El-Kassas Mohamed, Mostafa Hala, Abdellatif Wessam, Shoman Sohier, Esmat Gamal, Brahmania Mayur, Liu Hongqun, Lee Samuel S
Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.
Liver Disease Research Center, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
Aliment Pharmacol Ther. 2025 Feb;61(4):628-635. doi: 10.1111/apt.18478. Epub 2025 Jan 2.
The laxative lubiprostone has been shown to decrease intestinal permeability. We aimed to assess the safety and efficacy of lubiprostone administered for 48 weeks in patients with metabolic dysfunction-associated steatotic liver disease (MASLD).
A randomised placebo-controlled trial was conducted in a specialised MASLD outpatient clinic at the National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt. The recruited patients had radiological evidence of MASLD along with other criteria for diagnosis. Eligible patients were randomly assigned to receive either placebo or lubiprostone 24 μg orally twice daily for 48 weeks. The liver fat content was quantified by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF). Between November 2020 and February 2023, 176 patients were screened, of whom 116 were eligible. Fifty-nine patients were randomised to receive placebo, while 57 patients were randomised to receive lubiprostone. Due mostly to patient dropout (i.e., loss to follow-up), complete data were available for 40 patients in each group. Compared with placebo group, 48-week lubiprostone treatment significantly reduced fat quantity (p = 0.04). Despite a significant reduction in body weight in the control group, no significant difference was found between both groups regarding fibrosis score by transient elastography or in serum ALT levels. One patient in the lubiprostone group developed severe diarrhoea requiring treatment stoppage. No other serious adverse events occurred.
Lubiprostone was well tolerated and reduced liver fat content as measured by MRI-PDFF in patients with MASLD over 48 weeks. Lubiprostone appears promising to treat MASLD and warrants more extensive studies to confirm such efficacy.
ClinicalTrials.gov identifier: NCT05768334.
缓泻剂鲁比前列酮已被证明可降低肠道通透性。我们旨在评估鲁比前列酮治疗48周对代谢功能障碍相关脂肪性肝病（MASLD）患者的安全性和疗效。
在埃及开罗国家肝脏病和热带医学研究所的一个专门的MASLD门诊诊所进行了一项随机安慰剂对照试验。招募的患者有MASLD的影像学证据以及其他诊断标准。符合条件的患者被随机分配接受安慰剂或鲁比前列酮24μg，口服，每日两次，共48周。通过磁共振成像估计质子密度脂肪分数（MRI-PDFF）对肝脏脂肪含量进行定量。2020年11月至2023年2月，共筛选了176例患者，其中116例符合条件。59例患者被随机分配接受安慰剂，57例患者被随机分配接受鲁比前列酮。主要由于患者失访（即随访丢失），每组有40例患者可获得完整数据。与安慰剂组相比，48周的鲁比前列酮治疗显著降低了脂肪量（p = 0.04）。尽管对照组体重显著下降，但两组在瞬时弹性成像纤维化评分或血清ALT水平方面无显著差异。鲁比前列酮组有1例患者出现严重腹泻，需要停药。未发生其他严重不良事件。
鲁比前列酮耐受性良好，在48周内通过MRI-PDFF测量可降低MASLD患者的肝脏脂肪含量。鲁比前列酮似乎有望治疗MASLD，需要更广泛的研究来证实这种疗效。
ClinicalTrials.gov标识符：NCT05768334。
