宽胸气雾剂治疗冠心病心绞痛有效性和安全性的Meta分析
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篇名: 宽胸气雾剂治疗冠心病心绞痛有效性和安全性的Meta分析
TITLE: Efficacy and Safety of Kuanxiong Aerosol in the Treatment of Coronary Heart Disease Angina :A Meta-analysis
摘要: 目的:系统评价宽胸气雾剂治疗冠心病心绞痛的疗效和安全性,为临床用药提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、Embase、中国知网、万方数据、维普网、中国生物医学文献数据库等,检索时限均为建库起至2020年3月20日,收集宽胸气雾剂(试验组)对比硝酸甘油(对照组)治疗冠心病心绞痛的随机对照试验(RCT)。筛选文献,提取资料并采用Cochrane系统评价员手册5.1.0推荐的偏倚风险评估工具评价纳入文献质量后,采用RevMan5.3软件进行Meta分析,对结果的稳定性进行敏感性分析,并采用TSA0.9软件进行序贯分析。结果:共纳入11项RCT,共计1847例患者。Meta分析结果显示,试验组患者心绞痛缓解显效率(3min内)[RR=1.11,95%CI(1.02,1.22),P=0.02]、心绞痛缓解总有效率(5min内)[RR=1.04,95%CI(1.01,1.07),P=0.01]均显著高于对照组,不良反应发生率[RR=0.44,95%CI(0.35,0.57),P<0.00001]显著低于对照组;两组患者心电图总有效率[RR=1.02,95%CI(0.97,1.09),P=0.42]、治疗后一氧化氮水平[SMD=-0.08,95%CI(-0.61,0.45),P=0.76]比较,差异均无统计学意义。敏感性和序贯分析结果均显示,宽胸气雾剂治疗冠心病心绞痛的疗效证据不确切,但安全性证据确切。结论:宽胸气雾剂可能会提高冠心病心绞痛患者的疗效,且安全性较好,但疗效结论需扩大样本量进一步证实。
ABSTRACT: OBJECTIVE:To systematically evaluate the efficacy and safety of Kuanxiong aerosol in the treatment of coronary heart disease angina ,and to provide evidence-based reference for climical drug use . METHODS :Retrieved from Cochrane Library,PubMed,Embase,CKNI,Wanfang data ,VIP,and CBM ,randomized controlled trials (RCTs)about Kuanxiong aerosol (trial group )versus nitroglycerin (control group )in the treatment of coronary heart disease angina were collected during the inception to Mar. 20th,2020. After literature screening and data extraction ,quality assessment was performed using the bias risk assessment tool recommended by the Cochrane System Evaluator Manual 5.1.0. Meta-analysis was performed by using Rev Man 5.3 statistical software. Sensitivity analysis was conducted for the stability of the result ,and trial sequential analysis (TSA)was performed by using TSA 0.9 software. RESULTS :A total of 11 RCTs were included ,with a total of 1 847 cases. Meta-analysis showed that improvement rate of angina pectoris (within 3 min)[RR=1.11,95%CI(1.02,1.22),P=0.02] and total response rate of angina pectoris (within 5 min)[RR=1.04,95% CI(1.01,1.07),P=0.01] in trial group were significantly higher than control group;the incidence of ADR [RR=0.44,95%CI(0.35,0.57),P<0.000 01] in trial group was significantly lower than control group. There was no statistical significance in total response rate of ECG [RR=1.02,95%CI(0.97,1.09),P=0.42] or the level of NO after treatment [SMD =-0.08,95%CI(-0.61,0.45),P=0.76] between 2 groups. The results of sensitiv ity analysis and TSA showed that the efficacy evidence of Kuanxiong aerosol in the treatment of coronary heart disease pectoris was not accurate ,but the evidence of safety was accurate. CONCLUSIONS :Kuanxiong aerosol can improve the efficacy in patients with coronary heart disease angina ,and the safety is better ,but the conclusions of efficacy needs to be further confirmed by enlarging sample size.
期刊: 2020年第31卷第14期
作者: 王恒生,唐耀平,邓凯烽,冯娇群,韦夏薇,刘若雅
AUTHORS: WANG Hengsheng,TANG Yaoping,DENG Kaifeng,FENG Jiaoqun,WEI Xiawei,LIU Ruoya
关键字: 宽胸气雾剂;冠心病心绞痛;硝酸甘油;Meta分析;疗效;安全性
KEYWORDS: Kuanxiong aerosol ;Coronary heart disease angina ;Nitroglycerin;Meta-analysis;Efficacy;Safety
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