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在医疗服务不足人群中使用聚廿烷醇治疗人类免疫缺陷病毒相关血脂异常:一项随机对照临床试验

Policosanol for managing human immunodeficiency virus-related dyslipidemia in a medically underserved population: a randomized, controlled clinical trial.

作者信息

Swanson Barbara, Keithley Joyce K, Sha Beverly E, Fogg Louis, Nerad Judith, Novak Richard M, Adeyemi Oluwatoyin, Spear Gregory T

机构信息

Rush University College of Nursing, Chicago, Illinois, USA.

出版信息

Altern Ther Health Med. 2011 Mar-Apr;17(2):30-5.

PMID:21717822
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3654198/
Abstract

BACKGROUND

Human immunodeficiency virus (HIV) infection is associated with dyslipidemia and increased risk for cardiovascular events; however, the use ofstatins in HIV-infected people is complicated by pharmacokinetic interactions and overlapping toxicities with antiretroviral medications. Policosanol is a dietary supplement derived from sugar cane that is widely used as a statin alternative in Latin America.

PRIMARY STUDY OBJECTIVE

To collect feasibility data on sugar cane-derived policosanol to normalize dyslipidemic profiles in a sample of medically underserved HIV-infected people.

METHODS/DESIGN: Randomized, controlled, double-blind clinical trial.

SETTING

Two infectious disease outpatient clinics located in a Health Resources Service Administration-designated medically underserved neighborhood in Chicago, Illinois.

PARTICIPANTS

Fifty-four clinically stable HIV-infected people (91% black) with at least one lipid abnormality that warranted dietary modifications and/or drug therapy.

INTERVENTION

Participants received either 20 mg/day of policosanol or placebo for 12 weeks, followed by a 4-week washout and crossover to the other arm.

PRIMARY OUTCOME MEASURES

Efficacy measures included the standard lipid panel (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides) and nuclear magnetic resonance (NMR)-derived lipoprotein particle profiles. Safety measures included CD4+ T lymphocyte counts, plasma HIV ribonucleic acid levels, serum creatinine, and liver function tests.

RESULTS

Policosanol supplementation was not associated with normalization of any dyslipidemic parameters as measured by the standard lipid panel or NMR spectroscopy-measured lipoprotein size or concentration. The supplement was well tolerated and was not associated with any changes in parameters of HIV disease progression.

CONCLUSIONS

Our findings corroborate recent studies conducted outside Cuba that have failed to find any lipid modulatory effects for policosanol.

摘要

背景

人类免疫缺陷病毒(HIV)感染与血脂异常及心血管事件风险增加相关;然而,在HIV感染者中使用他汀类药物会因药代动力学相互作用以及与抗逆转录病毒药物的毒性重叠而变得复杂。聚多卡醇是一种从甘蔗中提取的膳食补充剂,在拉丁美洲被广泛用作他汀类药物的替代品。

主要研究目的

收集关于甘蔗衍生的聚多卡醇使医疗服务不足的HIV感染者样本中的血脂异常情况正常化的可行性数据。

方法/设计:随机、对照、双盲临床试验。

地点

位于伊利诺伊州芝加哥市一个由卫生资源与服务管理局指定的医疗服务不足社区的两家传染病门诊诊所。

参与者

54名临床稳定的HIV感染者(91%为黑人),至少有一项血脂异常,需要进行饮食调整和/或药物治疗。

干预措施

参与者接受20毫克/天的聚多卡醇或安慰剂治疗12周,随后进行4周的洗脱期,然后交叉到另一组。

主要结局指标

疗效指标包括标准血脂指标(低密度脂蛋白胆固醇、高密度脂蛋白胆固醇、甘油三酯)和核磁共振(NMR)衍生的脂蛋白颗粒谱。安全性指标包括CD4 + T淋巴细胞计数、血浆HIV核糖核酸水平、血清肌酐和肝功能检查。

结果

通过标准血脂指标或NMR光谱测量的脂蛋白大小或浓度衡量,补充聚多卡醇与任何血脂异常参数的正常化均无关联。该补充剂耐受性良好,且与HIV疾病进展参数的任何变化均无关联。

结论

我们的研究结果证实了古巴以外地区最近进行的研究,这些研究未能发现聚多卡醇有任何血脂调节作用。

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Nutritional supplements and serum lipids: does anything work?营养补充剂与血清脂质:有何作用?
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Effect of sugar cane policosanol on lipid profile in primary hypercholesterolemia.甘蔗多廿烷醇对原发性高胆固醇血症患者血脂水平的影响。
Phytother Res. 2008 Mar;22(3):318-22. doi: 10.1002/ptr.2315.
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