大株红景天注射液治疗心力衰竭临床疗效的Meta分析
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摘要
目的系统评价大株红景天注射液联合常规疗法治疗心力衰竭的临床疗效。方法计算机检索中英文数据库,收集大株红景天注射液治疗心力衰竭的临床随机对照试验(RCT)文献,检索时间为建库至2018年12月。按照Cochrane系统评价手册对纳入文献进行质量评价,运用RevMan 5.3和Stata12.0软件,对大株红景天注射液治疗心力衰竭的临床疗效进行Meta分析。结果共纳入15篇RCT文献,涉及患者1 549例。Meta分析结果显示,与常规疗法相比,大株红景天注射液联合常规疗法治疗心力衰竭有更好的综合疗效[OR=3.59,95%CI(2.45,5.26),P<0.000 01],并能提高左心室射血分数[SMD=1.10,95%CI(0.98,1.23),P<0.000 01],改善左心室舒张末期内径[SMD=-0.9,95%CI(-1.32,-0.48),P<0.000 01],降低血浆脑钠肽[SMD=-1.43,95%CI(-2.19,-0.68),P<0.000 01]和N末端B型脑钠肽前体[SMD=-4.89,95%CI(-7.50,-2.29),P<0.000 01]水平,提高6 min步行距离[MD=29.26,95%CI(20.90,37.61),P<0.000 01]。结论大株红景天注射液联合常规疗法治疗心力衰竭疗效优于单纯使用常规治疗;纳入分析的文献质量和数量有限,结论有待后续研究验证。
Objective To systematically evaluate the clinical efficacy of Sofren Injection combined with conventional therapy in treatment of heart failure. Method A computer-based search of Chinese and English databases was conducted on December 2018 to collect literatures on clinical randomized controlled trials(RCTs) with Sofren Injection in the treatment of heart failure. Quality evaluation was performed on the literatures included according to Cochrane Handbook for Systematic Reviews of Interventions. Using RevMan 5.3 and Stata 12.0, the clinical efficacy of Sofren Injection in the treatment of heart failure was analyzed by meta-analysis. Results Totally 15 RCTs with 1,549 patients were included. The results of meta-analysis showed that compared with conventional therapy, Sofren Injection combined with conventional therapy had better comprehensive efficacy in treating heart failure [OR=3.59, 95% CI(2.45, 5.26), P<0.000 01], increased the left ventricular ejection fraction(LVEF) [SMD=1.10, 95% CI(0.98, 1.23), P<0.000 01], improved the left ventricular end-diastolic diameter [SMD=-0.9, 95% CI(-1.32,-0.48), P<0.000 01], reduced the levels of plasma brain natriuretic peptide(BNP)(SMD=-1.43, 95% CI(-2.19,-0.68), P<0.000 01) and N-terminal B-type BNP precursor(SMD=-4.89, 95% CI(-7.50,-2.29), P<0.000 01), and increased the walking distance in 6-minute walking test [MD=29.26, 95% CI(20.90, 37.61), P<0.000 01]. Conclusion The efficacy of Sofren Injection combined with conventional therapy is superior to that of conventional therapy alone in treatment of heart failure. However, the quality and quantity of the literatures included in the analysis are limited, and the conclusion needs to be verified with follow-up studies.
Objective To systematically evaluate the clinical efficacy of Sofren Injection combined with conventional therapy in treatment of heart failure. Method A computer-based search of Chinese and English databases was conducted on December 2018 to collect literatures on clinical randomized controlled trials(RCTs) with Sofren Injection in the treatment of heart failure. Quality evaluation was performed on the literatures included according to Cochrane Handbook for Systematic Reviews of Interventions. Using RevMan 5.3 and Stata 12.0, the clinical efficacy of Sofren Injection in the treatment of heart failure was analyzed by meta-analysis. Results Totally 15 RCTs with 1,549 patients were included. The results of meta-analysis showed that compared with conventional therapy, Sofren Injection combined with conventional therapy had better comprehensive efficacy in treating heart failure [OR=3.59, 95% CI(2.45, 5.26), P<0.000 01], increased the left ventricular ejection fraction(LVEF) [SMD=1.10, 95% CI(0.98, 1.23), P<0.000 01], improved the left ventricular end-diastolic diameter [SMD=-0.9, 95% CI(-1.32,-0.48), P<0.000 01], reduced the levels of plasma brain natriuretic peptide(BNP)(SMD=-1.43, 95% CI(-2.19,-0.68), P<0.000 01) and N-terminal B-type BNP precursor(SMD=-4.89, 95% CI(-7.50,-2.29), P<0.000 01), and increased the walking distance in 6-minute walking test [MD=29.26, 95% CI(20.90, 37.61), P<0.000 01]. Conclusion The efficacy of Sofren Injection combined with conventional therapy is superior to that of conventional therapy alone in treatment of heart failure. However, the quality and quantity of the literatures included in the analysis are limited, and the conclusion needs to be verified with follow-up studies.
引文
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[7] 郑明华.Meta分析软件应用与实例解析[M].北京:人民卫生出版社,2013:1- 3.
[8] 程帅锋,赵士超,陈岩,等.大株红景天对慢性心力衰竭患者心功能及氧化应激反应的临床研究[J].世界最新医学信息文摘,2018,18(22):8- 9.
[9] 张远生,陈磊,陈跃武.大株红景天联合心脉隆对冠心病心力衰竭患者的疗效分析[J].辽宁中医杂志,2018,45(8):1660- 1662.
[10] 詹秋璇,赵受伟,詹荷妹.大株红景天治疗冠心病心力衰竭的疗效观察[J].临床医学工程,2017,24(2):219- 220.
[11] 吕静,时秀华,魏庆民,等.大株红景天注射液对肺栓塞心力衰竭患者右心功能的影响[J].中国老年学杂志,2018,38(13):3097- 3098.
[12] 田心,张笑铮,张广平.大株红景天注射液对冠心病心力衰竭临床观察[J].中医临床研究,2017,9(1):23- 24.
[13] 陈文生,杨立明,纪征.大株红景天注射液联合前列地尔治疗冠心病心力衰竭的疗效分析[J].辽宁中医杂志,2016,43(10):2131- 2133.
[14] 曹选超,黄改荣,段明勤,等.大株红景天注射液联合曲美他嗪片治疗冠心病心力衰竭的临床疗效[J].中国合理用药探索,2018,15(6):5- 8.
[15] 华翠娥,王达理,王经,等.大株红景天注射液联合曲美他嗪治疗冠心病心力衰竭的临床研究[J].现代药物与临床,2018,32(9):1643- 1646.
[16] 宁小康,王文丽,武向阳,等.大株红景天注射液联合重组人脑利钠肽治疗充血性心力衰竭的临床研究[J].现代药物与临床,2017,32(12):2339- 2343.
[17] 范晔,张曼,郑君君,等.大株红景天注射液联用单硝酸异山梨酯治疗顽固性心力衰竭疗效观察[J].中国药师,2017,20(12):2190- 2192.
[18] 张雯雯,张明.大株红景天注射液配合西药治疗慢性充血性心力衰竭29例[J].实用中医内科杂志,2011,25(12):33- 37.
[19] 胡威,易日霞,李朋,等.美托洛尔联合大株红景天注射液治疗粥样硬化性心脏病心力衰竭临床研究[J].中国药业,2018,12(5):59- 61.
[20] 金慧,李猛.前列地尔联合大株红景天注射液治疗冠心病心力衰竭疗效观察[J].现代中西医结合杂志,2016,25(31):3518- 3531.
[21] 石惠荣,王德伟,赵丹丹,等.大株红景天注射液治疗缺血性心肌病伴心力衰竭的效果及对血清hsCRP、VEGF的影响[J].河北医科大学学报,2016,37(2):129- 132.
[22] 林惠琴,郭志军,吴玉婷,等.大株红景天注射液对老年肺心病心衰患者右心功能的影响[J].中药材,2014,37(11):2123- 2124.
[23] 吕宝红.心力衰竭彩色多普勒超声心动图与B型脑钠肽及心功能分级的相关性[J].临床医学研究与实践,2019,4(1):18- 19.
[24] YANCY C W,JESSUP M,BOZKURT B,et al.2013 ACCF/AHA guideline for the management of heart failure a report of theAmerican college of cardiology foundation/American heart association task force on practice guidelines[J].Circulation,2013,128(16):240- 327.
[25] 侯雅竹,闫玲燕,毛静远,等.6 min步行试验在慢性心力衰竭临床评估中的应用价值[J].中国循证医学杂志,2018,18(9):907- 916.
[26] MCMURRAY J J,ADAMOPOULOS S,ANKER S D,et al.ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012:the task force for the diagnosis and treatment of acute and chronic heart failure 2012 of the European society of cardiology[J].Eur Heart Fail,2012,14(8):803- 869.
[27] 吴秀专,毕晓华,王燕芳,等.红景天苷药理作用研究进展概述[J].中国药师,2018,21(8):1460- 1462.
[28] 张俊彪,郭军霞.红景天苷对人心肌细胞缺氧损伤的保护作用及可能机制[J].中国现代医学杂志,2017,27(8):21- 26.
[29] 吴洁,尹涛,邹庆华,等.红景天苷对慢性心力衰竭大鼠心室重构及肾素血管紧张素醛固酮系统的影响[J].中国老年杂志,2016,10(36):4728- 4730.
[30] 齐江莉,李泱,解亚楠,等.红景天苷对力竭大鼠心肌收缩力的影响[J].解放军医学杂志,2018,43(6):472- 476.
[2] 中华医学会心血管病学分会.中国心力衰竭诊断和治疗指南2018[J].中华心血管病杂志,2018,45(10):746- 789.
[3] 薛博瑜,吴伟.中医内科学[M].3版.北京:人民卫生出版社,2016:94- 99.
[4] 冠心病中医临床研究联盟,中国中西医结合学会心血管疾病专业委员会,中华中医药学会心病分会,中国医师协会中西医结合医师分会心血管病学专家委员会.慢性心力衰竭中医诊疗专家共识[J].中医杂志,2014,55(14):1258- 1260.
[5] QUE Y,XIE Y M,LIAO X,et al.Systematic review on safety of sofren injection[J].China J Chin Mater Med,2016,41(20):3866- 3874.
[6] HIGGINS J P,ALTMAN D G,GOTZSCHE P C,et al.The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials[J].BMJ,2011,343(2):d5928.
[7] 郑明华.Meta分析软件应用与实例解析[M].北京:人民卫生出版社,2013:1- 3.
[8] 程帅锋,赵士超,陈岩,等.大株红景天对慢性心力衰竭患者心功能及氧化应激反应的临床研究[J].世界最新医学信息文摘,2018,18(22):8- 9.
[9] 张远生,陈磊,陈跃武.大株红景天联合心脉隆对冠心病心力衰竭患者的疗效分析[J].辽宁中医杂志,2018,45(8):1660- 1662.
[10] 詹秋璇,赵受伟,詹荷妹.大株红景天治疗冠心病心力衰竭的疗效观察[J].临床医学工程,2017,24(2):219- 220.
[11] 吕静,时秀华,魏庆民,等.大株红景天注射液对肺栓塞心力衰竭患者右心功能的影响[J].中国老年学杂志,2018,38(13):3097- 3098.
[12] 田心,张笑铮,张广平.大株红景天注射液对冠心病心力衰竭临床观察[J].中医临床研究,2017,9(1):23- 24.
[13] 陈文生,杨立明,纪征.大株红景天注射液联合前列地尔治疗冠心病心力衰竭的疗效分析[J].辽宁中医杂志,2016,43(10):2131- 2133.
[14] 曹选超,黄改荣,段明勤,等.大株红景天注射液联合曲美他嗪片治疗冠心病心力衰竭的临床疗效[J].中国合理用药探索,2018,15(6):5- 8.
[15] 华翠娥,王达理,王经,等.大株红景天注射液联合曲美他嗪治疗冠心病心力衰竭的临床研究[J].现代药物与临床,2018,32(9):1643- 1646.
[16] 宁小康,王文丽,武向阳,等.大株红景天注射液联合重组人脑利钠肽治疗充血性心力衰竭的临床研究[J].现代药物与临床,2017,32(12):2339- 2343.
[17] 范晔,张曼,郑君君,等.大株红景天注射液联用单硝酸异山梨酯治疗顽固性心力衰竭疗效观察[J].中国药师,2017,20(12):2190- 2192.
[18] 张雯雯,张明.大株红景天注射液配合西药治疗慢性充血性心力衰竭29例[J].实用中医内科杂志,2011,25(12):33- 37.
[19] 胡威,易日霞,李朋,等.美托洛尔联合大株红景天注射液治疗粥样硬化性心脏病心力衰竭临床研究[J].中国药业,2018,12(5):59- 61.
[20] 金慧,李猛.前列地尔联合大株红景天注射液治疗冠心病心力衰竭疗效观察[J].现代中西医结合杂志,2016,25(31):3518- 3531.
[21] 石惠荣,王德伟,赵丹丹,等.大株红景天注射液治疗缺血性心肌病伴心力衰竭的效果及对血清hsCRP、VEGF的影响[J].河北医科大学学报,2016,37(2):129- 132.
[22] 林惠琴,郭志军,吴玉婷,等.大株红景天注射液对老年肺心病心衰患者右心功能的影响[J].中药材,2014,37(11):2123- 2124.
[23] 吕宝红.心力衰竭彩色多普勒超声心动图与B型脑钠肽及心功能分级的相关性[J].临床医学研究与实践,2019,4(1):18- 19.
[24] YANCY C W,JESSUP M,BOZKURT B,et al.2013 ACCF/AHA guideline for the management of heart failure a report of theAmerican college of cardiology foundation/American heart association task force on practice guidelines[J].Circulation,2013,128(16):240- 327.
[25] 侯雅竹,闫玲燕,毛静远,等.6 min步行试验在慢性心力衰竭临床评估中的应用价值[J].中国循证医学杂志,2018,18(9):907- 916.
[26] MCMURRAY J J,ADAMOPOULOS S,ANKER S D,et al.ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012:the task force for the diagnosis and treatment of acute and chronic heart failure 2012 of the European society of cardiology[J].Eur Heart Fail,2012,14(8):803- 869.
[27] 吴秀专,毕晓华,王燕芳,等.红景天苷药理作用研究进展概述[J].中国药师,2018,21(8):1460- 1462.
[28] 张俊彪,郭军霞.红景天苷对人心肌细胞缺氧损伤的保护作用及可能机制[J].中国现代医学杂志,2017,27(8):21- 26.
[29] 吴洁,尹涛,邹庆华,等.红景天苷对慢性心力衰竭大鼠心室重构及肾素血管紧张素醛固酮系统的影响[J].中国老年杂志,2016,10(36):4728- 4730.
[30] 齐江莉,李泱,解亚楠,等.红景天苷对力竭大鼠心肌收缩力的影响[J].解放军医学杂志,2018,43(6):472- 476.