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目的:分析深圳地区2009年中药制剂不良反应(ADRs)报告,提出解决问题的对策,促进中药制剂的合理应用。方法:筛选出973份中药制剂ADRs报告,分别从患者年龄、性别、给药途径、临床表现、药品种类等方面进行统计分析。结果:中青年(19~39岁)ADRs发生率较高;女性患者ADRs发生率明显高于男性。发生ADRs的给药途径主要为口服和静脉注射,ADRs涉及的中药制剂共341个品种,其中口服制剂66种(19.35%),其次为注射剂。ADRs主要表现为皮肤及其附件损害(35.74%)。结论:应加强对口服和注射类中药制剂ADRs的监测以保障患者用药安全。
OBJECTIVE: To analyze the report of adverse drug reaction (ADRs) in 2009 in Shenzhen area and put forward the countermeasures to solve the problem so as to promote the rational application of TCM preparations. Methods: 973 samples of ADRs from Chinese traditional medicine were screened out and analyzed statistically in terms of patient’s age, sex, route of administration, clinical manifestation and type of drug. Results: The incidence of ADRs in middle-aged and young people (19-39 years old) was high. The incidence of ADRs in female patients was significantly higher than that in men. The main route of administration of ADRs was oral and intravenous injection. There were 341 Chinese herbal preparations involved in ADRs, of which 66 were oral preparations (19.35%), followed by injection. ADRs mainly manifested damage to the skin and its accessories (35.74%). Conclusion: Monitoring of ADRs in oral and injectable TCM preparations should be strengthened to ensure the safety of patients.