Department of Cardiology, First Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu 210029, China.
Chin Med J (Engl). 2011 Jan;124(1):76-83.
Premature ventricular contraction (PVC) is one of the most common kinds of arrhythmias for which the treatment falls into dilemma. Previous clinical application showed that the traditional Chinese Medicine Shensongyangxin (SSYX) capsule is efficacious for the treatment of PVCs. This randomized clinical trial aimed to further evaluate the efficacy and safety of SSYX capsule on treating PVC.
The subjects who had frequent PVCs with or without organic heart disease and normal cardiac function were enrolled in the study. The primary endpoint was the change of PVC numbers after eight-week medication with SSYX capsule. The secondary endpoints included change of clinical symptoms related to PVCs and the safety evaluation of SSYX capsule. Totally 188 PVC patients were randomly enrolled in the non-organic heart disease PVCs trial and orally took either SSYX capsules or analogues (three times per day, 4 capsules one time). A total of 671 PVCs patients were randomly enrolled in the organic heart disease PVCs trial, and orally took either SSYX capsules (three times per day, 4 capsules one time) or mexiletine tablet (three times per day, 150 mg one time). The PVCs were monitored and calculated with 24-hour Holter electrocardiogram. Routine blood, liver and kidney function were tested before and after medication with SSYX capsule.
SSYX capsules significantly decreased the PVCs numbers and alleviated the related symptoms in patients with or without organic heart disease. In non-organic heart disease group, SSYX capsules and the placebos decreased the PVCs from 12,561.34 ± 9,777.93 to 4,806.87 ± 6,507.17, and 12,605.69 ± 8,736.34 to 10,364.94 ± 9,903.41, respectively. The total effective rate was 74.2% and 28.9% in SSYX and placebo groups (P < 0.001). In organic heart disease group, SSYX capsule and mexiletine decreased the PVCs from 8,641.01 ± 8,923.57 to 3,853.68 ± 7,096.42, 8,621.61 ± 8,367.74 to 5,648.29 ± 8,667.38, respectively. The total effective rate was 65.8% and 50.7% in SSYX and mexiletine groups (P < 0.001). In addition, SSYX capsule significantly alleviated PVCs-related symptoms such as palpitations, chest tightness, insomnia, fatigue, and night sweats. No adverse cardiac events were observed except some slight gastrointestinal side effects during the study.
Compared with placebo or mexiletine, SSYX capsules have significant therapeutic efficacy in reducing PVCs numbers and alleviate PVCs-related symptoms.
室性早搏（PVC）是最常见的心律失常之一，其治疗存在困境。既往临床应用表明，中药参松养心胶囊对 PVC 有治疗作用。本随机临床试验旨在进一步评估参松养心胶囊治疗 PVC 的疗效和安全性。
本研究纳入了伴有或不伴有器质性心脏病和正常心功能的频发 PVC 患者。主要终点是参松养心胶囊治疗 8 周后 PVC 数量的变化。次要终点包括与 PVC 相关的临床症状的变化和参松养心胶囊的安全性评估。共有 188 例 PVC 患者被随机纳入非器质性心脏病 PVC 试验，口服参松养心胶囊或模拟剂（每日 3 次，每次 4 粒）。共有 671 例 PVC 患者被随机纳入器质性心脏病 PVC 试验，口服参松养心胶囊（每日 3 次，每次 4 粒）或美西律片（每日 3 次，每次 150mg）。通过 24 小时动态心电图监测和计算 PVC。参松养心胶囊治疗前后检测血常规、肝肾功能。
参松养心胶囊可显著减少伴有或不伴有器质性心脏病患者的 PVC 数量并缓解相关症状。在非器质性心脏病组中，参松养心胶囊和安慰剂分别使 PVC 从 12561.34±9777.93 降至 4806.87±6507.17 和 12605.69±8736.34 至 10364.94±9903.41，有效率分别为 74.2%和 28.9%（P<0.001）。在器质性心脏病组中，参松养心胶囊和美西律分别使 PVC 从 8641.01±8923.57 降至 3853.68±7096.42 和 8621.61±8367.74 至 5648.29±8667.38，有效率分别为 65.8%和 50.7%（P<0.001）。此外，参松养心胶囊可显著缓解心悸、胸闷、失眠、乏力和盗汗等 PVC 相关症状。除了一些轻微的胃肠道副作用外，研究期间未观察到不良心脏事件。
与安慰剂或美西律相比，参松养心胶囊在减少 PVC 数量和缓解 PVC 相关症状方面具有显著的治疗效果。
