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Lancet:NGM282治疗非酒精性脂肪性肝炎效果显著

2018-03-06 zhangfan MedSci原创

研究认为NGM282可快速有效的降低非酒精性脂肪性肝炎患者肝脂肪含量,并且安全性良好

非酒精性脂肪性肝炎是一种以肝脂肪变性、炎症和肝细胞损伤为特征的慢性肝病,是抗HCV后肝病领域新的药物研发热点。FGF19是一种调节胆汁酸合成和葡萄糖平衡的激素,近日研究人员考察了FGF19类似物NGM282治疗非酒精性脂肪性肝炎的疗效和安全性。

本次II期临床研究招募18-75岁活检证实的非酒精性脂肪性肝炎患者,患者非酒精性脂肪肝评分4分以上,纤维化1-3期,肝脂肪含量至少8%。患者随机接受3、6mg的NGM282或安慰剂。研究的主要终点是12周肝脂肪含量变化,MRI检查脂肪含量减少超过5%的患者定义为治疗响应阳性。

82名患者参与研究,其中3mg NGM282组患者27人,6mg组28人,安慰剂组27人。治疗12周后,3mg组20人(74%)以及6mg组22人(79%)治疗响应阳性 (rr,10.0 vs 11.4),安慰剂组仅2人 (7%)。82名患者中,76人(93%)报告不良事件,大部分为1级事件(67%),仅5人(6%)发生3级及以上不良事件。最常见的不良事件为注射部位疼痛、腹泻、腹痛以及恶心。治疗组的不良事件率较高,但未发生治疗导致的患者死亡。

研究认为NGM282可快速有效的降低非酒精性脂肪性肝炎患者肝脂肪含量,并且安全性良好。

原始出处:


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    2018-04-22 howi
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    2019-01-24 qjddjq

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