基于真实世界数据的他汀类药品不良反应信号分析

doi:10.19803/j.1672-8629.20250823

摘要/Abstract

摘要： 目的挖掘和分析他汀类药品不良反应（Adverse Drug Reactions, ADR）信号,为临床合理用药提供参考。方法收集成都市药品检验研究院2011年1月1日至2024年12月31日期间7种他汀类药品的所有ADR报告,采用报告比值比法对患者基本信息、累及系统-器官分类、ADR信号检测结果等进行分析。结果 7种他汀类药品为怀疑药品的ADR报告共1 223例,涉及的男性患者多于女性,年龄主要集中在56~70岁。报告累及18个系统-器官,主要包括肝胆系统疾病、胃肠系统疾病、皮肤及皮下组织类疾病、各种肌肉骨骼及结缔组织疾病、各类神经系统疾病等。挖掘出阿托伐他汀21个ADR信号,主要表现为血肌酸磷酸激酶升高、横纹肌溶解、血肌红蛋白升高、肌痛、转氨酶升高等;挖掘出瑞舒伐他汀6个ADR信号,主要表现为血肌酸磷酸激酶升高、肌痛、转氨酶升高;挖掘出辛伐他汀12个ADR信号,主要表现为横纹肌溶解、血肌酸磷酸激酶升高、脱发、肝损伤、肌痛等;挖掘出普伐他汀1个ADR信号,为肝功能异常。氟伐他汀、洛伐他汀、匹伐他汀因收集到的报告数量较少,未检测到信号。多数他汀类药品共有的ADR信号分别为肝功能异常、血肌酸磷酸激酶升高、肌痛和腹部不适。结论他汀类药品在肝胆系统及肌肉系统ADR中均有信号生成且关联强度较高,重点需要关注横纹肌溶解及肝损伤等严重的ADR。高血糖症在阿托伐他汀中生成1个可疑ADR信号。反流、面肿、虚弱等未被药品说明书记载的可疑ADR信号也值得关注。临床上使用他汀类药品时,应定期监测胆红素、血肌酸磷酸激酶及血糖水平,尽早发现风险,及时调整药品,必要时进行基因筛查,保证临床合理用药。

关键词: 他汀类药品, 报告比值比法, 肝损伤, 横纹肌溶解, 高血糖症, 药品不良反应, 信号分析

Abstract: Objective To analyze the adverse drug reaction (ADR) signals of statins and to provide a reference for rational clinical use of drugs. Methods The ADR reports of seven statins received by the Database of Chengdu Institute for Drug Control in 2011-2024 were collected. The reporting odds ratio (ROR) method was used to analyze patients' basic information, system organ classes involved, and detection results of ADR signals. Results A total of 1223 ADR reports with statins as suspected drugs were retrieved, involving more male patients than female ones, and most of the patients range from 56 to 70 in age. These reports involved 18 system organ classes, including diseases of the hepatobiliary system, diseases of the gastrointestinal system, diseases of the skin and subcutaneous tissue, musculoskeletal and connective tissue diseases, andneurological diseases. Twenty-one ADR signals were identified for atorvastatin, manifested in elevated blood creatinekinase (CK), rhabdomyolysis, increased blood myoglobin, myalgia and increased transaminase. Six ADR signals were mined for rosuvastatin, manifested in elevated blood CK and transaminase, myalgia. Twelve ADR signals were detected for simvastatin, manifested in rhabdomyolysis, elevated blood CK, hair loss, liver injury and myalgia and one ADR signal was identified for pravastatin, manifested in abnormal liver function. ADR signals were not detected for fluvastatin, lovastatin or pitavastatin due to the small number of collected reports. ADR signals common to most of the statins were abnormal liver function, elevated blood CK, myalgia and abdominal discomfort. Conclusion Statins can generate ADR signals with strong correlation strength in both the hepatobiliary and muscular systems, so clinicians should be alert to severe ADRs such as rhabdomyolysis and liver injury. A suspected ADR signal of hyperglycemia is identified for atorvastatin. Additionally, several new ADR signals, including constipation, regurgitation, abdominal pain, facial edema and asthenia, also merit attention. Regular monitoring of bilirubin, blood CK and blood glucose levels is critical when statins are used clinically. Risks should be identified as early as possible. Medications have to be adjusted and genetic screening is conducted when necessary to ensure rational clinical use of drugs.

Key words: Statins, Reporting Odds Ratio, Liver Injury, Rhabdomyolysis, Hyperglycemia, Adverse Drug Reaction, Signal Analysis

中图分类号:

李兴桥, 马思佳. 基于真实世界数据的他汀类药品不良反应信号分析[J]. 中国药物警戒, 2026, 23(5): 558-563.

LI Xingqiao, MA Sijia. Signal Analysis of Adverse Drug Reactions of Statins Based on Real-World Data[J]. Chinese Journal of Pharmacovigilance, 2026, 23(5): 558-563.

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