摘要
目的:系统评价宽胸气雾剂干预院前胸闷痛病人的临床疗效和安全性.方法:检索中文数据库[中国生物医学文献服务系统(SinoMed)、维普(VIP)、中国知网(CNKI)和万方]和英文数据库(the Cochrane Library、EMbase、PubMed、Web of Science)从建库至2022年 8月 1日发表的宽胸气雾剂治疗胸闷痛的随机对照试验研究(RCT).主要观察指标包括胸闷痛缓解率、心电图改善率和不良反应发生率.采用 RevMan 5.3软件进行偏倚风险评价、Meta分析、敏感性分析和发表偏倚分析.结果:共纳入 19 项 RCT,涉及2487例病人.Meta分析结果显示,宽胸气雾剂组(试验组)胸闷痛缓解率高于对照组,差异有统计学意义[RR=1.15,95%CI(1.06,1.25),P =0.001];心电图改善率与对照组相比差异无统计学意义[RR=1.04,95%CI(0.99,1.10),P =0.14];应用宽胸气雾剂不良反应发生率较应用硝酸甘油等常规药物低,差异有统计学意义[RR=0.41,95%CI(0.33,0.52),P<0.00001].纳入的 19 项研究中仅有 2项提及盲法(单盲),纳入文献质量偏低.结论:现有证据表明,宽胸气雾剂能提高胸闷痛缓解率,降低不良反应发生率,但心电图改善不明显.本研究纳入文献的方法学质量相对较低,仍然需要严格的、大样本的随机双盲试验加以验证宽胸气雾剂的临床疗效.
Abstract
Objective:To evaluate the clinical efficacy and safety of Kuanxiong Aerosol(KXA)in patients with chest tightness and pain pre-hospital.Methods:The Chinese database[Chinese Biomedical Literature Service System(SinoMed),China National Knowledge Infrastructure(CNKI),China Science and Technology Journal Database(VIP),Wanfang Database],and English database(PubMed,EMbase,the Cochrane Library,and Web of Science)were searched for identifying randomized controlled trials(RCTs)associated with KXA for the treatment of chest pain from the time of database establishment to 1 August,2022.Primary outcomes included chest pain relief rate,electrocardiogram(ECG)remission rate,and the incidence of adverse reactions.The Meta-analysis,risk of bias evaluation,sensitivity analysis,and publication bias were conducted by RevMan 5.3 software.Results:A total of 19 studies with 2487 patients were included.The Meta-analysis results showed that the chest tightness and pain relief rate of KXA group was higher than that of control group(RR=1.15,95%CI 1.06-1.25,P =0.001).The ECG remission rate in KXA group was not statistically significant compared with that in the control group(RR=1.04,95%CI 0.99-1.10,P =0.14).The incidence of adverse reactions in KXA group was significantly lower than that of nitroglycerin and other conventional drugs(RR=0.41,95%CI 0.33-0.52,P<0.00001).But there were 2 studies mentioned the blind method(single blind),indicating a low quality of the included literature.Conclusion:Available evidence indicates that KXA can improve the chest tightness and pain relief rate,reduce the incidence of adverse reactions,but it does not increase the ECG remission rate.The methodology and quality of included RCT in this study were relatively low,therefore,strictly-designed randomized double-blind trials with large-sample are still needed to verify the clinical efficacy of KXA.
基金项目
广东省中医院院内专项(HT2020-0974KY)
广东省中医药局科研项目(20211162)
白求恩医学科学研究基金(AX046DS)
维普
万方数据