Objective To evaluate the efficacy and safety of Ding Xin Recipe(DXR)combined with amiodarone in patients with PVCs.Methods A total of360patients with PVCs across7centers in China were randomly assigned in a1:1:1ratio...Objective To evaluate the efficacy and safety of Ding Xin Recipe(DXR)combined with amiodarone in patients with PVCs.Methods A total of360patients with PVCs across7centers in China were randomly assigned in a1:1:1ratio to receive up to8weeks of amiodarone combined with DXR placebo(amiodarone group),DXR combined with amiodarone placebo(DXR group),or DXR combined with amiodarone(DCA group)from July2012to December2013.Randomization was conducted according to a centralized randomization schedule prepared by an independent steering committee.Staff and patients at all sites were masked to treatment allocation.All patients received best-evidence advice.The primary outcome was the efficacy for treating PVCs,with efficacy assessed by the reduction of premature ventricular contractions.Other outcome measures included PVCs-related symptom scores.All data were analyzed by intention to treat.Results The efficacy for treating PVCs in the DCA group(90.7%)significantly increased compared with that in the amiodarone group(72.3%)and the DXR group(73.9%).The frequency,the degree,and the duration per week of heart palpitations,chest tightness,shortness of breath and fatigue improved significantly in the DCA group in comparison with the amiodarone group and the DXR group(P<0.05),while no significant difference was observed in the improvement of insomnia among the three groups(P>0.05).With regard to laboratory parameters for safety,there were no clinically relevant changes in the three groups.Conclusion The present study demonstrates that DXR combined with amiodarone is significantly more effective than DXR or amiodarone alone for treating PVCs.展开更多
基金funding support from the National Natural Sciences Foundation of China (No. 81373574 and No. 81774213)the Guangdong 211 key Disciplines
文摘Objective To evaluate the efficacy and safety of Ding Xin Recipe(DXR)combined with amiodarone in patients with PVCs.Methods A total of360patients with PVCs across7centers in China were randomly assigned in a1:1:1ratio to receive up to8weeks of amiodarone combined with DXR placebo(amiodarone group),DXR combined with amiodarone placebo(DXR group),or DXR combined with amiodarone(DCA group)from July2012to December2013.Randomization was conducted according to a centralized randomization schedule prepared by an independent steering committee.Staff and patients at all sites were masked to treatment allocation.All patients received best-evidence advice.The primary outcome was the efficacy for treating PVCs,with efficacy assessed by the reduction of premature ventricular contractions.Other outcome measures included PVCs-related symptom scores.All data were analyzed by intention to treat.Results The efficacy for treating PVCs in the DCA group(90.7%)significantly increased compared with that in the amiodarone group(72.3%)and the DXR group(73.9%).The frequency,the degree,and the duration per week of heart palpitations,chest tightness,shortness of breath and fatigue improved significantly in the DCA group in comparison with the amiodarone group and the DXR group(P<0.05),while no significant difference was observed in the improvement of insomnia among the three groups(P>0.05).With regard to laboratory parameters for safety,there were no clinically relevant changes in the three groups.Conclusion The present study demonstrates that DXR combined with amiodarone is significantly more effective than DXR or amiodarone alone for treating PVCs.
