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目的了解中药注射剂不良反应(ADR)的发生特点和一般规律。方法对石家庄市第三医院2014年1月至2014年11月上报国家药品不良反应监测中心的63例ADR报告,从患者性别、年龄、不良反应史、联合用药的情况、药品种类及数量、累及器官/系统、ADR发生的时间、给药途径、ADR的关联性分析及预后等进行统计分析。结果 63例ADR病例中有60例用静脉给药,以中老年患者(≥40岁)居多。不良反应临床表现以皮疹、瘙痒多见,其次为消化系统症状。63例ADR报告中共涉及7类15个品种,多为活血化瘀与清热解毒类药物。结论中药注射剂已广泛应用于临床,其不良反应也较常见,应给予足够重视,加强合理用药管理,确保患者用药安全。
Objective To understand the characteristics and general rules of adverse drug reaction (ADR) in Chinese medicine. Methods Sixty-three ADR cases reported by the Third Affiliated Hospital of Shijiazhuang City from January 2014 to November 2014 in National Adverse Drug Reaction Monitoring Center were analyzed, including gender, age, history of adverse reactions, combination therapy, types and quantities of drugs Organ / system, time of occurrence of ADR, route of administration, correlation analysis of ADR and prognosis were statistically analyzed. Results Sixty of 63 ADR cases were given intravenously, most of them were middle-aged and elderly (≥40 years old). Adverse reactions to the clinical manifestations of rash, itching more common, followed by digestive symptoms. 63 cases of ADR report involved a total of seven categories of 15 varieties, mostly blood circulation and heat detoxification drugs. Conclusion Traditional Chinese medicine injection has been widely used in clinical practice, its adverse reactions are more common, should pay enough attention to strengthen the rational use of drug management to ensure the safety of patients medication.