Pervez Muhammad Amjad, Khan Dishad Ahmet, Ijaz Aamir, Khan Shamrez
Armed Forces Institute of Pathology, National University of Medical Sciences, Islamabad, Pakistan.
Armed Forces Institute of Radiology, National University of Medical Sciences, Islamabad Pakistan.
Turk J Gastroenterol. 2018 Mar;29(2):170-176. doi: 10.5152/tjg.2018.17297.
BACKGROUND/AIMS: Non-alcoholic fatty liver disease (NAFLD) is a growing public health problem worldwide and is associated with increased morbidity and mortality. Currently, there is no definitive treatment for this disease. δ-Tocotrienol has potent anti-inflammatory and antioxidant properties and may reduce liver injury in NAFLD. The present study aims to evaluate the efficacy and safety of δ-tocotrienol in the treatment of NAFLD.
The present study was a randomized, double-blind, placebo-controlled pilot study conducted in patients aged > 20 years, belonging to both sexes, having ultrasound-proven fatty liver disease, having a fatty liver index (FLI) of ≥ 60, and persistent elevation of alanine transaminase. A total of 71 patients were assigned to receive either oral δ-tocotrienol (n=35, 300 mg twice daily) or placebo (n=36) for 12 weeks. At the baseline and at the end of the study, clinical and biochemical parameters, including lipid profile, liver function tests, high-sensitivity C-reactive protein (hs-CRP), and malondialdehyde (MDA) were measured. Body mass index and FLI were calculated, and ultrasound grading of hepatic steatosis was performed.
Out of 71 enrolled patients, 64 patients, 31 in the δ-tocotrienol group and 33 in the placebo group, completed the study. After 12 weeks of supplementation, δ-tocotrienol showed greater efficacy than placebo by decreasing serum aminotransferases, hs-CRP, MDA, and FLI score (p<0.001). However, it did not improve hepatic steatosis on ultrasound examination. No adverse effects were reported.
δ-Tocotrienol was safe, and it effectively improved aminotransferase levels and inflammatory and oxidative stress markers in patients with NAFLD. Large-scale randomized clinical trials are warranted to further support these findings.
背景/目的:非酒精性脂肪性肝病(NAFLD)是全球范围内日益严重的公共卫生问题,与发病率和死亡率增加相关。目前,该疾病尚无确切的治疗方法。δ-生育三烯酚具有强大的抗炎和抗氧化特性,可能减轻NAFLD中的肝损伤。本研究旨在评估δ-生育三烯酚治疗NAFLD的疗效和安全性。
本研究是一项随机、双盲、安慰剂对照的试点研究,纳入年龄>20岁、男女均有、经超声证实患有脂肪性肝病、脂肪肝指数(FLI)≥60且丙氨酸转氨酶持续升高的患者。共71例患者被分配接受口服δ-生育三烯酚(n = 35,每日两次,每次300 mg)或安慰剂(n = 36),持续12周。在基线和研究结束时,测量临床和生化参数,包括血脂谱、肝功能检查、高敏C反应蛋白(hs-CRP)和丙二醛(MDA)。计算体重指数和FLI,并进行肝脏脂肪变性的超声分级。
在71例入组患者中,64例患者完成了研究,其中δ-生育三烯酚组31例,安慰剂组33例。补充12周后,δ-生育三烯酚在降低血清转氨酶、hs-CRP、MDA和FLI评分方面显示出比安慰剂更高的疗效(p<0.001)。然而,超声检查未发现其改善肝脏脂肪变性。未报告不良反应。
δ-生育三烯酚是安全的,它有效改善了NAFLD患者的转氨酶水平以及炎症和氧化应激标志物。有必要进行大规模随机临床试验以进一步支持这些发现。