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FTY720(芬戈莫德)对肾移植受者移植物存活的影响:一项系统评价方案

Effect of FTY720 (fingolimod) on graft survival in renal transplant recipients: a systematic review protocol.

作者信息

Gholamnezhadjafari Reza, Falak Reza, Tajik Nader, Aflatoonian Reza, Ali Keshtkar Abbas, Rezaei Abbas

机构信息

Department of Immunology, Isfahan University of Medical Sciences, Isfahan, Iran.

Immunology Research Center, Iran University of Medical Sciences, Tehran, Iran Department of Immunology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.

出版信息

BMJ Open. 2016 Apr 28;6(4):e010114. doi: 10.1136/bmjopen-2015-010114.

Abstract

INTRODUCTION

Studies have shown that FTY720 has inconsistent effects in kidney transplant recipients. Several review articles on FTY720 have been published, but most have focused on the mechanism of action of FTY720. Therefore, this review aims to evaluate and determine the beneficial and harmful effects of FTY720 therapy in kidney transplant recipients.

METHODS AND ANALYSIS

We electronically searched the following databases: PubMed, Scopus, the Web of Sciences, EMBASE, Cochrane databases and the Cochrane Central Registry of Controlled Trials. Any clinical, randomised controlled trials relating to FTY720 for treating kidney transplant recipients were included without publication status or language restriction. Study selection, data extraction and assessment of study quality were performed independently by two researchers. Data were synthesised by either the fixed effects or the random effects model according to a heterogeneity test. If the extracted data were suitable for meta-analysis, STATA software was used to combine the relative risks for dichotomous outcomes, and the mean differences for continuous outcomes with 95% CIs were measured. Death, loss of function and incidence of acute kidney rejection were assessed as the primary outcomes. Renal graft function, malignancy, delayed graft function and infection were evaluated as secondary outcomes.

ETHICS/DISSEMINATION: This review does not require formal ethics approval because the data are not individualised. The resulting review article will be submitted for publication in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

CRD42015024648.

摘要

引言

研究表明,FTY720在肾移植受者中的作用效果并不一致。关于FTY720的几篇综述文章已经发表,但大多数都集中在FTY720的作用机制上。因此,本综述旨在评估并确定FTY720治疗对肾移植受者的有益和有害影响。

方法与分析

我们通过电子方式检索了以下数据库:PubMed、Scopus、科学网、EMBASE、Cochrane数据库以及Cochrane对照试验中心注册库。纳入任何与FTY720治疗肾移植受者相关的临床随机对照试验,不受发表状态或语言限制。由两名研究人员独立进行研究选择、数据提取和研究质量评估。根据异质性检验,采用固定效应模型或随机效应模型对数据进行综合分析。如果提取的数据适合进行荟萃分析,则使用STATA软件合并二分结果的相对风险,并测量连续结果的平均差异及95%置信区间。将死亡、功能丧失和急性肾排斥反应的发生率作为主要结局进行评估。将肾移植功能、恶性肿瘤、移植肾功能延迟恢复和感染作为次要结局进行评估。

伦理/传播:本综述不需要正式的伦理批准,因为数据并非个体化数据。所得的综述文章将提交至同行评审期刊发表。

试验注册号

CRD42015024648。

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