摘要
目的系统比较灯盏细辛注射液和丹参注射液治疗不稳定型心绞痛的临床有效性和安全性,并利用ITC软件间接比较二者临床疗效的差异。方法通过检索中英文数据(Pub Med、the Cochrane Library、EMBase、Medline、CNKI、CBM、VIP、万方数据库),筛选出灯盏细辛注射液和丹参注射液治疗不稳定型心绞痛的随机对照试验(Randomized controlled trials,RCTs)。采用系统评价的方法对符合纳入标准的研究进行风险评估和质量评价;用Rev Man5.3软件对研究结局指标进行直接的Meta分析,并利用间接比较法(Indirect treatment comparison,ITC)比较灯盏细辛注射液和丹参注射液治疗不稳定型心绞痛临床疗效的差异。结果(1)按照纳入和排除标准,最后共纳入30项研究,其中有关灯盏细辛注射液的20项研究和有关丹参注射液的10项研究,共涉及3050名患者;(2)Meta分析结果显示:灯盏细辛注射液联合西医常规和丹参注射液联合西医常规治疗不稳定型心绞痛的临床总有效率和心电图疗效均优于单纯西医常规治疗的情况,其中灯盏细辛注射液:心绞痛疗效[OR=3.49,95%CI=(2.69,4.54),P<0.001],心电图疗效[OR=2.56,95%CI=(2.06,3.19),P<0.001];丹参注射液:心绞痛疗效[OR=3.60,95%CI=(2.45,5.28),P<0.001],心电图疗效[OR=2.63,95%CI=(1.72,4.02),P<0.001];(3)通过间接比较得知,灯盏细辛注射液和丹参注射液在治疗不稳定型心绞痛方面的心绞痛临床疗效和心电图疗效方面均无明显差异,其中心绞痛临床疗效[OR=0.969,95%CI=(0.609,1.543),P=0.753],心电图疗效[OR=0.973,95%CI=(0.604,1.569),P=0.784];(4)安全性分析,20项有关灯盏细辛注射液的研究中有1项提及在治疗过程中出现3例干咳,10项有关丹参注射液的研究中有4项研究提及在治疗过程中出现了4例头晕头痛、1例皮疹、2例恶心、1例发热、2例腹胀等,未发生严重不良反应或不良事件。(5)倒漏斗图分析提示存在发表偏倚的可能性较小。结论
Objective To evaluate the effectiveness and safety of Erigeron breviscapus Injection(EBI)and Salvia miltiorrhiza Injection(SMI)in treating unstable angina pectoris(UAP)and indirectly compare the difference of clinical efficacy between the two injections by Indirect Treatment Comparison(ITC)analysis.Methods The randomized controlled trials(RCTs)were collected to compare EBI and SMI in the treatment of UAP by searching Chinese and English databases(PubMed,the Cochrane Library,EMBASE,MEDLINE,CNKI,CBM,VIP,and Wanfang database).Risk assessment and quality evaluation of the included studies were performed by using Cochrane systematic review.Meta-analysis was performed by RevMan 5.3 software and the indirect comparison of the difference of clinical efficacy between the two injections was performed by ITC software.Results(1)According to the inclusion and exclusion criteria,30 studies with 3,050 patients were included,including 20 studies on Erigeron breviscapus injection and 10 studies on salvia miltiorrhiza injection,involving 3050 patients.(2)Meta-analysis results showed that the total efficacy rate of angina pectoris improvement[OR=3.49,95%CI=(2.69,4.54),P<0.001]and electrocardiogram improvement[OR=2.56,95%CI=(2.06,3.19),P<0.001]in EBI were statistically significantly higher than those of control group(P<0.05);total efficacy rate of angina pectoris improvement[OR=3.60,95%CI=(2.45,5.28),P<0.001]and electrocardiogram improvement[OR=2.63,95%CI=(1-72,4.02),P<0.001]in SMI were statistically significantly higher than those of control group(P<0.05).(3)In the indirect comparison,there was no significant difference in the improvement of the total efficacy rate of angina pectoris between the two injections[OR=0.969,95%CI=(0.609,1.543),P=0.753]and no significant difference in the improvement of the electrocardiogram[OR=0.973,95%CI=(0.604,1.569),P=0.784].(4)On the safety aspect,1 of the 20 studies on EBI mentioned 3 cases of dry cough in the course of treatment;4 of the 10 studies on SMI mentioned 4 cases of dizziness and headach
作者
汤慧敏
龚俊豪
习元堂
吴辉
杨忠奇
Tang Huimin;Gong Junhao;Xi Yuantang;Wu Hui;Yang Zhongqi(The First Clinical Medical College of Guangzhou University of Traditional Chinese Medicine,Guangzhou 510405,China;The Third Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine,Guangzhou 510000,China)
出处
《世界科学技术-中医药现代化》
CSCD
北大核心
2021年第3期795-806,共12页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
国家重点研发计划课题(2018YFC1707401):注射用血栓通(冻干)治疗不稳定型心绞痛降低主要不良心血管事件发生率的临床研究,负责人:杨忠奇
国家中医药管理局第二批国家中医临床研究基地项目([2018]131号),负责人:杨忠奇。
关键词
不稳定型心绞痛
灯盏细辛注射液
丹参注射液
间接比较
META分析
Unstable angina pectoris
Erigeron breviscapus Injection
Salvia miltiorrhiza Injection
Indirect treatment comparison
Meta-analysis
