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目的了解某市中药制剂不良反应/事件(ADR/ADE)的发生情况,分析其发生的因素,特点与规律,以期为临床合理用药提供参考。方法对某市不良反应中心提供的某市2006～2009年540例中药制剂ADR/ADE报告进行统计分析。结果 540例中药制剂ADR/ADE以中老年人发生率较高;涉及119种药物,以注射剂居多(77.4%),前四位的分别为双黄连注射液(7.78%),参芪扶正注射液(5.74%),丹参注射液、喜炎平注射液(各4.26%)参麦注射液、生脉注射液(各3.89%);ADR/ADE临床表现以皮肤及其附件损害,全身性损害居多。结论中药制剂的ADR/ADE以注射剂的发生率最高,与患者年龄,药品种类,剂型、给药途径等因素有关,应加强对中药制剂特别是中药注射剂(ADR/ADE)监测工作,促进临床合理用药。
Objective To understand the occurrence of ADR / ADE in a city and to analyze the factors, characteristics and rules of its occurrence in order to provide a reference for clinical rational drug use. Methods The ADR / ADE reports of 540 cases of traditional Chinese medicine from 2006 to 2009 provided by a city adverse reaction center were statistically analyzed. Results The incidence of ADR / ADE was higher in 540 cases of middle-aged and older people. 119 kinds of drugs were involved in the injection, which were mostly injections (77.4%). The top four were Shuanghuanglian injection (7.78%), Shenqi Fuzheng injection (5.74%), Salvia injection, Xiyanping injection (4.26% each), Shenmai injection and Shengmai injection (3.89% each) respectively. The clinical manifestations of ADR / ADE were the damage of the skin and its appendages and the majority of systemic injuries . Conclusion The incidence of ADR / ADE in Chinese medicine preparation is the highest, which is related to the patient’s age, drug type, dosage form, route of administration and other factors. It is necessary to strengthen the monitoring of traditional Chinese medicine preparations, especially Chinese traditional medicine injection (ADR / ADE) Medication.