【摘要】 目的回顾性分析鱼腥草制剂药品不良反应(ADR)高发期的权威数据,为我国上市后中药注射剂安全性再评价提供参考依据。方法采用描述性分析方法,依据国家ADR中心数据库收集的2006年—2008年鱼腥草注射液不良反应信息,对鱼腥草制剂上市后的安全性数据进行分析。结果在国家ADR中心数据库于2006年—2008年收集的2 282例鱼腥草制剂所致ADR病例中,由静脉给药所致ADR占总病例数的98.07%(2 238例);ADR的发作时间大多发生在30 min内;ADR发生例次计4 238例次,以变态反应为主,累及多个系统。呼吸困难等呼吸系统损伤症状出现频次最高(27.25%),其次为皮肤及黏膜损伤(21.35%)。严重不良反应发生率为7.27%(308例次),过敏性休克的发生率达8.37%(191例),过敏性休克致死亡22例。结论加强中药注射剂的药品不良反应报告和监测工作,以控制中药注射剂安全风险;做好安全性再评价工作,以全面提高中药注射剂的安全性、有效性和质量可控性。更多还原

【Abstract】 Objective To retrospectively analyze adverse drug reaction( ADR) of Yuxingcao( Houttuyniae Herba)preparations,thus provide reference for post-market re-evaluation of traditional Chinese medicine injections. Methods The ADR from Chinese ADR spontaneous reporting system database from 2006 to 2008 were analyzed by descriptive statistic method.Results A total of 2 282 reports on ADR induced by Yuxingcao preparations were concluded in this study,and 98.07% ADR of the total cases( 2 238 case) were due to vein injection. The main ADR were anaphylactic reactions which injure multiple systems and organs.The most frequent symptoms were respiratory system damage,such as expiratory dyspnea( with the incidence rate of 27.25%).Skin and mucous membrane were the secondly susceptible( with the incidence rate of 21. 35%). The ratio of serious ADR in the total case was 13.50%( 308 case),rate of allergic shock was 8.37%( 191 case),and 22 cases were dead.Conclusion By strengthening the ADR reporting and monitoring,the risk of traditional Chinese medicine injection could be controlled.Safety re-evaluation should be performed to overall enhance safety,effectiveness and quality control of these kinds of medicine.更多还原