何首乌及其常用制剂相关不良反应文献研究及风险因素分析  

Literature Study on Adverse Drug Reactions and Analysis of Risk Factors of Polygonum multiflorum Thunb. and its Common Preparations

作　　者：于洪礼 于冬梅 宋海波[1] 任经天[1] YU Hongli;YU Dongmei;SONG Haibo;REN Jingtian(Center for Drug Reevaluation,CFDA,Beijing100045,China;Center for Health Food Review,CFDA,Beijing 100070,China)

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045 [2]国家食品药品监督管理总局保健食品审评中心,北京100070

出　　处：《中国药物警戒》2018年第8期470-475,共6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

摘　　要：目的探究何首乌及其常用制剂不良反应发生规律和特点,分析其风险因素,以期为其临床用药安全提供参考。方法检索涉及何首乌及其常用制剂不良反应的相关文献资料,分析其不良反应特点及风险因素。结果共纳入69例个例;不良反应发生在用药后10天至1个月的较多;累及系统-器官以肝胆系统损害最多,其次为胃肠系统损害;主要临床表现为巩膜及皮肤黄染、转氨酶升高、胆红素升高、尿黄等;多数不良反应停药或对症结合药物治疗后恢复正常。结论何首乌及其常用制剂的不良反应累及系统-器官主要为肝胆系统和胃肠系统损害,且停药或结合药物治疗后转归情况较好,但仍需开展深入研究,同时加强监管,确保用药安全。Objective To investigate the general characteristics of adverse drug reaction（ADR） induced by Polygonum multiflorum Thunb. and its common preparations, and analyze their risk factors, so as to provide reference for rational drug use in clinic. Methods The cases of ADR reduced by Polygonum multiflorum Thunb. and its common preparations were retrieved, to analyze the characteristics of ADRs and risk factors. Results In 69 cases included, most of ADR occurred in ten days to one month after treatment. The mainly involved system-organ was hepatobiliary disorders,followed by gastrointestinal disorders. The main clinical manifestations were icteric sclera and skin coloring yellow,ALT and AST increased, TBi L and DBi L increased, urinary coloring yellow, etc. Most patients could recover better after drug withdrawal or symptomatic treatment. Conclusion The mainly involved system-organ was hepatobiliary disorders and gastrointestinal disorders. And the clinical outcomes of patients were better. However, further research is still needed, while strengthening regulation to ensure the rational drug use.

关 键 词：何首乌 不良反应 文献分析 风险因素 

分 类 号：R994.11[医药卫生—毒理学]