舒血宁注射液联合硝酸酯类药物治疗冠心病心绞痛的有效性及安全性的系统评价  

Systematic Review on Efficacy and Safety of Shuxuening Injection Combined with Nitrates in the Treatment of Angina Pectoris of Coronary Heart Disease

作　　者：张洁洁 袁漂 孟伟[1] 李金根 ZHANG Jiejie;YUAN Piao;MENG Wei;LI Jingen(Dept.of Cardiology,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]北京中医药大学东直门医院心内科,北京100700

出　　处：《中国医院用药评价与分析》2023年第11期1350-1354,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家自然科学基金青年科学基金项目(No.82004301)。

摘　　要：目的:系统评价舒血宁注射液联合硝酸酯类药物治疗冠心病心绞痛的有效性及安全性。方法:检索中国知网、万方数据库、维普数据库、中国生物医学文献数据库、PubMed、Embase、the Cochrane Library和Web of Science数据库,检索时限为建库至2022年3月,根据纳入标准进行筛选,纳入公开发表的舒血宁注射液联合硝酸酯类药物(观察组)对照单纯使用硝酸酯类药物(对照组)治疗冠心病心绞痛的随机对照试验,并提取数据。通过Cochrane系统评价员手册5.1.0进行风险偏倚评估,采用RevMan 5.3软件进行临床疗效和安全性评价。结果:纳入19篇文献,共2 250例患者(观察组1 145例,对照组1 105例),文献质量一般。Meta分析结果显示,对比单纯使用硝酸酯类药物,舒血宁注射液联合硝酸酯类药物对于冠心病心绞痛患者的心绞痛临床症状疗效显著,同时,患者全血黏度、血浆黏度、纤维蛋白原水平和血小板黏附率降低更明显,心电图异常改善更明显,上述差异均有统计学意义(P<0.01)。仅3项研究报告了不良反应,两组患者不良反应发生情况的差异无统计学意义(P=0.19)。结论:舒血宁注射液联合硝酸酯类药物治疗冠心病心绞痛,可改善临床疗效和心电图异常,降低全血黏度、血浆黏度、纤维蛋白原水平和血小板黏附率。OBJECTIVE:To systematically review the efficacy and safety of Shuxuening injection combined with nitrates in the treatment of angina pectoris of coronary heart disease.METHODS:Databases of CNKI,Wanfang Data,VIP,CBM,PubMed,Embase,the Cochrane Library and Web of Science were retrieved,with the retrieval time from the establishment of the database to Mar.2022,the published randomized controlled trials of Shuxuening injection combined with nitrates(observation group)contrasted with nitrates alone(control group)in the treatment of angina pectoris of coronary heart disease were enrolled according to the literature inclusion criteria,so that the data was extracted.The risk bias wvaluation was conducted by using Cochrane system evaluator manual 5.1.0,the clinical efficacy and safety were evaluated by using RevMan 5.3 software.RESULTS:A total of 19 studies were enrolled,including 2250 patients(1145 cases in the observation group and 1105 cases in the control group),and the literature quality was general.Results of Meta-analysis showed that compared with using nitrates alone,Shuxuening injection combined with nitrates in the treatment of angina pectoris of coronary heart disease had significantly efficacy for the clinical symptoms of angina pectoris,more significant reduction in the whole blood viscosity,plasma viscosity,fibrinogen and platelet adhesion rate,more significantly improvement in ECG abnormality,with statistically significant differences(P<0.01).Only three studies reported adverse drug reactions,and the difference in the incidences of adverse drug reactions between two groups was not statistically significant(P=0.19).CONCLUSIONS:Shuxuening injection combined with nitrates in the treatment of angina pectoris of coronary heart disease can improve the clinical efficacy and ECG abnormality,reduce the whole blood viscosity,plasma viscosity,fibrinogen level and platelet adhesion rate.

关 键 词：舒血宁注射液 硝酸甘油 硝酸异山梨酯 心绞痛 Meta分析 

分 类 号：R932[医药卫生—生药学]