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治疗非酒精性脂肪肝炎的米索普罗斯托尔:随机对照试验
Mehreen Siyal1, Zaigham Abbas2, Muhammad Ali Qadeer2
1Department of Gastroenterology and Hepatology, Dr Ziauddin Hospital, Clifton Campus, Karachi, Pakistan drmehreensiyal@gmail.com.
与安慰剂相比,mizoprostol在非酒精性脂肪肝炎 (NASH) 患者中显示出改善的肝脂肪含量 (受控减弱参数). 虽然这两组都改善了肝功能测试,但mizoprostol并没有显著改变其他NASH标志物或胰岛素抵抗.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 胃肠病学 胃肠病学
- 临床药理学 临床药理学
背景情况:
- 非酒精性脂肪肝炎 (NASH) 是一个重要的未满足的临床需求.
- 作为前列腺素E1模拟剂的米索普罗斯托尔可以降低炎症性细胞因子,这表明NASH的治疗潜力.
- 这项研究研究了米索普罗斯托尔在NASH患者的疗效和安全性.
研究的目的:
- 评估米索普罗斯托尔在治疗非酒精性脂肪肝炎 (NASH) 的疗效.
- 评估NASH患者队列中mizoprostol的安全概况.
- 为了比较米索普罗斯托尔与安慰剂对肝功能和疾病标志物的影响.
主要方法:
- 一个第二阶段,双盲,随机,安慰剂对照试验.
- 50名NASH患者每天三次服用200微克米索普罗或安慰剂,持续2个月.
- 主要终点包括肝功能测试,IL-6和内毒素水平;次要终点包括胰岛素耐药性,失脂血症,纤维化和肉脂症.
主要成果:
- 与安慰剂相比,mizoprostol显著降低了受控减弱参数 (CAP) (p=0.039),表明肝脏肥胖症得到改善.
- 两组都显示出生化改善 (例如,ALT,AST),但没有统计学上显著的组间差异.
- 米索普罗斯托尔维持了稳定的IL-6和内毒素水平,而安慰剂显示IL-6增加 (p=0.049). 没有观察到胰岛素抵抗或纤维化的显著变化.
结论:
- 与NASH患者的安慰剂相比,mizoprostol在肝脏肥胖症 (CAP) 中显著改善.
- 在两组中都观察到生化改善,在mizoprostol和安慰剂之间没有统计学上显著的差异.
- 弥索普罗斯托尔的耐受性一般很好,腹是最常见的不良反应;没有发现严重的安全问题.
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