中国全科医学 ›› 2021, Vol. 24 ›› Issue (26): 3359-3368.DOI: 10.12114/j.issn.1007-9572.2021.01.210

所属专题: 中医最新文章合集

• 专题研究 • 上一篇    下一篇

大株红景天注射液治疗冠心病心绞痛的有效性和安全性的系统评价

李德恒1,王天园2,3,4,张会娜2,3,4,冯硕2,3,4,胡晶2,3,4,王宏2,3,4,李博2,3,4*   

  1. 1.571700海南省儋州市,海南西部中心医院 2.100010北京市,首都医科大学附属北京中医医院 3.100010北京市,北京市中医研究所 4.100010北京市,北京中医药循证医学中心
    *通信作者:李博,副主任医师;E-mail:libo@bjzhongyi.com1
  • 出版日期:2021-09-15 发布日期:2021-09-15

Systematic Review of Efficacy and Safety of Rhodiola Wallichiana Injection in Treating Coronary Heart Disease and Angina 

LI Deheng1,WANG Tianyuan2,3,4,ZHANG Huina2,3,4,FENG Shuo2,3,4,HU Jing2,3,4,WANG Hong2,3,4,LI Bo2,3,4*   

  1. .West Central Hospital of Hainan,Danzhou 571700,China
    2.Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China
    3.Beijing Institute of Traditional Chinese Medicine,Beijing 100010,China
    4.Beijing Evidence-based Chinese Medicine Center,Beijing 100010,China
    *Corresponding author:LI Bo,Associate chief physician;E-mail:libo@bjzhongyi.com

  • Published:2021-09-15 Online:2021-09-15

摘要: 背景 冠心病心绞痛是临床常见的心血管疾病,主要由于冠状动脉供血不足引发,可损害心功能,影响患者生活质量,甚至危及到其生命。现有常规治疗有可能引起低血压、内皮功能损害、肝脏损害和肌病等不良反应,红景天及其相关制剂已逐步应用于心血管疾病治疗中,但目前对该药的系统评价还不够全面。目的 系统评价大株红景天注射液治疗冠心病心绞痛的有效性与安全性。方法 计算机检索PubMed、The Cochrane Library、EMBase、中国知网、维普网、中国生物医学文献数据库、万方数据知识服务平台等数据库,检索时间均从数据库建库至2021-01-13。收集关于大株红景天注射液治疗冠心病心绞痛的随机对照试验,由2名研究独立筛选文献,提取试验组(大株红景天联合常规治疗组)及对照组(常规治疗组)的第一作者姓名、发表时间、样本量、年龄、干预措施、疗程、结局指标等信息,其中结局指标包括心绞痛疗效、心电图疗效、血液流变学指标(高切变率下全血黏度、低切变率下全血黏度、纤维蛋白原、D-二聚体)、氧化应激标志物〔超氧化物歧化酶(SOD)、丙二醛(MDA)〕、C反应蛋白(CRP)、临床有效率、不良反应发生率等。采用Cochrane风险偏倚评估工具对纳入研究质量进行评价,采用RevMan 5.3软件进行Meta分析。结果 共纳入28篇文献,2 475例患者,文献总体质量偏低。Meta分析结果显示,试验组治疗心绞痛疗效〔RR=1.22,95%CI(1.13,1.31),P<0.000 01〕、心电图改善率〔RR=1.22,95%CI(1.16,1.29),P<0.000 01〕、改善高切变率下全血黏度效果〔MD=-1.06,95%CI(-1.20,-0.91),P<0.05〕、改善低切变率下全血黏度效果〔MD=-1.61,95%CI(-1.90,-1.31),P<0.000 01〕、改善纤维蛋白原效果〔MD=-0.36,95%CI(-0.48,-0.24),P<0.000 01〕、改善D-二聚体效果〔MD=-19.84,95%CI(-45.58,-5.91),P=0.13〕、改善SOD效果〔SMD=2.52,95%CI(2.14,2.89),P<0.000 01〕、改善MDA效果〔SMD=2.56,95%CI(-3.57,-1.56),P<0.000 01〕、改善CRP效果〔MD=-2.15,95%CI(-2.62,-1.68),P<0.000 01〕、临床有效率〔RR=1.24,95%CI(1.17,1.30),P<0.000 01〕均优于对照组,不良反应发生率低于对照组〔RR=0.68,95%CI(0.35,1.35),P=0.27〕。结论 大株红景天注射液联合常规治疗对冠心病心绞痛患者的心电图、血液流变学、CRP和氧化应激指标的改善情况可能优于常规治疗,且不良反应发生率可能低于常规治疗。

关键词: 冠心病, 心绞痛, 大株红景天注射液, Meta分析, 有效性, 安全性, 系统评价(主题)

Abstract: Background Coronary heart disease and angina is often encountered clinically,which is mainly caused by insufficient blood supply of coronary artery,impairing the cardiac function,quality of life,and even threatening the life. Existing routine treatment may produce adverse reactions such as hypotension,endothelial function damage,liver damage and myopathy. Rhodiola and its related preparations have been gradually used for cardiovascular disease,but relevant systematic evaluations are not comprehensive enough. Objective To systematically assess the efficacy and safety of Rhodiola wallichiana injection(RWI)in coronary heart disease and angina. Methods Databases of PubMed,The Cochrane Library,Embase,CNKI,CQVIP,SinoMed,and Wanfang Data were searched from inception to January 13th,2021 for randomized controlled trials(RCTs)about coronary heart disease and angina patients treated with RWI and routine therapy(experimental group)compared with those treated with routine therapy(control group). Two researchers separately screened the literature,and extracted data from the included RCTs,including the first author,time of publication,size and age of the sample,interventions,course of treatment,outcome indicators〔angina response to treatment,and electrocardiographic response to treatment,hemorheological indices(whole blood viscosity at high and low shear rates,fibrinogen,D-dimer),oxidative stress markers(SOD,malondialdehyde),C-reactive protein,clinical response rate,and incidence of adverse reactions〕. The Cochrane risk-of-bias tool was used to evaluate the methodology quality. RevMan 5.3 was used for meta-analysis. Results Altogether,28 RCTs involving 2 475 participants were finally included. The overall quality of the RCTs was rated as relatively low. Meta-analysis showed that compared with the control group,the experimental group had higher angina response to treatment〔RR=1.22,95%CI(1.13,1.31),P<0.000 01〕,higher electrocardiographic response rate to treatment〔RR=1.22,95%CI(1.16,1.29),P<0.000 01〕,greater decrease in whole blood viscosity at a high shear rate〔MD=-1.06,95%CI(-1.20,-0.91),P<0.05〕,and at a low shear rate〔MD=-1.61,95%CI(-1.90,-1.31),P<0.000 01〕,greater improvement in levels of fibrinogen〔MD=-0.36,95%CI(-0.48,-0.24),P<0.000 01〕,D-dimer〔MD=-19.84,95%CI(-45.58,-5.91),P=0.13〕,SOD〔SMD=2.52,95%CI(2.14,2.89),P<0.000 01〕,malondialdehyde 〔SMD=2.56,95%CI(-3.57,-1.56),P<0.000 01〕,and CRP〔MD=-2.15,95%CI(-2.62,-1.68),P<0.000 01〕,as well as higher clinical response rate〔RR=1.24,95%CI(1.17,1.30),P<0.000 01〕. The incidence of adverse reactions was lower in the experimental group〔RR=0.68,95%CI(0.35,1.35),P=0.27〕. Conclusion Compared to routine treatment alone,its combination with RWI may generate better effect on improving the angina response to treatment,electrocardiographic response to treatment,hemorheological indices,CRP and oxidative stress markers,with lower incidence of adverse reactions.

Key words: Coronary disease, Rhodiola wallichiana injection, Coronary heart disease and angina, Meta-analysis, Effectiveness, Security, Systematic reviews as topic