临床研究棕榈维生素 E 生育三烯酚对脑白质的保护作用。
Clinical investigation of the protective effects of palm vitamin E tocotrienols on brain white matter.
机构信息
From the Faculty of Pharmacy, Universiti Teknologi Mara, Selangor, Malaysia (Y.G.); Advanced Medical and Dental Institute, Penang, Malaysia (I.L.S., E.M., M.A.A., M.R.A.B.); School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia (N.A.K.K., K.H.Y.); Hovid Research Sdn Bhd, Ipoh, Malaysia (J.W.W., B.H.N.); Malaysian Palm Oil Council (K.S.); Faculty of Medicine, Universiti Malaya, Kuala Lumpur, Malaysia (C.K.); Buckinghamshire Healthcare, NHS Trust, Buckinghamshire, United Kingdom (W.C.L.).
出版信息
Stroke. 2014 May;45(5):1422-8. doi: 10.1161/STROKEAHA.113.004449. Epub 2014 Apr 3.
BACKGROUND AND PURPOSE
Previous cell-based and animal studies showed mixed tocotrienols are neuroprotective, but the effect is yet to be proven in humans. Thus, the present study aimed to evaluate the protective activity of mixed tocotrienols in humans with white matter lesions (WMLs). WMLs are regarded as manifestations of cerebral small vessel disease, reflecting varying degrees of neurodegeneration and tissue damage with potential as a surrogate end point in clinical trials.
METHODS
A total of 121 volunteers aged ≥35 years with cardiovascular risk factors and MRI-confirmed WMLs were randomized to receive 200 mg mixed tocotrienols or placebo twice a day for 2 years. The WML volumes were measured from MRI images taken at baseline, 1 year, and 2 years using a validated software and were compared. Fasting blood samples were collected for full blood chemistry investigation.
RESULTS
According to per-protocol (88 volunteers) and intention-to-treat (121 volunteers) analyses, the mean WML volume of the placebo group increased after 2 years, whereas that of the tocotrienol-supplemented group remained essentially unchanged. The mean WML volume change between the 2 groups was not significantly different (P=0.150) at the end of 1 year but was significant at the end of 2 years for both per-protocol and intention-to-treat analyses (P=0.019 and P=0.018). No significant difference was observed in the blood chemistry parameters between the 2 groups.
CONCLUSIONS
Mixed tocotrienols were found to attenuate the progression of WMLs.
CLINICAL TRIAL REGISTRATION URL
http://www.clinicaltrials.gov. Unique identifier: NCT00753532.
背景与目的
先前的细胞和动物研究表明，混合生育三烯酚具有神经保护作用，但这一作用尚未在人类中得到证实。因此，本研究旨在评估混合生育三烯酚对有脑白质病变（WML）的人群的保护作用。WML 被认为是脑小血管疾病的表现，反映了不同程度的神经退行性变和组织损伤，具有成为临床试验替代终点的潜力。
方法
共有 121 名年龄≥35 岁、有心血管危险因素且 MRI 证实有 WML 的志愿者被随机分为两组，每天接受 200 mg 混合生育三烯酚或安慰剂，疗程为 2 年。采用一种经验证的软件，从基线、1 年和 2 年的 MRI 图像中测量 WML 体积，并进行比较。采集空腹血样进行全血化学检查。
结果
根据方案（88 名志愿者）和意向治疗（121 名志愿者）分析，安慰剂组在 2 年后 WML 体积增加，而生育三烯酚补充组的 WML 体积基本不变。2 组间的 WML 体积变化在 1 年末差异无统计学意义（P=0.150），但在 2 年末差异有统计学意义（方案分析 P=0.019，意向治疗分析 P=0.018）。2 组间的血液化学参数无显著差异。
结论
混合生育三烯酚可减缓 WML 的进展。
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