Chinese General Practice ›› 2019, Vol. 22 ›› Issue (8): 947-953.DOI: 10.12114/j.issn.1007-9572.2018.00.259

Special Issue: 泌尿系统疾病最新文章合集

• Monographic Research • Previous Articles     Next Articles

Efficacy and Safety of Bushenxiezhuo Therapy versus Allopurinol in the Treatment of Gouty Nephropathy:a Meta-analysis

  

  1. 1.Beijing University of Chinese Medicine,Beijing 100029,China
    2.Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China
    *Corresponding author:SUN Luying,Professor;E-mail:18600173188@163.com
  • Published:2019-03-15 Online:2019-03-15

补肾泄浊法对比别嘌醇治疗痛风性肾病疗效及安全性的Meta分析

  

  1. 1.100029北京市,北京中医药大学 2.100700北京市,北京中医药大学东直门医院
    *通信作者:孙鲁英,教授;E-mail:18600173188@163.com

Abstract: Background With the improvement of living standards,the prevalence of gout is increasing.Inappropriate treatment of gout may lead to gouty nephropathy (GN).In its treatment,western medicine advocates the use of allopurinol,which can reduce the level of serum uric acid,but cannot improve the pathological changes related to gouty nephropathy.In recent years,many physicians have achieved good clinical efficacy in the treatment of gouty nephropathy by Bushenxiezhuo,which means nourishing kidney and discharge waste.However,current studies are mainly based on small samples and there is still no evidence of evidence-based medicine to prove it.Objective To compare the efficacy and safety between Bushenxiezhuo therapy and allopurinol for GN.Methods  We searched CNKI,Wanfang Data,VIP,CBM,PubMed,Cochrane Library,EMBase,and printed conference proceedings as well as back issues of magazines collected in Library,Beijing University of Chinese Medicine for studies evaluating the efficacy and safety of Bushenxiezhuo therapy and allopurinol for GN published as of October 2017.Studies screening and data extraction were performed by two researchers separately.Meta-analysis was conducted with RevMan 5.3.The quality of evidence for outcome was evaluated by the GRADE system with GRADEprofiler 3.6.Results A total of 11 randomized controlled trials were included,involving 721 individuals.Meta-analysis showed that mean serum uric acid levels were similar in both Bushenxiezhuo-treated group and allopurinol-treated group 〔MD=-18.24,95%CI(-51.06,14.58),P=0.28〕;Bushenxiezhuo-treated group demonstrated much lower levels of mean serum creatinine 〔MD=-27.34,95%CI(-43.10,-11.58),P=0.000 7〕,mean blood urea nitrogen 〔MD=-1.68,95%CI(-2.15,-1.21),P<0.000 01〕,mean serum β2-microglobulin(β2-MG) 〔MD=-0.81,95%CI(-1.02,-0.59),P<0.000 01〕,and mean 24-hour urine total protein(24 hUTP)〔MD=-0.73,95%CI(-0.80,-0.67),P<0.000 01〕compared with the allopurinol-treated group;the incidence of side effects in Bushenxiezhuo-treated group was significantly lower than that of the allopurinol-treated group 〔OR=0.22,95%CI(0.07,0.67),P=0.008〕;the qualities of 24 hUTP,serum creatinine,serum β2-MG,blood uric acid,serum urea nitrogen for outcome,indicators(side effects) for safety,were moderate,low,low,very low,very low,very low,respectively.Conclusion  Our analysis found that although both Bushenxiezhuo therapy and allopurinol have similar effects on lowering blood uric acid level of GN patients,the former can better improve the renal function and reduce the urine protein level with higher safety.The qualities of indicators for outcome(24 hUTP,serum creatinine,β2-MG) and for safety need to be further verified by higher quality studies.

Key words: Gout, Nephrosis, Reinforcing kidney Xiezhuo Method, Allopurinol, Meta-analysis

摘要: 背景 随着生活水平的提高,痛风的患病率不断上升,而痛风失治、误治则致痛风性肾病。西医治疗本病主张使用别嘌醇等药物,虽可降低血尿酸水平,但无法改善痛风性肾病相关的病理改变。近年来不少医家运用补肾泄浊法治疗该病在临床上取得了一定疗效,但目前所开展的大多是小样本研究,尚缺乏循证依据证实。目的 系统评价补肾泄浊法对比别嘌醇治疗痛风性肾病的疗效及安全性。方法 计算机检索中国期刊全文数据库(CNKI)、万方数据知识服务平台、维普中文科技期刊数据库(VIP)、中国生物医学文献数据库(CBM)、PubMed、Cochrane Library、EMBase等数据库,手工补充检索北京中医药大学图书馆关于补肾泄浊法(干预组)对比别嘌醇(对照组)治疗痛风性肾病的重要会议集和过刊资料,检索截至2017年10月,由两名研究者单独筛选文献、提取资料。采用RevMan 5.3软件进行Meta分析,采用GRADEprofiler 3.6软件按照GRADE系统对Meta分析结局指标进行证据分级。结果 共纳入11篇随机对照试验,共721例痛风性肾病患者。Meta分析结果显示,干预组与对照组血尿酸水平比较,差异无统计学意义〔均数差(MD)=-18.24,95%CI(-51.06,14.58),P=0.28〕;干预组肌酐水平〔MD=-27.34,95%CI(-43.10,-11.58),P=0.000 7〕、尿素氮水平〔MD=-1.68,95%CI(-2.15,-1.21),P<0.000 01〕、β2微球蛋白(β2-MG)〔MD=-0.81,95%CI(-1.02,-0.59),P<0.000 01〕、24 h尿蛋白(24 hUTP)〔MD=-0.73,95%CI(-0.80,-0.67),P<0.000 01〕低于对照组;干预组不良反应发生率低于对照组〔比值比(OR)=0.22,95%CI(0.07,0.67),P=0.008〕。GRADE证据分级,24 hUTP为中等质量,肌酐和β2-MG为低质量,血尿酸、尿素氮和安全性指标为极低质量。结论 基于目前证据,对于痛风性肾病的治疗,补肾泄浊法为主的中药降血尿酸作用与别嘌醇相当,而改善患者肾功能、降低尿蛋白及安全性方面优于别嘌醇,且安全性更高。结局指标24 hUTP为中等质量,肌酐和β2-MG为低质量,血尿酸、尿素氮和安全性指标为极低质量,尚需高质量研究进一步验证本结论。

关键词: 痛风, 肾病, 补肾泄浊法, 别嘌醇, Meta分析