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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。

相似文献

1
[Pentoxifylline and intermittent claudication: critical analysis of clinical trials].[己酮可可碱与间歇性跛行:临床试验的批判性分析]
Therapie. 1995 Jan-Feb;50(1):73-8.
2
Management of intermittent claudication with pentoxifylline: meta-analysis of randomized controlled trials.己酮可可碱治疗间歇性跛行:随机对照试验的荟萃分析
CMAJ. 1996 Oct 15;155(8):1053-9.
3
Acenocoumarol and pentoxifylline in intermittent claudication. A controlled clinical study. The APIC Study Group.醋硝香豆素与己酮可可碱治疗间歇性跛行:一项对照临床研究。APIC研究小组
Angiology. 1989 Apr;40(4 Pt 1):237-48.
4
A controlled trial of pentoxifylline (Trental 400) in intermittent claudication: clinical, haemostatic and rheological effects.己酮可可碱(曲克芦丁400)治疗间歇性跛行的对照试验:临床、止血和流变学效应
N Z Med J. 1987 Jul 22;100(828):445-7.
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Cilostazol: new drug. Intermittent claudication: too little efficacy, too many risks.西洛他唑:新药。间歇性跛行:疗效欠佳,风险众多。
Prescrire Int. 2009 Apr;18(100):56-9.
6
Pentoxifylline and intermittent claudication: review of clinical trials and cost-effectiveness analyses.己酮可可碱与间歇性跛行:临床试验及成本效益分析综述
J Cardiovasc Pharmacol. 1995;25 Suppl 2:S44-50.
7
Pentoxifylline for intermittent claudication.己酮可可碱用于间歇性跛行。
Med Lett Drugs Ther. 1984 Nov 23;26(675):103-4.
8
[Intermittent claudication treated with pentoxifylline. A controlled trial].[己酮可可碱治疗间歇性跛行。一项对照试验]
Ugeskr Laeger. 1983 Nov 21;145(47):3649-52.
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A randomized trial of iloprost in patients with intermittent claudication.伊洛前列素治疗间歇性跛行患者的随机试验。
Vasc Med. 2008 Feb;13(1):5-13. doi: 10.1177/1358863X07084910.
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On the assessment of the efficacy of pentoxifylline (Trental).关于己酮可可碱(曲克芦丁)疗效的评估。
J Med. 1987;18(1):1-15.

引用本文的文献

1
Clinical pharmacokinetics of vasodilators. Part II.血管扩张剂的临床药代动力学。第二部分。
Clin Pharmacokinet. 1998 Jul;35(1):9-36. doi: 10.2165/00003088-199835010-00002.
2
Pentoxifylline (oxpentifylline). A review of its therapeutic efficacy in the management of peripheral vascular and cerebrovascular disorders.己酮可可碱(氧代己酮可可碱)。对其治疗外周血管疾病和脑血管疾病疗效的综述。
Drugs Aging. 1995 Dec;7(6):480-503. doi: 10.2165/00002512-199507060-00007.