红花黄色素注射液干预Ⅲ期糖尿病肾病的系统评价
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摘要
目的系统评价红花黄色素注射液干预Ⅲ期糖尿病肾病(DN)的疗效与安全性。方法计算机检索中国知网数据库(CNKI)、万方数据库(Wanfang)、维普数据库(VIP)、中国生物医学文献数据库(CBM)、CochraneLibrary、PubMed、Medline、EMbase、Ovid,查找红花黄色素注射液干预Ⅲ期DN的相关文献,然后按照纳入、排除标准,筛选出符合条件的文献,提取文献相关数据,采用Cochrane协作网提供的RevMan 5.3软件对提取数据进行Meta分析。方法学质量评价使用Jadad评分、Riskofbias偏倚风险评测工具。结果纳入14个研究,共1067例受试者。主要结局指标显示,红花黄色素注射液降低尿白蛋白排泄率的效果尚不稳定(P>0.05),敏感性分析后(P<0.01,MD=-38.22,95%CI[-49.76,-26.67]),但能够显著降低血肌酐(P<0.01,MD=-13.45,95%CI[-20.65,-6.25]),显著提高有效率(P<0.01,OR=4.56,95%CI[2.90,7.18])。结论基于现有研究证据,红花黄色素注射液能够有效提高Ⅲ期DN患者的治疗有效率,但受限于研究质量和样本量,其研究结论仍有待进一步高质量、多中心、大样本的随机双盲试验加以证实。
Objective To systematically review the effectiveness and safety of safflower yellow pigment injection on treating stage Ⅲ diabetic nephropathy. Methods We searched journals through databases such as CNKI,WANFANG, VIP, CBM, Cochrane Library, PubMed, Medline, EMbase, Ovid about randomized controlled trials of safflower yellow pigment injection on treating stage Ⅲ diabetic nephropathy. Then we collected studies which matched our inclusion and exclusion standards and extracted data from these journals. Finally,a meta-analysis was performed to make a full systematic review by using RevMan 5.3 software. Jadad and Risk of bias tools were used for the evaluation of methodological quality. Results A total of 14 studies involving 1067 participants were included. The main outcomes of the meta-analysis showed that: compared to the conventional treatment, the safflower yellow pigment injection combined conventional treatment group had no stable result in UAER(P>0.05,after sensitive analysis,P<0.01,MD=-38.22,95% CI[-61.98,-26.21]);but had significantly lower level of Scr(P<0.01,-13.45,95%CI [-19.61,-5.60]) and higher effective rate([P<0.01,OR=4.56,95%CI [2.90,7.18]). Conclusion According to the existing evidence,safflower yellow pigment injection combined with conventional treatment could be more effective on treating stage Ⅲ diabetic nephropathy. However,as most of the included studies were regarded low qualities,more well-designed RCTs should be carried out.
Objective To systematically review the effectiveness and safety of safflower yellow pigment injection on treating stage Ⅲ diabetic nephropathy. Methods We searched journals through databases such as CNKI,WANFANG, VIP, CBM, Cochrane Library, PubMed, Medline, EMbase, Ovid about randomized controlled trials of safflower yellow pigment injection on treating stage Ⅲ diabetic nephropathy. Then we collected studies which matched our inclusion and exclusion standards and extracted data from these journals. Finally,a meta-analysis was performed to make a full systematic review by using RevMan 5.3 software. Jadad and Risk of bias tools were used for the evaluation of methodological quality. Results A total of 14 studies involving 1067 participants were included. The main outcomes of the meta-analysis showed that: compared to the conventional treatment, the safflower yellow pigment injection combined conventional treatment group had no stable result in UAER(P>0.05,after sensitive analysis,P<0.01,MD=-38.22,95% CI[-61.98,-26.21]);but had significantly lower level of Scr(P<0.01,-13.45,95%CI [-19.61,-5.60]) and higher effective rate([P<0.01,OR=4.56,95%CI [2.90,7.18]). Conclusion According to the existing evidence,safflower yellow pigment injection combined with conventional treatment could be more effective on treating stage Ⅲ diabetic nephropathy. However,as most of the included studies were regarded low qualities,more well-designed RCTs should be carried out.
引文
[1]DURU O K,MIDDLETON T,TEWARI M K,et al.The landscape of diabetic kidney disease in the United States[J].Curr Diab Rep,2018,18(3):14.
[2]SANDHOLM N,GROOP P H.Genetic basis of diabetic kidney disease and other diabetic complications[J].Curr Opin Genet Dev,2018,50:17-24.
[3]MOGENSEN C E.Microalbuminuria,blood pressure and diabetic renal disease:origin and development of ideas[J].Diabetologia,1999,42(3):263-285.
[4]HIGGINS J,ALTMAN D,STERNE J,et al.Cochrane handbook for systematic reviews of interventions version 5.1.0[BE/OL].[2018-05-01].http://www.cochranehandbook.org.
[5]邱天林,王霞,袁珺,等.注射用红花黄色素辅助治疗早期糖尿病肾病的临床效果观察[J].现代生物医学进展,2013,13(30):5975-5977.
[6]施兆明.缬沙坦联合红花黄色素对糖尿病肾病UAER及hs-CRP的影响[J].现代诊断与干预,2015,26(15):3431-3432.
[7]张闽红.红花黄色素注射液联合依那普利治疗2型糖尿病肾病早期疗效观察[J].赣南医学院学报,2014,34(6):938-939.
[8]杨丽华,杨桂芹.红花黄色素治疗2型糖尿病早期肾病的临床研究[J].临床医药实践,2010,19(8):502-503.
[9]高燕,袁鲁亮,张丽敏,等.红花黄色素联合替米沙坦治疗早期糖尿病肾病44例分析[J].贵州医药,2015,39(11):986-988.
[10]李智,王伟莉.红花黄色素联合氯沙坦钾治疗早期糖尿病肾病疗效观察[J].人民军医,2012,28(S1):27-28.
[11]鲍喜静,李建英,彭一,等.红花黄色素联合二甲双胍对早期糖尿病肾病患者NF-κB炎症信号通路的影响[J].河北医药,2017,39(11):1664-1666.
[12]鲍喜静,李建英,彭一,等.红花黄色素联合二甲双胍对早期糖尿病肾病患者氧化应激、胰岛素抵抗及肾功能的影响[J].河北医药,2017,39(12):1780-1782,1787.
[13]鲍喜静,李建英,彭一,等.红花黄色素联合二甲双胍治疗早期糖尿病肾病疗效观察[J].河北医药,2017,39(10):1508-1510.
[14]郭登洲,王月华,陈志强,等.红花黄色素粉针与贝那普利联合治疗糖尿病肾病39例疗效观察[J].中国中西医结合杂志,2008,28(4):360-363.
[15]白雪梅,李向东,宋洁,等.红花黄色素对早期糖尿病肾病患者hs-CRP、IL-8的影响[J].中国中西医结合肾病杂志,2012,13(8):698-700.
[16]方镇福.缬沙坦联合红花黄色素钠治疗糖尿病肾病蛋白尿临床研究[J].亚太传统医药,2015,11(10):134-135.
[17]高燕,袁鲁亮,郑鹏,等.红花黄色素联合贝那普利对早期糖尿病肾病患者肾功能的影响[J].现代生物医学进展,2015,15(22):4333-4336.
[18]赵换敏,赵素娇.红花黄色素联合贝那普利治疗2型糖尿病早期肾病疗效观察[J].临床合理用药杂志,2013,6(32):44-45.
[19]王一明,刘玉波,冉海鸿.红花黄色素联合二甲双胍治疗早期糖尿病肾病的疗效观察[J].中国医院用药评价与分析,2017,17(10):1370-1371,1374.
[20]张向英.注射用红花黄色素联合厄贝沙坦治疗糖尿病肾病的临床疗效观察[J].实用临床医学,2010,11(5):24-26.
[21]LI L J,LI Y M,QIAO B Y,et al.The value of safflower yellow injection for the treatment of acute cerebral infarction:A randomized controlled trial[J].Evid Based Complement Alternat Med,2015,2015:478793.
[22]杨志福,文爱东,梅其炳,等.红花黄色素在急性血癖大鼠体内的药代动力学研究[J].中药材,2001,24(10):730-732.
[23]LIU Y,TIAN X,CUI M,et al.Safflower yellow inhibits angiotensin II-induced adventitial fibroblast proliferation and migration[J].J Pharmacol Sci,2014,126(2):107-114.
[24]ZHU H,WANG X,PAN H,et al.The Mechanism by which safflower yellow decreases body fat mass andimproves insulin sensitivity in HFD-induced obese mice[J].Front Pharmacol,2016,7:127.
[2]SANDHOLM N,GROOP P H.Genetic basis of diabetic kidney disease and other diabetic complications[J].Curr Opin Genet Dev,2018,50:17-24.
[3]MOGENSEN C E.Microalbuminuria,blood pressure and diabetic renal disease:origin and development of ideas[J].Diabetologia,1999,42(3):263-285.
[4]HIGGINS J,ALTMAN D,STERNE J,et al.Cochrane handbook for systematic reviews of interventions version 5.1.0[BE/OL].[2018-05-01].http://www.cochranehandbook.org.
[5]邱天林,王霞,袁珺,等.注射用红花黄色素辅助治疗早期糖尿病肾病的临床效果观察[J].现代生物医学进展,2013,13(30):5975-5977.
[6]施兆明.缬沙坦联合红花黄色素对糖尿病肾病UAER及hs-CRP的影响[J].现代诊断与干预,2015,26(15):3431-3432.
[7]张闽红.红花黄色素注射液联合依那普利治疗2型糖尿病肾病早期疗效观察[J].赣南医学院学报,2014,34(6):938-939.
[8]杨丽华,杨桂芹.红花黄色素治疗2型糖尿病早期肾病的临床研究[J].临床医药实践,2010,19(8):502-503.
[9]高燕,袁鲁亮,张丽敏,等.红花黄色素联合替米沙坦治疗早期糖尿病肾病44例分析[J].贵州医药,2015,39(11):986-988.
[10]李智,王伟莉.红花黄色素联合氯沙坦钾治疗早期糖尿病肾病疗效观察[J].人民军医,2012,28(S1):27-28.
[11]鲍喜静,李建英,彭一,等.红花黄色素联合二甲双胍对早期糖尿病肾病患者NF-κB炎症信号通路的影响[J].河北医药,2017,39(11):1664-1666.
[12]鲍喜静,李建英,彭一,等.红花黄色素联合二甲双胍对早期糖尿病肾病患者氧化应激、胰岛素抵抗及肾功能的影响[J].河北医药,2017,39(12):1780-1782,1787.
[13]鲍喜静,李建英,彭一,等.红花黄色素联合二甲双胍治疗早期糖尿病肾病疗效观察[J].河北医药,2017,39(10):1508-1510.
[14]郭登洲,王月华,陈志强,等.红花黄色素粉针与贝那普利联合治疗糖尿病肾病39例疗效观察[J].中国中西医结合杂志,2008,28(4):360-363.
[15]白雪梅,李向东,宋洁,等.红花黄色素对早期糖尿病肾病患者hs-CRP、IL-8的影响[J].中国中西医结合肾病杂志,2012,13(8):698-700.
[16]方镇福.缬沙坦联合红花黄色素钠治疗糖尿病肾病蛋白尿临床研究[J].亚太传统医药,2015,11(10):134-135.
[17]高燕,袁鲁亮,郑鹏,等.红花黄色素联合贝那普利对早期糖尿病肾病患者肾功能的影响[J].现代生物医学进展,2015,15(22):4333-4336.
[18]赵换敏,赵素娇.红花黄色素联合贝那普利治疗2型糖尿病早期肾病疗效观察[J].临床合理用药杂志,2013,6(32):44-45.
[19]王一明,刘玉波,冉海鸿.红花黄色素联合二甲双胍治疗早期糖尿病肾病的疗效观察[J].中国医院用药评价与分析,2017,17(10):1370-1371,1374.
[20]张向英.注射用红花黄色素联合厄贝沙坦治疗糖尿病肾病的临床疗效观察[J].实用临床医学,2010,11(5):24-26.
[21]LI L J,LI Y M,QIAO B Y,et al.The value of safflower yellow injection for the treatment of acute cerebral infarction:A randomized controlled trial[J].Evid Based Complement Alternat Med,2015,2015:478793.
[22]杨志福,文爱东,梅其炳,等.红花黄色素在急性血癖大鼠体内的药代动力学研究[J].中药材,2001,24(10):730-732.
[23]LIU Y,TIAN X,CUI M,et al.Safflower yellow inhibits angiotensin II-induced adventitial fibroblast proliferation and migration[J].J Pharmacol Sci,2014,126(2):107-114.
[24]ZHU H,WANG X,PAN H,et al.The Mechanism by which safflower yellow decreases body fat mass andimproves insulin sensitivity in HFD-induced obese mice[J].Front Pharmacol,2016,7:127.