大株红景天注射液治疗心力衰竭临床疗效的Meta分析及GRADE评价  

Meta-analysis and GRADE evaluation of the clinical efficacy of Dazhu Rhodiola injection in the treatment of heart failure

作　　者：张彩旗 吴斌[2] 罗雪挺[2] Zhang Caiqi;Wu Bin;Luo Xueting(Hubei University of Traditional Chinese Medicine,Wuhan430061,China)

机构地区：[1]湖北中医药大学,湖北武汉430061 [2]湖北省中医院

出　　处：《华北理工大学学报（医学版）》2023年第2期129-139,共11页Journal of North China University of Science and Technology：Health Sciences Edition

基　　金：湖北省卫生健康委员会中医药科研项目(编号:ZY2021M063)。

摘　　要：目的评价大株红景天注射液联合西医治疗心力衰竭临床总有效率及证据质量。方法检索知网、万方、CBM、维普、Pubmed、Embase、Cochrane Library,筛选出符合纳入标准的随机对照试验并分组,中药组为观察组,单纯西医治疗为对照组,使用Cochrane评价手册、Revman 5.4及GRADE profiler软件进行分析。结果共26篇文献,Meta分析示:观察组在多项结果上优于对照组,如临床总有效率(OR=4.42,95%CI:3.33~5.86,P<0.00001);改善心功能指标中左心室射血分数LVEF(SMD=1.47,95%CI:1.15~1.80,P<0.00001)、左心室收缩末期内径LVESD(SMD=-1.03,95%CI:-1.54~-0.52,P<0.0001)、左心室舒张末期内径LVEDD(SMD=-0.95,95%CI:-1.24~0.65,P<0.00001)、左心房舒张末期内径LAEDD(MD=-6.17,95%CI:-7.06~-5.28,P<0.00001)等;改善心衰标志物N末端B型利钠肽原NT-proBNP(SMD=-4.14,95%CI:-5.42~2.86,P<0.00001)、B型利钠肽BNP(SMD=-1.62,95%CI:-2.19~-1.05,P<0.00001)等;改善6min步行试验6MWT(MD=29.15,95%CI:22.98~35.32,P<0.00001)、超敏C反应蛋白hs-CRP(SMD=-1.34,95%CI:-1.83~-0.84,P<0.00001)、中医证候(MD=-8.74,95%CI:-10.25~-7.23,P<0.00001)等。两组发生不良反应相当且均轻微(OR=0.73,95%CI:0.31~1.75,P=0.48)。按照GRADE评价标准,LAEDD为中等质量证据,改善LVEF、LVESD、LVEDD、6MWT等为低质量证据,改善总有效率、BNP、NT-ProBNP、hs-CRP、中医症状、不良反应等为极低质量证据。结论观察组治疗心力衰竭疗效优于对照组,且安全性好,改善LAEDD的可信度较稳定,但纳入文献的数量及质量有限,需要更进一步的临床设计加以验证。Objective To evaluate the clinical efficacy and evidence quality of Dazhu Hongjingtian injection or combined with western medicine in the treatment of heart failure.Methods CNKI,Wanfang,CBM,VIP,Pubmed,Embase,and Cochrane Library were searched,and randomised controlled trials that met the inclusion criteria were screened and grouped.5.4 and GRADE profiler software for analysis.Results A total of 26 literatures were published.Meta-analysis showed that the observation group was superior to the control group in many outcomes,such as the total clinical effective rate(OR=4.42,95%CI:3.33~5.86,P<0.00001);improvement in cardiac function indicators Left ventricular ejection fraction LVEF(SMD=1.47,95%CI:1.15~1.80,P<0.00001),left ventricular end-systolic diameter LVESD(SMD=-1.03,95%CI:-1.54~-0.52,P<0.0001),left ventricular end-diastolic diameter LVEDD(SMD=-0.95,95%CI:-1.24~-0.65,P<0.00001),left atrial end-diastolic diameter LAEDD(MD=-6.17,95%CI:-7.06~-5.28,P<0.00001)and so on;improve the heart failure marker N-terminal pro-B-type natriuretic peptide NT-proBNP(SMD=-4.14,95%CI:-5.42~-2.86),P<0.00001),B-type natriuretic peptide BNP(SMD=-1.62,95%CI:-2.19~-1.05,P<0.00001),etc.;improved 6-minute walk test 6MWT(MD=29.15,95%CI:22.98~35.32,P<0.00001),high-sensitivity C-reactive protein hs-CRP(SMD=-1.34,95%CI:-1.83~-0.84,P<0.00001),TCM syndrome(MD=-8.74,95%CI:-10.25~-7.23,P<0.00001)and so on.Adverse reactions occurred in the two groups were comparable and mild(OR=0.73,95%CI:0.31~1.75,P=0.48).According to the GRADE evaluation criteria,LAEDD was moderate-quality evidence,improving LVEF,LVESD,LVEDD,6MWT,etc.,were low-quality evidence,and improving total effective rate,BNP,NT-ProBNP,hs-CRP,TCM symptoms,and adverse reactions were very low-quality evidence.Conclusion The efficacy of the observation group in the treatment of heart failure is better than that of the control group,and the safety is good and the reliability of improving LAEDD is relatively stable,but the quantity and quality of the included literature are limited,and further cl

关 键 词：大株红景天注射液 心力衰竭 临床总有效率 META分析 GRADE评价 

分 类 号：R543.2[医药卫生—心血管疾病]