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芬多沙尔与阿司匹林用于产后子宫疼痛

Fendosal and aspirin in postpartum uterine pain.

作者信息

Bloomfield S S, Barden T P, Mitchell J

出版信息

Clin Pharmacol Ther. 1978 Apr;23(4):390-6. doi: 10.1002/cpt1978234390.

Abstract

The analgesic efficacy of fendosal, a new nonsteroidal anti-inflammatory agent structurally related to salicylic acid, was compared with that of aspirin and placebo in 100 patients with postpartum uterine pain in a single oral dose, parallel, stratified, randomized, double-blind design. With 650 mg aspirin and with 200 or 400 mg fendosal, but not with 100 mg, analgesic effects, as measured subjectively by mean pain intensity scores, began within 1 hr and had similar time-effect patterns for the first 4 or 5 hr. Thereafter with the 2 higher doses of fendosal analgesia contimued to increase, reaching a peak at 6 hr (p less than 0.05) and persisting beyond 7 hr (p less than 0.01), whereas there was no aspirin analgesia after the fifth hour. With 100 mg fendosal time of onset tended to be delayed 2 hr or more, and duration was short. The most effective treatment (largest mean 7-hr sum of pain intensity difference [SPID] scores) was 400 mg fendosal (p less than 0.01); 200 mg fendosal was rated second (p less than 0.01), 650 mg aspirin, third (p less than 0.05), 100 mg fendosal, fourth, and placebo, fifth. There was no significant side effects. These results demonstrate the efficacy of single doses of fendosal as well as the dose-dependent magnitude and time course of effects on postpartum uterine pain.

摘要

在一项单剂量、平行、分层、随机、双盲设计中,将一种结构上与水杨酸相关的新型非甾体抗炎药芬多沙(fendosal)的镇痛效果与阿司匹林和安慰剂进行了比较,研究对象为100名产后子宫疼痛患者。给予650毫克阿司匹林、200或400毫克芬多沙,但不是100毫克,以平均疼痛强度评分主观测量的镇痛效果在1小时内开始,并且在最初4或5小时内具有相似的时效模式。此后,随着芬多沙的2种较高剂量,镇痛作用持续增强,在6小时达到峰值(p<0.05)并持续超过7小时(p<0.01),而第五小时后阿司匹林没有镇痛作用。给予100毫克芬多沙时,起效时间往往延迟2小时或更长,且持续时间短。最有效的治疗(最大平均7小时疼痛强度差异总和[SPID]评分)是400毫克芬多沙(p<0.01);200毫克芬多沙排名第二(p<0.01),650毫克阿司匹林排名第三(p<0.05),100毫克芬多沙排名第四,安慰剂排名第五。没有明显的副作用。这些结果证明了单剂量芬多沙的疗效以及对产后子宫疼痛的剂量依赖性作用强度和时间过程。

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