2012年浙江省疑似药品不良反应死亡病例报告分析

Analysis of suspected deaths from adverse drug reactions in Zhejiang province in 2012

目的:分析药品在使用过程中可能导致患者死亡的主要特点和一般规律,为临床安全、合理用药提供参考。方法:对2012年浙江省药品不良反应监测中心收到的23例疑似药品不良反应死亡病例报告进行统计与分析。结果:抗感染药物引起的疑似死亡病例最为多见(25.35%);给药途径以静脉滴注所占比例最大(71.83%);超过半数病例在用药后2 h内出现不良反应症状(78.30%);患者死因中,因过敏样反应和过敏性休克导致死亡最为多见(47.80%),其次为循环系统损伤、呼吸系统损伤致死等。结论:导致药品严重不良反应甚至死亡的主要因素可能为抗感染药物或静脉滴注给药方式的广泛应用,临床不合理用药和药品质量的良莠不齐等。应加强临床合理用药,提高药品质量控制水平。

Objective： To investigate the features and general pattern of suspected deaths caused by drug uses for providing references of clinically rational and safe use of drugs. Methods ： A total of 23 deaths collected in Zhejiang center for ADR monitoring in 2012 were analyzed retrospectively. Results： A total of 71 drugs were in- volved in the 23 deaths, among which the main type was anti-infective drugs （25.35%）. The main route of admin- istration was by intravenous drip （71.83%）. More than half of the deaths appeared symptoms of adverse reactions within 2 hours after using the drugs. Death resulted from allergic-like reactions and anaphylactic shock was the most common （47.80%） , followed by circulatory system damage and respiratory injury. Conclusion： ADR monitoring and reporting should be strengthened to ensure clinically safe, effective and rational drug use. The drug-related sus- pected deaths are mainly induced by the popular use of anti-infective drugs, and intravenous use of the drugs. Be- cause of existing unreasonable drug use and uneven qualities of drugs, control measures of rational drug use should be tightened.