Yu Guang, Guo Mao, Zou Junju, Zhou Xiaotao, Ma Yuerong
College of Basic Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu.
Pain Clinic, The People's Hospital of Luzhou, Luzhou.
Medicine (Baltimore). 2020 Sep 18;99(38):e22181. doi: 10.1097/MD.0000000000022181.
By now, the incidence of chronic kidney disease (CKD) is increasing. The development of various CKD is attributed to the continuous aggravation of renal interstitial fibrosis (RIF) in the process of end-stage renal disease (ESRD). Oral treatment of traditional Chinese medicine (TCM) is one of the therapies for RIF. Randomized controlled trials (RCTs) of TCM treatment RIF have been reported, but its effectiveness and safety have yet been systematically investigated. Therefore, through the systematic analysis and meta-analysis, our study will summarize the effectiveness and safety of oral treatment RIF of TCM, in order to provides scientific reference for clinical practice.
This protocol follows Preferred Reporting Items for Systematic Evaluation and Meta-Analysis. RCTs will be only selected. Such databases as the PubMed, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Excerpt Medical Database (Embase), WanFan Data, Chinese Biomedical Literature Database (CBM), WHO International Clinical Trials Registry Platform will be searched from the inception to June, 2020 to collect the RCTs about taking TCM orally in treating RIF. The literature according to the inclusion and exclusion criteria, data-extracted and the methodological quality evaluated will be performed independently by 2 reviewers. The clinical outcomes including renal function indices (Scr, BUN, 24-hour urinary protein quantity) and Indicators of RIF (TGF-β1, Notch1, Jagged-1). The risk of bias included in the RCTs will be evaluated by the bias risk assessment tool provided in the Cochrane System Evaluation Manual 5.1.0. Review Manager 5.3 provided by the Cochrane collaboration network will be used to process the data.
Some more targeted and practical results about the efficacy of taking TCM orally in RIF have been provided by our study. The available evidence suggests that the therapeutic effects of combining TCM with Western medicine therapies is much better for RIF than Western medicine therapies only.
目前,慢性肾脏病(CKD)的发病率正在上升。各种CKD的发展归因于终末期肾病(ESRD)过程中肾间质纤维化(RIF)的持续加重。口服中药是治疗RIF的疗法之一。已有关于中药治疗RIF的随机对照试验(RCT)报道,但其有效性和安全性尚未得到系统研究。因此,通过系统分析和荟萃分析,我们的研究将总结口服中药治疗RIF的有效性和安全性,以便为临床实践提供科学参考。
本方案遵循系统评价和荟萃分析的首选报告项目。仅选择RCT。将检索PubMed、中国知网(CNKI)、维普中文科技期刊数据库(VIP)、荷兰医学文摘数据库(Embase)、万方数据、中国生物医学文献数据库(CBM)、世界卫生组织国际临床试验注册平台等数据库,从建库至2020年6月,收集关于口服中药治疗RIF的RCT。由2名评价员独立根据纳入和排除标准进行文献筛选、数据提取和方法学质量评价。临床结局包括肾功能指标(Scr、BUN、24小时尿蛋白量)和RIF指标(TGF-β1、Notch1、Jagged-1)。将采用Cochrane系统评价手册5.1.0中提供的偏倚风险评估工具评估RCT中存在的偏倚风险。将使用Cochrane协作网提供的Review Manager 5.3对数据进行处理。
我们的研究提供了一些关于口服中药治疗RIF疗效更具针对性和实用性的结果。现有证据表明,中西医结合治疗RIF的疗效优于单纯西医治疗。