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一项关于切除胃癌辅助化疗方案的系统评价和网络荟萃分析方案

A systematic review and network meta-analysis protocol of adjuvant chemotherapy regimens for resected gastric cancer.

作者信息

Ge Long, Hou Liangying, Yang Qingxia, Wu Yiting, Shi Xiue, Li Jiang, Yang Kehu

机构信息

The First Clinical Medical College.

Evidence Based Social Science Research Center, School of Public Health.

出版信息

Medicine (Baltimore). 2019 Feb;98(7):e14478. doi: 10.1097/MD.0000000000014478.

Abstract

BACKGROUND

Gastric cancer is the third leading cause of cancer death in the world. The benefit of adjuvant chemotherapy has been demonstrated by published individual patient data meta-analysis and Cochrane systematic review. However, there is no consensus on which is the optimal adjuvant chemotherapy regimens. Present network meta-analysis aims to compare the differences of effect between all available adjuvant chemotherapy regimens in improving overall survival and disease-free survival, and to rate the certainty of evidence from present network meta-analysis.

METHODS

We will conduct this systematic review and network meta-analysis using Bayesian method and according to Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) statement. We will search PubMed, EMBASE.com, the Cochrane Central Register of Controlled Trials (CENTRAL), Chinese National Knowledge Infrastructure (CNKI), and Chinese Biological Medical Database (CBM), and ClinicalTrials.gov (http://clinicaltrials.gov/) to identify randomized controlled trials (RCTs) comparing adjuvant chemotherapy to surgery alone. We will assess the risk of bias of individual RCTs using a modified version of Cochrane tool. We will also use the advance of GRADE to rate the certainty of network meta-analysis. Data analysis will be performed with R-3.4.1 and WinBUGS software.

RESULTS

The results of this study will be published in a peer-reviewed journal.

DISCUSSION

To the best of our knowledge, this systematic review and network meta-analysis will firstly use both direct and indirect evidence to compare the differences of all available adjuvant chemotherapy regimens for resected gastric cancer patients. This is a protocol of systematic review and meta-analysis, so the ethical approval and patient consent are not required.

摘要

背景

胃癌是全球癌症死亡的第三大主要原因。已发表的个体患者数据荟萃分析和Cochrane系统评价证实了辅助化疗的益处。然而,对于哪种辅助化疗方案是最佳方案尚无共识。当前的网络荟萃分析旨在比较所有可用辅助化疗方案在改善总生存期和无病生存期方面的疗效差异,并对当前网络荟萃分析的证据确定性进行评级。

方法

我们将根据系统评价和荟萃分析方案的首选报告项目(PRISMA-P)声明,采用贝叶斯方法进行这项系统评价和网络荟萃分析。我们将检索PubMed、EMBASE.com、Cochrane对照试验中央注册库(CENTRAL)、中国知网(CNKI)、中国生物医学数据库(CBM)以及ClinicalTrials.gov(http://clinicaltrials.gov/),以识别比较辅助化疗与单纯手术的随机对照试验(RCT)。我们将使用改良版的Cochrane工具评估单个RCT的偏倚风险。我们还将使用GRADE进展对网络荟萃分析的确定性进行评级。数据分析将使用R-3.4.1和WinBUGS软件进行。

结果

本研究结果将发表在同行评审期刊上。

讨论

据我们所知,这项系统评价和网络荟萃分析将首次同时使用直接和间接证据,比较所有可用辅助化疗方案对已切除胃癌患者的疗效差异。这是一项系统评价和荟萃分析方案,因此无需伦理批准和患者同意。

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