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Pharmacoepidemiol Drug Saf:药物非特异性不良事件的类型、频率和负担

2017-08-11 何娜 环球医学资讯

2017年7月,发表在《Pharmacoepidemiol Drug Saf》的一项由法国科学家进行的基于随机、安慰剂对照、临床试验的分析,考察了药物非特异性不良事件的类型、频率和负担。

2017年7月,发表在《Pharmacoepidemiol Drug Saf》的一项由法国科学家进行的基于随机、安慰剂对照、临床试验的分析,考察了药物非特异性不良事件的类型、频率和负担。

目的:分析特定疾病的随机、安慰剂对照、临床试验(PRCCT)中不良事件(AE)数据的少数研究表明,相当大比例收集的AE与服药不相关。本研究分析了RPCCT中,主动药物暴露中发生的非特异性AE,该分析适用于大范围的医疗条件。

方法:检索2006~2012年在5个主要医学期刊上发表的RPCCT。试验的入组标准为:在头对头的情况下,评估阳性药物vs安慰剂的口服或胃肠外给药。对于≥10个RPCCT中报道的AE,计算了皮尔森关联系数(r),用于确定安慰剂和阳性药物使用者中,AE率的相关性。随机效应Meta分析用于计算阳性药物使用者中的非特异性AE的比例,最高截断值在100%。

结果:研究者纳入了231项试验,对各种医疗领域或健康参与者进行了研究。对于88个分析的AE变量,安慰剂和阳性药物使用者的AE率一般都强烈相关(r>0.50)或非常强烈相关(r>0.80)。阳性药物使用者的非特异性AE的汇总比例为:任何AE为96.8%(95% CI,95.5~98.1),严重AE为100%(97.9~100),药物相关AE为77.7%(72.7~83.2)。个体医疗领域和健康参与者中,结果相似。82个系统器官类别和个体AE类型的非特异性汇总比例范围为:38%~100%。

结论:RPCCT中,阳性药物使用者报道的大比例的非特异性AE(包括严重和药物相关AE)强调了使用临床试验数据来确定药物耐受性的局限性。

专家点评:随机对照试验的设计多为验证药物的有效性,因此对于安全性的结局多为非特异性的不良事件,因此这些结局非特异性的指标可能不能作为评估耐受性的主要依据,药物上市后持续的观察性研究应作为对药物安全性考虑的重要补充。

原始出处:
Mahr A, Golmard C, Pham E, et al.Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials.Pharmacoepidemiol Drug Saf. 2017 Jul;26(7):731-741. doi: 10.1002/pds.4169. Epub 2017 Feb 7.

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    2017-09-18 爆笑小医
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    2018-02-08 yb6560
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    2017-10-07 jj000001
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