补脾益肾、化瘀消癥法治疗Ⅲ期糖尿病肾病有效性和安全性系统评价与Meta分析
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摘要
目的评价"补脾益肾、化瘀消癥"法治疗Ⅲ期糖尿病肾病的有效性和安全性。方法检索PubMed、Wiley、Ovid、Cochrane图书馆、Clinical Trials.gov、ChiCTR、中国知网、维普、中国生物医学文献数据库、万方及SIGLE数据库建库至今以"补脾益肾,化瘀消癥"法治疗Ⅲ期糖尿病肾病的临床随机对照研究,按照Cochrane手册规定方法依次对文献进行筛选、数据提取和质量评价,Meta分析采用Rev-Man 5.3软件。结果最终共纳入12篇文献,1123名Ⅲ期糖尿病肾病患者。2篇为低偏倚文章,余偏倚风险不确定。系统评价与Meta分析显示"补脾益肾、化瘀消癥"法用于Ⅲ期糖尿病肾病的治疗可提高其临床疗效[OR=4.57,95%CI(3.16,6.59)],减少UAER[SMD=-1.85,95%CI(-2.61,-1.10)],降低临床症状积分[MD=-6.72,95%CI(-8.97,-4.46)],且安全性较好,未见明显发表偏倚,结果较稳健。结论目前证据支持"补脾益肾、化瘀消癥"法可提高Ⅲ期DN的临床疗效,改善和缓解患者的临床症状,延缓其进展,且安全性较好。
Objective To evaluate the efficacy and safety of the method of "supplementing spleen and kidney, stasis-dissolving and mass-resolving" as a treatment for Ⅲ diabetic nephropathy(DN). Methods PubMed, Wiley, Ovid, Cochrane Library, Clinical Trials.gov, ChiCTR, CNKI, VIP, CBMdisc, Wanfang and SIGLE were searched to identify the clinical randomized controlled trials of using the method of "supplementing spleen and kidney, stasis-dissolving and mass-resolving" as a treatment for Ⅲ DN. The studies were selected, extracted data and assessed quality according to Cochrane Handbook. Rev-man 5.3 software was used for meta-analysis.Results According to the systematic review and meta-analysis, the method of "supplementing spleen and kidney, stasis-dissolving and mass-resolving" as a treatment for Ⅲ DN resulted in higher clinical efficacy [OR = 4.57, 95% CI(3.16, 6.59)], lower UAER [SMD =-1.85, 95% CI(-2.61,-1.10)] and clinical symptom score [MD =-6.72, 95% CI(-8.97,-4.46)], with good security rather than obvious publication bias and the results were robust.Conclusion Currently, the evidence supports that the method of "supplementing spleen and kidney, stasis-dissolving and mass-resolving" as a treatment for Ⅲ DN can incresase the clinical effects, improve and relieve the clinical symptoms, as well as delay the progression and its security is good.
Objective To evaluate the efficacy and safety of the method of "supplementing spleen and kidney, stasis-dissolving and mass-resolving" as a treatment for Ⅲ diabetic nephropathy(DN). Methods PubMed, Wiley, Ovid, Cochrane Library, Clinical Trials.gov, ChiCTR, CNKI, VIP, CBMdisc, Wanfang and SIGLE were searched to identify the clinical randomized controlled trials of using the method of "supplementing spleen and kidney, stasis-dissolving and mass-resolving" as a treatment for Ⅲ DN. The studies were selected, extracted data and assessed quality according to Cochrane Handbook. Rev-man 5.3 software was used for meta-analysis.Results According to the systematic review and meta-analysis, the method of "supplementing spleen and kidney, stasis-dissolving and mass-resolving" as a treatment for Ⅲ DN resulted in higher clinical efficacy [OR = 4.57, 95% CI(3.16, 6.59)], lower UAER [SMD =-1.85, 95% CI(-2.61,-1.10)] and clinical symptom score [MD =-6.72, 95% CI(-8.97,-4.46)], with good security rather than obvious publication bias and the results were robust.Conclusion Currently, the evidence supports that the method of "supplementing spleen and kidney, stasis-dissolving and mass-resolving" as a treatment for Ⅲ DN can incresase the clinical effects, improve and relieve the clinical symptoms, as well as delay the progression and its security is good.
引文
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[12] 白云,谢明映,黄波铃,等.养生益肾汤对早期糖尿病肾病气阴两虚证的防治研究[J].中国实验方剂学杂志,2017,23(2):169-174.
[13] 郭建忠.丹芪补肾活血汤联合洛汀新治疗早期糖尿病肾病的临床观察[D].济南:山东中医药大学,2011.
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[15] 高彦彬,赵慧玲,关崧,等.糖肾宁治疗气阴两虚、络脉瘀滞型早期糖尿病肾病临床研究[J].中华中医药杂志,2006,21(7):409-411.
[16] 周莉莉,楼晓佳.中西医结合治疗对2型早期糖尿病肾病患者血糖、肾功能和生活质量的影响[J].南京中医药大学学报,2014,30(2):124-126.
[17] 陈雪兰,丘余良,阮诗玮.益肾降浊冲剂对脾肾气虚型糖尿病肾病Ⅲ期患者尿微量白蛋白的影响[J].中国中西医结合肾病杂志,2011,12(12):1066-1068.
[18] 黄延芹,徐云生.补肾活血通络法治疗早期糖尿病肾病38例临床观察[J].中医杂志,2008,49(5):421-423.
[19] 王凤丽,陈志强,王月华,等.益气养阴消癥通络方治疗早期糖尿病肾病临床观察[J].中国中西医结合杂志,2012,32(1):35-38.
[20] 王艳,黄萍,付明捷,等.健脾益肾活血中药对早期 2 型糖尿病肾病的临床疗效分析[J].中医中药,2012,9(5):99-103.
[21] 余毅,陈杭军,林宏初,等.益气补肾活血法辅助治疗早期糖尿病肾病的临床观察[J].中国中西医结合肾病杂志,2005,6(7):389-392.
[22] 仝小林,周强,赵林华,等.糖尿病肾病的中医辨治经验[J].中华中医药杂志,2014,29(1) :144-146.
[2] ALTEMTAM N,RUSSELL J,El Nahas M.A study of the natural history of diabetic kidney disease (DKD)[J].Nephrol Dial Transplant.2012;27(5):1847-1854.
[3] SHAW JE,SICREE RA,ZIMMET PZ.Global estimates of the prevalence of diabetes for 2010 and 2030[J].Diabetes Res Clin Pract.2010;87(1):4-14.
[4] YANG W,LU J,WENG J ,et al.Prevalence of diabetes among men and women in China.N Engl J Med[J].2010;362(12):1090-1101.
[5] RUGGENENTI P,FASSI A,ILIEVA AP,et al.Preventing microalbuminuria in type 2 diabetes[J].N Engl J Med.2004;351(19):1941-1951.
[6] BRENNER BM,COOPER ME,DE Zeeuw D,et al.Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy[J].N Engl J Med.2001;345(12):861-869.
[7] 胡钢.早期糖尿病肾病的中医药治疗进展[J].湖北中医杂志,2015,37(5) :77-78.
[8] 许成群,徐明松,王元,等.健脾补肾、化瘀通络法治疗糖尿病肾病机制探讨[J].中医杂志,2011,52(11):924-926.
[9] 张兰,洒晓亮,姜维娜,等.早期糖尿病肾病中医治疗用药规律分析[J].中医临床研究,2012,4(2):25-27.
[10] 魏海霞,荆长军,刘天易.健脾益肾祛瘀汤治疗早期糖尿病肾病40例[J].中国实验方剂学杂志,2015,21(18):183-186.
[11] 林永强,王超超,沈飞霞.中西医结合治疗糖尿病肾病3期40例临床研究[J].新中医,2014,46(12):77-79.
[12] 白云,谢明映,黄波铃,等.养生益肾汤对早期糖尿病肾病气阴两虚证的防治研究[J].中国实验方剂学杂志,2017,23(2):169-174.
[13] 郭建忠.丹芪补肾活血汤联合洛汀新治疗早期糖尿病肾病的临床观察[D].济南:山东中医药大学,2011.
[14] LI P,CHEN Y,LIU J,et al.Efficacy and Safety of Tangshen Formula on Patients with Type 2 Diabetic Kidney Disease:A Multicenter Double-Blinded Randomized Placebo-Controlled Trial[J].PLoS ONE,2015,10(5):1-16.
[15] 高彦彬,赵慧玲,关崧,等.糖肾宁治疗气阴两虚、络脉瘀滞型早期糖尿病肾病临床研究[J].中华中医药杂志,2006,21(7):409-411.
[16] 周莉莉,楼晓佳.中西医结合治疗对2型早期糖尿病肾病患者血糖、肾功能和生活质量的影响[J].南京中医药大学学报,2014,30(2):124-126.
[17] 陈雪兰,丘余良,阮诗玮.益肾降浊冲剂对脾肾气虚型糖尿病肾病Ⅲ期患者尿微量白蛋白的影响[J].中国中西医结合肾病杂志,2011,12(12):1066-1068.
[18] 黄延芹,徐云生.补肾活血通络法治疗早期糖尿病肾病38例临床观察[J].中医杂志,2008,49(5):421-423.
[19] 王凤丽,陈志强,王月华,等.益气养阴消癥通络方治疗早期糖尿病肾病临床观察[J].中国中西医结合杂志,2012,32(1):35-38.
[20] 王艳,黄萍,付明捷,等.健脾益肾活血中药对早期 2 型糖尿病肾病的临床疗效分析[J].中医中药,2012,9(5):99-103.
[21] 余毅,陈杭军,林宏初,等.益气补肾活血法辅助治疗早期糖尿病肾病的临床观察[J].中国中西医结合肾病杂志,2005,6(7):389-392.
[22] 仝小林,周强,赵林华,等.糖尿病肾病的中医辨治经验[J].中华中医药杂志,2014,29(1) :144-146.