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单次剂量右丙氧芬单独及与对乙酰氨基酚合用用于术后疼痛。

Single dose dextropropoxyphene, alone and with paracetamol (acetaminophen), for postoperative pain.

作者信息

Collins S L, Edwards J E, Moore R A, McQuay H J

机构信息

Cochrane Pain, Palliative and Supportive Care Group, Pain Research Unit, Churchill Hospital, Old Road, Oxford, UK, OX3 7LJ.

出版信息

Cochrane Database Syst Rev. 2000;1999(2):CD001440. doi: 10.1002/14651858.CD001440.

Abstract

BACKGROUND

Patient surveys have shown that postoperative pain is often not managed well, and there is a need to assess the efficacy and safety of commonly used analgesics as newer treatments become available. Dextropropoxyphene is one example of an opioid analgesic in current use, and is widely prescribed for pain relief in combination with paracetamol under names such as Co-proxamol and Distalgesic.

OBJECTIVES

To determine the analgesic efficacy and adverse effects of single dose oral Dextropropoxyphene alone and in combination with paracetamol (acetaminophen) for moderate to severe postoperative pain.

SEARCH STRATEGY

Published reports were identified from: Medline (1966 - November 1996), Biological Abstracts (1985 - 1996), Embase (1980 - 1996), the Cochrane Library (Issue 4 1996), and the Oxford Pain Relief Database (1954 - 1994). Additional studies were identified from the reference lists of retrieved reports. Date of the most recent searches: July 1998.

SELECTION CRITERIA

The inclusion criteria used were: full journal publication, postoperative pain, postoperative oral administration, adult patients, baseline pain of moderate to severe intensity, double-blind design, and random allocation to treatment groups which included dextropropoxyphene and placebo or a combination of dextropropoxyphene plus paracetamol and placebo.

DATA COLLECTION AND ANALYSIS

Data were extracted by two independent reviewers, and trials were quality scored. Summed pain intensity and pain relief data were extracted and converted into dichotomous information to yield the number of patients with at least 50% pain relief. This was used to calculate the relative benefit and number-needed-to-treat (NNT) for one patient to achieve at least 50% pain relief.

MAIN RESULTS

Six trials (440 patients) compared dextropropoxyphene with placebo and five (963 patients) compared dextropropoxyphene plus paracetamol 650 mg with placebo. For a single dose of dextropropoxyphene 65 mg in postoperative pain the NNT for at least 50% pain relief was 7.7 (95% confidence interval 4.6 to 22) when compared with placebo over 4-6 hours. For the equivalent dose of dextropropoxyphene combined with paracetamol 650 mg the NNT was 4.4 (3.5 to 5.6) when compared with placebo. These results were compared with those for other analgesics obtained from equivalent systematic reviews. Pooled data showed increased incidence of central nervous system adverse effects for dextropropoxyphene plus paracetamol compared with placebo.

REVIEWER'S CONCLUSIONS: The combination of dextropropoxyphene 65 mg with paracetamol 650 mg shows similar efficacy to tramadol 100 mg for single dose studies in postoperative pain but with a lower incidence of adverse effects. The same dose of paracetamol combined with 60 mg codeine appears more effective but, with the slight overlap in the 95% confidence intervals, this conclusion is not robust. Adverse effects of both combinations were similar. Ibuprofen 400 mg has a lower (better) NNT than both dextropropoxyphene 65 mg plus paracetamol 650 mg and tramadol 100 mg.

摘要

背景

患者调查显示,术后疼痛常常未得到良好控制,随着新的治疗方法出现,有必要评估常用镇痛药的疗效和安全性。右丙氧芬是目前使用的阿片类镇痛药的一个例子,常与对乙酰氨基酚联合使用,以如丙氧氨酚和达而丰等名称广泛用于缓解疼痛。

目的

确定单剂量口服右丙氧芬单独使用以及与对乙酰氨基酚联合使用对中度至重度术后疼痛的镇痛效果和不良反应。

检索策略

从以下来源识别已发表的报告:医学索引数据库(1966年 - 1996年11月)、生物学文摘数据库(1985年 - 1996年)、荷兰医学文摘数据库(1980年 - 1996年)、考科蓝图书馆(1996年第4期)以及牛津疼痛缓解数据库(1954年 - 1994年)。从检索到的报告的参考文献列表中识别其他研究。最近一次检索日期:1998年7月。

选择标准

所使用的纳入标准为:完整的期刊发表、术后疼痛、术后口服给药、成年患者、中度至重度强度的基线疼痛、双盲设计以及随机分配至治疗组,治疗组包括右丙氧芬和安慰剂或右丙氧芬加对乙酰氨基酚与安慰剂的组合。

数据收集与分析

由两名独立的审阅者提取数据,并对试验进行质量评分。提取疼痛强度总和及疼痛缓解数据,并将其转换为二分信息,以得出疼痛缓解至少50%的患者数量。这用于计算一名患者实现至少50%疼痛缓解的相对获益和需治疗人数(NNT)。

主要结果

六项试验(440名患者)比较了右丙氧芬与安慰剂,五项试验(963名患者)比较了650毫克右丙氧芬加对乙酰氨基酚与安慰剂。对于术后疼痛单剂量65毫克右丙氧芬,与安慰剂相比,4至6小时内疼痛缓解至少50%的NNT为7.7(95%置信区间4.6至22)。对于等效剂量的右丙氧芬与650毫克对乙酰氨基酚联合使用,与安慰剂相比,NNT为4.4(3.5至5.6)。将这些结果与从等效系统评价中获得的其他镇痛药结果进行比较。汇总数据显示,与安慰剂相比,右丙氧芬加对乙酰氨基酚的中枢神经系统不良反应发生率增加。

审阅者结论

在术后疼痛的单剂量研究中,65毫克右丙氧芬与650毫克对乙酰氨基酚的组合显示出与100毫克曲马多相似的疗效,但不良反应发生率较低。相同剂量的对乙酰氨基酚与60毫克可待因联合使用似乎更有效,但由于95%置信区间略有重叠,该结论并不确凿。两种组合的不良反应相似。布洛芬400毫克的NNT低于65毫克右丙氧芬加650毫克对乙酰氨基酚以及100毫克曲马多。

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