Holubarsch Christian J F, Colucci Wilson S, Meinertz Thomas, Gaus Wilhelm, Tendera Michal
Median Clinics Bad Krozingen, Bad Krozingen, Germany.
Eur J Heart Fail. 2008 Dec;10(12):1255-63. doi: 10.1016/j.ejheart.2008.10.004. Epub 2008 Nov 18.
Crataegus preparations have been used for centuries especially in Europe. To date, no proper data on their efficacy and safety as an add-on-treatment are available. Therefore a large morbidity/mortality trial was performed.
To investigate the efficacy and safety of an add-on treatment with Crataegus extract WS 1442 in patients with congestive heart failure.
In this randomised, double-blind, placebo-controlled multicenter study, adults with NYHA class II or III CHF and reduced left ventricular ejection fraction (LVEF< or =35%) were included and received 900 mg/day WS 1442 or placebo for 24 months. Primary endpoint was time until first cardiac event.
2681 patients (WS 1442: 1338; placebo: 1343) were randomised. Average time to first cardiac event was 620 days for WS 1442 and 606 days for placebo (event rates: 27.9% and 28.9%, hazard ratio (HR): 0.95, 95% CI [0.82;1.10]; p=0.476). The trend for cardiac mortality reduction with WS 1442 (9.7% at month 24; HR: 0.89 [0.73;1.09]) was not statistically significant (p=0.269). In the subgroup with LVEF> or =25%, WS 1442 reduced sudden cardiac death by 39.7% (HR 0.59 [0.37;0.94] at month 24; p=0.025). Adverse events were comparable in both groups.
In this study, WS 1442 had no significant effect on the primary endpoint. WS 1442 was safe to use in patients receiving optimal medication for heart failure. In addition, the data may indicate that WS 1442 can potentially reduce the incidence of sudden cardiac death, at least in patients with less compromised left ventricular function.
山楂制剂已使用了几个世纪，尤其在欧洲。迄今为止，尚无关于其作为附加治疗的疗效和安全性的适当数据。因此开展了一项大型发病率/死亡率试验。
研究山楂提取物 WS 1442 作为附加治疗对充血性心力衰竭患者的疗效和安全性。
在这项随机、双盲、安慰剂对照的多中心研究中，纳入了纽约心脏协会（NYHA）心功能 II 级或 III 级、左心室射血分数降低（LVEF≤35%）的成年人，给予其每天 900 毫克 WS 1442 或安慰剂，为期 24 个月。主要终点是直至首次心脏事件发生的时间。
2681 名患者（WS 1442 组：1338 例；安慰剂组：1343 例）被随机分组。WS 1442 组至首次心脏事件的平均时间为 620 天，安慰剂组为 606 天（事件发生率：27.9%和 28.9%，风险比（HR）：0.95，95%置信区间[0.82；1.10]；p = 0.476）。WS 1442 降低心脏死亡率的趋势（24 个月时为 9.7%；HR：0.89[0.73；1.09]）无统计学意义（p = 0.269）。在 LVEF≥25%的亚组中，WS 1442 使心源性猝死降低了 39.7%（24 个月时 HR 0.59[0.37；0.94]；p = 0.025）。两组的不良事件相当。
在本研究中，WS 1442 对主要终点无显著影响。WS 1442 用于接受心力衰竭最佳药物治疗的患者是安全的。此外，数据可能表明 WS 1442 可能会降低心源性猝死的发生率，至少在左心室功能受损较轻的患者中如此。
