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稳心颗粒联合美托洛尔治疗功能性室性期前收缩的临床随机对照试验系统评价
The System Evaluation of Clinical Randomized Controlled Trials of Wenxin Keli and Metoprolol in the Treatment of Functional Ventricular Premature Contraction
【作者】 刘青;
【导师】 韩震;
【作者基本信息】 成都中医药大学 , 中西医结合临床, 2015, 硕士
【摘要】 目的:评价中成药稳心颗粒联合西药美托洛尔治疗功能性室性期前收缩的疗效和安全性。资料:收集目前国内外已发表的稳心颗粒联合美托洛尔治疗功能性室性期前收缩的中英文临床随机对照试验(RCT)相关文献,根据循证医学的方法来评价稳心颗粒联合美托洛尔治疗功能性室性期前收缩的临床疗效及其安全性,从而为中西医结合治疗功能性室性期前收缩的临床应用提供循证医学证据,为临床深入研究中西医结合治疗室性心律失常的可行性提供依据。实施方法:按照检索关键词“稳心颗粒”“倍他乐克”“美托洛尔”“室性早搏”“室性期前收缩”“心悸”“随机”,全面检索PubMed数据库、Ovid循证医学数据库(Cochrane DSR, ACP Journal Club, DARE, and CCTr)、EBSCO学术资源检索数据库、SPringer外文数据库(生物与生命科学、医学专辑)、中国生物医学文献数据库、中国知网/中国中文期刊全文数据库(CNKI)(查询截止至2015年03月31日),将收集的文献依据纳入和排除标准,选出符合随机对照试验的文献进行资料提取,并对纳入研究的文献从随机方法及分配隐藏、盲法与退出、试验方案、试验数据等方面进行文献质量评价,由Cochrane协作网提供的Review Manager5.3软件,对临床疗效、心电图或动态心电图、不良反应等指标进行统计学处理,进行疗效合成,通过计算比值比(OR)或相对危险度(RR)及其95%的可信区间(CI),来评价药稳心颗粒联合西药美托洛尔的治疗功能性室性期前收缩的疗效,结果:共检索到稳心颗粒联合美托洛尔治疗室性期前收缩的相关文献444篇次,其中通过去除相同篇次文献,阅读题目、摘要及全文进行筛选,去除与本研究不相关的研究文献432篇次,最终共纳入符合本次稳心颗粒联合美托洛尔治疗功能性室性期前收缩研究文献的纳入和排除标准,治疗周期≥2周的文献12篇,通过对所入选文献资料进行Meta分析及质量评价,结果显示Jadan评分在0-2分,CONSORT for TCM标准随机对照试验质量评价大多数文献质量总占比低,Meta分析显示文献中试验在稳心颗粒联合美托洛尔对照其他药物时,在临床总有效率、显效率,心电图或动态心电图的总有效率、显效率的改善上均具有统计学意义(P<0.00001),在不良反应对比上不具有统计学差异(P>0.05)结论:稳心颗粒联合美托洛尔治疗功能性室性期前收缩在临床症状疗效、心电图/动态心电图疗效的总有效率及显效率均优于对照组,且其安全性好、不良反应少,但由于所纳入文献质量较低,尚需更多高质量研究以增加证据的强度。
【Abstract】 OBJECTIVE:To evaluate the safety and the efficacy of combined treament of Wenxin Keli and MetoProlol in treating functional ventricular Premature contraction.REFERENCES:Collecting the Clinical randomized controlled trials of literatures at Present Published domestic and foreign In both Chinese and English,which is about the treatment of functional VPC with combined Wenxin Keli and MetoProlol. Based on evidence-based medicine aPProach,evaluate the safety and the efficacy of the treatment of functional VPC with combined Wenxin Keli and MetoProlol. Thus functional ventricular Premature beat treated with combination of traditional Chinese and Western medicine of clinical aPPlication of evidence-based medicine evidence, Which are Providing evidence for clinical research the feasibility of ventricular arrhythmias treated with combination of traditional Chinese and Western medicine.METHODS:According to retrieval key words"Wenxin Keli"" MetoProlol" "ventricular Premature beat" "VPC" "PalPitation "" Random", comPrehensive search the PubMed database, Ovid evidence-based medicine database(Cochrane DSR,ACP Journal Club, DARE and CCTr),Database search of EBSCO academic resources,SPringer database(Biological and Life sciences,Medical record),Chinese biomedical literature database, Chinese HowNet/China Chinese Periodical full text database (CNKI).The collected literature according to the inclusion and Exclusion criteria, selected randomized controlled trial literature data were extracted,and the included literatures from randommethod and allocation concealment, blind method and exit, the exPerimental scheme, exPerimental data and other asPects of quality evaluation of literature, is Provided by the Cochrane collaboration’s Review Manager5.3 software, the clinical curative effect ECG/HOLTER ordynamic electrocardiogram adverse reactions and other indicators were statistically analyzed, effects of synthesis, by calculating the odds ratio (OR) or relative risk(RR) and its 95% confidence interval (CI) the curative effect in treatment of functional VPC contraction of Wenxin Keli combined with western medicine metroProlol.RESULTS:Totally retrieved Wenxin Keli with metoProlol theraPy contracts before sexual Period the related literature of 444 times, by removing the same Piece of these documents, read the title and full text filtering, the removal of this study is not related research literature 432 times, eventually were in accord with the Wenxin Keli with metoProlol theraPy functional contracts before sexual Period of research literature and exclusion criteria,2 weeks of treatment cycle with 12 references, based on what is included in the literature to Meta analysis and quality evaluation. Results shows Jadan score in the 0 to 2 Points, the CONSORT for TCM quality standard randomised controlled trial to evaluate the quality total ProPortion is low, most of the literature in Meta analysis showed that literature exPeriment in the Wenxin Keli with metoProlol contrast to other drugs, the clinical total effective efficiency and total effective rate in ECG/HOLTER show on the imProvement of the efficiency were statistically significant (P< 0.00001), and no statistically differences in adverse reactions to contrast (P>0.05)CONCLUSIONS:Wenxin keli with metoProlol theraPy functional contracts before sexual Period in the clinical curative effect ECG/dynamic electrocardiogram curative effect of total effective rate and the efficiency is better than that of control grouP, and its security is good Less adverse reaction, but due to the low quality are included in the literature, more high quality research is necessary to increase the strength of the evidence.
【Key words】 Wenxin keli; metoProlol; VPC; randomized control; system evaluation;