Rheumatology:类风湿性关节炎患者治疗的真实有效性:随机对照vs观察性研究

2018-02-26 安雅晶 环球医学网

2018年2月,发表于《Rheumatology (Oxford)》上的一项研究,考察了在随机对照试验(RCTs)和观察性研究中接受治疗的类风湿关节炎(RA)患者,药物在改善治疗效果的特征上是否具有差异。

2018年2月,发表于《Rheumatology (Oxford)》上的一项研究,考察了在随机对照试验(RCTs)和观察性研究中接受治疗的类风湿关节炎(RA)患者,药物在改善治疗效果的特征上是否具有差异。

目的:旨在调查入组到RCTs和观察性研究的RA患者是否在改善治疗效果的特征上具有差异,造成疗效-有效性的差距。

方法:研究者进行了系统的文献回顾,鉴别出接受利妥昔单抗、托珠单抗或依那西普治疗的RA患者的RCTs和观察性研究。研究者提取了基线特征,比较了RCTs(使用固定效应Meta分析)和观察性研究(使用随机效应Meta分析)的数据。研究者也评估了基线特征是否随着时间而改变。

结果:与入组到RCTs中的患者相比,观察性研究中的患者平均大3.0岁(P<0.001),RA病程长3.1年(P<0.001),既往服用的改善病情类药物多1.6个(P=0.001),具有较低的DAS-28评分(差异,-0.6;P<0.001)。CRP和ESR水平在RCTs中稍高。HAQ残疾指数(HAQ-DI)评分在RCTs中稍低。纳入的女性或RF阳性率百分比无差异。随着时间,研究者发现RCTs和注册的患者中,DAS-28都显着降低-0.08,HAQ-DI显着降低-0.04。此外,RCTs患者的ESR和CRP随着时间降低,而观察性研究患者并非如此。

结论:RCTs和注册的RA患者特征具有很大的系统性差异。RCTs中观察到的疗效可能并不反映真实世界的有效性。


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    2018-07-08 amyloid
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    2018-02-28 lmm397
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