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目的:分析孝感市上报的新的/严重药品不良反应(ADR)的特点,为ADR监测工作和安全用药提供参考。方法:收集国家ADR监测系统中2011~2015年孝感市上报的新的/严重ADR报告1 463例,对ADR患者情况,怀疑药品种类及给药途经,ADR发生时间、累及器官及临床表现,严重不良反应发生的特点等进行统计分析。结果:抗感染药物的ADR比例最高,其次是中药注射剂;静脉滴注给药所致ADR最多;用药2 h内发生ADR 1 088例(74.37%)。新的一般病例以皮肤及其附件损害、胃肠系统损害和全身性损害为主;严重病例以全身性损害、皮肤及其附件损害和中枢及外周神经系统损害为主。新的/严重ADR中发生频率较高的药品为香丹注射液、参麦注射液、左氧氟沙星、头孢曲松、头孢呋辛等。结论:抗感染药物和中药注射剂是新的/严重ADR发生的主要药品,过敏反应是常见的严重ADR,高警示药品的ADR后果严重,在ADR监测要重点关注,尽可能减少ADR的风险。
Objective: To analyze the characteristics of new / serious drug adverse reactions (ADRs) reported by Xiaogan City and provide reference for ADR monitoring and safe drug use. Methods: A total of 1 463 cases of new / severe ADR reported by Xiaogan City from 2011 to 2015 in national ADR monitoring system were collected. The data of ADR patients, the types of drugs and the route of drug administration, the time of occurrence of ADR, organ and clinical manifestations, The characteristics of adverse reactions such as statistical analysis. Results: The highest proportion of ADR was antiinfective drug, followed by Chinese medicine injection. The most ADR was caused by intravenous drip infusion. ADR was found in 088 cases (74.37%) within 2 h. The new general case is characterized by damage to the skin and its appendages, gastrointestinal and systemic injuries, and severe cases with generalized lesions, damage to the skin and its accessories, and damage to the central and peripheral nervous systems. New / serious ADR occurred in higher frequency drugs Xiangdan injection, Shenmai injection, levofloxacin, ceftriaxone, cefuroxime and so on. Conclusion: Anti-infectives and Chinese medicine injections are the main drugs for new / severe ADR. Allergic reactions are common serious ADRs. High-alert drugs have serious ADR consequences. The focus of ADR monitoring should be to minimize the risk of ADR.