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药物治疗稳定型心绞痛的疗效:一项随机对照试验网络荟萃分析方案

Drug efficacy in treating stable angina pectoris: a protocol for network meta-analysis of randomised controlled trials.

作者信息

Jia Yongliang, Leung Siu-Wai

机构信息

State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China.

State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China School of Informatics, University of Edinburgh, Edinburgh, UK.

出版信息

BMJ Open. 2014 Jun 19;4(6):e005453. doi: 10.1136/bmjopen-2014-005453.

Abstract

INTRODUCTION

There were 11 pairwise meta-analysis on the efficacy of β-blockers (including atenolol, propranolol, bisoprolol, metoprolol and nadolol), calcium channel blockers (including amlodipine, diltiazem, felodipine, nifedipine and verapamil), and nitrates (including isosorbide dinitrate, isosorbide mononitrate and nitroglycerin) in treating stable angina pectoris. No network meta-analytic study has been published to evaluate the efficacies of these antianginal drugs. Current clinical guidelines (eg, National Institute of Health and Care Excellence (NICE) clinical guideline 126) are only based on the findings of limited clinical trials and pairwise meta-analysis. This study aims to fill this gap of research by conducting a Bayesian network meta-analysis to compare all these antianginal drugs.

METHODS AND ANALYSES

Randomised controlled trials (RCT) on the drug therapy of stable angina pectoris with multiple outcome measures, selected from symptomatic relief, ECG tests, exercise tests, heart rates and blood pressures, etc, will be included. Overall effect sizes will be represented as mean differences with 95% credible intervals (CrI) for continuous outcome data and as ORs with 95% CrI for dichotomous outcome data. Bayesian network meta-analysis by WinBUGS will be conducted to compare the efficacies of these drugs. Sensitivity analysis on the quality of RCTs and subgroup analysis on the category of included drugs will be performed.

ETHICS AND DISSEMINATION

Ethical approval is not required because this study includes no confidential personal data and interventions on the patients. Network meta-analysis is based on the RCT reports of eligible drugs in treating stable angina pectoris. The results of this study will be disseminated by an open access and peer-reviewed publication.

TRIAL REGISTRATION NUMBER

PROSPERO CRD42014007113.

摘要

引言

已有11项关于β受体阻滞剂(包括阿替洛尔、普萘洛尔、比索洛尔、美托洛尔和纳多洛尔)、钙通道阻滞剂(包括氨氯地平、地尔硫卓、非洛地平、硝苯地平和维拉帕米)以及硝酸盐类药物(包括硝酸异山梨酯、单硝酸异山梨酯和硝酸甘油)治疗稳定型心绞痛疗效的成对荟萃分析。尚未发表网络荟萃分析研究来评估这些抗心绞痛药物的疗效。当前的临床指南(例如英国国家卫生与临床优化研究所(NICE)临床指南126)仅基于有限的临床试验和成对荟萃分析的结果。本研究旨在通过进行贝叶斯网络荟萃分析来比较所有这些抗心绞痛药物,以填补这一研究空白。

方法与分析

将纳入对稳定型心绞痛药物治疗进行多结局测量的随机对照试验(RCT),这些测量指标选自症状缓解、心电图检查、运动试验、心率和血压等。对于连续性结局数据,总体效应量将表示为具有95%可信区间(CrI)的均值差;对于二分结局数据,则表示为具有95% CrI的比值比(OR)。将采用WinBUGS进行贝叶斯网络荟萃分析,以比较这些药物的疗效。将对RCT的质量进行敏感性分析,并对纳入药物的类别进行亚组分析。

伦理与传播

由于本研究不包括机密的个人数据和对患者的干预措施,因此无需伦理批准。网络荟萃分析基于符合条件的药物治疗稳定型心绞痛的RCT报告。本研究结果将通过开放获取和同行评审出版物进行传播。

试验注册号

PROSPERO CRD42014007113。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a36/4067836/e5167846b682/bmjopen2014005453f01.jpg

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