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目的:分析参麦注射液不良反应发生的基本情况,为临床药品不良反应监测及合理用药提供参考。方法:对166份参麦注射液不良反应/事件报告有关数据进行统计、分析。结果:ADR累及的系统器官主要为皮肤及其附件损害(32.34%)、呼吸系统损害(19.14%)、心血管系统损害(18.48%)、全身性损害(13.86%);由静脉给药途径所致;严重的报告比例高(28.31%)。结论:参麦注射液导致ADR/ADE原因涉及药品使用、生产等多种因素,建议临床要根据中医辨证进行论治,生产企业应提高参麦注射液生产工艺和质量标准、加强说明书安全性标识信息,加强不良反应监测,降低不良反应/事件发生。
Objective: To analyze the basic situation of adverse reactions of Shenmai injection and provide references for monitoring adverse drug reactions and rational drug use. Methods: 166 cases of Shenmai injection adverse reactions / events reported data were statistically analyzed. Results: The systemic organs affected by ADR were 32.34% of the skin and its appendages, respiratory system damage (19.14%), cardiovascular system damage (18.48%) and systemic injury (13.86%), To; serious report a high proportion (28.31%). Conclusion: The causes of ADR / ADE caused by Shenmai injection are related to the factors of drug use and production. It is suggested that clinical treatment should be based on syndrome differentiation of traditional Chinese medicine. The manufacturer should increase the production technology and quality standard of Shenmai injection and strengthen the safety labeling Information, strengthen adverse reaction monitoring, reduce adverse reactions / events.