Lu Zongliang, Kou Wenrong, Du Baomin, Wu Yangfeng, Zhao Shuiping, Brusco Osvaldo A, Morgan John M, Capuzzi David M, Li S
Fuwai Hospital, Peking Union Medical College, Chinese Academy of Medical Science, Beijing, Peoples Republic of China.
Am J Cardiol. 2008 Jun 15;101(12):1689-93. doi: 10.1016/j.amjcard.2008.02.056. Epub 2008 Apr 11.
Results of well-controlled prospective clinical trials showed the efficacy of lipid-lowering therapies in the reduction of cardiovascular (CV) events in western populations, but they were not reported with a Chinese population. This multicenter study was conducted to determine the effects of Xuezhikang (XZK), a partially purified extract of red yeast rice, on lipoprotein and CV end points in Chinese patients who experienced a previous myocardial infarction. Nearly 5,000 of these patients with average low-density lipoprotein cholesterol levels at baseline were randomly assigned either to placebo or to XZK daily for an average of 4.5 years. The primary end point was a major coronary event that included nonfatal myocardial infarction and death from coronary heart disease. Frequencies of the primary end point were 10.4% in the placebo group and 5.7% in the XZK-treated group, with absolute and relative decreases of 4.7% and 45%, respectively. Treatment with XZK also significantly decreased CV and total mortality by 30% and 33%, the need for coronary revascularization by 1/3, and lowered total and low-density lipoprotein cholesterol and triglycerides, but raised high-density lipoprotein cholesterol levels. In conclusion, long-term therapy with XZK significantly decreased the recurrence of coronary events and the occurrence of new CV events and deaths, improved lipoprotein regulation, and was safe and well tolerated.
严格控制的前瞻性临床试验结果显示，降脂疗法在西方人群中可有效降低心血管（CV）事件发生率，但尚无针对中国人群的相关报道。本多中心研究旨在确定血脂康（XZK）（一种红曲米的部分纯化提取物）对既往有心肌梗死病史的中国患者脂蛋白及心血管终点事件的影响。近5000例基线低密度脂蛋白胆固醇水平平均的患者被随机分为两组，分别每日服用安慰剂或血脂康，平均治疗4.5年。主要终点事件为包括非致死性心肌梗死和冠心病死亡在内的主要冠脉事件。安慰剂组主要终点事件发生率为10.4%，血脂康治疗组为5.7%，绝对降低率和相对降低率分别为4.7%和45%。血脂康治疗还使心血管死亡率和总死亡率显著降低30%和33%，冠脉血运重建需求降低1/3，并降低了总胆固醇、低密度脂蛋白胆固醇和甘油三酯水平，但提高了高密度脂蛋白胆固醇水平。总之，血脂康长期治疗可显著降低冠脉事件复发率及新的心血管事件和死亡的发生率，改善脂蛋白调节，且安全、耐受性良好。
