2025 Volume 27 Issue 10 Published: 28 October 2025
  

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  • A randomized controlled clinical study on the prevention and treatment of adverse bleeding events caused by chemotherapy in patients with advanced lung cancer with Yiqi Yangxue Shengsui (益气养血生髓方) Formula
    Liao Yu, Liu Fangfang, Li Cheng, Yuan Surui, Liu Lingshuang
    2025, 27(10): 577-583. https://doi.org/10.3760/cma.j.cn114015-20241126-00169
    Abstract ( ) PDF ( )
    Objective To observe the clinical effect of the Yiqi Yangxue Shengsui Formula in the prevention and treatment of adverse bleeding events caused by platinum-based dual drugs combined with bevacizumab chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).　Methods A prospective, single-center, randomized controlled trial design was adopted. The research subjects were patients with stage Ⅲb-Ⅳb non-squamous NSCLC who were hospitalized at Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from December 2022 to March 2024. Patients who met the inclusion criteria were randomly assigned to the experimental group and the control group in a 1∶1 ratio. The control group received a platinum-based doublet regimen ［pemetrexed disodium for injection+cisplatin/carboplatin, or paclitaxel protein-bound for injection+cisplatin/carboplatin］ combined with bevacizumab for 4 courses of treatment; the experimental group was treated with the same regimen plus the traditional Chinese medicine Yiqi Yangxue Shengsui Formula, nourishing blood and generating bone marrow. The primary observation index was the incidence and grade of adverse bleeding events during the 4 courses of treatment. The secondary observation indices were the occurrence time and duration of bleeding, the grade of the lowest platelet count during treatment, the platelet count grade at the time of bleeding, and coagulation function indicators.　Results A total of 77 patients were included, with 39 in the experimental group and 38 in the control group. Among them, 29 were male (37.7%) and 48 were female (62.3%); 35 were aged 65 years or older and 42 were younger than 65 years. There were no statistically significant differences between the 2 groups in terms of gender, age, lung cancer stage, pathological type, and chemotherapy drug selection (P>0.05). The incidence of adverse bleeding events in the experimental group was significantly lower than that in the control group [17.9%(7/39) vs. 39.5%(15/38), P=0.037]. There was no statistically significant difference in the grading of adverse bleeding events between the 2 groups (P>0.05). The duration of bleeding in the experimental group was shorter than that in the control group ［(2.57±1.13) days vs. (5.67±1.80) days， P<0.001］. The minimum platelet count classification during the treatment period, and the platelet count classification at the time of bleeding in the experimental group were both better than those in the control group (P<0.05). The prothrombin time and international normalized ratio when bleeding occurred in the experimental group were both lower than those in the control group ［(10.96±0.39) s vs. (11.49±0.50) s and 0.97±0.04 vs. 1.02±0.06, P<0.05]. There were no statistically significant differences between the 2 groups of patients in terms of activated partial thromboplastin time, fibrinogen degradation products and D-dimer (P>0.05).　Conclusion The Yiqi Yangxue Shengsui formula can effectively prevent and treat bleeding adverse events related to platinum-based dual-drug chemotherapy combined with bevacizumab in patients with advanced NSCLC. The mechanism may be related to the increase of platelet count and the improvement of exogenous coagulation function indicators.
  • Analysis of clinical characteristics of adverse drug reactions of novel antineoplastic drugs in patients with HIV/AIDS: a case-control study
    Xue Xiaola, Xiao Lirong, Tian Chunyu, Yang Xuan
    2025, 27(10): 584-591. https://doi.org/10.3760/cma.j.cn114015-20241210-00195
    Abstract ( ) PDF ( )
    Objective To explore clinical characteristics of adverse drug reactions of novel antineoplastic drugs in patients with human immunodeficiency virus infection/acquired immunodeficiency syndrome(HIV/AIDS).　Methods The study was a retrospective case-control design. The subjects were selected from patients who used novel antineoplastic drugs in Henan Provincial Infectious Disease Hospital from January 1 to December 31, 2023. Clinical data of patients were collected through the hospital electronic medical record system. Adverse reactions of novel antineoplastic drugs were screened and the incidence was calculated. According to results of HIV antibody testing, adverse reaction incidence was compared between HIV antibody-negative and -positive patients. Then the patients with HIV/AIDS were divided into 2 groups according to whether adverse reactions occurred and the differences in clinical data between them were compared; the clinical manifestations, intervention and outcomes of adverse reactions were analyzed descriptively.　Results A total of 182 patients were enrolled in this study, the overall incidence rate of adverse reactions of novel antineoplastic drugs was 56.6% (103/182), and the incidences in HIV antibody-positive and -negative patients were 55.9% (76/136) and 58.7% (27/46), respectively, with no statistically significant difference (P>0.05). In patients with HIV/AIDS, the proportions of patients over 50 years old ［80.3% (61/76) vs. 63.3% (38/60)］, with a history of previous adverse reactions ［43.4% (33/76) vs. 23.3% (14/60)］, and with other comorbidities ［57.9% (44/76) vs. 40.0% (24/60)］ in the adverse reactions group were higher than those in the non-adverse reactions group, and the differences were all statistical significance (all P<0.05). No statistically significant differences were found in gender, CD4+ T lymphocyte levels, HIV viral load, antiretroviral treatment regimens, and tumor types between the 2 groups (all P>0.05). Adverse reactions occurred for 91 times in the 76 patients, 27 (29.7%) of which were grade 1, 45 (49.4%) were grade 2, and 19 (20.9%) were grade 3 or severer. According to clinical characteristics, there were 209 performances of adverse reactions in 76 patients, mainly including hand-foot syndrome, fatigue, hypertension, rash, etc., with the main affected system and organs being the skin and its appendages and the gastrointestinal system. The involved drugs mainly were anlotinib (44 cases, 21.0%), lenvatinib (29 cases, 13.9%), and bevacizumab (23 cases, 11.0%). After drug adjustments and symptomatic treatments, 80 times of adverse reactions were eventually improved, 4 were not, and 3 were with unknown information.　Conclusions The incidences of adverse reactions of novel antineoplastic drugs were similar between patients with and without HIV/AIDS. In HIV/AIDS patients with tumors, those over 50 years old, with other diseases, and with a history of adverse reactions might have higher risks of adverse reactions, which mainly involved the skin and its appendages and the gastrointestinal system, with a severity of mostly grade 1 to 2. With timely managements, the prognosis was favorable.
  • Correlation between erythropoiesis-stimulating agents and seizures: a study based on Mendelian randomization and the FAERS database
    Liang Cuilyu, Wang Peihong
    2025, 27(10): 592-599. https://doi.org/10.3760/cma.j.cn114015-20241021-00109
    Abstract ( ) PDF ( )
    Objective To explore the correlation between erythropoiesis-stimulating agents (ESAs) and seizures.　Methods Drug target Mendelian randomization (MR) and multivariate MR analysis were employed to evaluate the causal correlation between ESAs and seizures as well as status epilepticus. The data were sourced from published genome-wide association studies (GWAS) in the UK Biobank and Finland FinnGen databases. The instrumental variables were ESA-related single-nucleotide polymorphisms (SNPs) with F>10, the exposure factor was ESAs treatment, and outcome measures were seizures and status epilepticus. The methods of inverse variance weighted (IVW), weighted median estimator (WME) and MR-Egger regression were applied in the drug-target MR analysis, and the methods of IVW, MR-Egger regression and MR-LASSO were applied in the multivariate MR analysis. Adverse event reports from January 2004 to June 2024 in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database were collected. The signals of ESA-related seizures and status epilepticus were detected by reporting odds ratio (ROR) method and proportional reporting ratio (PRR) method.　Results A total of 15 SNPs were included in the MR analysis. Drug-target MR analysis showed that ESAs were significantly associated with the risk of seizures ［IVW odds ratio (OR)=1.575, 95% confidence interval (CI): 1.055-2.353, P=0.026］, but not associated with the risk of status epilepticus (OR=1.818, 95%CI: 0.403-8.207, P=0.437). Multivariate MR analysis showed that the above significant association was not found after correcting the risk factors of seizures such as stroke, pulmonary embolism, brain tumor, and dementia (OR=0.359, 95%CI: -0.014- 0.732, P=0.059). No risk signals of seizures and status epilepticus caused by 3 ESAs (recombinant human erythropoietin, darbepoetin alfa, methoxy polyethylene glycol-epoetin beta) were detected in FAERS database.　Conclusion ESAs may not lead to an increase in risk of seizures.
  • Rationality analysis of magnesium sulfate injection for obstetric inpatients
    Ju Kanglu, Liu Zhenguo, Niu Rui, Chen Hui, Chang Ying
    2025, 27(10): 600-604. https://doi.org/10.3760/cma.j.cn114015-20240711-00536
    Abstract ( ) PDF ( )
    Objective To understand the clinical application of magnesium sulfate injection in inpatients of the obstetrical department, and analyze retrospectively its rationality and existing problems.　　Methods The clinical data of obstetric inpatients who used magnesium sulfate injection in the hospital information system of our hospital from September 2022 to January 2023 were collected. Based on the drug instructions, guidelines for the diagnosis and treatment of hypertensive disorders in pregnancy, domestic and foreign guidelines, and literature reports, the rationality of magnesium sulfate injection in terms of obstetric medication indications, dosage and administration, and treatment course was evaluated.　Results A total of 303 obstetric patients were included in the use of magnesium sulfate injection, with an age of 32 (ranging from 18 to 44) years and a gestational age of 14 to 40 weeks. Among them, 33 cases were used for threatened abortion, 141 cases for threatened preterm birth, and 129 cases for the prevention of eclampsia attacks. Among the 303 patients, 134 cases (44.22%) had no indications for medication. Among them, 13 patients with threatened abortion were treated for fetal brain protection, and 20 patients with threatened abortion and 101 patients with threatened preterm birth were treated for preventing miscarriage by uterine contraction inhibition. There were 118 cases (38.94%) with inappropriate administration methods, mainly due to inappropriate usage and dosage, as well as overly long treatment courses. Of them, 26 cases (22.03%, 26/118) used for brain protectors of premature fetuses were not given loading doses, 15 (12.71%, 15/118) cases had a total medication duration of more than 48 hours, 76 cases (64.41%, 76/118) used for the prevention of eclampsia were not given loading dose, and 1 case （0.85%，1/118） received rapid infusion time of the loading dose more than 30 minutes. Among the 303 patients, 3 patients presented nausea and vomiting, constipation, and skin flushing, respectively.　Conclusions Nearly half of the magnesium sulfate injection used in obstetrics department in our hospital has inappropriate indications and over one-third has non-standard usage, dosage, and treatment courses. Clinicians should comprehensively assess the patient′s condition and strictly follow recommended methods in the guidelines and drug instructions for standardized use.
  • Standardization of terms for linezolid-related adverse reactions and database establishment based on ICD-10 code
    Qiu Shengnan, Li Hailong, Ma Wenwen, Jing Shen′ao, Li Chenghao, Huang Xin
    2025, 27(10): 605-612. https://doi.org/10.3760/cma.j.cn114015-20250126-00049
    Abstract ( ) PDF ( )
    Objective To establish a standardized code database of adverse drug reactions (ADRs) terms related to linezolid and analyze the common ADRs of linezolid.　Methods Linezolid drug labels, websites (including Side Effect Resource, and the official websites of US Food and Drug Administration, European Medicines Agency and National Medical Products Administration) and scientific literature database (including CNKI, Wanfang, VIP, PubMed, Embase and Web of Science databases) were systematically searched, and ADR terms about linezolid were collected. ADR terms were mapped to the international classification of diseases-10 (ICD-10) code to establish a linezolid adverse reaction database.　Results A total of 117 ADR terms about linezolid were collected and 91 ICD-10 codes were obtained after being mapped to ICD-10. A standardized database was constructed and successfully embedded into the ADR spontaneous reporting system as a specific drug submodule. The gastrointestinal system, skin and subcutaneous tissue system, various nervous systems, blood and lymphatic systems were the most common system organs involved in linezolid-related ADRs under the 91 ICD-10 codes. Among them, ADRs under the gastrointestinal system codes K14.302 (black hairy tongue) and K52.104 (drug-induced gastroenteritis and colitis), the skin and subcutaneous tissue system code L27.005 (drug-induced dermatitis), various nervous system codes G90.800 (other disorders of autonomic nervous system), G62.001 (drug-induced polyneuropathy) and G44.400 (drug-induced headache, not elsewhere classified), the blood and lymphatic system codes D69.502 (drug- induced thrombocytopenia) and D70.x02 (drug-induced granulocytopenia), the metabolic and nutritional codes E87.204 (lactic acidosis), as well as the endocrine system code E16.000 (drug-induced hypoglycaemia without coma) had been reported frequently in the scientific literature. In addition, there were 14 ADR terms related to linezolid under 13 ICD-10 codes not recorded in the drug instructions.　Conclusions It is feasible to use ICD-10 code to standardize ADR terms related to linezolid and establish a database. Common ADRs of linezolid include thrombocytopenia, lactic acidosis, neutropenia, black hairy tongue, gastroenteritis/colitis, hypoglycemia, rash, serotonin syndrome, peripheral neuropathy and headache, which should be paid attention to and researched furtherly.
  • Development of high-alert medication recommended list based on big data of medication error reports in China#br#
    Li Siyan, Wang Yuqin, Yan Suying, Qiu Yujie, Zhang Qiang, Zhang Qingxia, Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs
    2025, 27(10): 613-620. https://doi.org/10.3760/cma.j.cn114015-20241121-00160
    Abstract ( ) PDF ( )
    Objective To construct a recommended list of high-alert medication (HAM) based on big data from medication error (ME) reports in China, providing reference for preventing and reducing HAM-related risks.　Methods The drugs involved in the serious ME reports of the National Monitoring Network for Clinical Safe Medication (Monitoring Network) were collected (as of December 31, 2023), and the candidate drugs were preliminarily determined referring to the HAM list of China 2023 (Chinese list) and the latest three lists of American Institute for Safe Medication Practices (ISMP). Candidate drugs that were included in both the Chinese list and ISMP lists, as well as those existed in the Chinese list but had never been included in the ISMP lists were included in the current list, and their risk levels followed the original risks in the Chinese list. Candidate drugs that existed in the Chinese list but had been excluded from the ISMP lists, and those existed in the ISMP lists but had not been included in the Chinese list were listed as suspected drugs. For the other candidate drugs, those did not meet the definition of HAM were excluded firstly, and those related to ME that had caused serious harm were listed as suspected drugs, according to the judicial cases on ME of China Judgements Online and PKULAW database. Two methods, including Delphi expert consultation and questionnaire survey, were used to determine whether the above suspected drugs were included in the HAM list and their risk levels.　Results A total of 138 drugs were obtained through the initial screening, 106 of which were directly included in the current list, and 32 of which were listed as drugs requiring further assessment. After 2 rounds of Delphi expert consultation by 18 experts and surveys with 136 valid questionnaires, 32 suspected drugs did not meet the inclusion criteria. Finally, a total of 106 drugs were included in the current list, including 51 A-class drugs in 9 categories, 33 B-class drugs in 9 categories, and 22 C-class drugs in 5 categories.　Conclusion Based on the big data of the ME reports in China, a HAM list is constructed, which is accurate and concise and better fits the actual clinical drug risks in China, helping to improve the drug safety management.
  • Implementation of US FDA boxed warning in drug labels from 2019 to 2024 and comparison with relevant situations in China
    Zhang Yinan, Jiang Wenshuo, Zhang Xiao, Yan Yilong, Zhao Zhigang
    2025, 27(10): 621-628. https://doi.org/10.3760/cma.j.cn114015-20250114-00028
    Abstract ( ) PDF ( )
    Objective To investigate the implementation of boxed warning of drug labels in US Food and Drug Administration (FDA) from 2019 to 2024, and compared it with the relevant situations in China, in order to provide reference for the revision of drug labels and safe drug use.　Methods Data on boxed warning revisions in the US FDA "Drugs Safety Related Labeling Changes" Database from January 1, 2019 to December 31, 2024 were retrieved, and the revised contents were classified. The drug labels for newly marketed drugs in the United States during the same period were collected, the boxed warnings were recorded and summarized, and compared with the warning statements in drug labels of relevant drugs approved in China.　Results From 2019 to 2024, FDA revised boxed warnings in 209 drug labels. Among them, 22 items (10.53%) were newly added, 63 items (30.14%) were major updates, 115 items (55.02%) were minor updates, and 9 items (4.31%) were removed. A total of 293 new drugs were approved in the United States from 2019 to 2024, of which 69 (23.55%) had boxed warnings when they were approved, and 4 (1.37%) were added boxed warnings when they were revised in the labels. Up to December 31, 2024, 92 of the 293 new drugs had been approved in China. Compared with the labeling in the United States, some drugs lacked warning statements section in China, including zolpidem tartrate, dexzopiclone, zaleplon, montelukast sodium, denosumab, terlipressin, etc.　Conclusions The warning statements in some Chinese drug labels are inconsistent with the boxed warnings in the American drug labels. It is suggested that the revision of the boxed warning by US FDA should be regarded as one of the new sources of safety information to assess the risks of related drugs and determine whether it is necessary to revise the relevant drug labels in China.
  • Diabetes ketoacidosis and hypothyroidism caused by tislelizumab
    Zhou Zhongyan, Wang Kexin, Wang Yanfang, Shi Erxia
    2025, 27(10): 629-631. https://doi.org/10.3760/cma.j.cn114015-20241118-00153
    Abstract ( ) PDF ( )
    A 70-year-old male patient with T2N2M0 stage ⅢA lung squamous cell carcinoma was switched to monotherapy with tislelizumab (200 mg by intravenous infusion on day 1, 21 days as a cycle) after 5 cycles of chemotherapy with paclitaxel protein-bound and cisplatin, one cycle of combined chemotherapy and immunotherapy with tislelizumab, paclitaxel protein-bound and cisplatin. After 10 days of tislelizumab administration in the 4th cycle of monotherapy, the patient developed symptoms such as nausea, vomiting, abdominal pain, and abdominal distension. Laboratory tests showed fasting blood glucose of 26.3 mmol/L, glycated hemoglobin of 12.5%, fasting C-peptide<0.01 μg/L, free triiodothyronine of 3.31 pmol/L, free thyroxine of 4.9 pmol/L, and thyroid stimulating hormone of 49.4 mU/L, urinary ketones (++), and urinary glucose (++). Ketoacidosis and hypothyroidism were diagnosed, which was considered to be caused by tislelizumab. After 7 days of treatments with insulin, fluid replacement, potassium supplemen- tation, and maintenance of electrolytes and acid-base balance, the patient′s fasting blood glucose was 7.6 mmol/L. The hypoglycemic regimen was changed to subcutaneous injection insulin glargine (10 U in the morning) and insulin lispro (6 U before breakfast, 5 U before lunch and dinner), and levothyroxine sodium 100 μg once daily orally was given at the same time. Two weeks later, due to the condition, the patient received tislelizumab again once, and subsequently developed ketoacidosis 3 times. Tislelizumab was not used again thereafter. Follow-up once a month within 6 months showed no significant changes in the patient′s thyroid function compared to before. The patient continued to use insulin to control blood glucose.
  • Immune-related corneal ulcer caused by camrelizumab
    Zheng Yan, Chen Yufeng, Chen Xiaomin, Ke Min
    2025, 27(10): 632-634. https://doi.org/10.3760/cma.j.cn114015-20241216-00205
    Abstract ( ) PDF ( )
    A 57-year-old male patient with lung adenocarcinoma accompanied by brain metastasis received radiotherapy and chemotherapy with poor efficacy. Subsequently, he was given camrelizumab at a dose of 200 mg intravenously once every 21 days, combined with intermittent chemotherapy or targeted drug therapy. After 22 months, the patient developed right eye pain with visual loss. Slit lamp examination showed a transverse oval shallow ulcer with clear boundary, clean surface and a maximum diameter of about 6 mm in the center of the cornea of the right eye, with positive fluorescein staining. Immune-related corneal ulcers due to camrelizumab were considered. Camrelizumab was discontinued, and the patients′ ocular symptoms were gradually improved after systemic and local glucocorticoid and corneal repair drugs were given. Seven months later, due to the patient did not follow the doctor′s advice to replace eye drops, overuse of gluco- corticoid occurred, resulting in perforation of the original ulcer. The glucocorticoid-containing eye drops was discontinued, the patient underwent amniotic membrane grafting combined with amniotic membrane patching on the right eye, and the patient's condition was improved.
  • Sudden deafness induced by abrocitinib
    Huang Huiping, Huang Dayun, Chen Xiufen
    2025, 27(10): 635-637. https://doi.org/10.3760/cma.j.cn114015-20241204-00181
    Abstract ( ) PDF ( )
    A 66-year-old male patient received abrocitinib 100 mg once daily orally for atopic dermatitis. After 3 and a half months, the patient′s condition was significantly improved and the dose of abrocitinib was reduced to 100 mg once every 2 days orally. After 35 days of continuous medication, the patient developed a sense of stuffiness in both ears, occasional tinnitus, and hearing loss. According to specialized examinations in otolaryngology, the sudden deafness was diagnosed, which was considered to be related to abrocitinib. Abrocitinib was stopped. After 38 days of treatments with nurturing nerves, improving circulation, his hearing basically returned to normal. After that, dermatitis recurred in the patient, and he received abrocitinib 100 mg once daily orally again. One month later, the patient developed hearing loss again. After 9 days of drug withdrawal, the patient′s tinnitus and other symptoms were basically relieved. Subsequently, abrocitinib was placed by dupilumab to treat atopic dermatitis in the patient. At a six-month of follow-up, symptoms such as tinnitus and hearing loss did not recur.
  • Severe liver injury induced by mesalazine#br#
    Gao Hanyun, Zhang Junchao, Zheng Zhongjian
    2025, 27(10): 637-640. https://doi.org/10.3760/cma.j.cn114015-20241021-00108
    Abstract ( ) PDF ( )
    A 38-year-old male patient with ulcerative colitis was treated with mesalazine enteric- coated tablets 2 g twice daily, and developed pruritus, dark urine and jaundice approximately 8 months later. Laboratory tests revealed severe liver function abnormalities, showing alanine aminotransferase (ALT) 1 251 U/L, aspartate aminotransferase (AST) 1 102 U/L, γ-glutamyl transferase (GGT) 615 U/L, alkaline phosphatase (ALP) 715 U/L, total bile acid (TBA) 244.72 μmol/L, total bilirubin (TBil) 456.9 μmol/L, direct bilirubin (DBil) 350.6 μmol/L and indirect bilirubin (IBil) 106.3 μmol/L. Abdominal CT showed no significant abnormalities. Mesalazine was discontinued, and hepatoprotective therapy was initiated with magnesium isoglycyrrhizinate, ademetionine 1,4 butanedisulfonate, acetylcysteine, and ursodeoxycholic acid. Viral hepatitis, Wilson′s disease, and hemochromatosis were ruled out in further investigations and liver biopsy. Severe drug-induced liver injury (DILI) caused by mesalazine was suspected, but autoimmune hepatitis (AIH) could not be entirely excluded. The hepatoprotective treatments were continued, and the patient′s liver function was improved significantly, showing ALT 48 U/L, AST 35 U/L, GGT 144 U/L, ALP 202 U/L, TBA 24.72 μmol/L, TBil 71.8 μmol/L, DBil 62.3 μmol/L and IBil 9.5 μmol/L by day 24 of treat- ments. Later, he was treated only with ursodeoxycholic acid and bicyclol. The patient′s liver function normalized approximately one and a half months later. However, the patient self-reinitiated mesalazine several days thereafter, and the liver function tests showed ALT 155 U/L and AST 80 U/L after about 2 months of resumed use. Mesalazine was discontinued again, and his liver function returned to normal within 1 week with supportive treatments. AIH was excluded, DILI induced by mesalazine was considered at last.
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