Antihyperlipidemic effects of Pleurotus ostreatus (oyster mushrooms) in HIV-infected individuals taking antiretroviral therapy.

Antihyperlipidemic effects of Pleurotus ostreatus (oyster mushrooms) in HIV-infected individuals taking antiretroviral therapy.
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DOI:
10.1186/1472-6882-11-60
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发表时间:
2011-08-10
影响因子:
--
通讯作者:
Stamets P
Stamets P
中科院分区:
医学3区
文献类型:
--
作者:
Abrams DI;Couey P;Shade SB;Kelly ME;Kamanu-Elias N;Stamets P

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HIV患者的抗逆转录病毒治疗(ART)方案通常会导致显著的脂质升高,包括甘油三酯和胆固醇的增加。高胆固醇血症的标准治疗包括HMG CoA还原酶抑制剂或“他汀类药物”。“由于许多ART药物和他汀类药物共享一个共同的代谢途径,使用细胞色素P450酶系统,ART与他汀类药物的联合给药可以显着增加他汀类药物的血浆水平。平菇在动物模型中被证明可以降低血脂水平,这一发现得到了一项小型人体试验的初步数据的支持。为了评估糙皮侧耳在HIV和ART诱导的高脂血症患者中的安全性和疗效,进行了一项为期8周的单臂、开放标签、概念验证研究,目标入组20例受试者。入组ART诱导的非HDL胆固醇水平升高(> 160 mg/dL)的研究患者。参与者在8周的试验期内接受口服给药的冻干糙皮侧耳包(15 gm/天)。每两周抽取一次血脂水平以评估疗效。安全性评估包括自我报告的肌肉疼痛发生率以及肝脏和肌肉酶的测量。使用广义估计方程来估计脂质水平的平均个体内变化,以解释对个体的重复观察。非HDL胆固醇降低30 mg/dL被认为具有临床意义。筛选了126例患者,入组25例,其中20例完成了8周研究。平均年龄为46.4岁(36-60岁)。患者平均感染艾滋病毒13.7年。第0天平均非HDL胆固醇为204.5 mg/dL,第56天为200.2 mg/dL(平均人内变化= -1.70; 95%置信区间(CI)=-17.4,14.0)。HDL胆固醇水平从第0天的37.8 mg/dL增加到第56天的40.4 mg/dL(平均人内变化= 2.6; 95% CI =-0.1,5.2)。甘油三酯从第0天的336.4 mg/dL降至第56天的273.4 mg/dL(平均人内变化= -63.0; 95% CI =-120.9,-5.1)。治疗8周后,仅3例患者的非HDL胆固醇达到持续的临床显著性(30 mg/dL)下降。除了患者对制剂的厌恶外,未报告任何不良反应。肝功能检查和肌肉酶不受8周治疗的影响。本实验中给药的平菇并没有降低ART诱导的高胆固醇血症的HIV患者的非HDL胆固醇。HDL和甘油三酯的微小变化不具有临床意义,无需进一步研究。clinicaltrials.gov标识符:NCT 00069524
Antiretroviral treatment (ART) regimens in HIV patients commonly cause significant lipid elevations, including increases in both triglycerides and cholesterol. Standard treatments for hypercholesterolemia include the HMG CoA reductase inhibitors, or "statins." Because many ART agents and statins share a common metabolic pathway that uses the cytochrome P450 enzyme system, coadministration of ART with statins could increase statin plasma levels significantly. The oyster mushroom, Pleurotus ostreatus, has been shown in animal models to decrease lipid levels - a finding that has been supported by preliminary data in a small human trial. To assess the safety and efficacy of P. ostreatus in patients with HIV and ART-induced hyperlipidemia, a single-arm, open-label, proof-of-concept study of 8 weeks' duration with a target enrollment of 20 subjects was conducted. Study patients with ART-induced elevated non-HDL cholesterol levels (> 160 mg/dL) were enrolled. Participants received packets of freeze-dried P. ostreatus (15 gm/day) to be administered orally for the 8 week trial period. Lipid levels were drawn every two weeks to assess efficacy. Safety assessments included self-reported incidence of muscle aches and measurement of liver and muscle enzymes. Mean within-person change in lipid levels were estimated using generalized estimating equations to account for repeated observations on individuals. A 30 mg/dL decrease in non-HDL cholesterol was deemed clinically significant. 126 patients were screened to enroll 25, of which 20 completed the 8-week study. The mean age was 46.4 years (36-60). Patients had a mean 13.7 yrs of HIV infection. Mean non-HDL cholesterol was 204.5 mg/dL at day 0 and 200.2 mg/dL at day 56 (mean within-person change = -1.70; 95% confidence interval (CI) = -17.4, 14.0). HDL cholesterol levels increased from 37.8 mg/dL at day 0 to 40.4 mg/dL on day 56 (mean within-person change = 2.6; 95% CI = -0.1, 5.2). Triglycerides dropped from 336.4 mg/dL on day 0 to 273.4 mg/dL on day 56 (mean within-person change = -63.0; 95% CI = -120.9, -5.1). Only 3 individuals achieved a sustained clinically significant (30 mg/dL) decline in non-HDL cholesterol after 8 weeks of therapy. There were no adverse experiences reported other than patients' distaste for the preparation. Liver function tests and muscle enzymes were not affected by the 8 weeks of treatment. Pleurotus ostreatus as administered in this experiment did not lower non-HDL cholesterol in HIV patients with ART-induced hypercholesterolemia. Small changes in HDL and triglycerides were not of a clinical magnitude to warrant further study. clinicaltrials.gov Identifier: NCT00069524
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