【摘要】 目的：评估海博麦布治疗原发性高胆固醇血症的有效性和安全性。方法：本研究为多中心、随机、双盲、安慰剂平行对照的Ⅲ期临床试验。共纳入分析原发性高胆固醇血症患者373例，按2:1随机接受海博麦布（试验组，n=248）或安慰剂（对照组，n=125）20 mg/d治疗12周（治疗评价期）。延伸期持续40周，两组均口服海博麦布20 mg/d。主要疗效终点为第12周低密度脂蛋白胆固醇（LDL-C）较基线的变化率，次要疗效终点为治疗评价期和延伸期其他血脂指标的变化率，同时观察用药安全性。结果：第12周试验组LDL-C较基线的变化率为（-10.23±13.58）%，显著优于对照组（4.34±15.88）%,P<0.05。试验组非高密度脂蛋白胆固醇（non-HDL-C）、总胆固醇（TC）和载脂蛋白B(Apo B)的变化率分别为（-10.81±12.28）%、（-7.92±9.88）%和（-12.06±11.32）%，均显著优于对照组的（3.22±15.90）%、（2.18±11.68）%和（0.51±13.37）%(P均<0.05)，而高密度脂蛋白胆固醇、甘油三酯和载脂蛋白AI变化率的差异无统计学意义。试验组与对照组不良反应的发生率在第12周分别为4.55%和8.40%，在延伸期分别为4.43%和7.07%，未发现新的或加重的与海博麦布可能相关的不良事件。结论：海博麦布可以有效降低原发性高胆固醇血症患者的LDL-C、non-HDL-C、TC和Apo B水平，降脂效果可长期持续，不良反应发生率低，耐受性好。更多还原

【Abstract】 Objectives: To evaluate the efficacy and safety of hybutimibe in treating primary hypercholesterolemia.Methods: This was a multi-center, randomized, double-blind, placebo-controlled phase Ⅲ clinical trial. A total of 373patients with primary hypercholesterolemia were randomized at 2:1 ratio to receive hybutimibe(20 mg/d, n=248) or placebo(20 mg/d, n=125) for 12 weeks. In the subsequent extension study, both groups received hybutimibe(20 mg/d) for 40 weeks.The primary endpoint was the percentage change of low-density lipoprotein cholesterol(LDL-C) from baseline at week 12.Secondary endpoints were the percentage changes of other blood lipid levels. Safety was also observed.Results: At week 12, the percentage change of LDL-C in the hybutimibe group was(-10.23 ± 13.58)%, significantly superior to(4.34 ± 15.88)% in the placebo group(P<0.05). The percentage changes of non-HDL-C([-10.81 ± 12.28]%vs. [3.22 ± 15.90]%), TC([-7.92 ± 9.88]% vs. [2.18 ± 11.68]%) and Apo B([-12.06 ± 11.32]% vs. [0.51 ± 13.37]%) in the hybutimibe group were significantly superior to those of the placebo group(all P<0.05), while there were no differences in the percentage changes of HDL-C, Apo AI and TG. The incidences of adverse reactions in the hybutimibe and placebo groups were 4.55% and 8.40% at week 12, and 4.43% and 7.07% at week 52, respectively. Neither new nor aggravated adverse events that might be associated with hybutimibe were observed during the extension study.Conclusions: Hybutimibe can reduce LDL-C, non-HDL-C, TC and Apo B levels in patients with primary hypercholesterolemia, with stable effects and low incidences of long-term adverse events.更多还原