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安慰剂、苯噻啶与1-异丙基-3-羟基-5-氨基脲基-6-氧代-2,3,5,6-四氢吲哚(Divascan)预防偏头痛的比较。

A comparison between placebo, pizotifen and 1-isopropyl-3-hydroxy-5-semicarbazono-6-oxo-2.3.5.6-tetrahydroindol (Divascan) in migraine prophylaxis.

作者信息

Osterman P O

出版信息

Acta Neurol Scand. 1977 Jul;56(1):17-28. doi: 10.1111/j.1600-0404.1977.tb01405.x.

Abstract

The effects and side-effects in migraine prophylaxis of placebo, Divascan (1-isopropylnoradrenochrome--5--monosemicarbazone) and pizotifen were compared in a double-blind cross-over study. The dosage was for Divascan 15 mg a day and for pizotifen 3 mg a day. Data from the last 6 weeks of each test period of 8 weeks were used to assess the effect of the treatment. Thirty patients entered the trial. Data from 28 patients treated with placebo and Divascan and 27 patients treated with pizotifen were used for final evaluation. Pizotifen significantly reduced the number of migraine attacks, headache index and the consumption of ergotamine. Divascan also seemed to have effect. The consumption of ergotamine was reduced compared with placebo and there was a reduction, although not significant, of headache frequency and headache index. Pizotifen gave significantly larger reduction in headache frequency and headache index than Divascan and signficantly more patients stated a preference for pizotifen compared with Divascan. A good or very good effect was reported by 11 per cent of the patients on placebo, 39 per cent on Divascan and 70 per cent on pizotifen. Pizotifen had frequent side-effects, mainly drowsiness and weight gain, whereas Divascan in this respect did not differ from placebo. Physical examinations and laboratory investigations did not show any significant changes, apart from weight gain.

摘要

在一项双盲交叉研究中,比较了安慰剂、地伐司琼(1-异丙基去甲肾上腺素铬-5-单氨基脲)和苯噻啶在偏头痛预防中的疗效和副作用。地伐司琼的剂量为每日15毫克,苯噻啶的剂量为每日3毫克。每个8周测试期的最后6周的数据用于评估治疗效果。30名患者进入试验。来自28名接受安慰剂和地伐司琼治疗的患者以及27名接受苯噻啶治疗的患者的数据用于最终评估。苯噻啶显著减少了偏头痛发作次数、头痛指数和麦角胺的消耗量。地伐司琼似乎也有效果。与安慰剂相比,麦角胺的消耗量有所减少,头痛频率和头痛指数也有所降低,尽管不显著。苯噻啶在降低头痛频率和头痛指数方面比地伐司琼显著更大,并且与地伐司琼相比,更多患者表示更喜欢苯噻啶。11%接受安慰剂治疗的患者、39%接受地伐司琼治疗的患者和70%接受苯噻啶治疗的患者报告有良好或非常好的效果。苯噻啶有频繁的副作用,主要是嗜睡和体重增加,而地伐司琼在这方面与安慰剂没有差异。体格检查和实验室检查除体重增加外未显示任何显著变化。

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