 drugs of the top 20 drugs in signal intensity (clofarabine, gemcitabine, interleukin-3, denileukin diftitox, dinutuximab, filgrastim, trabectedin, cytarabine, busulfan, docetaxel, trastuzumab, vildagliptin and melphalan) were high-risk drugs causing CLS, among which cytarabine, docetaxel, busulfan, trastuzumab, vildagliptin, and melphalan were not recorded to cause CLS in the labels. The other 7 drugs (asparaginase, fludarabine, amphotericin B, bosutinib, daunorubicin, ponatinib, and bleomycin) were low-risk drugs causing CLS. Conclusions Thirteen drugs are high-risk drugs that may cause CLS, among which cytarabine, docetaxel, busulfan, trastuzumab, vildagliptin and melphalan are not recorded causing CLS in the labels. It is suggested that clinicians and pharmacists should be vigilant against high-risk drugs, especially those not recorded causing CLS in the labels.

  • Liu Yuyan, Jiang Li, Lou Ran, Wang Meiping
    Adverse Drug Reactions Journal. 2025, 27(7): 403-408. https://doi.org/10.3760/cma.j.cn114015-20240701-00502
    Objective To evaluate the consistency of steady-state blood trough concentration of vancomycin and minimum inhibitory concentration to the area under the serum concentration-time curve (AUC/MIC) and promote the rational use of vancomycin. Methods It was a single center retrospective study. The clinical data of patients admitted to Xuanwu Hospital, Capital Medical University from January 1, 2019 to December 31, 2020, who were treated with vancomycin and met the inclusion criteria, were collected. Vancomycin calculator was used to calculate AUC/MIC. According to the steady-state blood trough concentration and AUC/MIC standards, the patients were divided into not meeting standard group, meeting standard group, and exceeding standard group, respectively. The standard-reaching status of steady-state blood trough concentration and AUC/MIC in each group was evaluated, as well as the consistency in patients under the 2 different grouping methods. The patients who met the AUC/MIC standard were divided into not meeting standard group, meeting standard group, and exceeding standard group based on steady-state blood trough concentration. The anti-infection efficacy and incidence of vancomycin-associated acute kidney injury (VA-AKI) were evaluated between the different groups to assess clinical effectiveness and safety. Results A total of 153 patients were included in the study. Among them, 98 (64.1%) patients were male, with age of 61.0 (53.0, 73.0) years, body mass index of 23.9 (21.5, 27.0) kg/m2, creatinine clearance rate of 107.2 (84.1, 147.0) ml/min, and acute physiology and chronic health evaluationⅡscore of 9.0 (6.0, 14.0) points. Among the 153 patients, the AUC/MIC and steady-state blood trough concentration did not meet standards in 86 cases, met the standards in 17 cases, and exceeded the upper limit of the standards in 14 cases; the results were consistent in 117 cases for both methods, and the consistency rate was 76.5%; the results were inconsistent in 36 patients (23.5%). Among the 36 patients, the steady-state blood trough concentration did not meet the standard in 34 cases [with initial steady-state blood trough concentration of 13.9 (12.8, 14.4) mg/L], while the AUC/MIC met the standard [437 (420, 471)]. AUC/MIC met the standard in 51 patients (33.3%), of which 34 had the steady-state blood trough concentration of less than 15.0 mg/L, and 17 had the concentration of 15.0-20.0 mg/L; the efficacy of anti-infection was 88.2% and 13/17, respectively, the incidence of VA-AKI was 2.9% and 1/17, respectively; the difference was not significant (all P>0.05). No patients had the steady-state blood trough concentration over than 20.0 mg/L. Conclusions The consistence between steady-state trough concentration of vancomycin and AUC/MIC is 76.5%, which is acceptable. For those who meet the AUC/MIC standard for vancomycin, even if the steady-state blood trough concentration is less than 15.0 mg/L, as long as the AUC/MIC meets the standard, the efficacy and safety can be guaranteed.