Derosa Giuseppe, Romano Davide, D'Angelo Angela, Maffioli Pamela
Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS, Policlinico S. Matteo, Pavia, Italy; Center for the Study of Endocrine-Metabolic Pathophysiology and Clinical Research, University of Pavia, Pavia, Italy.
Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS, Policlinico S. Matteo, Pavia, Italy.
Atherosclerosis. 2015 Mar;239(1):87-92. doi: 10.1016/j.atherosclerosis.2014.12.043. Epub 2014 Dec 24.
To evaluate the effects of Berberis aristata combined with Silybum marianum in dyslipidemic patients intolerant to statins at high doses.
137 euglycemic, dyslipidemic subjects, with previous adverse events to statins at high doses, were enrolled. Statins were stopped for 1 month (run-in), then they were re-introduced at the half of the previously taken dose. At randomization, patients tolerating the half dose of statin, were assigned to add placebo or B. aristata/S. marianum 588/105 mg, 1 tablet during the lunch and 1 tablet during the dinner, for six months. We evaluated lipid profile and safety parameters variation at randomization, and after 3, and 6 months.
B. aristata/S. marianum reduced fasting plasma glucose (-9 mg/dl), insulin (-0.7 μU/ml), and HOMA-index (-0.35) levels compared to baseline and also to placebo. Lipid profile did not significantly change after 6 months since the reduction of statin dosage and the introduction of B. aristata/S. marianum, while it worsened in the placebo group both compared to placebo and with active treatment (+23.4 mg/dl for total cholesterol, +19.6 mg/dl for LDL-cholesterol, +23.1 mg/dl for triglycerides with placebo compared to B. aristata/S. marianum). We did not record any variations of safety parameters in nether of groups.
B. aristata/S. marianum can be considered as addition to statins in patients not tolerating high dose of these drugs.
评估印度小檗与水飞蓟宾联合用药对大剂量他汀类药物不耐受的血脂异常患者的影响。
纳入137例血糖正常、血脂异常且既往有大剂量他汀类药物不良事件的受试者。他汀类药物停用1个月（导入期），然后以先前服用剂量的一半重新引入。随机分组时，能耐受一半剂量他汀类药物的患者被分配添加安慰剂或588/105毫克的印度小檗/水飞蓟宾，午餐时服用1片，晚餐时服用1片，共6个月。我们在随机分组时、3个月和6个月后评估血脂谱和安全参数的变化。
与基线水平以及安慰剂相比，印度小檗/水飞蓟宾降低了空腹血糖（-9毫克/分升）、胰岛素（-0.7微单位/毫升）和HOMA指数（-0.35）水平。自减少他汀类药物剂量并引入印度小檗/水飞蓟宾后，6个月时血脂谱没有显著变化，而安慰剂组与安慰剂相比以及与积极治疗组相比均恶化（总胆固醇比印度小檗/水飞蓟宾组高23.4毫克/分升，低密度脂蛋白胆固醇高19.6毫克/分升，甘油三酯高23.1毫克/分升）。两组均未记录到安全参数的任何变化。
对于不耐受高剂量他汀类药物的患者，印度小檗/水飞蓟宾可被视为他汀类药物的辅助用药。
