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[己酮可可碱与间歇性跛行:临床试验的批判性分析]

[Pentoxifylline and intermittent claudication: critical analysis of clinical trials].

作者信息

Charansonney O L, Spriet A

机构信息

Laboratoires Hoechst, Puteaux, France.

出版信息

Therapie. 1995 Jan-Feb;50(1):73-8.

PMID:7754482
Abstract

Drug utility in the treatment of intermittent claudication is controversial, mainly because of data heterogeneity and not too obvious benefit in the clinical trials. Pentoxifylline is the world's largest prescribed drug for intermittent claudication. In an attempt to define its benefit in the global care of the claudicants, we have analysed all the randomized double-blind, placebo-controlled trials listed from the international data-bases. Methodology of these trials have been compared with the European and FDA guidelines. In this respect, the 3 best suitable studies are consistent with one other and with a statistical benefit of pentoxifylline on the claudication distances. Although this effect is not truly predictive of the long term benefit-risk ratio of the drug, it seems clinically useful, especially when considering stable patients and when using the drug after previous physical training.

摘要

药物在间歇性跛行治疗中的效用存在争议,主要是因为数据的异质性以及在临床试验中益处不太明显。己酮可可碱是全球用于间歇性跛行处方量最大的药物。为了确定其在间歇性跛行患者全球治疗中的益处,我们分析了国际数据库中列出的所有随机双盲、安慰剂对照试验。这些试验的方法已与欧洲和美国食品药品监督管理局的指南进行了比较。在这方面,3项最合适的研究相互一致,且己酮可可碱对跛行距离有统计学上的益处。尽管这种效果并不能真正预测该药物的长期效益风险比,但在临床上似乎是有用的,尤其是在考虑病情稳定的患者以及在先前进行体育锻炼后使用该药物时。

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