Jia Yongliang, Lao Yaoguang, Leung Siu-Wai
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.
BMJ Open. 2015 Mar 11;5(3):e006139. doi: 10.1136/bmjopen-2014-006139.
Past studies of network meta-analysis focused on evaluating drug combinations in treating type 2 diabetes but not on evaluating antidiabetic drugs in monotherapy. Clinical guidelines (eg, NICE (National Institute of Health and Care Excellence) clinical guidelines 66 and 87) were based only on the findings of individual clinical trials and pairwise meta-analysis in evaluating monotherapy. This study aims to fill this gap of research by conducting a Bayesian network meta-analysis to compare major antidiabetic drugs, including metformin, glimepiride, glyburide, glipizide, repaglinide, nateglinide, sitagliptin, vildagliptin, saxagliptin and SGLT-2 (sodium-glucose transporter-2) inhibitors.
Randomised controlled trials (RCTs) on the drug therapy of type 2 diabetes with outcome measures including glycosylated haemoglobin or fasting blood glucose will be included. The quality of included RTCs will be evaluated according to the Cochrane Collaboration's risk of bias tool. Traditional pairwise meta-analysis and Bayesian network meta-analysis will be conducted to compare the efficacies of antidiabetic drugs. Sensitivity analysis on the sample size of RCTs, meta-regression analysis on the follow-up periods, dosages and baselines of outcome measure, contradiction analysis between pairwise and network meta-analyses, and publication bias analysis, will be performed.
Ethical approval is not required because this study includes no confidential personal data and interventions on the patients. Pairwise and network meta-analyses are based on the published RCT reports of eligible drugs in treating type 2 diabetes. The results of this study will be disseminated by a peer-reviewed publication.
PROSPERO CRD42014010567.
既往网络荟萃分析研究主要集中于评估治疗2型糖尿病的药物组合，而非评估单药治疗的抗糖尿病药物。临床指南（如英国国家卫生与临床优化研究所（NICE）临床指南66和87）在评估单药治疗时仅基于个体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填补这一研究空白，以比较主要的抗糖尿病药物，包括二甲双胍、格列美脲、格列本脲、格列吡嗪、瑞格列奈、那格列奈、西他列汀、维格列汀、沙格列汀和钠-葡萄糖协同转运蛋白2（SGLT-2）抑制剂。
将纳入以糖化血红蛋白或空腹血糖作为结局指标的2型糖尿病药物治疗随机对照试验（RCT）。将根据Cochrane协作网的偏倚风险工具评估纳入的随机对照试验的质量。将进行传统的成对荟萃分析和贝叶斯网络荟萃分析，以比较抗糖尿病药物的疗效。将对随机对照试验的样本量进行敏感性分析，对结局指标的随访期、剂量和基线进行荟萃回归分析，对成对和网络荟萃分析之间的矛盾进行分析，并进行发表偏倚分析。
本研究无需伦理批准，因为研究不包括保密的个人数据和对患者的干预措施。成对和网络荟萃分析基于已发表的合格药物治疗2型糖尿病的随机对照试验报告。本研究结果将通过同行评审出版物进行传播。
PROSPERO CRD42014010567。
