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[用酮色林治疗系统性硬化症。27例患者的随机双盲6个月研究]

[Treatment of systemic scleroderma with ketanserin. Randomized, double-blind 6-months study of 27 cases].

作者信息

Cadranel J, Blétry O, Guillevin L, Lacombe C, Fraitag B, Duloroy J, Mouthon J M, Godeau P

出版信息

Ann Med Interne (Paris). 1986;137(3):260-3.

PMID:3532900
Abstract

Twenty-seven patients with systemic scleroderma and Raynaud's phenomenon underwent a randomised double blind therapeutic trial: monotherapy with Ketanserine (80 mg/day for 6 months) against Placebo. The secondary effects were comparable in both groups as were the withdrawals from the trial for aggravation of Raynaud's phenomenon (one in each group). No significant difference was observed between the two groups as regards the evolution of the Raynaud's phenomenon or skin changes. Dysphagia was improved in the Ketanserine group (p less than 0.05) but not in the Placebo group. Some patients in the Ketanserine group experienced an improvement in the Raynaud's phenomenon at the end of the trial period; there were no improvements in the Placebo group. Three haemorrheological parameters (total blood viscosity, plasma viscosity and thixotropism) were abnormal at the beginning of the trial and did not improve by the end in the Ketanserine group. The K infinity coefficient of Quemada's law was normal at the start of the trial and increased after treatment (p less than 0.05).

摘要

27例系统性硬化症伴雷诺现象患者进行了一项随机双盲治疗试验:酮色林单药治疗(80毫克/天,持续6个月)与安慰剂对照。两组的副作用相当,因雷诺现象加重而退出试验的情况也相当(每组各1例)。在雷诺现象或皮肤变化的进展方面,两组之间未观察到显著差异。酮色林组的吞咽困难有所改善(p<0.05),而安慰剂组则没有。在试验期结束时,酮色林组的一些患者雷诺现象有所改善;安慰剂组则无改善。三项血液流变学参数(全血粘度、血浆粘度和触变性)在试验开始时异常,在酮色林组中到试验结束时也未改善。试验开始时,Quemada定律的K无穷大系数正常,治疗后升高(p<0.05)。

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