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目的:观察进口普罗布考对高脂血症患者的降脂作用,并评价其疗效。方法:纳入符合要求的高脂血症患者264例,应用优效性设计,并随机分为实验组(普罗布考)和对照组(安慰剂),其中实验组127例,对照组137例。检测总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)、氧化低密度脂蛋白(oxLDL)等血脂指标;分别于访视0、访视2、访视3时进行测量,共观察8周。结果:实验后4周及8周TC与LDL-C均较实验前降低,且普罗布考对TC和LDL-C的降低作用明显优于安慰剂;实验后4周及8周oxLDL在两组间均无明显降低,且试验后普罗布考与安慰剂组间无差异;实验后4周及8周普罗布考对TG均有降低趋势,但是与安慰剂相比没有统计学意义;而普罗布考降低HDL-C较安慰剂显著。结论:本试验证实进口普罗布考对降低中国高血脂症患者血脂中TC、LDL-C、HDL-C有明显作用,适宜推广。
Objective: To observe the lipid-lowering effect of imported probucol in patients with hyperlipidemia and to evaluate its efficacy. Methods: Two hundred and sixty-six patients with hyperlipidemia were enrolled in the study. The patients were randomly divided into two groups: experimental group (probucol) and control group (placebo), including 127 experimental group and 137 control group. The levels of total cholesterol (TC), triglyceride (TG), LDL-C, HDL-C and oxLDL were measured. Visit 0, visit 2, visit 3 when measured, observed a total of 8 weeks. Results: The levels of TC and LDL-C decreased 4 weeks and 8 weeks after the experiment, and the reduction effects of probucol on TC and LDL-C were better than placebo. At 4 weeks and 8 weeks after the experiment, oxLDL in two groups There was no significant difference between the two groups, and there was no difference between probucol and placebo after the test. Probucol tended to lower TG at 4 weeks and 8 weeks after the experiment, but there was no statistical significance compared with placebo. However, Clinically tested lower HDL-C than placebo. Conclusion: This study confirmed that imported probucol could significantly reduce the level of TC, LDL-C and HDL-C in blood lipids in Chinese patients with hyperlipidemia.