白晶雪, 雷根平, 王婷, 董盛, 谢炯东, 陆娴, 杨东. 中药复方治疗特发性膜性肾病的安全性及有效性网状Meta分析. 2024. biomedRxiv.202412.00003
中药复方治疗特发性膜性肾病的安全性及有效性网状Meta分析
通讯作者: 雷根平, baijingxuebtz2023@163.com
DOI:10.12201/bmr.202412.00003
Safety and effectiveness of traditional Chinese medicine compound in treating idiopathic membranous Nephropathy Network Meta-analysis
Corresponding author: Lei Genping, baijingxuebtz2023@163.com
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摘要:目的:基于中医证型系统评价不同中药复方联合常规西药改善特发性膜性肾病(idiopathic membranous nephropathy,IMN)的临床有效性及安全性。方法:计算机检索中国知网(CNKI)、万方(Wanfang)、PubMed、Web of Science等8个数据库,搜集中药复方联合常规西药治疗IMN的随机临床对照试验(randomized controlled trial,R常规西药),检索时限为建库至2023年10月。采用Cochrane偏倚风险评估工具2.0版本(RoB2.0)评价纳入文献的质量,使用Stata18.0软件进行网状Meta分析,并用累积排名曲线下的面积对6种干预措施的临床疗效和安全性进行了排序,以期为临床合理选方治疗IMN患者提供循证依据。结果:最终纳入35篇RCTs,涉及6种干预措施,包含2518例IMN患者。结论:最终纳入文献35篇,涉及2518例患者。补虚化瘀类方+常规西药对于降低24小时尿蛋白定量(SUCRA:95.3%)和总胆固醇水平(SUCRA:98.2%)作用显著;在提高总有效率方面,补虚化瘀祛湿类方+常规西药(SUCRA:71.2%)更为有效;而补虚化瘀清热祛湿类方+常规西药对于降低血肌酐(SUCRA:80.4%)和升高血清白蛋白水平(SUCRA:72.9%)效果明显;在降低M型磷脂酶A2受体抗体滴度方面,补虚类方+常规西药(SUCRA:86.0%)展现出更佳效果。在安全性方面,中药复方联合常规西药的不良反应整体少于单用常规西药。整体纳入的RCT质量偏低,在临床适用性方面还需更为严谨、大样本量RCT和基础性研究加以验证。
Abstract: Objective: To evaluate the clinical effectiveness and safety of different traditional Chinese medicine prescriptions combined with conventional western drugs to improve idiopathic membranous nephropathy (IMN) based on the Chinese medicine evidence system. METHODS: A computerized search of eight databases, including China Knowledge Network (CNKI), Wanfang, PubMed, and Web of Science, was conducted to collect randomized controlled trials (RCTs) of TCM compound formulas combined with conventional western medicines for the treatment of IMN, with a search timeframe of the period from the establishment of the database to 2023 October. The quality of the included literature was evaluated using the Cochrane Risk of Bias Assessment Tool version 2.0 (RoB2.0), reticulated Meta-analysis was performed using Stata 18.0 software, and the area under the cumulative ranking curve was used to rank the clinical efficacy and safety of the six interventions, with the aim of providing an evidence-based basis for the rational clinical selection of prescriptions for treating patients with IMN. RESULTS: Thirty-five RCTs involving 6 interventions and containing 2518 IMN patients were finally included.CONCLUSION: Thirty-five papers involving 2518 patients were finally included in the literature. The effect of the formula of tonifying deficiency and eliminating stasis + conventional western medicine was significant in lowering 24-hour urine protein quantification (SUCRA: 95.3%) and total cholesterol level (SUCRA: 98.2%); the formula of tonifying deficiency, eliminating stasis and dispelling dampness + conventional western medicine (SUCRA: 71.2%) was more effective in increasing the total effective rate; and the formula of tonifying deficiency, eliminating stasis and purging heat and dispelling dampness + conventional Western medicine was effective in lowering blood creatinine ( SUCRA: 80.4%) and increased serum albumin level (SUCRA: 72.9%), while the formula for tonifying deficiency and clearing heat and dampness and conventional western medicine was more effective in lowering M-type phospholipase A2 receptor antibody titer (SUCRA: 86.0%). In terms of safety, the adverse effects of the TCM compound formula combined with conventional western drugs were overall less than those of conventional western drugs alone. The overall quality of the included RCTs was low, and more rigorous, large-sample size RCTs and basic studies are needed to verify the clinical applicability.
Key words: Compound Chinese medicine; idiopathic membranous nephropathy; mesh Meta-analysis; 24hUTP; ALB; PLA2R; SCr; TC提交时间:2024-12-02
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序号 提交日期 编号 操作 1 2024-11-03 bmr.202412.00003V1
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