雷诺嗪治疗冠心病的有效性及安全性评价的Meta分析

发布时间：2018-03-27 07:33

本文选题：冠心病　切入点：雷诺嗪　出处：《山东大学》2017年硕士论文

【摘要】：背景:雷诺嗪是一类以降低缺血细胞内钠离子负荷以及继发的钙离子负荷为核心机制,进而遏制细胞内钙超载及其所伴随的一系列病理生理不良事件,从而实现抗心肌缺血目的的新药。近年来有关该药治疗各类冠心病的临床试验增多,但尚未达成较一致的共识。目的:本研究旨在借助系统综述及Meta分析的方式,通过着眼于雷诺嗪在冠心病治疗中的有效性及安全性,对该药的抗心肌缺血疗效以及病人服药后的耐受性予以粗略评价。方法:使用计算机检索系统,按照预定的检索策略,通过PubMed,Embase,Cochrane Library等英文数据库以及CNKI(中国知网)、万方等中文数据库,对各库建库以来至2016年7月份为止收录的中英文论文进行检索和筛选,逐层剔除无关或低质量研究后,选取符合纳入标准的研究文献。在对各临床试验方法学的科学性进行仔细评估定级后,将有效可靠的数据进行提取、整合,并根据资料类型选取合适的合并效应指标,包括均数差(mean differences,MDs)、危险比(risk ratios,RRs)、风险比(hazard ratios,HRs)、危险差(risk difference,RD)以及 NNH(number needed to harm,发生一例不良反应所需要治疗的病例数)等,之后借助于RevMan 5.3软件对其进行统计、分析,以期得到科学的统计学结论。最后再结合相关基础研究成果及雷诺嗪的其他临床领域使用背景,对该药的作用机制、临床价值和用药风险进行详细讨论,以期得到科学的临床结论。结果:本研究共纳入了 17个随机对照临床试验(Randomized controlled trials,RCTs)进行定性分析,并对其中14个随机对照临床试验共计12429名患者的效应指标进行了 Meta分析。有效性方面,相比于对照组而言,雷诺嗪组显著地改善了患者静息指标,即心绞痛发作状态(包括每周心绞痛发作频率、每周硝酸甘油使用量、心绞痛每次发作持续时间);活动指标,即运动踏板试验表现(包括每次运动持续时间、诱发心绞痛发作所需运动时间、诱发心电图ST段压低1mm所需运动时间);以及主观指标,即西雅图心绞痛量表评分(包括心绞痛频率、治疗满意度和生活质量等维度)。安全性方面,相比对照组而言,雷诺嗪并未增加全因死亡率在内的各类心血管事件再发率;相反地,雷诺嗪组有减少短期内心梗发作率的趋势。该药未发现诱发恶性心律失常的作用,其不良反应主要有便秘、恶心、头晕、乏力和晕厥,以往文献提及的头痛尚不足以认定为雷诺嗪不良反应。另外,该药对血流动力学参数的影响较小。结论:雷诺嗪具有较好的耐受性和良好的抗心肌缺血疗效。同时,雷诺嗪的使用并不影响甚或可以改善冠心病患者的临床结局。
[Abstract]:Background: ranolazine is a kind of mechanism which focuses on reducing the intracellular sodium load and the secondary calcium load of ischemic cells, and thus inhibits intracellular calcium overload and a series of pathophysiological adverse events associated with it. In recent years, the clinical trials of this drug for the treatment of various kinds of coronary heart disease have increased, but no consensus has been reached. Objective: the purpose of this study is to use systematic review and Meta analysis. By focusing on the efficacy and safety of ranolazine in the treatment of coronary heart disease, the effect of the drug on myocardial ischemia and the patient's tolerance after taking medicine were roughly evaluated. By means of the English database of PubMedine Embase Cochrane Library and the Chinese database CNKI, the Chinese and English papers collected since the establishment of each database until July 2016 were searched and screened, and the irrelevant or low-quality studies were eliminated layer by layer. After carefully evaluating the scientific nature of each clinical trial methodology, the valid and reliable data were extracted, integrated, and the appropriate combined effect indexes were selected according to the data types. These include mean difference in mean value, risk ratio, risk ratio, risk ratio, NNH(number needed to harmfulness, and the number of cases where an adverse reaction needs to be treated. After that, RevMan 5.3 software was used to analyze the risk. Finally, the mechanism, clinical value and risk of the drug were discussed in detail, combining with the related basic research results and other clinical application background of ranolazine. Results: a total of 17 randomized controlled trialsof RCTs were included in this study. Meta analysis was performed on 12429 patients in 14 randomized controlled clinical trials. Compared with the control group, Renolonazine group significantly improved the resting index of the patients. That is, angina pectoris attack state (including weekly angina pectoris attack frequency, weekly nitroglycerin usage, angina pectoris duration per attack, activity indicators, that is, exercise pedal test performance (including each exercise duration, The exercise time needed to induce angina pectoris attack, St segment depression of 1mm induced electrocardiogram, and subjective index, the score of Seattle angina scale (including the frequency of angina pectoris), In terms of safety, treatment satisfaction and quality of life, ranolazine did not increase the recurrence rate of all cardiovascular events, including all-cause mortality, compared to the control group. Renolazine group showed a tendency to reduce the incidence of myocardial infarction in the short term. The drug had no effect on inducing malignant arrhythmias. The adverse effects were mainly constipation, nausea, dizziness, fatigue and syncope, the main adverse effects were constipation, nausea, dizziness, fatigue and syncope. The headache mentioned in the previous literature is not enough to be considered as an adverse reaction of ranolazine. In addition, the effect of the drug on hemodynamic parameters is small. Conclusion: ranolazine has good tolerance and good anti-myocardial ischemia effect. The use of ranolazine does not affect or even improve the clinical outcome of patients with coronary heart disease.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R541.4

【参考文献】