中药不良反应监测管理分析

An analysis of adverse reactions management of TCM preparations

目的：探讨中医制剂在临床应用中所产生的不良反应,从而为合理用药提供参考依据。方法：对2012年7月-2014年6月我院发生的260例中药制剂不良反应病例报告进行统计分析,了解患者的性别、年龄、损害部位和临床症状表现、中药制剂剂型、给药途径等情况,计算出各项参数的不良反应例数及所占比例。结果：出现不良反应的患者集中在71岁以上（26.9%）、61~70岁（22.7%）、51~60岁（21.2%）;不良反应主要损害的部位是皮肤（73.8%）和消化系统（10.8%）;发生不良反应的剂型主要是注射剂（67.3%）和外用膏剂（13.8%）;给药途径主要是静脉注射（64.6%）和局部外用（23.1%）。结论：中药制剂在治疗疾病的同时,也存在一定的不良反应。应该根据不良反应的高发年龄段、损害部位、制剂类型、给药途径等,制定科学合理的用药管理制度,密切监测不良反应的发生,提高防范意识,从而增加临床用药安全性。

Objective： To investigate adverse reactions of TCM preparations, in order to provide reference for rational medicine application. Methods： 260 cases of adverse reactions caused by the TCM preparations from July 2012 to June 2014 were analyzed. Patients’ sex, age, lesion, clinical symptoms, TCM preparations dosage and route of administration were realized. The time of adverse reactions was calculated. The proportion of adverse reactions was calculated, too. Results： Adverse reactions occurred mainly in following patients： 71 years old （26.9%）, 61~70 years old （22.7%）, 51~60 years old （21.2%）. Affected by adverse reactions, skin （73.8%） and digestive system （10.8%） were damaged. Injections （67.3%） and topical ointment （13.8%） may resulted in adverse reactions. The main route of administration was intravenous injection （64.6%） and external application （23.1%）. Conclusion： Sometimes, TCM preparations might come with some adverse reactions. Based on the high incidence age, lesion, type of formulation, route of administration, etc., scientific and rational drug management system should be developed to closely monitor for the adverse reactions.