636例中药注射剂不良反应报告分析

目的:了解汕头市中药注射剂不良反应(ADR)的发生情况,分析ADR发生的因素,特点,为临床合理使用中药注射剂提供参考。方法:对汕头市药品不良反应监测中心收集的2006～2011年636例中药注射剂ADR进行统计分析。结果:636例中药注射剂ADR以一般反应为主(92.46%),临床表现主要为皮疹、寒战、发热等过敏性反应,大部分ADR对原患疾病无明显影响,预后较好;发生ADR药品广泛,涉及51种药物。结论:中药注射剂ADR的临床表现多样,治疗及时预后较好,使用不规范可能是中药注射剂不良反应发生的原因之一,应加强中药注射剂临床使用监测,开展中药注射剂上市后再评价工作,进一步完善药品说明书,促进临床合理用药。

Analysis of 636 Cases of Adverse Reaction Reports of Traditional Chinese Medicine Injection

Objective：To understand the adverse drug reaction（ADR） of traditional Chinese medicine（TCM） injections in Shantou City,the factors,characteristics and rules that lead to ADR were studied and useful information was provided for the rational use of TCM injections.Methods：Statistical analysis were performed to the 636 cases of TCM injections ADR reports that collected from 2006 to 2011 by the center of ADR.Results：Four hundred and two cases（92.46%） out of the 636 TCM injections ADR reports were general responses with clinical manifestations of anaphylaxis including tetter,chill,fever and so on.Most of ADR have no obvious effect to the original illness.In this study,51 kinds of TCM injections showed ADR.Conclusion：The clinical manifestations of TCM injections ADR were various.If receiving treatment in time,ADR can be charmed off.One of the major reasons for ADR may be nonstandard use of TCM injection.To avoid ADR and promote the clinical rational use of TCM injection,monitoring of the clinical use and the reevaluation of TCM injections should be performed and the user menu should be further completed.