补阳还五汤治疗早期糖尿病肾病的疗效及安全性的Meta分析
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摘要
补阳还五汤具有补气活血通络功效,是益气活血法中的代表方,目前用于治疗早期糖尿病肾病,但其疗效和安全性有待验证。故该研究旨在系统评价补阳还五汤治疗早期糖尿病肾病的疗效及安全性。计算机检索PubMed,EMbase,the Cochrane Library,CBM,CNKI,VIP,Wan Fang数据库,搜索补阳还五汤治疗早期糖尿病肾病的随机对照试验(RCT),检索时限从建库至2018年9月16日。由2名研究者独立筛选文献、提取资料、评价偏倚风险后,运用Rev Man 5. 3软件进行Meta分析,最终纳入15篇RCT,共计1 402例患者。Meta分析结果显示,补阳还五汤联合常规治疗组(联合治疗组)在降低24 h尿白蛋白排泄率(MD=-40. 23,95%CI[-71. 25,-9. 21],P=0. 01)、总胆固醇(MD=-0. 75,95%CI[-1. 02,-0. 48],P<0. 000 01)方面均优于常规治疗组,血肌酐(MD=-1. 48,95%CI[-4. 48,1. 53],P=0. 34) 2组疗效相当;而在降低甘油三脂方面受疗程的影响,疗程≤8周(MD=-0. 33,95%CI[-0. 97,0. 31],P=0. 31) 2组疗效相当;疗程12周(MD=-0. 30,95%CI[-0. 58,-0. 22],P=0. 03)和疗程≥16周(MD=-0. 49,95%CI[-0. 9,-0. 08],P=0. 02)联合治疗组优于常规治疗组;不良反应发生率2组间差异无统计学意义(OR=1. 38,95%CI[0. 28,6. 8],P=0. 69)。结果表明补阳还五汤联合常规治疗可显著提高防治早期糖尿病肾病的临床疗效,但受纳入研究质量的限制,上述结论尚需开展更多高质量的RCT加以验证。
Buyang Huanwu Decoction(BHD) has the effect in benefiting Qi and activating blood circulation,and is the representative prescription for benefiting Qi and activating blood. At present,it is used for treatment of early diabetic nephropathy. However,its efficacy and safety remained to be verified. Therefore,this study aims to systematically evaluate the efficacy and safety of Buyang Huanwu Decoction for early-stage diabetic nephropathy. Data of randomized controlled trials(RCTs) of Buyang Huanwu Decoction for earlystage diabetic nephropathy were collected through the retrieval of electronic databases,including PubMed,EMbase,the Cochrane Library,CBM,CNKI,VIP and Wan Fang Data from inception to September 16,2018. Two reviewers independently screened out literatures,extracted data,and assessed the risk of bias. And then Meta-analysis was conducted by Rev Man 5. 3 software. A total of 15 RCTs involving 1 402 patients were included. The results of Meta-analysis indicated that Buyang Huanwu Decoction and conventional treatment group(combination treatment group) were superior to conventional treatment group in reducing 24 h urinary albumin excretion rates(MD =-40. 23,95% CI[-71. 25,-9. 21],P = 0. 01) and total cholesterol(MD =-0. 75,95% CI[-1. 02,-0. 48],P <0. 000 01). The effects of the two groups in reducing serum creatinine were similar(MD =-1. 48,95%CI[-4. 48,1. 53],P = 0. 34).However,the reduction of triglyceride was affected by the course of treatment. The effects were similar in less than or equal to eight weeks(MD =-0. 33,95%CI[-0. 97,0. 31],P = 0. 31),whereas the combination group was superior to the conventional treatment group in 12 weeks(MD =-0. 30,95%CI[-0. 58,-0. 22],P = 0. 03) and more than or equal to 16 weeks(MD =-0. 49,95% CI[-0. 9,-0. 08],P= 0. 02). There were no significant difference in adverse events between the two groups(OR= 1. 38,95%CI[0. 28,6. 8],P = 0. 69). The results showed that combination treatment group has a significantly higher efficacy on early diabetic nephropathy.The above conclusion shall be verified with more high-quality RCTs because of the low quality of the included studies.
Buyang Huanwu Decoction(BHD) has the effect in benefiting Qi and activating blood circulation,and is the representative prescription for benefiting Qi and activating blood. At present,it is used for treatment of early diabetic nephropathy. However,its efficacy and safety remained to be verified. Therefore,this study aims to systematically evaluate the efficacy and safety of Buyang Huanwu Decoction for early-stage diabetic nephropathy. Data of randomized controlled trials(RCTs) of Buyang Huanwu Decoction for earlystage diabetic nephropathy were collected through the retrieval of electronic databases,including PubMed,EMbase,the Cochrane Library,CBM,CNKI,VIP and Wan Fang Data from inception to September 16,2018. Two reviewers independently screened out literatures,extracted data,and assessed the risk of bias. And then Meta-analysis was conducted by Rev Man 5. 3 software. A total of 15 RCTs involving 1 402 patients were included. The results of Meta-analysis indicated that Buyang Huanwu Decoction and conventional treatment group(combination treatment group) were superior to conventional treatment group in reducing 24 h urinary albumin excretion rates(MD =-40. 23,95% CI[-71. 25,-9. 21],P = 0. 01) and total cholesterol(MD =-0. 75,95% CI[-1. 02,-0. 48],P <0. 000 01). The effects of the two groups in reducing serum creatinine were similar(MD =-1. 48,95%CI[-4. 48,1. 53],P = 0. 34).However,the reduction of triglyceride was affected by the course of treatment. The effects were similar in less than or equal to eight weeks(MD =-0. 33,95%CI[-0. 97,0. 31],P = 0. 31),whereas the combination group was superior to the conventional treatment group in 12 weeks(MD =-0. 30,95%CI[-0. 58,-0. 22],P = 0. 03) and more than or equal to 16 weeks(MD =-0. 49,95% CI[-0. 9,-0. 08],P= 0. 02). There were no significant difference in adverse events between the two groups(OR= 1. 38,95%CI[0. 28,6. 8],P = 0. 69). The results showed that combination treatment group has a significantly higher efficacy on early diabetic nephropathy.The above conclusion shall be verified with more high-quality RCTs because of the low quality of the included studies.
引文
[1] Wang L,Gao P,Zhang M,et al. Prevalence and ethnic pattern of diabetes and prediabetes in China in 2013[J]. JAMA,2017,317(24):2515.
[2] Zhang L,Long J,Jiang W,et al. Trends in chronic kidney disease in China[J]. N Engl J Med,2016,375(9):905.
[3] Reutens A T,Atkins R C. Epidemiology of diabetic nephropathy[J].Contrib Nephrol,2011,170:1.
[4]中华医学会DM学分会.中国2型DM防治指南(2017年版)[J].中国实用内科杂志,2018,38(4):292.
[5]王世谦,梅勇,宋世震.补肾益气活血类中药联合RAAS阻断剂治疗早期糖尿病肾病的荟萃分析[J].时珍国医国药,2017,28(12):3068.
[6]王涓涓,邵岩,韩向莉,等.小陷胸汤合补阳还五汤治疗早期DN临床观察[J].中国实验方剂学杂志,2016,22(21):152.
[7] National Kidney Foundation. KDOQI clinical practice guideline for diabetes and CKD:2012 update[J]. Am J Kidney Dis,2012,60(5):850.
[8] Mogensen C E,Schmitz A,Christensen C K. Comparative renal pathophy siology relevant to IDDM and NIDDM patients[J]. Science,1999,286(5449):2511.
[9] WHO Consultation. Definition,diagnosis and classification of diabetes mellitus and its complications[EB/OL].[2018-10-27].http://www.oalib.com/references/11194618.
[10] Higgins J P T. Cochrane handbook for systematic reviews of interventions version 5. 1. 0[EB/OL].[2018-10-27]. http://www.handbook.coch-Rance.org/.
[11]袁艳丽.补阳还五汤对早期DN患者血脂水平及血液流变学指标的影响[J].河南医学研究,2017,26(19):3574.
[12]朱安龙.补阳还五汤联合厄贝沙坦对早期DN患者血清IL-6及TNF-α的影响[J].中国老年学杂志,2017,37(24):6075.
[13]叶程程,张爱鸣,巫小燕.补阳还五汤辅助治疗对早期DN患者的血糖控制及肾功能保护作用[J].中国生化药物杂志,2016,36(11):167.
[14]郭春芳.补阳还五汤联合贝那普利治疗早期DN临床研究[J].亚太传统医药,2015,11(6):114.
[15]何颖华.补阳还五汤联合贝那普利治疗早期DN的疗效观察[J].中外医学研究,2014,12(20):40.
[16]伊春花,张霞,王艳霞,等.补阳还五汤治疗DN疗效观察[J].中药药理与临床,2012,28(1):173.
[17]叶启铭,陈芳.补阳还五汤联合贝那普利治疗早期DN 30例[J].福建中医药,2011,42(3):7.
[18]柳传鸿,沈桂根.加味补阳还五汤治疗早期DN 34例[J].陕西中医,2010,31(5):557.
[19]李宝纯,刘树文,李青.补阳还五汤治疗Ⅲ期DN 102例临床观察[J].中国中医药科技,2009,16(2):142.
[20]叶仁群,谢嘉嘉,林国彬,等.补阳还五汤对早期DN患者血管内皮生长因子及其受体Flt-1的影响[J].中国中西医结合肾病杂志,2009,10(2):137.
[21]刘小菊,叶玉珠.补阳还五汤加减治疗早期DN 58例[J].浙江中医药大学学报,2009,33(1):75.
[22]冯琼,邵跃斌,冉建民,等.补阳还五汤联合替米沙坦治疗早期DN疗效观察[J].广东医学,2008(8):1414.
[23]王爱军.补阳还五汤加减治疗早期DN疗效观察[J].四川中医,2007(12):67.
[24]李琳.补阳还五汤加减治疗早期DN 34例临床观察[J].中医药导报,2006(6):16.
[25]贾在金,孙静,张维霞,等.糖肾气血汤辅助治疗临床期DN患者60例[J].中国中西医结合杂志,2003,23(7):542.
[26] Noori N,Tabibi H,Hosseinpanah F,et al.Effects of combined lipoic acid and pyridoxine on albuminuria,advanced glycation end-products,and blood pressure in diabetic nephropathy[J].Int J Vitam Nutr Res,2013,83(2):77.
[27]吴青华,李冰涛,涂珺.复方中药治疗糖尿病的研究进展[J].中国中药杂志,2019,44(6):1104.
[28]杨柳,李爱平,张王宁,等.黄芪及含黄芪经方在治疗肾病方面的药理作用及临床应用研究进展[J].中草药,2018,49(14):3419.
[29]尤良震,林逸轩,方朝晖,等.黄芪甲苷治疗糖尿病及其并发症药理作用研究进展[J].中国中药杂志,2017,42(24):4700.
[30]王金玉.血管紧张素转换酶抑制剂不良反应及处理方法[J].临床医学,2012,32(7):102.
[31]李作森.补阳还五汤治疗糖尿病肾病的Meta分析[J].数理医药学杂志,2011,24(5):585.
[2] Zhang L,Long J,Jiang W,et al. Trends in chronic kidney disease in China[J]. N Engl J Med,2016,375(9):905.
[3] Reutens A T,Atkins R C. Epidemiology of diabetic nephropathy[J].Contrib Nephrol,2011,170:1.
[4]中华医学会DM学分会.中国2型DM防治指南(2017年版)[J].中国实用内科杂志,2018,38(4):292.
[5]王世谦,梅勇,宋世震.补肾益气活血类中药联合RAAS阻断剂治疗早期糖尿病肾病的荟萃分析[J].时珍国医国药,2017,28(12):3068.
[6]王涓涓,邵岩,韩向莉,等.小陷胸汤合补阳还五汤治疗早期DN临床观察[J].中国实验方剂学杂志,2016,22(21):152.
[7] National Kidney Foundation. KDOQI clinical practice guideline for diabetes and CKD:2012 update[J]. Am J Kidney Dis,2012,60(5):850.
[8] Mogensen C E,Schmitz A,Christensen C K. Comparative renal pathophy siology relevant to IDDM and NIDDM patients[J]. Science,1999,286(5449):2511.
[9] WHO Consultation. Definition,diagnosis and classification of diabetes mellitus and its complications[EB/OL].[2018-10-27].http://www.oalib.com/references/11194618.
[10] Higgins J P T. Cochrane handbook for systematic reviews of interventions version 5. 1. 0[EB/OL].[2018-10-27]. http://www.handbook.coch-Rance.org/.
[11]袁艳丽.补阳还五汤对早期DN患者血脂水平及血液流变学指标的影响[J].河南医学研究,2017,26(19):3574.
[12]朱安龙.补阳还五汤联合厄贝沙坦对早期DN患者血清IL-6及TNF-α的影响[J].中国老年学杂志,2017,37(24):6075.
[13]叶程程,张爱鸣,巫小燕.补阳还五汤辅助治疗对早期DN患者的血糖控制及肾功能保护作用[J].中国生化药物杂志,2016,36(11):167.
[14]郭春芳.补阳还五汤联合贝那普利治疗早期DN临床研究[J].亚太传统医药,2015,11(6):114.
[15]何颖华.补阳还五汤联合贝那普利治疗早期DN的疗效观察[J].中外医学研究,2014,12(20):40.
[16]伊春花,张霞,王艳霞,等.补阳还五汤治疗DN疗效观察[J].中药药理与临床,2012,28(1):173.
[17]叶启铭,陈芳.补阳还五汤联合贝那普利治疗早期DN 30例[J].福建中医药,2011,42(3):7.
[18]柳传鸿,沈桂根.加味补阳还五汤治疗早期DN 34例[J].陕西中医,2010,31(5):557.
[19]李宝纯,刘树文,李青.补阳还五汤治疗Ⅲ期DN 102例临床观察[J].中国中医药科技,2009,16(2):142.
[20]叶仁群,谢嘉嘉,林国彬,等.补阳还五汤对早期DN患者血管内皮生长因子及其受体Flt-1的影响[J].中国中西医结合肾病杂志,2009,10(2):137.
[21]刘小菊,叶玉珠.补阳还五汤加减治疗早期DN 58例[J].浙江中医药大学学报,2009,33(1):75.
[22]冯琼,邵跃斌,冉建民,等.补阳还五汤联合替米沙坦治疗早期DN疗效观察[J].广东医学,2008(8):1414.
[23]王爱军.补阳还五汤加减治疗早期DN疗效观察[J].四川中医,2007(12):67.
[24]李琳.补阳还五汤加减治疗早期DN 34例临床观察[J].中医药导报,2006(6):16.
[25]贾在金,孙静,张维霞,等.糖肾气血汤辅助治疗临床期DN患者60例[J].中国中西医结合杂志,2003,23(7):542.
[26] Noori N,Tabibi H,Hosseinpanah F,et al.Effects of combined lipoic acid and pyridoxine on albuminuria,advanced glycation end-products,and blood pressure in diabetic nephropathy[J].Int J Vitam Nutr Res,2013,83(2):77.
[27]吴青华,李冰涛,涂珺.复方中药治疗糖尿病的研究进展[J].中国中药杂志,2019,44(6):1104.
[28]杨柳,李爱平,张王宁,等.黄芪及含黄芪经方在治疗肾病方面的药理作用及临床应用研究进展[J].中草药,2018,49(14):3419.
[29]尤良震,林逸轩,方朝晖,等.黄芪甲苷治疗糖尿病及其并发症药理作用研究进展[J].中国中药杂志,2017,42(24):4700.
[30]王金玉.血管紧张素转换酶抑制剂不良反应及处理方法[J].临床医学,2012,32(7):102.
[31]李作森.补阳还五汤治疗糖尿病肾病的Meta分析[J].数理医药学杂志,2011,24(5):585.