普伐他汀、植物甾醇及联合疗法对HIV感染患者血脂谱的影响：一项开放标签、随机交叉研究。

Effects of pravastatin, phytosterols, and combination therapy on lipid profile in HIV-infected patients: an open-labelled, randomized cross-over study.

作者信息

Kietsiriroje Noppadol, Leelawattana Rattana

机构信息

Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkla, 90110, Thailand.

出版信息

BMC Res Notes. 2015 Jul 7;8:294. doi: 10.1186/s13104-015-1225-6.

DOI:10.1186/s13104-015-1225-6

PMID:26148680

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4492082/

Abstract

BACKGROUND

To determine the effects of 40 mg of pravastatin, 2 g of phytosterols, and combination therapy on lipid profiles and to compare the reduction of LDL cholesterol between combination therapy and monotherapy.

METHODS

Thirty-six HIV-infected patients treated with ARVs who had high LDL cholesterol levels but no current usage of any lipid-lowering agents were enrolled into the open-labelled, randomized, cross-over study. All patients were assigned randomly into one of four intervention groups: (1) pravastatin 40 mg cross-over to the combination of pravastatin 40 mg and phytosterols 2 g (combination group), (2) the combination group cross-over to pravastatin 40 mg, (3) phytosterols 2 g cross-over to the combination group, and (4) the combination group cross-over to phytosterols 2 g. Each active treatment lasted 4 weeks with a wash-out period of 4 weeks.

RESULTS

The baseline mean TC, TG, HDL-c, and LDL-c levels in 36 HIV patients were 248.09 ± 34.73, 172.36 ± 125.44, 54.92 ± 16.67, and 175.13 ± 29.00 mg/dl, respectively. Pravastatin, phytosterols, and combination therapy reduced TC and LDL-c but TG and HDL-c were not significantly different from the baselines. The mean LDL-c reductions in the pravastatin, phytosterols, and the combination groups were 28.76 ± 9.32, 9.12 ± 7.84, and 27.08 ± 15.58%, respectively. The LDL-c levels in the pravastatin and combination groups were reduced more than in the phytosterols group (p < 0.01). There was no difference in the LDL-c reduction between the combination and pravastatin monotherapy groups (-25.61 ± 10.43 vs. -28.12 ± 14.07%, p = 0.555).

CONCLUSION

Pravastatin had moderate potency on LDL-c lowering in HIV patients but could not bring LDL-c to goal. Adding phytosterols to pravastatin for a 4-week duration could not demonstrate any additional lipid-lowering effect

TRIAL REGISTRATION

Thai Clinical Trial Registry: TCTR20150126002 date: January 23, 2015.

摘要

背景

确定40毫克普伐他汀、2克植物甾醇及联合治疗对血脂谱的影响，并比较联合治疗与单一疗法降低低密度脂蛋白胆固醇的效果。

方法

36名接受抗逆转录病毒药物治疗、低密度脂蛋白胆固醇水平高但目前未使用任何降脂药物的HIV感染患者被纳入这项开放标签、随机、交叉研究。所有患者被随机分配到四个干预组之一：（1）40毫克普伐他汀组交叉至40毫克普伐他汀与2克植物甾醇联合组（联合组）；（2）联合组交叉至40毫克普伐他汀组；（3）2克植物甾醇组交叉至联合组；（4）联合组交叉至2克植物甾醇组。每种积极治疗持续4周，洗脱期为4周。

结果

36名HIV患者的基线平均总胆固醇（TC）、甘油三酯（TG）、高密度脂蛋白胆固醇（HDL-c）和低密度脂蛋白胆固醇（LDL-c）水平分别为248.09±34.73、172.36±125.44、54.92±16.67和175.13±29.00毫克/分升。普伐他汀、植物甾醇及联合治疗降低了TC和LDL-c，但TG和HDL-c与基线相比无显著差异。普伐他汀组、植物甾醇组和联合组的平均LDL-c降低率分别为28.76±9.32%、9.12±7.84%和27.08±15.58%。普伐他汀组和联合组的LDL-c水平降低幅度大于植物甾醇组（p<0.01）。联合治疗组与普伐他汀单一治疗组的LDL-c降低率无差异（-25.61±10.43%对-28.12±14.07%，p = 0.555）。