BMJ:地高辛的安全性和疗效性(荟萃分析)

2015-09-07 崔倩 译 MedSci原创

为了澄清所有观察性和随机对照试验中地高辛对死亡和临床结果的影响,研究人员对研究设计和方法进行了一项系统性研究和荟萃分析。该研究的数据来源于 Medline, Embase,Cochrane图书馆,参考文献目录的综合文献检索,以及根据一项前瞻性注册设计(PROSPERO:CRD42014010783)正在进行的研究,包括从1960年到2014年7月发表使用地高辛治疗与对照组相比(安慰剂或不治疗)的研

为了澄清所有观察性和随机对照试验中地高辛对死亡和临床结果的影响,研究人员对研究设计和方法进行了一项系统性研究和荟萃分析。

该研究的数据来源于 Medline, Embase,Cochrane图书馆,是参考文献目录的综合文献检索,以及根据一项前瞻性注册设计(PROSPERO:CRD42014010783)正在进行的研究,包括从1960年到2014年7月发表的使用地高辛治疗且有对照组相比(安慰剂或不治疗)的研究。根据研究设计、分析方法、以及偏差的风险汇集了未调整和调整的数据。主要结果(全因死亡率)和次要结果(包括住院)通过随机效应模型进行了荟萃分析。

研究人员对52项研究进行了系统的回顾,共包括621845例患者。地高辛使用者比对照参与者的年龄大2.4岁(加权差95%置信区间为1.3〜3.6),并且有较低的射血分数(33% vs 42%),更多的糖尿病患者,并且有更多的使用利尿剂和抗心律失常药物的病例。荟萃分析包括75项研究分析,研究人员进行了4006210病人年的随访期。与对照组相比,使用地高辛汇集的死亡危险比在未调整的分析中为1.76(1.57〜1.97),调整后的分析为1.61(1.31〜1.97),在倾向匹配研究中为1.18(1.09〜1.26),在随机对照试验中为0.99 (0.93〜1.05)。荟萃回归分析证实治疗组之间的基线差异对与地高辛相关的死亡率有显著影响,包括心脏衰竭严重性标记如使用利尿剂(P=0.004)。有更好的方法和较低的风险偏差更有可能报告出一个中性的地高辛与死亡率的相关性(P<0.001)。在所有的研究类型中,地高辛可导致小的,但显著降低全因住院率(风险比0.92,0.89〜0.95,P<0.001,n=29525)。

在随机试验中,地高辛与死亡率有一个中性的相关性,在所有类型的研究中,地高辛可以降低入院率。但不管统计分析如何,处方的偏差限制了观察数据的价值。

原始出处:

Oliver J Ziff, Deirdre A Lane, Monica Samra, et al.Safety and efficacy of digoxin,BMJ,2015.8.30

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    2015-11-08 gaoxiaoe
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    2015-10-18 zhouxue1990

    地高辛的安全性有待评估

    0

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