双歧杆菌联合补充剂治疗非酒精性脂肪性肝病：一项随机、双盲、安慰剂对照的初步研究。
Synbiotic supplementation in nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled pilot study.
机构信息
Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute Shahid Beheshti University of Medical Science, Tehran, Iran (TE and AH); the Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran (TE, HP, MS, and RM); and the Gastroenterology and Liver Disease Research Center, Firoozgar Hospital, Tehran University of Medical Sciences, Tehran, Iran (FZ).
出版信息
Am J Clin Nutr. 2014 Mar;99(3):535-42. doi: 10.3945/ajcn.113.068890. Epub 2014 Jan 8.
BACKGROUND
Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in the world. Oral administration of synbiotic has been proposed as an effective treatment of NAFLD because of its modulating effect on the gut flora, which can influence the gut-liver axis.
OBJECTIVE
The objective was to evaluate the effects of supplementation with synbiotic on hepatic fibrosis, liver enzymes, and inflammatory markers in patients with NAFLD.
DESIGN
In a randomized, double-blind, placebo-controlled clinical trial conducted as a pilot study, 52 patients with NAFLD were supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule. Both groups were advised to follow an energy-balanced diet and physical activity recommendations.
RESULTS
At the end of the study, the alanine aminotransferase (ALT) concentration decreased in both groups; this reduction was significantly greater in the synbiotic group. At the end of the study, the following significant differences [means (95% CIs)] were seen between the synbiotic and placebo groups, respectively: ALT [-25.1 (-26.2, -24) compared with -7.29 (-9.5, -5.1) IU/L; P < 0.001], aspartate aminotransferase [-31.33 (-32.1, -30.5) compared with -7.94 (-11.1, -4.8) IU/L; P < 0.001], γ-glutamyltransferase [-15.08 (-15.5, -14.7) compared with -5.21 (-6.6, -3.9) IU/L; P < 0.001], high-sensitivity C-reactive protein [-2.3 (-3, -1.5) compared with -1.04 (-1.5, -0.6) mmol/L; P < 0.05], tumor necrosis factor-α [-1.4 (-1.7, -1.1) compared with -0.59 (-0.8, -0.3) mmol/L; P < 0.001], total nuclear factor κ-B p65 [-0.016 (-0.022, -0.011) compared with 0.001 (-0.004, -0.007) mmol/L; P < 0.001], and fibrosis score as determined by transient elastography [- 2.98 (-3.6, -2.37) compared with -0.77 (-1.32, -0.22) kPa; P < 0.001].
CONCLUSIONS
Synbiotic supplementation in addition to lifestyle modification is superior to lifestyle modification alone for the treatment of NAFLD, at least partially through attenuation of inflammatory markers in the body. Whether these effects will be sustained with longer treatment durations remains to be determined.
背景
非酒精性脂肪性肝病（NAFLD）是世界上最常见的慢性肝病。口服共生元被提议作为 NAFLD 的有效治疗方法，因为它对肠道菌群具有调节作用，而肠道菌群可以影响肠道-肝脏轴。
目的
本研究旨在评估补充共生元对 NAFLD 患者肝纤维化、肝酶和炎症标志物的影响。
设计
在一项作为试点研究的随机、双盲、安慰剂对照临床试验中，52 名 NAFLD 患者每天服用两次共生元或安慰剂胶囊，持续 28 周。两组均被建议遵循能量平衡饮食和身体活动建议。
结果
研究结束时，两组丙氨酸氨基转移酶（ALT）浓度均降低；共生元组的降低更为显著。研究结束时，共生元组与安慰剂组分别出现以下显著差异[平均值（95%CI）]：ALT[-25.1（-26.2，-24）比-7.29（-9.5，-5.1）IU/L；P<0.001]，天冬氨酸氨基转移酶[-31.33（-32.1，-30.5）比-7.94（-11.1，-4.8）IU/L；P<0.001]，γ-谷氨酰转移酶[-15.08（-15.5，-14.7）比-5.21（-6.6，-3.9）IU/L；P<0.001]，高敏 C 反应蛋白[-2.3（-3，-1.5）比-1.04（-1.5，-0.6）mmol/L；P<0.05]，肿瘤坏死因子-α[-1.4（-1.7，-1.1）比-0.59（-0.8，-0.3）mmol/L；P<0.001]，总核因子 κ-B p65[-0.016（-0.022，-0.011）比 0.001（0.004，0.007）mmol/L；P<0.001]，以及通过瞬时弹性成像测定的纤维化评分[-2.98（-3.6，-2.37）比-0.77（-1.32，-0.22）kPa；P<0.001]。
结论
与生活方式改变相比，共生元补充剂联合生活方式改变治疗 NAFLD 优于单独生活方式改变，至少部分通过减轻体内炎症标志物来实现。随着治疗时间的延长，这些效果是否会持续还有待确定。
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