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长期阿片类药物管理治疗慢性非癌痛的随机试验系统评价。

A systematic review of randomized trials of long-term opioid management for chronic non-cancer pain.

机构信息

Pain Management Center of Paducah, Paducah, KY, USA.

出版信息

Pain Physician. 2011 Mar-Apr;14(2):91-121.

PMID:21412367
Abstract

BACKGROUND

Even though opioids have been used for pain for thousands of years, opioid therapy for chronic non-cancer pain is controversial due to concerns regarding the long-term effectiveness and safety, particularly the risk of tolerance, dependance, or abuse. While the debate continues, the use of chronic opioid therapy for chronic non-cancer pain has increased exponentially. Even though evidence is limited, multiple expert panels have concluded that chronic opioid therapy can be effective therapy for carefully selected and monitored patients with chronic non-cancer pain.

STUDY DESIGN

A systematic review of randomized trials of opioid management for chronic non-cancer pain.

OBJECTIVE

The objective of this systematic review is to evaluate the clinical efficacy of opioids in the treatment of chronic non-cancer pain.

METHODS

A comprehensive evaluation of the literature relating to opioids in chronic non-cancer pain was performed. The literature was evaluated according to Cochrane review criteria for randomized controlled trials (RCTs) and Jadad criteria. A literature search was conducted by using PubMed, EMBASE, Cochrane library, ECRI Institute Library, U.S. Food and Drug Administration (FDA) website, U.S. National Guideline Clearinghouse (NGC), Database of Abstracts of Reviews of Effectiveness (DARE), clinical trials, systematic reviews and cross references from systematic reviews. The level of evidence was classified as good, fair, or poor based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF) and used by other systematic reviews and guidelines.

OUTCOME MEASURES

Pain relief was the primary outcome measure. Other outcome measures were functional improvement, withdrawals, and adverse effects.

RESULTS

Based on the USPSTF criteria, the indicated level of evidence was fair for Tramadol in managing osteoarthritis. For all the drugs assessed, including Tramadol, for all other conditions, the evidence was poor based on either weak positive evidence, indeterminate evidence, or negative evidence.

LIMITATIONS

A paucity of literature, specifically with follow-up beyond 12 weeks for all types of opioids with controlled trials for various chronic non-cancer pain conditions.

CONCLUSIONS

This systematic review illustrated fair evidence for Tramadol in managing osteoarthritis with poor evidence for all other drugs and conditions. Thus, recommendations must be based on non-randomized studies.

摘要

背景

尽管阿片类药物已经被用于治疗疼痛数千年,但由于对长期有效性和安全性的担忧,特别是对耐受、依赖或滥用的风险的担忧,阿片类药物治疗慢性非癌性疼痛仍存在争议。虽然争议仍在继续,但慢性阿片类药物治疗慢性非癌性疼痛的使用呈指数级增长。尽管证据有限,但多个专家小组得出结论,慢性阿片类药物治疗可以成为对精心选择和监测的慢性非癌性疼痛患者有效的治疗方法。

研究设计

对慢性非癌性疼痛的阿片类药物管理的随机试验进行系统评价。

目的

本系统评价的目的是评估阿片类药物治疗慢性非癌性疼痛的临床疗效。

方法

对与慢性非癌性疼痛中的阿片类药物相关的文献进行了全面评估。根据 Cochrane 随机对照试验 (RCT) 评价标准和 Jadad 标准对文献进行了评价。通过 PubMed、EMBASE、Cochrane 图书馆、ECRI 研究所图书馆、美国食品和药物管理局 (FDA) 网站、美国国家指南清除中心 (NGC)、疗效摘要数据库 (DARE)、临床试验、系统评价和系统评价的参考文献进行文献检索。根据美国预防服务工作组 (USPSTF) 制定的证据质量标准和其他系统评价和指南,将证据水平分为良好、中等或差。

主要结果

疼痛缓解是主要的观察指标。其他观察指标包括功能改善、停药和不良反应。

结果

根据 USPSTF 标准,曲马多治疗骨关节炎的证据水平为中等。对于评估的所有药物,包括曲马多,对于所有其他疾病,证据均较差,要么是弱阳性证据、不确定证据,要么是阴性证据。

局限性

文献数量有限,特别是对于所有类型的阿片类药物和各种慢性非癌性疼痛疾病的对照试验,随访时间均超过 12 周。

结论

本系统评价表明曲马多治疗骨关节炎的证据为中等,而其他药物和疾病的证据较差。因此,建议必须基于非随机研究。

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