骨康胶囊肝损伤风险特点及因素分析  

Characteristics and Risk Factors Analysis of Liver Injury induced by Gukang Capsule

作　　者：朱兰 逄瑜[1] 杨乐[1] 胡银燕 ZHU Lan;PANG Yu;YANG Le;HU Jin-yan(Center for Drug Reevaluation,CFDA,Beijing 10020, China;Beijing Clinical Medicines Institute, Beijing 100035, Chin)

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100020 [2]北京市卫生局临床药学研究所,北京100035

出　　处：《中国药物警戒》2018年第4期248-250,256,共4页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项(2015ZX09501004-001-001):基于SRS系统的动态、长效中药风险信号早期发现研究;国家中医药管理局中医药行业科研专项(201507004-4-2):基于流行病学调查的何首乌肝损伤人群特征研究

摘　　要：目的研究骨康胶囊致肝损伤的特点及风险因素,为骨康胶囊临床合理用药提供参考。方法梳理骨康胶囊致肝损伤的个案、群案文献报道,以及上市后不良反应监测数据文献报道,对文献中的相关病例进行分析;此外,进一步分析骨康胶囊所含补骨脂以及同类药物肝损伤风险特点,分析骨康胶囊肝损伤风险特点及因素。结果骨康胶囊主要严重不良反应为肝损伤,该风险主要与方中补骨脂有关,长时间用药、老年患者用药、既往存在肝脏疾病可能是服用骨康胶囊后引起肝损伤的易感因素。结论关注骨康胶囊肝损伤及风险因素,为临床合理用药提供参考。同时,药品生产企业应进一步加强药物警戒及风险管理,保障患者用药安全。Objective To investigate the characteristics and risk factors of liver injury induced by Gukang capsule, provide technical support for safe and rational use of drugs in clinic. Methods References and reports of liver injury caused by Gukang capsules were summarized and adverse drug reaction monitoring data was collected, and relevant cases were reviewed.The characteristics and causes were also analyzed through studying the potential risk of psoraleae fructus or drugs in the same class in Gukang capsule. Results Liver injury, being the main serious adverse reaction of Gukang capsule,was related to psoraleae fructus. The risk factors may include long-term usage, aged patients, previous history of hepatitis etc. Conclusion The risk of liver injury should be paid attention to. Reference is provided to the clinical usage of Gukang capsule. The drug manufacturers should strengthen pharmacovigilance and risk management to ensure drug safety.

关 键 词：骨康胶囊 补骨脂 肝损伤 

分 类 号：R994.11[医药卫生—毒理学]