To evaluate the effect of berberine (BBR) plus bezafibrate administration on the lipid profile of patients with mixed dyslipidemia. A double-blind randomized pilot clinical trial with parallel groups was carried out in 36 patients, aged 30–60 years with mixed dyslipidemia [triglycerides (TG) ≥1.7 mM and total cholesterol (TC) ≥5.2 mM]. Patients were assigned to 3 groups of 12 patients each, receiving oral administration during 90 days of BBR 500 mg t.i.d., bezafibrate 400 mg b.i.d., or BBR 500 mg t.i.d. plus bezafibrate 400 mg b.i.d, respectively. Clinical evaluation, lipid profile, glucose, creatinine, and uric acid levels were measured before and after the pharmacological intervention. Kruskal–Wallis, Wilcoxon, Mann–Whitney U, and χ² tests were used for statistical analyses; a P ≤ .05 was considered statistically significant. BBR reduced TC levels. Bezafibrate decreased TG, TC, low-density lipoprotein cholesterol (LDL-C), and very low-density lipoprotein (VLDL) concentrations. BBR plus bezafibrate decreased TG (2.6 ± 0.8 vs. 1.3 ± 0.7 mM, P = .007), TC (6.3 ± 0.7 vs. 4.6 ± 1.2 mM, P = .005), LDL-C (3.4 ± 0.6 vs. 2.2 ± 1.3 mM, P = .037), and VLDL (0.5 ± 0.2 vs. 0.2 ± 0.1 mM, P = .007) levels. Bezafibrate and BBR plus bezafibrate significantly decreased TG, TC, LDL-C, and VLDL concentrations, and thus, remitting the diagnosis of mixed dyslipidemia in 90% of the patients.

中文翻译：

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小ber碱加苯甲酸酯对混合血脂异常患者血脂谱的影响：一项临床试验

评估小ber碱（BBR）加上苯扎贝特对混合血脂异常患者脂质分布的影响。对36名年龄在30至60岁，混合血脂异常[甘油三酸酯（TG）≥1.7mM和总胆固醇（TC）≥5.2 mM]的患者进行了平行分组的双盲随机试验临床试验。将患者分为3组，每组12位患者，分别在90天之内口服BBR 500 mg tid，苯扎贝特400 mg bid或BBR 500 mg tid加苯扎贝特400 mg bid。在药理学干预之前和之后，测量临床评估，血脂谱，葡萄糖，肌酐和尿酸水平。秩和检验，魏氏，曼-惠特尼U，和χ ^2个被用于统计分析试验。一个P ≤.05被认为具有统计学意义。BBR降低了TC含量。苯扎贝特可降低TG，TC，低密度脂蛋白胆固醇（LDL-C）和极低密度脂蛋白（VLDL）浓度。BBR加苯扎贝特降低TG（2.6±0.8 vs. 1.3±0.7 mM，P  = .007），TC（6.3±0.7 vs. 4.6±1.2 mM，P  = .005），LDL-C（3.4±0.6 vs.2.2） ±1.3 mM，P  = .037）和VLDL（0.5±0.2 vs. 0.2±0.1 mM，P  = .007）水平。苯扎贝特和BBR加苯扎贝特可显着降低TG，TC，LDL-C和VLDL浓度，因此，在90％的患者中诊断出混合血脂异常。