摘要
目的系统评价参仙升脉口服液治疗窦性心动过缓的临床疗效及安全性。方法电子检索CNKI、VIP、CBM、Wan Fang Data、PubMed、The Cochrane Library、Embase,查找有关参仙升脉口服液治疗窦性心动过缓的临床疗效及安全性的RCT试验,检索时限为2000年4月(临床应用)—2014年11月。由两名研究人员根据纳入和排除标准独立筛选文献、提取资料和评价质量,采用RevMan5.3进行系统评价。评价指标:临床疗效、平均心率、最低心率和不良反应等。结果共纳入5个随机对照研究,包括患者453例。描述性分析结果显示:与对照组比较,3个RCT表明参仙升脉口服液可明显提高窦性心动过缓临床疗效;分别有4个、1个、3个RCT显示参仙升脉口服液可显著提升患者动态心电图中平均心率、24h总心率数、最低心率;1个RCT显示参仙升脉口服液组显著缩短心电图窦房结恢复时间(SNRT)与窦房传导时间(SACT);1个RCT未发现参仙升脉口服液组心电图PR间期和QRS波时限的差异。各研究中不良事件及安全性指标未见显著性差异。结论参仙升脉口服液可能对窦性心动过缓患者临床疗效提高、心率提升等有效安全。但由于纳入试验研究的方法学质量普遍较低,期待更多设计合理、方法科学的大样本多中心随机对照临床试验,提供高质量的证据。
Objective To systematical y review the clinical effects and safety of Shenxian Shengmai oral liquid （SSOL） for treatment of sinus bradycardia.Methods We searched in CNKI,VIP,CBM,Wan Fang DATA,PubMed,The Cochrane Library ,Embase,and other relevant databases,journals,Internet,proceeding and manufacturer data to identify randomized control ed trials （RCTs）on SSOL for treatment of sinus bradycardia from April 2000（clinical application）to November 2014.Two reviewers independently screened the liter-ature according to the inclusion and exclusion criteria,extracted the data,and assessed the methodological quality.Meta analyses were performed using RevMan 5. 3 software. The evaluation indexes included clinical therapeutic effects,mean heart rate,minimal heart rate,adverse events and safety indicators,etc. Results Five eligible studies included 453 patients. Compared with control groups,the results of descriptive analysis showed that SSOL group could precisely improve the clinical therapeutic effects in 3 RCTs. The results pointed out that SSOL could separately promote mean heart rate in 4 RCTs,total heart rate in 1 RCTs,minimal heart rate in 3 RCTs from Holter Monitor system.1 RCT revealed that SSOL group could obviously reduce SNRT,SACT in the bedside ECG.1 RCT showed that SSOL had rarely change than western medicine alone on the electrocardiogram PR interval and QRS duration.Ad-verse events and safety indicators were also not significantly different in RCTs above.Conclusion SSOL may be effective and safe for the patients of sinus bradycardia in improving the clinical symptoms and Increasing the heart rate.However,the methodological quality of study was low.The current evidence was insufficient to define the efficacy of the treatment,and further large scale,high quality randomized control ed trials were needed.
出处
《中西医结合心脑血管病杂志》
2015年第2期137-141,共5页
Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease
基金
国家自然科学基金项目(No.81102698)
河南省高校科技创新团队支持计划(No.13IRTSTHN012)
河南中医学院科技创新团队支持计划(No.2010XCXTD10)
