Background：Premature ventricular contractions （PVCs） are common in the general population,and frequent PVCs may result in the poor quality of life or even the damage of cardiac function.We examined the efficacy and...Background：Premature ventricular contractions （PVCs） are common in the general population,and frequent PVCs may result in the poor quality of life or even the damage of cardiac function.We examined the efficacy and safety of a traditional Chinese medicine Wenxin Keli for the treatment of frequent PVCs among a relatively large Chinese cohort.Methods：We performed a randomized,double-blind,placebo-controlled,parallel-group,multicenter trial.A total of 1200 eligible participants were randomly assigned in a ratio of 1：1 to receive Wenxin Keli or the placebo for 4 weeks.The primary and secondary endpoint was the change of PVC numbers and PVC-related symptoms after a 4-week treatment compared with baseline,respectively.In addition,vital signs,laboratory values,and electrocardiographic parameters were assessed in a safety analysis.Results：At the initial evaluation,no significant differences in the baseline characteristics were observed between the Wenxin Keli group and the placebo group.A smaller number of PVCs was observed after the 4-week treatment than at baseline,in both the Wenxin Keli group （5686 ± 5940 vs.15,138 ± 7597 beats/d,P ＜ 0.001） and the placebo group （10,592 ± 8009 vs.14,529 ± 5929 beats/d,P ＜ 0.001）;moreover,the Wenxin Keli group demonstrated a significantly greater reduction in the frequency of PVCs than the placebo group （P ＜ 0.001）.In a full analysis set,patients in the Wenxin Keli group exhibited significantly higher total effective responses in the reduction of PVCs compared to those in the placebo group （83.8％ vs.43.5％,P ＜ 0.001）.The per-protocol analysis yielded similar results （83.0％ vs.39.3％,P ＜ 0.001）.Treatment with Wenxin Keli also demonstrated superior performance compared to the placebo with respect to PVC-related symptoms.No severe adverse effects attributable to Wenxin Keli were reported.Conclusions：Wenxin Keli treatment effectively reduced the overall number of PVCs and alleviated PVC-related symptoms in patients without structural h展开更多
目的:对稳心颗粒治疗心房颤动(房颤)的有效性及安全性进行全面系统的评价。方法:电子检索PubMed、Web of Science、Cochrane Library等外文数据库及中国知识基础设施工程(CNKI)、万方数据知识服务平台(Wan Fang Data)、维普期刊资源整...目的:对稳心颗粒治疗心房颤动(房颤)的有效性及安全性进行全面系统的评价。方法:电子检索PubMed、Web of Science、Cochrane Library等外文数据库及中国知识基础设施工程(CNKI)、万方数据知识服务平台(Wan Fang Data)、维普期刊资源整合服务平台(VIP)、中国生物医学文献服务系统(SinoMed)等中文数据库,时间截至2018年10月1日。按照Cochrane手册推荐的质量评价标准对纳入研究进行质量学评价,采用Rev Man 5.3软件进行数据分析,采用Stata 14软件Begg检验进行发表偏倚分析。结果:共纳入24篇随机对照试验(RCTs),涉及到2246名房颤患者。结果显示,稳心颗粒单用或者联合西药治疗在控制快速心室率(MD=-7.14,95%CI:-8.42--5.87),降低房颤发作次数和持续时间,缩短窦律转复时间(MD=-3.04,95%CI:-3.47--2.61),增加窦律转复率(RR=1.19,95%CI:1.09-1.29),减少房颤复发率(RR=0.28,95%CI:0.13-0.59),提高左室射血分数(LVEF)(MD=3.44,95%CI:0.87-6.01),改善左心室舒张末内径(LVEDD)(MD=-2.47,95%CI:-2.86--2.08),降低左心房内径(LAd)(MD=-0.91,95%CI:-1.58--0.25),减少P波离散度(Pd)(MD=-4.04,95%CI:-4.15--3.93)等方面效果优于空白对照、安慰剂或单用西药治疗。稳心颗粒联合小剂量胺碘酮在改善P波最大时限(Pmax)优于单用常规剂量胺碘酮治疗(MD=-8.25,95%CI:-10.33--6.17),而稳心颗粒联合常规剂量胺碘酮治疗效果更优(MD=-13.10,95%CI:-13.65--12.55)。与对照组相比,联合治疗组不良反应发生更少,且Begg检验未发现发表偏倚。结论:稳心颗粒单用或者联合西药在房颤治疗中有良好疗效,但仍需要高质量证据予以验证。展开更多
文摘Background：Premature ventricular contractions （PVCs） are common in the general population,and frequent PVCs may result in the poor quality of life or even the damage of cardiac function.We examined the efficacy and safety of a traditional Chinese medicine Wenxin Keli for the treatment of frequent PVCs among a relatively large Chinese cohort.Methods：We performed a randomized,double-blind,placebo-controlled,parallel-group,multicenter trial.A total of 1200 eligible participants were randomly assigned in a ratio of 1：1 to receive Wenxin Keli or the placebo for 4 weeks.The primary and secondary endpoint was the change of PVC numbers and PVC-related symptoms after a 4-week treatment compared with baseline,respectively.In addition,vital signs,laboratory values,and electrocardiographic parameters were assessed in a safety analysis.Results：At the initial evaluation,no significant differences in the baseline characteristics were observed between the Wenxin Keli group and the placebo group.A smaller number of PVCs was observed after the 4-week treatment than at baseline,in both the Wenxin Keli group （5686 ± 5940 vs.15,138 ± 7597 beats/d,P ＜ 0.001） and the placebo group （10,592 ± 8009 vs.14,529 ± 5929 beats/d,P ＜ 0.001）;moreover,the Wenxin Keli group demonstrated a significantly greater reduction in the frequency of PVCs than the placebo group （P ＜ 0.001）.In a full analysis set,patients in the Wenxin Keli group exhibited significantly higher total effective responses in the reduction of PVCs compared to those in the placebo group （83.8％ vs.43.5％,P ＜ 0.001）.The per-protocol analysis yielded similar results （83.0％ vs.39.3％,P ＜ 0.001）.Treatment with Wenxin Keli also demonstrated superior performance compared to the placebo with respect to PVC-related symptoms.No severe adverse effects attributable to Wenxin Keli were reported.Conclusions：Wenxin Keli treatment effectively reduced the overall number of PVCs and alleviated PVC-related symptoms in patients without structural h
文摘目的:对稳心颗粒治疗心房颤动(房颤)的有效性及安全性进行全面系统的评价。方法:电子检索PubMed、Web of Science、Cochrane Library等外文数据库及中国知识基础设施工程(CNKI)、万方数据知识服务平台(Wan Fang Data)、维普期刊资源整合服务平台(VIP)、中国生物医学文献服务系统(SinoMed)等中文数据库,时间截至2018年10月1日。按照Cochrane手册推荐的质量评价标准对纳入研究进行质量学评价,采用Rev Man 5.3软件进行数据分析,采用Stata 14软件Begg检验进行发表偏倚分析。结果:共纳入24篇随机对照试验(RCTs),涉及到2246名房颤患者。结果显示,稳心颗粒单用或者联合西药治疗在控制快速心室率(MD=-7.14,95%CI:-8.42--5.87),降低房颤发作次数和持续时间,缩短窦律转复时间(MD=-3.04,95%CI:-3.47--2.61),增加窦律转复率(RR=1.19,95%CI:1.09-1.29),减少房颤复发率(RR=0.28,95%CI:0.13-0.59),提高左室射血分数(LVEF)(MD=3.44,95%CI:0.87-6.01),改善左心室舒张末内径(LVEDD)(MD=-2.47,95%CI:-2.86--2.08),降低左心房内径(LAd)(MD=-0.91,95%CI:-1.58--0.25),减少P波离散度(Pd)(MD=-4.04,95%CI:-4.15--3.93)等方面效果优于空白对照、安慰剂或单用西药治疗。稳心颗粒联合小剂量胺碘酮在改善P波最大时限(Pmax)优于单用常规剂量胺碘酮治疗(MD=-8.25,95%CI:-10.33--6.17),而稳心颗粒联合常规剂量胺碘酮治疗效果更优(MD=-13.10,95%CI:-13.65--12.55)。与对照组相比,联合治疗组不良反应发生更少,且Begg检验未发现发表偏倚。结论:稳心颗粒单用或者联合西药在房颤治疗中有良好疗效,但仍需要高质量证据予以验证。
