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口服或透皮阿片类药物治疗膝或髋骨关节炎的疗效和安全性比较:系统评价和贝叶斯网络荟萃分析方案。

Comparative efficacy and safety of oral or transdermal opioids in the treatment of knee or hip osteoarthritis: a systematic review and Bayesian network meta-analysis protocol.

机构信息

Department of Orthopaedics, The First Affiliated Hospital of Anhui Medical University, Anhui, China.

Department of Plastic Surgery, The Fourth Affiliated Hospital of Anhui Medical University, Anhui, China.

出版信息

BMJ Open. 2018 Oct 18;8(10):e022142. doi: 10.1136/bmjopen-2018-022142.

Abstract

INTRODUCTION

Osteoarthritis is a common degenerative joint disease that eventually leads to disability and poor quality of life. The main symptoms are joint pain and mobility disorders. If the patient has severe pain or other analgesics are contraindicated, opioids may be a viable treatment option. To evaluate and compare the efficacy and safety of opioids in the treatment of knee or hip osteoarthritis, we will integrate direct and indirect evidence using a Bayesian network meta-analysis to establish hierarchies of these drugs.

METHODS AND ANALYSIS

We will search the Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Web of Science and PsycINFO databases as well as published and unpublished research in international registries and regulatory agency websites for osteoarthritis reports published prior to 5 January 2018. There will be no restrictions on the language. Randomised clinical trials that compare oral or transdermal opioids with other various opioids, placebo or no treatment for patients with knee or hip osteoarthritis will be included. The primary outcomes of efficacy will be pain and function. We will use pain and function scales to evaluate the main outcomes. The secondary outcomes of safety will be defined as the proportion of patients who have stopped treatment due to side effects. Pairwise meta-analyses and Bayesian network meta-analyses will be performed for all related outcome measures. We will conduct subgroup analyses and sensitivity analyses to assess the robustness of our findings. The Grading of Recommendations, Assessment, Development and Evaluations framework will be used to assess the quality of the evidence contributing to each network assessment.

ETHICS AND DISSEMINATION

This study does not require formal ethical approval because individual patient data will not be included. The findings will be disseminated through peer-reviewed publications or conference presentations.

PROSPERO REGISTRATION NUMBER

CRD42018085503.

摘要

简介

骨关节炎是一种常见的退行性关节疾病,最终会导致残疾和生活质量下降。主要症状为关节疼痛和活动障碍。如果患者疼痛剧烈或其他止痛药禁忌,阿片类药物可能是一种可行的治疗选择。为了评估和比较阿片类药物治疗膝或髋骨关节炎的疗效和安全性,我们将使用贝叶斯网状meta 分析整合直接和间接证据,建立这些药物的层级关系。

方法与分析

我们将检索 Medical Literature Analysis and Retrieval System Online、Excerpta Medica 数据库、Cumulative Index to Nursing and Allied Health Literature、Cochrane Library、Web of Science 和 PsycINFO 数据库以及国际注册处和监管机构网站上发表和未发表的关于骨关节炎的研究,检索时间截至 2018 年 1 月 5 日之前。语言没有限制。将纳入比较口服或透皮阿片类药物与其他各种阿片类药物、安慰剂或不治疗膝或髋骨关节炎患者的随机对照临床试验。疗效的主要结局是疼痛和功能。我们将使用疼痛和功能量表来评估主要结局。安全性的次要结局定义为因副作用停止治疗的患者比例。我们将对所有相关结局指标进行两两荟萃分析和贝叶斯网状meta 分析。我们将进行亚组分析和敏感性分析,以评估我们研究结果的稳健性。将使用推荐、评估、制定和评价分级框架来评估对每个网络评估有贡献的证据质量。

伦理与传播

本研究不需要正式的伦理批准,因为不会纳入个体患者数据。研究结果将通过同行评议的出版物或会议报告进行传播。

PROSPERO 注册号:CRD42018085503。

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