摘要
目的评价芪苈强心胶囊辅助治疗急性冠脉综合征后心力衰竭的疗效及安全性。方法系统检索PubMed,Embase,Cochrane library,Sinomed,CNKI,万方等主流中英文数据库,系统收集芪苈强心胶囊治疗急性冠脉综合征后心力衰竭的临床随机对照试验,通过系统评价及meta分析的方法形成证据体,并通过证据推荐分级的评估,制定与评价系统(GRADE)评估证据体证据质量。结果经电子检索,共计纳入相关研究6篇,均为中文研究。6篇研究存在较大的偏倚风险,合并结果显示,芪苈强心胶囊联合常规抗心衰治疗,与单纯抗心衰治疗比较,可以有效改善患者6min步行距离(WMD=46.83,95%CI:34.96,58.7),改善患者左室射血分数(WMD=5.39,95%CI:3.31,7.48)和左室舒张末期内径(WMD=-5.46,95%CI:-6.86,-4.07),提高治疗有效率(RR=1.21,95%CI:1.13,1.29),差异有统计学意义。实验室指标脑钠肽(WMD=-144.10,95%CI:-196.97,-91.23)和氨基末端脑钠肽前体(WMD=-0.47,95%CI:-0.61,-0.34),差异有统计学意义。但由于纳入研究涉及关键终点指标较少,偏倚风险较大,且样本量较小,合并结果的证据质量不高,临床价值有限。结论现有的证据表明:芪苈强心胶囊联合常规治疗改善急性冠脉综合征后心衰患者相关症状的实际临床获益有限,证据质量低,安全性亦尚不明确,临床应用时尚需充分考虑患者的实际合理应用。
Objective To evaluate the efficacy and safety of Qiliqiangxin Capsule in the treatment of heart failure after acute coronary syndrome.Methods PubMed,Embase,Cochrane library,Sinomed,CNKI,Wanfang databases were systematically searched to collect clinical randomized controlled trials of Qiliqiangxin Capsules in the treatment of heart failure after acute coronary syndrome.The evidence body was developed by systematic review and meta-analysis,and the quality of the evidence body was evaluated by GRADE methodology.Results After electronic retrieval,a total of six RCTs were included,all of which were in Chinese.Six studies all had high risk of bias.The combined results showed that,comparing with conventional therapy only,Qiliqiangxin capsule combined with conventional therapy effectively improved the patient′s 6-min walking distance(WMD=46.83,95%CI:34.96,58.7),the patients′LVEF(WMD=5.39,95%CI:3.31,7.48)and LVEDD(WMD=-5.4695%CI:-6.86,-4.07),and the effective rate of treatment(RR=1.21,95%CI:1.13,1.29).The difference of them was statistically significant.Laboratory indicators of brain natriuretic peptide(WMD=-144.10,95%CI:-196.97,-91.23)and N terminal pro B type natriuretic peptide(WMD=-0.47,95%CI:-0.61,-0.34).The difference of them was statistically significant.However,included studies involved few key endpoint measures simultaneously with high risk of bias and small sample size,the quality of the body of evidence was very low,as a result of which,the clinical significance of the difference is limited.Conclusion Existing evidence showed that the actual clinical benefit of Qingliqiangxin Capsule combined with conventional treatment is limited on patients after AGS with heart failure.However,the quality of the evidence is low and the safety is still unclear.It is necessary to carefully consider the clinical settings and the condition of patients in clinical.
作者
陈昊
高锦
黄晋晨
米子硕
张禹杰
马杰
Chen Hao;Gao Jin;Huang Jinchen;Mi Zishuo;Zhang Yujie;Ma Jie(School of Health Rehabilitation,College of Acupuncture and Massage,Nanjing University of Chinese Medicine,Nanjing 210023,China;College of Nursing,Nanjing University of Chinese Medicine,Nanjing 210023,China;College of Acupuncture and Massage,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
出处
《世界科学技术-中医药现代化》
CSCD
北大核心
2022年第7期2530-2538,共9页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
上海市科学委员会面上项目(21ZR1463200):基于TGF-β1/Smad3的强心饮调控内皮间充质转化缓解心衰纤维化的效应机制研究,负责人:马杰
严世芸国医大师传承工作室建设项目,负责人:马杰
上海市卫生和健康委员会面上项目(202040484):“苍山太阳炷燎”穴位敷贴干预慢性心力衰竭临床研究,负责人:马杰。
作者简介
通讯作者:马杰,医学博士,副主任医师,硕士研究生导师,主要研究方向:中医药防治心血管疾病、代谢综合征、慢性失眠等临床研究工作。
