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目的:对中药制剂导致发生的613例严重不良反应(ADR)报告进行研究分析。方法:对2010年1月-2013年1月我省药品不良反应监测中心数据库收集的613例中药制剂致严重ADR资料进行分析,根据患者性别、年龄、用药剂型、ADR发生时间以及累及器官/系统等进行分析统计。结果:45岁以上的患者有387例,占63.1%;共包含60种中药制剂品种,前3位分别是清开灵注射剂、脉络宁注射剂以及双黄连注射剂;中药注射剂严重ADR主要累及器官/系统的前三种为呼吸系统、全身性系统以及皮肤及附件;314例好转,294例治愈,3例有后遗症,2例未好转。结论:中药制剂导致发生的不良反应具有普遍性特点,为降低其不良反应发生率,需要加强注射剂ADR监测,做好中药注射剂安全性的评价工作,有效防止不良反应重复发生。
Objective: To study the 613 cases of serious adverse reactions (ADRs) caused by traditional Chinese medicine preparations. Methods: According to the sex, age, dosage form, ADR occurrence time and organ / systemic involvement, 613 cases of TCM preparations collected from January 2010 to January 2013 in our hospital ADRM database were analyzed. Analysis and statistics. Results: A total of 387 patients (63.1%) were over the age of 45 with a total of 60 kinds of traditional Chinese medicine preparations. The top three were Qingkailing Injection, Mailuoning Injection and Shuanghuanglian Injection respectively. Serious ADR of TCM injection mainly involved organ / system The first three were respiratory system, systemic system and skin and accessories; 314 cases improved, 294 cases were cured, 3 cases had sequelae and 2 cases did not improve. Conclusion: The adverse reactions caused by traditional Chinese medicine preparations have universal characteristics. To reduce the incidence of adverse reactions, it is necessary to strengthen the monitoring of injection of ADR and evaluate the safety of traditional Chinese medicine injection to prevent the repeated occurrence of adverse reactions.