丹参酚酸制剂辅助治疗冠心病、心绞痛及脑梗死相关疾病有效性及安全性的系统评价  

Efficacy and safety of salvianolic acid preparations for adjuvant therapy on related diseases of coronary heart disease,angina and cerebral infarction:a systematic review

作　　者：张静 张恺 易湛苗[3,4] ZHANG Jing;ZHANG Kai;YI Zhanmiao(Department of Pharmacy,Beijing Yangfangdian Hospital,Beijing 100038,China;Department of Pharmacy,Beijing Tongren Hospital,Capital Medical University,Beijing 100730,China;Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,BeiJing 100191,China)

机构地区：[1]北京市羊坊店医院药剂科,北京100038 [2]首都医科大学附属北京同仁医院药学部,北京100730 [3]北京大学第三医院药学部,北京100191 [4]北京大学医学部药物评价中心,北京100191

出　　处：《中国药物警戒》2024年第8期910-915,920,I0004-I0006,共10页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(72104003)。

摘　　要：目的评价注射用丹参多酚酸盐和注射用丹参多酚酸(简称“丹参酚酸制剂”)辅助治疗冠心病、心绞痛及脑梗死相关疾病的有效性及安全性。方法检索PubMed、Embase、Cochrane Library、中国知网、万方数据、维普网等数据库,自建库起至2023年2月1日,收集丹参酚酸制剂辅助治疗冠心病、心绞痛及脑梗死相关疾病不良心血管事件的随机对照试验研究,对纳入的研究进行质量评价和Meta分析。结果共纳入16项研究,2018例患者。Meta分析结果显示,在随访180 d亚组中,丹参酚酸制剂辅助治疗冠心病、心绞痛相关疾病可显著降低主要不良心血管事件复合结局[相对危险度,RR=0.46,95%CI(0.31,0.67),P<0.001]、[NNT=12.19,95%CI(11.71,12.68)]和心绞痛[RR=0.49,95%CI(0.33,0.73),P<0.001]、[NNT=14.44,95%CI(13.88,14.99)]的发生风险,但对降低心血管死亡、心肌梗死、脑卒中、血运重建的发生风险差异无统计学意义。药品不良反应发生风险差异无统计学意义(P=0.10);不良反应主要表现为ALT/AST升高、腹胀、恶心、头晕/头痛、乏力等,各不良反应的发生风险差异无统计学意义(P=0.25)。结论在随访180 d亚组中,丹参酚酸制剂辅助治疗冠心病、心绞痛相关疾病可降低心绞痛的发生风险,且安全性良好,但尚需进一步证实。Objective To evaluate the efficacy and safety of salvianolic acid salts for injection and salvianolic acid for injection(referred to as“salvianolic acid preparations”)for adjuvant therapy on related diseases of coronary heart disease,angina and cerebral infarction.Methods Randomized controlled trials of adverse cardiovascular events of salvianolic acid preparations for adjuvant treatment on related diseases of coronary heart disease,angina and cerebral infarction were collected by searching PubMed,Embase,Cochrane Library,CNKI,WanFang Data and VIP,et al.from the inception to February 1,2023.The quality and Meta-analysis of the included studies were evaluated.Results A total of 16 RCTs involving 2018 patients were included.The results of the Meta-analysis showed that salvianolic acid preparations for adjuvant therapy on related diseases of coronary heart disease and angina could significantly reduce the risk of the composite outcomes of MACEs[RR=0.46,95%CI(0.31,0.67),P<0.001],[NNT=12.19,95%CI(11.71,12.68)]and angina[RR=0.49,95%CI(0.33,0.73),P<0.001],[NNT=14.44,95%CI(13.88,14.99)]in the 180 d follow-up subgroup,and there were no significant differences in the risk of cardiovascular death,myocardial infarction,stroke,revascularization between the intervention group and the control group.There was no statistical difference in the risk of adverse drug reactions between the intervention group and the control group(P=0.10).Major adverse drug reactions were elevated ALT/AST,abdominal distension,nausea,dizziness/headache,fatigue and so on.There was no statistical difference in the risk of various adverse drug reactions(P=0.25).Conclusion In the 180 d follow-up subgroup,salvianolic acid preparations for the adjuvant therapy on related diseases of coronary heart disease and angina could reduce the risk of angina,and were safe.But the above conclusions still need further confirmation.

关 键 词：丹参酚酸 辅助治疗 主要不良心血管事件 冠心病 心绞痛 脑梗死 系统评价 Meta分析 

分 类 号：R972[医药卫生—药品] R994.11[医药卫生—药学]