苦碟子注射液与丹参注射液治疗不稳定型心绞痛患者有效性及安全性的Meta分析

Effectiveness and Safety of Kudiezi Injection and Danshen Injection in Treating Unstable Angina Pectoris:a Meta-analysis

目的评价苦碟子注射液与丹参注射液治疗不稳定型心绞痛(UAP)的有效性及安全性。方法计算机检索PubMed、EMBase、The Cochrane Library、中国知网、中国生物医学文献数据库、维普网、万方数据知识服务平台等数据库,检索时间为建库至2018-03-01;筛选有关苦碟子注射液/丹参注射液联合常规治疗UAP的随机对照试验或临床对照试验,其中苦碟子注射液组患者采用苦碟子注射液联合常规治疗,丹参注射液组患者采用丹参注射液联合常规治疗,对照组患者仅采用常规治疗。采用RevMan 5.3.0软件进行Meta分析。结果 (1)最终纳入18篇文献,均为中文文献,共包括1 839例患者。(2)Meta分析结果显示,苦碟子注射液组患者心绞痛改善总有效率[OR=4.17,95%CI(2.83,6.14)]、心电图改善总有效率[OR=2.53,95%CI(1.59,4.05)]高于对照组(P<0.05);丹参注射液组患者心绞痛改善总有效率[OR=3.60,95%CI(2.29,5.67)]、心电图改善总有效率[OR=2.40,95%CI(1.35,4.26)]高于对照组(P<0.05)。(3)6篇文献报道苦碟子注射液治疗期间未出现不良反应,其余5篇文献未报道苦碟子注射液治疗期间不良反应发生情况;1篇文献报道丹参注射液治疗期间出现发热1例、头晕2例、恶心腹胀2例,1篇文献报道丹参注射液治疗期间出现搏动性头痛2例,3篇文献报道丹参注射液治疗期间未出现不良反应,其余2篇文献未报道丹参注射液治疗期间不良反应发生情况。(4)绘制漏斗图发现,报道心绞痛改善效果的文献存在发表偏倚的可能性较小。结论现有文献证据表明,与常规治疗相比,苦碟子注射液与丹参注射液联合常规治疗均能有效提高UAP患者心绞痛改善效果及心电图改善效果,而苦碟子注射液安全性可能高于丹参注射液。

Objective To evaluate the effectiveness and safety of kudiezi injection and danshen injection in treating unstable angina pectoris(UAP).Methods PubMed,EMBase,The Cochrane Library,CNKI,CBM,VIP and Wanfang Data were searched to screen RCTs or clinical controlled trials about kudiezi injection/danshen injection combined with routine treatment in treating UAP from the establishment of database to 2018-03-01.Patients in kudiezi group received kudiezi injection combined with routine treatment,while patients in danshen group received danshen injection combined with routine treatment,patients in control group received routine treatment only.Meta-analysis was performed by RevMan 5.3 software.Results (1)Eighteen Chinese articles with 1,839 patients were included.(2)Meta-analysis results showed that,total efficacy rate of angina pectoris improvement〔OR=4.17,95%CI(2.83,6.14)〕and electrocardiogram improvement〔OR=2.53,95%CI(1.59,4.05)〕in kudiezi group were statistically significantly higher than those in the control group(P<0.05);total efficacy rate of angina pectoris improvement〔OR=3.60,95%CI(2.29,5.67)〕and electrocardiogram improvement〔OR=2.40,95%CI(1.35,4.26)〕in danshen group were statistically significantly higher than those in control group(P<0.05).(3)Six literatures reported no adverse reactions during treatment with Kudiezi injection,and the other five did not report adverse reactions during the treatment;one literature reported fever in one case,dizziness in two cases,nausea and abdominal distention in two cases during treatment with danshen injection;one literature reported pulsatile headache in two cases during treatment with danshen injection,and three literatures reported no adverse reactions during treatment with danshen injection,the other two literatures did not report adverse reactions during the treatment.(4)The funnel plot showed that,there was less possibility of publication bias in the literatures reported the improvement of angina pectoris.Conclusion Current evidences showed that,compared with routine treatment,kudiezi injection and danshen injection combined with routine treatment could improve the improvement effect of angina pectoris electrocardiogram in treating UAP,but safety of kudiezi injection is possibly higher than that of danshen injection.