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一项随机、开放标签临床试验的结果,该试验研究补充波斯阿魏提取物作为血脂异常辅助治疗的效果。

Results of a randomized,open-label,clinical trial investigating the effects of supplementation with Heracleumpersicum extract as an adjunctive therapy for dyslipidemia.

作者信息

Panahi Yunes, Pishgoo Bahram, Beiraghdar Fatemeh, Araghi Zahra Mohammadi, Sahebkar Amirhossein, Abolhasani Ehsan

机构信息

Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.

出版信息

ScientificWorldJournal. 2011 Mar 7;11:592-601. doi: 10.1100/tsw.2011.43.

Abstract

The present study evaluated the potential benefit of supplementation with Heracleumpersicum as an adjunctive therapy to atorvastatin in dyslipidemic subjects. In a randomized, open-label, clinical trial, 100 dyslipidemic subjects were randomly assigned to: (1) H. persicum group (n=50, completers=18), receiving H. persicum extract (500 mg/day) + atorvastatin (10 mg/day) for 8 weeks, or (2) atorvastatin group (n=50, completers=34), receiving only atorvastatin (20 mg/day) for 8 weeks. Weight, body mass index (BMI), lipid profile, and biomarkers of hepatic and renal injury were determined at baseline and at the end of the trial. There were significant reductions in serum total cholesterol and LDL-C in both the H. persicum (p=0.001) and atorvastatin (p< 0.001) groups. Serum HDL-C was elevated in the atorvastatin group (p< 0.05), while no significant change was observed in the H. persicum group (p> 0.05). Serum triglyceride levels remained statistically unchanged by the end of the trial in both groups (p> 0.05). Serum alanine (p=0.049) and aspartate aminotransferase (p=0.013) levels rose in the atorvastatin, but not the H. persicum(p> 0.05) group. In comparison with baseline values, no significant change was observed in weight and BMI, as well as serum levels of creatinine, blood urea nitrogen, and fasting blood sugar in either of the groups (p> 0.05). Apart from HDL-C, the effects of atorvastatin (20 mg/day) on other lipid profile parameters do not appear to be significantly superior to those achieved by combination therapy with H. persicum+ atorvastatin (10 mg/day).

摘要

本研究评估了补充波斯阿魏作为阿托伐他汀辅助治疗对血脂异常患者的潜在益处。在一项随机、开放标签的临床试验中,100名血脂异常患者被随机分为:(1)波斯阿魏组(n = 50,完成者 = 18),接受波斯阿魏提取物(500毫克/天)+阿托伐他汀(10毫克/天)治疗8周;或(2)阿托伐他汀组(n = 50,完成者 = 34),仅接受阿托伐他汀(20毫克/天)治疗8周。在基线和试验结束时测定体重、体重指数(BMI)、血脂谱以及肝肾功能损伤的生物标志物。波斯阿魏组(p = 0.001)和阿托伐他汀组(p < 0.001)的血清总胆固醇和低密度脂蛋白胆固醇均显著降低。阿托伐他汀组的血清高密度脂蛋白胆固醇升高(p < 0.05),而波斯阿魏组未观察到显著变化(p > 0.05)。两组在试验结束时血清甘油三酯水平在统计学上均无变化(p > 0.05)。阿托伐他汀组的血清丙氨酸(p = 0.049)和天冬氨酸转氨酶(p = 0.013)水平升高,但波斯阿魏组未升高(p > 0.05)。与基线值相比,两组的体重、BMI以及血清肌酐、血尿素氮和空腹血糖水平均未观察到显著变化(p > 0.05)。除高密度脂蛋白胆固醇外,阿托伐他汀(20毫克/天)对其他血脂谱参数的影响似乎并不显著优于波斯阿魏 + 阿托伐他汀(10毫克/天)联合治疗所取得的效果。

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