The efficacy and safety of tonifying-kidney and invigorating-blood circulation (Bushen-Huoxue) formula on renal fibrosis in patients with chronic kidney disease: A protocol for systematic review and meta-analysis

Xiaoxiao Li, Weijie Liang, Haiyun Lu, Jiandi Wu, Xiuwen Luo, Zhi Kang, Qian He, Chenglong Jiang
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Abstract

The incidence of chronic kidney disease (CKD) is increasing and the progression of renal interstitial fibrosis (RIF) in end-stage renal disease is attributed to the development of various CKD. One of the treatments for RIF is an oral treatment known as Bushen-Huoxue (BSHX), which stimulates blood circulation and tonifies the kidney. Randomized controlled trials of BSHX treatment of RIF have been reported, but their efficacy and safety have not been comprehensively examined. Therefore, our study aims to describe the efficacy and safety of oral application of the traditional Chinese medicine (TCM) formula of BSHX on treating RIF in CKD by systematic analysis and meta-analysis. A total of 13 databases, including PubMed, EMBASE, MEDLINE, Web of Science, Cochrane Library, SpringerLink, WHO International Clinical Trials Registry Platform, Wanfang China database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific Journal Database, and China’s Conference Papers Database and China Dissertation database will be searched from inception to July 2023. In addition, other suitable search strategies will be used as well to complete this review. All randomized controlled trials that use the BSHX formula for RIF to apply TCM treatments externally for CKD will be included. The eligible studies will be selected to enroll by 2 independent researchers following a predetermined protocol. The review manager software (Rev-Man 5.3) will be used to assess the risk of bias, reporting bias, and data synthesis. We will compile and discuss the recent examples of the TCM BSHX formula treatment for RIF in CKD. We will provide strong evidences for evaluating the efficacy and safety of the TCM BSHX formula treatment for RIF in CKD.
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补肾活血方对慢性肾脏病患者肾脏纤维化的疗效和安全性:系统综述和荟萃分析方案
慢性肾脏病(CKD)的发病率越来越高,而终末期肾脏病中肾间质纤维化(RIF)的进展是导致各种慢性肾脏病发展的原因。治疗肾间质纤维化的方法之一是口服布参补肾汤(BSHX),它具有活血补肾的功效。目前已有关于 BSHX 治疗 RIF 的随机对照试验的报道,但尚未对其疗效和安全性进行全面研究。因此,我们的研究旨在通过系统分析和荟萃分析,描述中药配方 BSHX 口服治疗 CKD RIF 的有效性和安全性。 从开始到 2023 年 7 月,将检索 13 个数据库,包括 PubMed、EMBASE、MEDLINE、Web of Science、Cochrane Library、SpringerLink、WHO 国际临床试验注册平台、万方中国数据库、中国国家知识基础设施、中国生物医学文献数据库、中文科技期刊数据库、中国会议论文数据库和中国学位论文数据库。此外,还将采用其他合适的检索策略来完成本综述。所有使用 BSHX 方进行 RIF 中医外治法治疗 CKD 的随机对照试验都将被纳入。符合条件的研究将由两名独立研究人员按照预先确定的方案进行筛选。我们将使用综述管理软件(Rev-Man 5.3)来评估偏倚风险、报告偏倚和数据综合。 我们将汇编并讨论近期中医 BSHX 方剂治疗 CKD RIF 的实例。 我们将为评估中医 BSHX 方治疗 CKD RIF 的有效性和安全性提供有力证据。
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