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121例严重药品不良反应/事件报告分析

Analysis on 121 Cases of Serious ADR/ADE Reports
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摘要 目的:探讨严重的药品不良反应/事件(ADR/ADE)发生的特点、一般规律,为促进临床用药安全提供依据。方法:对湘西自治州2011年上报的121例严重的ADR报表,进行统计分析。结果:女性患者及老年患者严重的ADR/ADE发生率较高;静脉滴注引起的严重的ADR/ADE明显高于其他给药途经;在涉及的所有药物中,抗感染药品比例较大,中药剂型以中药注射剂比例最大;严重的ADR/ADE累及系统-器官以全身性、呼吸、皮肤损害较多。结论:严重的ADR/ADE发生因素包括患者年龄、性别、药品种类、给药途经等,应加强抗感染药、中药注射剂的临床用药监测,确保临床用药安全有效。 Objective:To study the characteristics of the serious adverse drug reaction/event(ADR/ADE) for promoting clinical safe administration.Methods:121 cases of serious ADR reports of Xiangxi Autonomous Prefecture reported in 2011 were statistical analyzed.Results:Most serious ADR /ADE cases are female and aged.Intravenous infusion is the main way for administration,and most cases induced by anti-infective drugs.Chinese native medicine injection has the maximum ratio of serious ADR /ADE in Chinese native medicine.The main types of serious ADR /ADE are systemic damage,respiratory system injury,and skin lesion.Conclusion:The factors induced serious ADR /ADE include age,sex,drugs type,administration route and so on.The cases prompted that clinicians and clinical pharmacists should pay attention to the adverse reactions monitoring in anti-infective drugs and traditional Chinese medicine injection.Moreover,they should carefully monitor the impact of drugs on the system-organ,in order to promote clinical curative efficacy and reduce adverse drug reaction /event.
出处 《中国药物评价》 2012年第5期351-353,359,共4页 Chinese Journal of Drug Evaluation
关键词 严重药品不良反应/事件 报告分析 Serious ADR/ADE Report analysis
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