肾康注射液治疗慢性肾衰竭有效性和安全性Meta分析
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摘要
目的慢性肾衰竭(chronic renal failure,CRF)是指各种原因造成慢性进行性肾实质损害。本研究系统评价肾康注射液治疗CRF的有效性和安全性。方法检索Medline、Embase、Cochrane library、中国知网、万方和维普数据库等电子数据库中应用肾康注射液治疗慢性肾衰竭患者的随机对照试验(randomized controlled trial,RCT),检索时间均为建库至2017-12-31。结果共纳入15个RCT (n=1 054)。Meta分析结果显示,常规治疗联合肾康注射液治疗CRF能够提高总有效率(RR=1.43,95%CI为1.31～1.56,P<0.001,nRCT=11)、降低血尿素氮水平(SMD=-0.86,95%CI为-1.12～-0.60,P<0.001,nRCT=14)、降低血肌酐水平(SMD=-1.05,95%CI为-1.44～-0.67,P<0.001,nRCT=14)及降低24h尿蛋白定量水平(SMD=-0.44,95%CI为-0.55～-0.33,P<0.001,nRCT=6),以上结果差异均有统计学意义。7篇RCT报道了不良反应,其中6篇发生率均为0,1篇为8.33%。结论常规综合治疗基础上联合肾康注射液治疗慢性肾衰竭具有一定的疗效,且不增加不良反应。
OBJECTIVE Chronic renal failure(CRF)refers to chronic progressive renal parenchymal damage caused by various causes.This study systematically evaluates the efficacy and safety of Shenkang injection in the treatment of CRF.METHODS Search for randomized controlled trials(RCT)of patients with chronic renal failure treated with Shenkang injection in electronic databases such as Medline,Embase,Cochrane library,China Knowledge Network,Wanfang and Weipu Database.The search time was from database construction to same as December 31,2017.RESULTS Fifteen RCTs involving 1 054 patients were included.Meta-analysis showed that conventional treatment combined with Shenkang injection for CRF increased the total effective rate(RR=1.43,95%CI:1.31-1.56,P<0.001,nRCT=11),and reduced blood urea nitrogen level(SMD=-0.86,95%CI:-1.12--0.60,P<0.001,nRCT =14),reduced serum creatinine level(SMD=-1.05,95%CI:-1.44--0.67,P<0.001,nRCT=14)and reduced the 24-hour urine protein level(SMD=-0.44,95%CI:-0.55--0.33,P<0.001,nRCT=6).The above differences were statistically significant.The adverse drug reaction(ADR)was 0 in 6 RCTs and 8.33%in 1 RCT of 7 RCTs.CONCLUSION Routine treatment combing Shenkang injection has shown better curative effect on chronic renal failure and less adverse reactions.
OBJECTIVE Chronic renal failure(CRF)refers to chronic progressive renal parenchymal damage caused by various causes.This study systematically evaluates the efficacy and safety of Shenkang injection in the treatment of CRF.METHODS Search for randomized controlled trials(RCT)of patients with chronic renal failure treated with Shenkang injection in electronic databases such as Medline,Embase,Cochrane library,China Knowledge Network,Wanfang and Weipu Database.The search time was from database construction to same as December 31,2017.RESULTS Fifteen RCTs involving 1 054 patients were included.Meta-analysis showed that conventional treatment combined with Shenkang injection for CRF increased the total effective rate(RR=1.43,95%CI:1.31-1.56,P<0.001,nRCT=11),and reduced blood urea nitrogen level(SMD=-0.86,95%CI:-1.12--0.60,P<0.001,nRCT =14),reduced serum creatinine level(SMD=-1.05,95%CI:-1.44--0.67,P<0.001,nRCT=14)and reduced the 24-hour urine protein level(SMD=-0.44,95%CI:-0.55--0.33,P<0.001,nRCT=6).The above differences were statistically significant.The adverse drug reaction(ADR)was 0 in 6 RCTs and 8.33%in 1 RCT of 7 RCTs.CONCLUSION Routine treatment combing Shenkang injection has shown better curative effect on chronic renal failure and less adverse reactions.
引文
[1]李立,蔡琴,王栋颖,等.肾康注射液治疗慢性肾功能衰竭临床观察[J].亚太传统医药,2016,12(24):151-153.
[2] Yang J,Sun Z,Li D,et al.A novel liquid chromatography Orbitrap mass spectrometry method with full scan for simultaneous determination of multiple bioactive constituents of Shenkang injection in rat tissues:Application to tissue distribution and pharmacokinetic studies[J/CD].Biomed Chromatogr,2018,32(10):e4306.
[3] Xu T,Zuo L,Sun Z,et al.Chemical profiling and quantification of ShenKang injection,a systematic quality control strategy using ultra high performance liquid chromatography with Q Exactive hybrid quadrupole orbitrap high-resolution accurate mass spectrometry[J].J Sep Sci,2017,40(24):4872-4879.
[4]廉江平,韩珊,方志远,等.肾康注射液治疗慢性肾衰竭的有效性和安全性[J].中成药,2015,8(8):1677-1682.
[5]邓金华,张奉莲,王定勇,等.肾康注射液治疗慢性肾衰竭的Meta分析[J].现代药物与临床,2015,5(30):595-599.
[6]李爱峰,李赛.肾康注射液治疗慢性肾衰竭的系统评价[J].河南中医,2010,9(30):930-931.
[7]中西医结合学会肾脏疾病专业委员会中.慢性肾衰竭中西医结合诊疗指南[J].中国中西医结合杂志,2015,9(35):1029-1033.
[8]郑晶,肖旋,李宓.肾康注射液治疗慢性肾功能衰竭的疗效观察[J].中国误诊学杂志,2007,7(3):464-465.
[9]胡江平,申平,罗方.肾康注射液治疗慢性肾功能衰竭56例临床疗效观察[J].河南中医,2008,28(7):97-98.
[10]段勤功.肾康注射液治疗慢性肾功能衰竭疗效观察[J].基层医学论坛,2009,13(20):669.
[11]甄明富.肾康注射液治疗慢性肾衰竭35例[A].中国药理学会、同济医院《医药导报》编辑部.《医药导报》第八届编委会成立大会暨2009年度全国医药学术交流会和临床药学与药学服务研究进展培训班论文集[C].中国药理学会、同济医院《医药导报》编辑部:中国药理学会,2009:2.
[12]郝文革.肾康注射液治疗慢性肾功能衰竭临床疗效观察[J].航空航天医学杂志,2011,22(12):1456-1457.
[13]杨垒,陆星竹,唐俊,等.肾康注射液治疗慢性肾功能衰竭35例临床疗效观察[J].贵州医药,2011,35(3):257-259.
[14]行延霞.肾康注射液治疗慢性肾功能衰竭50例临床观察[J].山西医药杂志,2012,41(2):189-190.
[15]何萍,王维平,韩年华,等.肾康注射液治疗慢性肾衰竭非透析患者微炎症的疗效分析[J].右江医学,2013,41(4):499-502.
[16]李若福,王成燎,刘丰.肾康注射液治疗慢性肾功能衰竭44例[J].中国药业,2013,22(4):75-76.
[17]陈永炤.肾康注射液治疗慢性肾衰竭临床疗效观察[J].中外医学研究,2014,12(1):38-39.
[18]张佰玲.肾康注射液与前列地尔联合治疗糖尿病肾病的疗效观察[J].黑龙江医学,2014,38(4):427-428.
[19]高颖颖,张艳琴,辛小龙.肾康注射液结合前列地尔治疗慢性肾衰竭疗效观察[J].现代中西医结合杂志,2015,24(30):3388-3390.
[20]施澄洲.肾康注射液治疗慢性肾衰竭的效果分析(附20例报告)[J].世界最新医学信息文摘,2015,15(3):24,26.
[21]程可佳.肾康注射液治疗慢性肾功能衰竭的治疗效果研究[J].中国实用医药,2016,9(25):183-184.
[22]孙娅楠.肾康注射液联合护理干预对慢性肾功能衰竭患者肾功能的影响[J].海南医学院学报,2016,22(18):2126-2128.
[2] Yang J,Sun Z,Li D,et al.A novel liquid chromatography Orbitrap mass spectrometry method with full scan for simultaneous determination of multiple bioactive constituents of Shenkang injection in rat tissues:Application to tissue distribution and pharmacokinetic studies[J/CD].Biomed Chromatogr,2018,32(10):e4306.
[3] Xu T,Zuo L,Sun Z,et al.Chemical profiling and quantification of ShenKang injection,a systematic quality control strategy using ultra high performance liquid chromatography with Q Exactive hybrid quadrupole orbitrap high-resolution accurate mass spectrometry[J].J Sep Sci,2017,40(24):4872-4879.
[4]廉江平,韩珊,方志远,等.肾康注射液治疗慢性肾衰竭的有效性和安全性[J].中成药,2015,8(8):1677-1682.
[5]邓金华,张奉莲,王定勇,等.肾康注射液治疗慢性肾衰竭的Meta分析[J].现代药物与临床,2015,5(30):595-599.
[6]李爱峰,李赛.肾康注射液治疗慢性肾衰竭的系统评价[J].河南中医,2010,9(30):930-931.
[7]中西医结合学会肾脏疾病专业委员会中.慢性肾衰竭中西医结合诊疗指南[J].中国中西医结合杂志,2015,9(35):1029-1033.
[8]郑晶,肖旋,李宓.肾康注射液治疗慢性肾功能衰竭的疗效观察[J].中国误诊学杂志,2007,7(3):464-465.
[9]胡江平,申平,罗方.肾康注射液治疗慢性肾功能衰竭56例临床疗效观察[J].河南中医,2008,28(7):97-98.
[10]段勤功.肾康注射液治疗慢性肾功能衰竭疗效观察[J].基层医学论坛,2009,13(20):669.
[11]甄明富.肾康注射液治疗慢性肾衰竭35例[A].中国药理学会、同济医院《医药导报》编辑部.《医药导报》第八届编委会成立大会暨2009年度全国医药学术交流会和临床药学与药学服务研究进展培训班论文集[C].中国药理学会、同济医院《医药导报》编辑部:中国药理学会,2009:2.
[12]郝文革.肾康注射液治疗慢性肾功能衰竭临床疗效观察[J].航空航天医学杂志,2011,22(12):1456-1457.
[13]杨垒,陆星竹,唐俊,等.肾康注射液治疗慢性肾功能衰竭35例临床疗效观察[J].贵州医药,2011,35(3):257-259.
[14]行延霞.肾康注射液治疗慢性肾功能衰竭50例临床观察[J].山西医药杂志,2012,41(2):189-190.
[15]何萍,王维平,韩年华,等.肾康注射液治疗慢性肾衰竭非透析患者微炎症的疗效分析[J].右江医学,2013,41(4):499-502.
[16]李若福,王成燎,刘丰.肾康注射液治疗慢性肾功能衰竭44例[J].中国药业,2013,22(4):75-76.
[17]陈永炤.肾康注射液治疗慢性肾衰竭临床疗效观察[J].中外医学研究,2014,12(1):38-39.
[18]张佰玲.肾康注射液与前列地尔联合治疗糖尿病肾病的疗效观察[J].黑龙江医学,2014,38(4):427-428.
[19]高颖颖,张艳琴,辛小龙.肾康注射液结合前列地尔治疗慢性肾衰竭疗效观察[J].现代中西医结合杂志,2015,24(30):3388-3390.
[20]施澄洲.肾康注射液治疗慢性肾衰竭的效果分析(附20例报告)[J].世界最新医学信息文摘,2015,15(3):24,26.
[21]程可佳.肾康注射液治疗慢性肾功能衰竭的治疗效果研究[J].中国实用医药,2016,9(25):183-184.
[22]孙娅楠.肾康注射液联合护理干预对慢性肾功能衰竭患者肾功能的影响[J].海南医学院学报,2016,22(18):2126-2128.