益肾通络法治疗肾纤维化的Meta分析
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摘要
目的:系统评价益肾通络法治疗慢性肾脏病肾纤维化的临床疗效及安全性。方法:计算机检索中国知网数据库(CNKI)、万方数据库、重庆维普全文数据库(VIP)、中国生物医学文献数据(CBM)、PubMed、The Cochrane Library、Embase等数据库中运用中医益肾通络法治疗慢性肾脏病肾纤维化的临床文献,并辅以手工检索。检索时限为建库之日起至2017年9月。由2名研究员依据预设纳入和排除标准进行质量评价、数据资料提取,采用Cochrane协作网提供的RevMan 5.3软件进行Meta分析。结果:最终纳入15项研究,共1284例患者。与对照组相比,中医益肾通络法更有效地降低患者血清肌酐(Scr),并在降低透明质酸(HA)、血浆层黏连蛋白(LN)、血清Ⅲ型前胶原(PC-Ⅲ)、Ⅳ型胶原(C-Ⅳ)、提高临床疗效有效率等方面显示出优势,但目前证据尚不足以证明其降低BUN较对照组更为有效。所纳入的文献方法学评价质量较低,漏斗图显示不对称,可能存在发表偏倚风险。结论:益肾通络法在改善慢性肾脏病肾纤维化方面总体比单纯西药治疗有优势,值得临床推广,但仍需更多大样本、多中心、高质量的随机双盲对照临床试验进行验证。
Objective: To evaluate the clinical efficacy and safety of kidney-nourishing and collateral-activating therapy for the treatment of renal fibrosis in chronic kidney disease. Methods: We searched the databases of CNKI, Wanfang, VIP, CBM, PubMed, the Cochrane Library, Embase and other databases for clinical literature concerning renal fibrosis of chronic kidney disease treated by kidney-nourishing and collateral-activating therapy of traditional Chinese medicine, supplemented by manual retrieval. The search period was from the date of establishment to September 2017. Two investigators evaluated the quality and extracted the data according to the pre-set inclusion and exclusion criteria, followed by Meta-analysis using RevMan 5.3 software provided by the Cochrane Collaboration. Results:There were 15 studies eventually enrolled, including 1284 patients. Compared with the control group, kidney-nourishing and collateral-activating therapy could effectively reduce the serum creatinine(Scr),the levels of hyaluronic acid(HA), plasma laminin(LN), serum type III procollagen(PC-Ⅲ), type Ⅳ collagen(C-Ⅳ) in patients, subsequently improving the effectiveness of the clinical efficacy,but there was no exact evidence to suggest that reducing urea nitrogen(BUN)was superior to the control group. However, the quality of the included literature was low, indicated by methodological evaluation, and funnel charts suggested asymmetry. Therefore,there may be the risk of publication bias. Conclusion:Kidney-nourishing and collateral-activating therapy has advantages in improving the renal fibrosis of chronic kidney disease than that of Western medicine alone. It is worthy of clinical promotion. However, more large sample, multi-center and high quality randomized double-blind controlled clinical trials are needed.
Objective: To evaluate the clinical efficacy and safety of kidney-nourishing and collateral-activating therapy for the treatment of renal fibrosis in chronic kidney disease. Methods: We searched the databases of CNKI, Wanfang, VIP, CBM, PubMed, the Cochrane Library, Embase and other databases for clinical literature concerning renal fibrosis of chronic kidney disease treated by kidney-nourishing and collateral-activating therapy of traditional Chinese medicine, supplemented by manual retrieval. The search period was from the date of establishment to September 2017. Two investigators evaluated the quality and extracted the data according to the pre-set inclusion and exclusion criteria, followed by Meta-analysis using RevMan 5.3 software provided by the Cochrane Collaboration. Results:There were 15 studies eventually enrolled, including 1284 patients. Compared with the control group, kidney-nourishing and collateral-activating therapy could effectively reduce the serum creatinine(Scr),the levels of hyaluronic acid(HA), plasma laminin(LN), serum type III procollagen(PC-Ⅲ), type Ⅳ collagen(C-Ⅳ) in patients, subsequently improving the effectiveness of the clinical efficacy,but there was no exact evidence to suggest that reducing urea nitrogen(BUN)was superior to the control group. However, the quality of the included literature was low, indicated by methodological evaluation, and funnel charts suggested asymmetry. Therefore,there may be the risk of publication bias. Conclusion:Kidney-nourishing and collateral-activating therapy has advantages in improving the renal fibrosis of chronic kidney disease than that of Western medicine alone. It is worthy of clinical promotion. However, more large sample, multi-center and high quality randomized double-blind controlled clinical trials are needed.
引文
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[3] 谢席胜,李飞燕,樊均明.慢性肾脏病的中医药循证治疗[J].中国处方药,2009(3):54-56.
[4] 张东亮.基于抗组织纤维化的慢性肾脏病治疗新进展[J].首都医科大学学报,2015,36(3):333-337.
[5] 钟建,史伟,吴金玉.肾纤维化的中医机制及其干预靶点[J].辽宁中医杂志,2010,37(9):1695-1696.
[6] 王杰,何立群.“肾络癥瘕”理论指导下的肾纤维化治疗思路辨析[J].中外医学研究,2017,15(26):157-159.
[7] 钟建,赵宁博.肾纤维化络病实质及辨治探讨[J].南京中医药大学学报,2014,30(6):510-512.
[8] 高智,库宝庆,秦永芳,等.排毒合剂对慢性肾衰竭纤维化指标和肾功能影响的临床研究[J].新中医,2007,39(10):90-92.
[9] 黄东华,何红涛,檀银川.肾络通汤对慢性肾小球肾炎患者TGF-β1,MMP-9和TMP-1因子的影响[J].中国实验方剂学杂志,2017(15):196-201.
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[12] 李婧,李月红.补阳还五汤加味治疗慢性肾功能衰竭疗效观察[J].现代中西医结合杂志,2015(32):3568-3569.
[13] 李康康,张宇,马鸿杰,等.活血通络法延缓慢性肾脏病早期肾纤维化的优化方案研究[J].辽宁中医杂志,2015,42(5):916-918.
[14] 刘剑勇,杨芳,范伏元.益气活血化瘀汤治疗慢性肾炎(气虚血瘀证)30例临床观察[J].中医药导报,2007,13(8):20-22.
[15] 任飞,周家俊.活肾通络方改善慢性肾衰患者致纤维化因子临床研究[J].吉林中医药,2013,33(10):1022-1024.
[16] 王怡,何立群,郑平东.抗纤灵冲剂对慢性肾衰竭肾功能及纤维化指标影响的临床研究[J].中国中西医结合肾病杂志,2002,3(7):396-398.
[17] 吴锋,张新志,王骆冰,等.益肾止衰颗粒治疗慢性肾脏病3～5期的随机对照研究[J].中国中西医结合肾病杂志,2015(4):311-313.
[18] 杨瑞霞.扶正泄浊保肾汤治疗慢性肾功能衰竭患者的临床疗效[J].光明中医,2016,31(24):3547-3549.
[19] 张长明,周家俊,何立群,等.抗纤灵方对CKD3—4期患者疗效及机制的临床多中心随机对照研究[J].辽宁中医杂志,2013,40(1):122-124.
[20] 钟丹,杨霓芝,赵代鑫,等.中药复方“通脉口服液”治疗慢性肾炎气虚血瘀证的临床研究[J].井冈山大学学报(自然科学版),2007,28(4):88-91.
[21] 钟宏琳,李德干,蒋翎,等.补肾活血排毒方延缓慢性肾功能衰竭患者肾衰竭进程的临床研究[J].中国中医药信息杂志,2009,16(6):17-18.
[22] 朱海慧,马居里,崔娜,等.扶正泄浊保肾汤对慢性肾功能衰竭患者HA,LN的影响[J].中国实验方剂学杂志,2011,17(16):262-264.
[23] 辛冰牧,杨红振,胡卓伟.肾纤维化发病机制及治疗学研究进展[J].国际药学研究杂志,2008,35(5):349-354.
[24] Liu Y.Renal fibrosis:new insights into the pathogenesis and therapeutics[J].Kidney International,2006,69(2):213-217.
[25] 卢祖礼,王小琴.浅析肾纤维化的中医病机[J].湖北中医杂志,2004,26(11):18-19.
[26] 王杰,何立群.“肾络癥瘕”理论指导下的肾纤维化治疗思路辨析[J].中外医学研究,2017(26):157-159.
[27] 钟建,黎凤仪.益肾活血方对UUO大鼠肾脏HIF-1α、PDGF-BB、ICAM-1及VCAM-1表达的影响[J].山东中医药大学学报,2014(1):52-55.
[28] 孙世竹,孙伟.抗肾纤维化中药复方配伍规律探讨[J].中国中西医结合肾病杂志,2005,6(12):734-736.
[29] 巴元明,王林群.活血化瘀法治疗CRF的Meta分析[J].辽宁中医杂志,2014,41(2):200-204.
[30] 梁栋,王辉,王涛,等.联合检测TNF、尿β_2-MG、肝纤四项对肾纤维化无创诊断的评价[J].中国中西医结合肾病杂志,2008,9(1):91-92.
[2] 杨云华,艾维.慢性肾脏病与肾脏纤维化研究进展[J].实用医学杂志,2009,25(20):3357-3359.
[3] 谢席胜,李飞燕,樊均明.慢性肾脏病的中医药循证治疗[J].中国处方药,2009(3):54-56.
[4] 张东亮.基于抗组织纤维化的慢性肾脏病治疗新进展[J].首都医科大学学报,2015,36(3):333-337.
[5] 钟建,史伟,吴金玉.肾纤维化的中医机制及其干预靶点[J].辽宁中医杂志,2010,37(9):1695-1696.
[6] 王杰,何立群.“肾络癥瘕”理论指导下的肾纤维化治疗思路辨析[J].中外医学研究,2017,15(26):157-159.
[7] 钟建,赵宁博.肾纤维化络病实质及辨治探讨[J].南京中医药大学学报,2014,30(6):510-512.
[8] 高智,库宝庆,秦永芳,等.排毒合剂对慢性肾衰竭纤维化指标和肾功能影响的临床研究[J].新中医,2007,39(10):90-92.
[9] 黄东华,何红涛,檀银川.肾络通汤对慢性肾小球肾炎患者TGF-β1,MMP-9和TMP-1因子的影响[J].中国实验方剂学杂志,2017(15):196-201.
[10] 金亚明,殷敏,邓跃毅,等.大黄虫丸治疗肾纤维化血瘀证的临床研究[J].中国中西医结合肾病杂志,2009,10(9):788-790.
[11] 蓝健姿,严晓华,阮诗玮,等.解毒通瘀复肾汤对慢性肾衰患者尿CTGF的影响[J].康复学报,2011,21(6):13-16.
[12] 李婧,李月红.补阳还五汤加味治疗慢性肾功能衰竭疗效观察[J].现代中西医结合杂志,2015(32):3568-3569.
[13] 李康康,张宇,马鸿杰,等.活血通络法延缓慢性肾脏病早期肾纤维化的优化方案研究[J].辽宁中医杂志,2015,42(5):916-918.
[14] 刘剑勇,杨芳,范伏元.益气活血化瘀汤治疗慢性肾炎(气虚血瘀证)30例临床观察[J].中医药导报,2007,13(8):20-22.
[15] 任飞,周家俊.活肾通络方改善慢性肾衰患者致纤维化因子临床研究[J].吉林中医药,2013,33(10):1022-1024.
[16] 王怡,何立群,郑平东.抗纤灵冲剂对慢性肾衰竭肾功能及纤维化指标影响的临床研究[J].中国中西医结合肾病杂志,2002,3(7):396-398.
[17] 吴锋,张新志,王骆冰,等.益肾止衰颗粒治疗慢性肾脏病3～5期的随机对照研究[J].中国中西医结合肾病杂志,2015(4):311-313.
[18] 杨瑞霞.扶正泄浊保肾汤治疗慢性肾功能衰竭患者的临床疗效[J].光明中医,2016,31(24):3547-3549.
[19] 张长明,周家俊,何立群,等.抗纤灵方对CKD3—4期患者疗效及机制的临床多中心随机对照研究[J].辽宁中医杂志,2013,40(1):122-124.
[20] 钟丹,杨霓芝,赵代鑫,等.中药复方“通脉口服液”治疗慢性肾炎气虚血瘀证的临床研究[J].井冈山大学学报(自然科学版),2007,28(4):88-91.
[21] 钟宏琳,李德干,蒋翎,等.补肾活血排毒方延缓慢性肾功能衰竭患者肾衰竭进程的临床研究[J].中国中医药信息杂志,2009,16(6):17-18.
[22] 朱海慧,马居里,崔娜,等.扶正泄浊保肾汤对慢性肾功能衰竭患者HA,LN的影响[J].中国实验方剂学杂志,2011,17(16):262-264.
[23] 辛冰牧,杨红振,胡卓伟.肾纤维化发病机制及治疗学研究进展[J].国际药学研究杂志,2008,35(5):349-354.
[24] Liu Y.Renal fibrosis:new insights into the pathogenesis and therapeutics[J].Kidney International,2006,69(2):213-217.
[25] 卢祖礼,王小琴.浅析肾纤维化的中医病机[J].湖北中医杂志,2004,26(11):18-19.
[26] 王杰,何立群.“肾络癥瘕”理论指导下的肾纤维化治疗思路辨析[J].中外医学研究,2017(26):157-159.
[27] 钟建,黎凤仪.益肾活血方对UUO大鼠肾脏HIF-1α、PDGF-BB、ICAM-1及VCAM-1表达的影响[J].山东中医药大学学报,2014(1):52-55.
[28] 孙世竹,孙伟.抗肾纤维化中药复方配伍规律探讨[J].中国中西医结合肾病杂志,2005,6(12):734-736.
[29] 巴元明,王林群.活血化瘀法治疗CRF的Meta分析[J].辽宁中医杂志,2014,41(2):200-204.
[30] 梁栋,王辉,王涛,等.联合检测TNF、尿β_2-MG、肝纤四项对肾纤维化无创诊断的评价[J].中国中西医结合肾病杂志,2008,9(1):91-92.