补脾益肾、通络泄浊法联合ACEI/ARB类药治疗Ⅲ～Ⅳ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、通络泄浊法联合血管紧张素转化酶抑制剂(ACEI)/血管紧张素受体阻滞剂(ARB)类药治疗Ⅲ～Ⅳ期糖尿病肾病(DN)的有效性和安全性。方法检索Cochrane图书馆、Pub Med、Wiley、Ovid、Clinical Trials. gov、Chi CTR、中国知网(CNKI)、中文科技期刊数据库(VIP)、中国生物医学文献数据库(CBM)、万方数据库、欧洲灰色文献信息系统(SIGLE)建库—2018-04以补脾益肾、通络泄浊法联合ACEI/ARB类药治疗Ⅲ～Ⅳ期DN的临床随机对照研究,按照Cochrane协作网系统评价员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。结果最终纳入15篇文献,1 460例Ⅲ～Ⅳ期DN患者。Meta分析显示补脾益肾、通络泄浊法联合ACEI/ARB类药可有效提高Ⅲ～Ⅳ期DN患者的临床疗效[优势比(OR)=4. 56,95%可信区间(CI)(3. 36,6. 17)],降低证候积分[均数差(MD)=-4. 72,95%CI(-6. 12,-3. 32)],降低24 h尿蛋白定量[标准化均数差(SMD)=-1. 15,95%CI(-1. 30,-0. 99)],降低尿白蛋白排泄率(UAER)[SMD=-2. 10,95%CI(-3. 10,-1. 10)],保护和改善患者肾功能,且安全性较好。1篇文献存在高发表偏倚,敏感性分析显示Meta结果较稳健。结论目前证据支持补脾益肾、通络泄浊法联合ACEI/ARB类西药可提高Ⅲ～Ⅳ期DN患者的临床疗效,改善和缓解临床症状,延缓病情进展,且安全性较好。
Objective To evaluate the effectiveness and safety of Bupi Yishen and Tongluo Quzhuo herbs combined with ACEI/ARB western medicine in treating stage Ⅲ ～ Ⅳ diabetic nephropathy. Methods Through search the Cochrane Library,Pub Med,Wiley,Ovid,Clinical Trials. gov,Chi CTR,CNKI,VIP,China Biomedical Literature Database( CBM),Wanfang Database,European Grey Document Information System( SIGLE) to establish a clinical randomized controlled trial of Bupi Yishen and Tongluo Quzhuo herbs combined with ACEI/ARB western medicine in the treatment of stage Ⅲ ～ Ⅳ DN,according to the method of Cochrane manual,screening,data extraction and quality evaluation. The analysis was performed using Rev-Man 5. 3 software. Results A total of 15 articles were included,and 1 460 patients with stage Ⅲ ～ Ⅳ DN were included. Meta-analysis showed that Bupi Yishen and Tongluo Xiezhuo herbs combined with ACEI/ARB western medicine can effectively improve the clinical efficacy of patients with stage Ⅲ ～ Ⅳ DN[OR = 4. 56,95% CI( 3. 36,6. 17) ],reduce TCM syndrome score [MD =-4. 72,95% CI(-6. 12,-3. 32) ],reduced 24 h urine protein [SMD =-1. 15,95% CI(-1. 30,-0. 99) ][SMD=-2. 10,95% CI(-3. 10,-1. 10) ],protects and improves renal function in patients,and is safer. One article has high publication bias,and sensitivity analysis shows that the Meta Results are more robust. Conclusion The current evidence supports that the combination of Bupi Yishen and Tongluo Xiezhuo herbs and ACEI/ARB can improve the clinical efficacy of patients with stage Ⅲ ～ Ⅳ DN,improve and relieve clinical symptoms,delay their progress,and is more safety.
Objective To evaluate the effectiveness and safety of Bupi Yishen and Tongluo Quzhuo herbs combined with ACEI/ARB western medicine in treating stage Ⅲ ～ Ⅳ diabetic nephropathy. Methods Through search the Cochrane Library,Pub Med,Wiley,Ovid,Clinical Trials. gov,Chi CTR,CNKI,VIP,China Biomedical Literature Database( CBM),Wanfang Database,European Grey Document Information System( SIGLE) to establish a clinical randomized controlled trial of Bupi Yishen and Tongluo Quzhuo herbs combined with ACEI/ARB western medicine in the treatment of stage Ⅲ ～ Ⅳ DN,according to the method of Cochrane manual,screening,data extraction and quality evaluation. The analysis was performed using Rev-Man 5. 3 software. Results A total of 15 articles were included,and 1 460 patients with stage Ⅲ ～ Ⅳ DN were included. Meta-analysis showed that Bupi Yishen and Tongluo Xiezhuo herbs combined with ACEI/ARB western medicine can effectively improve the clinical efficacy of patients with stage Ⅲ ～ Ⅳ DN[OR = 4. 56,95% CI( 3. 36,6. 17) ],reduce TCM syndrome score [MD =-4. 72,95% CI(-6. 12,-3. 32) ],reduced 24 h urine protein [SMD =-1. 15,95% CI(-1. 30,-0. 99) ][SMD=-2. 10,95% CI(-3. 10,-1. 10) ],protects and improves renal function in patients,and is safer. One article has high publication bias,and sensitivity analysis shows that the Meta Results are more robust. Conclusion The current evidence supports that the combination of Bupi Yishen and Tongluo Xiezhuo herbs and ACEI/ARB can improve the clinical efficacy of patients with stage Ⅲ ～ Ⅳ DN,improve and relieve clinical symptoms,delay their progress,and is more safety.
引文
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[12]彭书磊.健脾补肾活血法治疗糖尿病肾病的临床研究及对炎症因子的影响[D].济南:山东中医药大学,2014.
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[15]梁立革.参芪地黄汤合桃核承气汤化裁辨治气阴亏虚、瘀浊阻络证糖尿病肾病的临床研究[J].辽宁中医杂志,2016,43(10):2115-2117.
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[17]陈春菊,杜文齐.健脾益肾通络方联合缬沙坦治疗糖尿病肾病肾功能不全的疗效观察[J].陕西中医,2016,37(5):558-560.
[18]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.
[19]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.
[20] 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):e0126027.
[21]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.
[22]王雪威,南红梅.南征教授从毒损肾络说论治消渴肾病经验[J].世界中西医结合杂志,2007,2(5):254-255.
[23]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]中华医学会糖尿病学分会.中国2型糖尿病防治指南(2013年版)[J].中国糖尿病杂志,2014,22(8):21-22.
[3]孙毅宏,富丽萍.糖尿病肾病的治疗进展[J].医学综述,2015,21(17):3191-3193.
[4]俞翔,陈敏.中医药治疗糖尿病肾病的研究进展[J].现代中西医结合杂志,2016,25(25):2847-2850.
[5]江旭锋,曾庆春,黄岑汉,等.糖尿病肾病中医病因病机探要[J].河南中医,2016,36(5):924-926.
[6]中华中医药学会肾病分会.糖尿病肾病诊断、辨证分型及疗效评定标准(试行方案)[J].上海中医药杂志,2007,41(7):7-8.
[7]孙毅,张勉之.补肾活血法治疗糖尿病肾病临床期的疗效观察[J].北京中医药大学学报,2013,36(5):353-356.
[8]杨秀利.黄芪益肾汤联合西药治疗早期糖尿病肾病随机平行对照研究[J].实用中医内科杂志,2015,29(1):107-108.
[9]潘晓琼,林素珍,金斌斌,等.健脾补肾活血方对糖尿病肾病患者血清超敏C反应蛋白和肿瘤坏死因子α及尿单核细胞趋化蛋白1的影响[J].中国慢性病预防与控制,2016,24(10):734-736.
[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]刘嵘.通络益肾方联合坎地沙坦治疗糖尿病肾病临床研究[J].新中医,2015,47(3):89-92.
[12]彭书磊.健脾补肾活血法治疗糖尿病肾病的临床研究及对炎症因子的影响[D].济南:山东中医药大学,2014.
[13]郭家安,王红燕.益气养阴补肾活血方治疗早期糖尿病肾病的临床研究[J].中医学报,2013,28(9):1348-1349.
[14]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.
[15]梁立革.参芪地黄汤合桃核承气汤化裁辨治气阴亏虚、瘀浊阻络证糖尿病肾病的临床研究[J].辽宁中医杂志,2016,43(10):2115-2117.
[16]吴祖荣.卡托普利联合益肾化瘀中药治疗糖尿病肾病大量蛋白尿疗效观察[J].现代中西医结合杂志,2015,24(20):2202-2204.
[17]陈春菊,杜文齐.健脾益肾通络方联合缬沙坦治疗糖尿病肾病肾功能不全的疗效观察[J].陕西中医,2016,37(5):558-560.
[18]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.
[19]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.
[20] 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):e0126027.
[21]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.
[22]王雪威,南红梅.南征教授从毒损肾络说论治消渴肾病经验[J].世界中西医结合杂志,2007,2(5):254-255.
[23]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.