Zhu Feng-Shang, Liu Su, Chen Xi-Mei, Huang Zhi-Gang, Zhang Dong-Wei
Department of Gastroenterology, Tongji Hospital, Digestive Disease Institute of Tongji University, Shanghai 200065, China.
World J Gastroenterol. 2008 Nov 7;14(41):6395-400. doi: 10.3748/wjg.14.6395.
To investigate the efficacy and safety of n-3 polyunsaturated fatty acids (PUFA) from seal oils for patients with nonalcoholic fatty liver disease (NAFLD) associated with hyperlipidemia.
One hundred and forty-four patients with NAFLD associated with hyperlipidemia were included in the 24-wk, randomized, controlled trial. The patients were randomized into two groups. Group A (n=72) received recommended diet and 2 g n-3 PUFA from seal oils, three times a day. Group B (n=72) received recommended diet and 2 g placebo, three times a day. Primary endpoints were fatty liver assessed by symptom scores, liver alanine aminotransferase (ALT) and serum lipid levels after 8, 12, 16, and 24 wk. Hepatic fat infiltration was detected by ultrasonography at weeks 12 and 24 after treatment.
A total of 134 patients (66 in group A, 68 in group B) were included in the study except for 10 patients who were excluded from the study. After 24 wk of treatment, no change was observed in body weight, fasting blood glucose (FBG), renal function and blood cells of these patients. Total symptom scores, ALT and triglyceride (TG) levels decreased more significantly in group A than in group B (P<0.05). As expected, there was a tendency toward improvement in aspartate aminotransferase (AST), gamma-glutamyltranspeptidase (GGT), and total cholesterol (TCHO) and high-density lipoprotein (HDL) cholesterol levels (P<0.05) after administration in the two groups. However, no significant differences were found between the two groups. The values of low-density lipoprotein (LDL) were significantly improved in group A (P<0.05), but no significant change was found in group B at different time points and after a 24-wk treatment. After treatment, complete fatty liver regression was observed in 19.70% (13/66) of the patients, and an overall reduction was found in 53.03% (35/66) of the patients in group A. In contrast, in group B, only five patients (7.35%, 5/68) achieved complete fatty liver regression (P=0.04), whereas 24 patients (35.29%, 24/68) had a certain improvement in fatty liver (P=0.04). No serious adverse events occurred in all the patients who completed the treatment.
Our results indicate that n-3 PUFA from seal oils is safe and efficacious for patients with NAFLD associated with hyperlipidemia and can improve their total symptom scores, ALT, serum lipid levels and normalization of ultrasonographic evidence. Further study is needed to confirm these results.
探讨海豹油中n-3多不饱和脂肪酸（PUFA）对非酒精性脂肪性肝病（NAFLD）合并高脂血症患者的疗效及安全性。
144例NAFLD合并高脂血症患者纳入为期24周的随机对照试验。患者随机分为两组。A组（n=72）接受推荐饮食及每日3次、每次2g海豹油n-3 PUFA。B组（n=72）接受推荐饮食及每日3次、每次2g安慰剂。主要终点为治疗8、12、16及24周后通过症状评分、肝脏丙氨酸氨基转移酶（ALT）及血脂水平评估的脂肪肝情况。治疗12周和24周后通过超声检查检测肝脏脂肪浸润情况。
除10例被排除研究的患者外，共134例患者（A组66例，B组68例）纳入研究。治疗24周后，这些患者的体重、空腹血糖（FBG）、肾功能及血细胞未见变化。A组总症状评分、ALT及甘油三酯（TG）水平较B组下降更显著（P<0.05）。如预期，两组给药后天冬氨酸氨基转移酶（AST）、γ-谷氨酰转肽酶（GGT）、总胆固醇（TCHO）及高密度脂蛋白（HDL）胆固醇水平有改善趋势（P<0.05）。然而，两组间无显著差异。A组低密度脂蛋白（LDL）值显著改善（P<0.05），但B组在不同时间点及24周治疗后无显著变化。治疗后，A组19.70%（13/66）的患者脂肪肝完全消退，53.03%（35/66）的患者总体减轻。相比之下，B组仅5例患者（7.35%，5/68）脂肪肝完全消退（P=0.04），24例患者（35.29%，24/68）脂肪肝有一定改善（P=0.04）。所有完成治疗的患者均未发生严重不良事件。
我们的结果表明，海豹油中的n-3 PUFA对NAFLD合并高脂血症患者安全有效，可改善其总症状评分、ALT、血脂水平及超声检查结果的正常化。需要进一步研究来证实这些结果。
