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口服 Imm124-E 可缓解胰岛素抵抗和肝损伤,其机制与增加 Tregs 有关,并与血清 GLP-1 和脂联素增加相关:NASH 的 I/II 期临床试验结果。

Alleviation of insulin resistance and liver damage by oral administration of Imm124-E is mediated by increased Tregs and associated with increased serum GLP-1 and adiponectin: results of a phase I/II clinical trial in NASH.

机构信息

Liver Unit, Hebrew University-Hadassah Medical Center, Jerusalem, Israel.

出版信息

J Inflamm Res. 2012;5:141-50. doi: 10.2147/JIR.S35227. Epub 2012 Dec 20.

DOI:10.2147/JIR.S35227
PMID:23293533
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3534391/
Abstract

BACKGROUND

Nonalcoholic steatohepatitis (NASH) is considered to be part of the nonalcoholic fatty liver disorders and its incidence is increasing. Imm124-E (Immuron Ltd, Melbourne, Australia), containing hyperimmune bovine colostrum, has been shown to exert an immunomodulatory effect and to alleviate target organ damage in animal models of NASH. The aim of our study was to determine the safety and efficacy of oral administration of Imm124-E to patients with insulin resistance and NASH.

METHODS

In an open-label trial, ten patients with biopsy-proven NASH and insulin resistance were orally treated with Imm124-E for 30 days.

RESULTS

Oral administration of Imm124-E was safe, and no side effects were noted. Alleviation of insulin resistance was reflected by significantly improved hemoglobin A(1c) (HbA(1c)) values in all ten treated patients. For between five and eight responders, the following effects were noted: a decrease in fasting glucose levels; improved oral glucose tolerance test (OGGT) and homeostatic model assessment insulin resistance (HOMA) scores; and alleviation in lipid profile. These effects were accompanied by increased serum levels of glucagon-like peptide 1 (GLP-1), adiponectin and T regulatory cells.

CONCLUSION

Hyperimmune colostrum alleviates NASH.

摘要

背景

非酒精性脂肪性肝炎(NASH)被认为是非酒精性脂肪性肝病的一部分,其发病率正在上升。Imm124-E(澳大利亚墨尔本 Immuron 有限公司生产,含有高免疫牛初乳)已被证明具有免疫调节作用,并能减轻 NASH 动物模型中的靶器官损伤。我们的研究目的是确定口服 Imm124-E 对胰岛素抵抗和 NASH 患者的安全性和疗效。

方法

在一项开放性试验中,10 名经活检证实患有 NASH 和胰岛素抵抗的患者口服 Imm124-E 治疗 30 天。

结果

口服 Imm124-E 是安全的,未观察到不良反应。所有 10 名接受治疗的患者的血红蛋白 A1c(HbA1c)值均显著改善,表明胰岛素抵抗得到缓解。在五到八名应答者中,还观察到以下效果:空腹血糖水平降低;口服葡萄糖耐量试验(OGTT)和稳态模型评估胰岛素抵抗(HOMA)评分改善;血脂谱改善。这些作用伴随着血清胰高血糖素样肽 1(GLP-1)、脂联素和 T 调节细胞水平的升高。

结论

高免疫牛初乳可缓解 NASH。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea8d/3534391/61b00fa45754/jir-5-141f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea8d/3534391/075cccfcba53/jir-5-141f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea8d/3534391/ee97f24ce2c6/jir-5-141f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea8d/3534391/e76d23b0ca29/jir-5-141f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea8d/3534391/c909f4ae398f/jir-5-141f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea8d/3534391/61b00fa45754/jir-5-141f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea8d/3534391/075cccfcba53/jir-5-141f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea8d/3534391/ee97f24ce2c6/jir-5-141f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea8d/3534391/e76d23b0ca29/jir-5-141f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea8d/3534391/c909f4ae398f/jir-5-141f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea8d/3534391/61b00fa45754/jir-5-141f5.jpg

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