中药注射剂218例不良反应回顾性分析

Retrospective Analysis of Chinese Medicine Injection Adverse Reaction Involving 218 Cases

目的分析医院中药注射剂不良反应的发生情况,促进临床合理用药。方法收集2003年12月至2009年12月发生的中药注射剂不良反应发生病例,对其进行回顾性分析。结果共有218例由中药注射剂引起的不良反应,其中寒战、发热、皮疹等症状比较常见,新的不良反应达39.91%,参麦注射液和清开灵注射液是不良反应发生较多的药物,大部分药物不良反应对原患疾病的病情无明显影响,但未能找到发生严重不良反应的危险因素。结论中药注射剂不良反应的临床表现多样,新的不良反应较多;应关注常用中药注射剂的不良反应;使用不规范可能是中药注射剂不良反应发生的原因之一,建议对使用说明书作进一步的修改和完善。

Objective To investigate the adverse reaction of Chinese medicine injection in Guangdong Provincial Hos- pital of Traditional Chinese Medicine. Methods we retrospectively investigated the adverse reaction of Chinese medicine injection from December, 2003 to December, 2009. Results 218 cases were involved in adverse drug reactions （ADRs）. Chilling, fever, and skin rash were commonly manifestations, and the incidence of new ADRs accounted for 39.91%. Shenmai Injection and Qingkailing Injection had the higher incidence of ADRs. Most ADRs had less influence on original diseases. We failed in finding the risk factors of serious ADRs. Conclusion Drug adverse reaetion of Chinese medicine injection are varied, and new ADRs show high incidence. Therefore, the clinicians should pay more attention to the ADRs of commonly-used Chinese medicine injection, and further modification and improvement should be made for the instruction of Chinese medicine injection in order to reduce the nonstandard usage.