Nanjing University of Chinese Medicine, Nanjing, China.
Tongliang Traditional Chinese Medicine Hospital, Chongqing, China.
Biomed Res Int. 2020 Apr 9;2020:5358467. doi: 10.1155/2020/5358467. eCollection 2020.
Chinese herbal medicine Dingji Fumai Decoction (DFD) is widely clinically used for ventricular premature contraction (VPC). This real-word trial was designed to assess the safety and effectiveness of DFD for VPC.
This was a double-blinded, randomized placebo-controlled trial. Patients with VPC were randomized (1 : 1) to treatment with DFD combined with metoprolol (DFD arm) or metoprolol combined with placebo (MET arm). A primary end point was a composite of clinical symptoms and signs determined by the traditionalChinese medicine syndrome score and the number of VPC determined by the Holter examination. Second outcomes were adverse events, medication compliance, and laboratory examination.
144 patients were randomized to DFD arm (76 patients) or MET arm (68 patients), and 136 cases (71 in DFD arm and 65 in MET arm) finally completed this trial. After a 12-week follow-up, DFD arm significantly decreased traditional Chinese medicine syndrome score and the number of VPC compared with MET arm ( = 0.003 and 0.034, respectively). There was no adverse drug effect and patient medication compliance was good.
Superiority with DFD arm for VPC was demonstrated over MET arm for both the safety and effectiveness end points.
中药定悸复脉汤（DFD）广泛应用于临床室性早搏（VPC）的治疗。本真实世界研究旨在评估 DFD 治疗 VPC 的安全性和有效性。
这是一项双盲、随机、安慰剂对照试验。VPC 患者按 1:1 比例随机分配至 DFD 联合美托洛尔（DFD 组）或美托洛尔联合安慰剂（MET 组）治疗。主要终点为传统中医证候评分和动态心电图检查确定的室性早搏数量的综合临床症状和体征。次要结局为不良事件、用药依从性和实验室检查。
144 例患者被随机分配至 DFD 组（76 例）或 MET 组（68 例），最终有 136 例（DFD 组 71 例，MET 组 65 例）完成了本试验。经过 12 周的随访，DFD 组较 MET 组明显降低了中医证候评分和室性早搏数量（分别为 =0.003 和 0.034）。未发生药物不良反应，患者用药依从性良好。
DFD 组在安全性和有效性终点方面均优于 MET 组。
