益气活血清利法联合西药治疗特发性膜性肾病的meta分析

Clinical effect of enriching qi, activating blood circulation, clearing away dampness and heat combined with western medicine in the treatment of idiopathic membranous nephropathy: A meta-analysis

目的:客观评价中医益气活血利湿清热法(以下简称“益气活血清利法”)联合西药治疗特发性膜性肾病(idiopathic membranous nephropathy,IMN)的有效性与安全性。方法:检索中文数据库:中国知网、维普、万方、中国生物医学文献,英文数据库:Pub Med、The Cochrane Library、Medline中建库至2021年10月发表的益气活血清利法联合西药治疗IMN的随机对照临床试验研究文献,参照Cochrane Collaboration标准对文献进行质量评价,并提取试验的疗效评价指标:24 h尿蛋白定量、血清白蛋白、血肌酐、尿素氮、血清总胆固醇、甘油三酯,以及安全性评价指标:不良反应发生情况。运用Review Manager 5.3软件进行统计学分析。结果:纳入符合条件的文献14篇,纳入患者836例。Meta分析结果显示,益气活血清利法联合西药治疗IMN,对降低患者24 h尿蛋白定量[WMD=-0.97,95%CI(-1.30,-0.65),Z=5.86,P<0.001]、升高血清白蛋白[WMD=3.83,95%CI(2.10,5.57),Z=4.33,P<0.001]、降低血清总胆固醇[WMD=-0.82,95%CI(-1.08,-0.56),Z=6.18,P<0.001]、降低血清甘油三酯[WMD=-1.22,95%CI(-2.00,-0.44),Z=6.06,P<0.01]、治疗安全性[OR=0.29,95%CI(0.16,0.50),Z=4.35,P<0.001]方面优于单纯西药治疗,差异具有统计学意义(P<0.05)。但在降低血肌酐[WMD=-5.52,95%CI(-18.06,7.03),Z=0.86,P=0.39]、尿素氮[WMD=-0.90,95%CI(-2.22,0.41),Z=1.35,P=0.18]方面的作用与西药治疗组相当,差异无统计学意义(P>0.05)。结论:益气活血清利法联合西药治疗IMN的疗效确切,且较单纯西药治疗的安全性高。但因纳入的文献质量偏低,尚需要更多设计严瑾、大样本的多中心随机对照试验证实益气活血清利法联合西药治疗IMN的临床疗效。

Objective:To systemically review the efficacy and safety of enriching qi,activating blood circulation,clearing away dampness and heat combined with western medicine in the treatment of idiopathy membranous nephropathy(IMN). Methods:We collected the randomized controlled trials of IMN treated by enriching qi,activating blood circulation,clearing away dampness and heat from PubMed,the Cochrane Library,Medline,China National Knowledge Infrastructure,China Biology Medicine disc,Wanfang Data,and Wiper Databases. Bias of risk of retrieval literature was evaluated according to Cochrane Collaboration standard,and Review Manager 5.3 software was used for statistical analysis. Results:Fourteen trials(836 participants)were included in the meta-analysis. Enriching qi,activating blood circulation,clearing away dampness and heat combined with western medicine showed significant differences in reducing 24-hour urinary protein[WMD=-0.97,95%CI(-1.30,-0.65),Z=5.86,P<0.001]and elevating serum albumin[WMD=3.83,95%CI(2.10,5.57),Z=4.33,P<0.001],lowering serum cholesterol[WMD=-0.82,95%CI(-1.08,-0.56),Z=6.18,P<0.001],triglycerides[WMD=-1.22,95%CI(-2.00,-0.44),Z=6.06,P<0.01]and showed higher therapeutic safety than controls[OR=0.29,95%CI(0.16,0.50),Z=4.35,P<0.001]as compared with controls. However,there was no difference in serum creatinine[WMD=-5.52,95%CI(-18.06,7.03),Z=0.86,P=0.39]or urea nitrogen[WMD=-0.90,95%CI(-2.22,0.41),Z=1.35,P=0.18]. Conclusion:The method of enriching qi,activating blood circulation,clearing away dampness and heat combined with western medicine has certain advantages and higher safety in treating patients with IMN. However,considering inferiority of the included studies,high-quality and large-sample prospective randomized controlled trials are needed for further verification.