Department of Nephrology, Zibo Central Hospital, Shandong, China.
Medicine (Baltimore). 2022 Dec 30;101(52):e32366. doi: 10.1097/MD.0000000000032366.
Approximately half of people with heart failure have chronic kidney disease (CKD). Tolvaptan is reported to be effective in treating heart failure. However, the safety and efficacy of its use in patients with CKD is uncertain. In this study, we conducted a protocol for systematic review and meta-analysis to investigate the efficacy and safety of tolvaptan on patients with heart failure and CKD.
This study protocol has been registered in the PROSPERO and the registration number is CRD42022368148. The consent of this protocol report is based on the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement guidelines. We will include randomized controlled trials related to tolvaptan in patients with heart failure and CKD. Two research members will electronically and independently search 4 English databases (EMBASE, PubMed, National Guideline Clearinghouse, and Cochrane Central Register of Controlled Trials) and 4 Chinese databases (Chinese Biomedical Literature Database, Chinese National Knowledge Infrastructure, Wanfang Database, and VIP Database) from their inception to November 2022. The risk of bias in each included study will be assessed utilizing the Cochrane Collaboration's risk of bias tool. All statistical analyses will be conducted using the software program Review Manager version 5.3.
The results of this systematic review will be published in a peer-reviewed journal.
This review can provide convincing evidence to help clinicians make decisions when dealing with heart failure and CKD.
约有一半心力衰竭患者患有慢性肾脏病（CKD）。托伐普坦据报道可有效治疗心力衰竭。然而，其在 CKD 患者中的安全性和疗效尚不确定。在这项研究中，我们制定了一项系统评价和荟萃分析的方案，以调查托伐普坦治疗心力衰竭合并 CKD 患者的疗效和安全性。
本研究方案已在 PROSPERO 中注册，注册号为 CRD42022368148。本方案报告的同意书基于系统评价和荟萃分析方案的首选报告项目（PRISMA-P）2015 声明指南。我们将纳入有关托伐普坦治疗心力衰竭合并 CKD 患者的随机对照试验。两名研究人员将电子检索和独立检索 4 个英文数据库（EMBASE、PubMed、国家指南清除库和 Cochrane 对照试验中心注册库）和 4 个中文数据库（中国生物医学文献数据库、中国知网、万方数据库和 VIP 数据库），检索时间从建库至 2022 年 11 月。将使用 Cochrane 协作风险偏倚工具评估每个纳入研究的偏倚风险。所有的统计分析将使用 Review Manager 版本 5.3 软件程序进行。
本系统评价的结果将发表在同行评议的期刊上。
本综述可以提供有说服力的证据，帮助临床医生在处理心力衰竭和 CKD 时做出决策。
