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目的:分析120例中药制剂不良反应报告的用药情况及特点,探讨中药制剂不良反应发生的相关因素。方法:采用回顾性分析方法,对新疆生产建设兵团药品不良反应监测中心2010年接收的621份药品不良反应报告中的120例中药制剂不良反应报告进行统计分析。结果:120例中药制剂不良反应报告中,共涉及中药制剂50种。主要ADR的临床表现为皮肤及附件损害。发生频率排在前10位均为中药注射剂。结论:重视中药制剂风险管理,加强中药制剂不良反应的监控力度,提高临床合理用药水平,保障患者用药安全。
Objective: To analyze the situation and characteristics of 120 cases of adverse reactions reported by traditional Chinese medicine preparations and to explore the related factors of adverse reactions of traditional Chinese medicine preparations. Methods: A retrospective analysis method was used to analyze the adverse reaction reports of 120 Chinese traditional medicine preparations in 621 adverse drug reaction reports received by Xinjiang Production and Construction Corps Drug Adverse Reaction Monitoring Center in 2010. Results: 120 cases of adverse reactions in Chinese medicine report, involving a total of 50 kinds of Chinese medicine preparations. The clinical manifestations of major ADR are skin and accessory damage. The frequency of occurrence of the top 10 are Chinese medicine injection. Conclusion: Pay attention to risk management of traditional Chinese medicine preparation, strengthen the monitoring of adverse reactions of traditional Chinese medicine preparations, improve clinical rational drug use and ensure the safety of patients.