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口服环拉马多与可待因缓解术后疼痛的双盲对照研究。

A double-blind comparison of orally administered ciramadol and codeine for relief of postoperative pain.

作者信息

Graf D F, Pandit S K, Kothary S P, Freeland G R

出版信息

J Clin Pharmacol. 1985 Nov-Dec;25(8):590-5. doi: 10.1002/j.1552-4604.1985.tb02882.x.

Abstract

Ciramadol, a new analgesic with mixed narcotic agonist-antagonist actions, was compared with codeine and placebo in a double-blind study in 343 patients with postoperative pain. The patients received a single oral dose of either 30 or 60 mg of ciramadol, 60 mg of codeine, or placebo. As indicated by three efficacy measures (verbal and visual analog pain scores and pain relief scores), the three active treatments were superior to placebo in relieving pain, and 30 and 60 mg of ciramadol generally were equivalent and superior, respectively, to 60 mg of codeine. The group who took 60 mg of ciramadol had a significantly (P less than .05) lower cumulative remedication frequency than that for the other three groups and the highest proportion of satisfactory evaluations by patients and physicians. There was no statistically significant difference in the incidence of side effects (4% to 11%) among the treatment groups. Demonstrated safety and efficacy suggest a role for ciramadol in the treatment of postoperative pain.

摘要

环拉马朵是一种具有混合麻醉激动-拮抗作用的新型镇痛药,在一项针对343例术后疼痛患者的双盲研究中,将其与可待因和安慰剂进行了比较。患者单次口服30或60毫克环拉马朵、60毫克可待因或安慰剂。根据三种疗效指标(语言和视觉模拟疼痛评分以及疼痛缓解评分)显示,三种活性治疗在缓解疼痛方面均优于安慰剂,30毫克和60毫克环拉马朵通常分别等同于并优于60毫克可待因。服用60毫克环拉马朵的组累积补救用药频率显著低于其他三组(P<0.05),患者和医生满意度评价比例最高。各治疗组间副作用发生率(4%至11%)无统计学显著差异。已证实的安全性和有效性表明环拉马朵在治疗术后疼痛方面有一定作用。

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