2025 Volume 27 Issue 8 Published: 28 August 2025
  

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  • Annual report of National Monitoring Network for Clinical Safe Medication (2024)
    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
    2025, 27(8): 449-457. https://doi.org/10.3760/cma.j.cn114015-20250522-00281
    Abstract ( ) PDF ( )
    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.
  • Investigation and safety analysis on off-label drug use in patients with nontuberculous mycobacterial pulmonary disease at a specialty hospital
    Gao Yunling, Lin Lanxin, Yang Qingming, Chen Xiaohong
    2025, 27(8): 458-464. https://doi.org/10.3760/cma.j.cn114015-20250417-00207
    Abstract ( ) PDF ( )
    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.
  • Study on occurrence and influencing factors of potentially inappropriate medication in hospitalized elderly patients with bacterial pneumonia
    Zhang Xiaotong, Liu Biqing, Xing Xiaoxuan, Wang Zhizhou, Wang Ke, Zhuang Wei, Zhang Lan, Dong Xianzhe
    2025, 27(8): 465-471. https://doi.org/10.3760/cma.j.cn114015-20240715-00576
    Abstract ( ) PDF ( )
    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.
  • Risk signal mining of adverse reactions to triazole antifungal drugs: a comparative study on domestic and foreign adverse drug reaction/event reports
    Zhao Jinxia, Xie Yanjun, Jing Shen′ao, Zhang Ying, Sun Nannan, Li Xia, Han Yi
    2025, 27(8): 472-478. https://doi.org/10.3760/cma.j.cn114015-20241122-00161
    Abstract ( ) PDF ( )
    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.
  • Analysis of adverse reaction reports on Xuesaitong （血塞通） preparations and mining of coagulation disorders/bleeding risk signals
    Gao Wenwen, Guo Lubo, Xie Yanjun, Zhang Qiuhong, Li Xia, Yin Yanhui
    2025, 27(8): 479-485. https://doi.org/10.3760/cma.j.cn114015-20240711-00553
    Abstract ( ) PDF ( )
    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.
  • Safety evaluation of food and drug packaging pigments
    Yang Ruomeng, Wang Lifang, Du Wei, Jia Shouqian, Feng Rundong
    2025, 27(8): 486-494. https://doi.org/10.3760/cma.j.cn114015-20241125-00167
    Abstract ( ) PDF ( )
    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.
  • Literature analysis on the application of prescription sequence symmetry analysis in pharmacovigilance
    Dou Wei, Liu Xin, Zuo Wei, Yu Jiaxin, Wu Jiayu, Zhang Bo
    2025, 27(8): 495-501. https://doi.org/10.3760/cma.j.cn114015-20241124-00164
    Abstract ( ) PDF ( ) Supplementary files
    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.
  • Minocycline-induced increased intracranial pressure in a child
    Peng Longxi, Li Zhengxiang, Yuan Hengjie
    2025, 27(8): 502-504. https://doi.org/10.3760/cma.j.cn114015-20241206-00185
    Abstract ( ) PDF ( )
    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.
  • Adalimumab-associated intracranial Neisseria meningitidis infection
    Guang Jiejie, Zhu Zhonghua
    2025, 27(8): 505-507. https://doi.org/10.3760/cma.j.cn 114015-20241015-00092
    Abstract ( ) PDF ( )
    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.
  • Erythema multiforme due to tislelizumab
    Zhang Jing, Zhang Xinyi
    2025, 27(8): 507-509. https://doi.org/10.3760/cma.j.cn114015-20240711-00539
    Abstract ( ) PDF ( )
    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.
  • Carbamazepine-associated hemophagocytic lymphohistiocytosis
    Chen Guoxiang, Feng Youfan, Hao Jianshu, Zhang Qike, Sun Yanqing
    2025, 27(8): 510-512. https://doi.org/10.3760/cma.j.cn114015-20241021-00103
    Abstract ( ) PDF ( )
    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.
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