内镜下袖状胃成形术联合生活方式干预治疗代谢功能障碍相关脂肪性肝炎患者：一项多中心、假手术对照、随机试验
Endoscopic Sleeve Gastroplasty Plus Lifestyle Intervention in Patients With Metabolic Dysfunction-associated Steatohepatitis: A Multicenter, Sham-controlled, Randomized Trial.
作者信息
Abad Javier, Llop Elba, Arias-Loste María Teresa, Burgos-Santamaría Diego, Martínez Porras José Luis, Iruzubieta Paula, Graus Javier, Ruiz-Antorán Belén, Sánchez Yuste María Rosario, Romero-Gómez Manuel, Albillos Agustin, Crespo Javier, Calleja José Luis
机构信息
Department of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro, Majadahonda, Spain.
Department of Gastroenterology and Hepatology, Hospital Universitario Marqués de Valdecilla, Santander, Spain.
出版信息
Clin Gastroenterol Hepatol. 2025 Aug;23(9):1556-1566.e3. doi: 10.1016/j.cgh.2024.10.027. Epub 2024 Dec 16.
BACKGROUND & AIMS: Metabolic dysfunction-associated steatohepatitis (MASH) is commonly seen in biopsy-proven steatotic liver disease. Lifestyle intervention reaching a weight loss higher than 10% promotes MASH resolution, but this goal is only achieved by a small number of patients. Endoscopic sleeve gastroplasty (ESG) has recently emerged as a safe and effective option to promote weight loss in the obese population. We report the results of a multicenter, randomized, controlled, and double-blind study to evaluate the effectiveness and safety of ESG in patients with MASH.
METHODS
Forty patients were randomized 1:1 to ESG plus lifestyle modification vs sham endoscopy (SE) plus lifestyle intervention. Inclusion criteria included biopsy-proven MASH with nonalcoholic fatty liver disease activity score (NAS) ≥3 and fibrosis stage F0 to F3. Eighteen patients from the ESG group and 19 from the endoscopic simulated intervention (ESI) group completed follow-up over 72 weeks. Baseline to end of follow-up changes in body weight, liver tests, liver stiffness (vibration-controlled transient elastography), and liver histology were recorded RESULTS: Total body weight loss (TBWL) was 9.47% (±9.38%) in the ESG group vs 3.91% (±5.43%) in the ESI group (P < .05). Liver stiffness decreased 5.63 (±7.17) KPa in the ESG group vs 0.2 (±5.38) KPa in the ESI group (P < .05). Steatosis was significantly reduced in the ESG group (-0.94 ± 0.87) vs the ESI group (-0.26 ± 0.99) (P = .033). No differences on NAS (-1.89 ± 2.11 vs -1.47 ± 2.01) score or fibrosis (-0.1 ± 0.91 vs -0.84 ± 1.21) was seen. In patients achieving weight loss >10%, we found a significant improvement on NAS score (-4 ± 0.94 vs -0.81 ± 1.62; P < .01), but not in fibrosis stage (-0.3 ± 1.06 vs -0.59 ± 1.25). Only 2 patients from the ESG group had adverse events that required admission; these resolved conservatively in 72 hours.
CONCLUSION
ESG is an effective and safe method to promote weight reduction associated with significant improvement in patients with MASH and obesity.
CLINICALTRIALS
gov, Number: NCT03426111.
背景与目的
代谢功能障碍相关脂肪性肝炎（MASH）在经活检证实的脂肪性肝病中很常见。体重减轻超过10%的生活方式干预可促进MASH的缓解，但只有少数患者能达到这一目标。内镜下袖状胃成形术（ESG）最近已成为肥胖人群中促进体重减轻的一种安全有效的选择。我们报告了一项多中心、随机、对照、双盲研究的结果，以评估ESG对MASH患者的有效性和安全性。
方法
40例患者按1:1随机分为ESG联合生活方式改善组与假内镜检查（SE）联合生活方式干预组。纳入标准包括经活检证实的MASH，非酒精性脂肪性肝病活动评分（NAS）≥3，纤维化分期F0至F3。ESG组的18例患者和内镜模拟干预（ESI）组的19例患者完成了72周的随访。记录从基线到随访结束时体重、肝功能检查、肝脏硬度（振动控制瞬时弹性成像）和肝脏组织学的变化。结果：ESG组的总体重减轻（TBWL）为9.47%（±9.38%），而ESI组为3.91%（±5.43%）（P < .05）。ESG组的肝脏硬度降低了5.63（±7.17）kPa，而ESI组降低了0.2（±5.38）kPa（P < .05）。ESG组的脂肪变性显著减轻（-0.94±0.87），而ESI组为（-0.26±0.99）（P = .033）。NAS评分（-1.89±2.11 vs -1.47±2.01）或纤维化（-0.1±0.91 vs -0.84±1.21）无差异。在体重减轻>10%的患者中，我们发现NAS评分有显著改善（-4±0.94 vs -0.81±1.62；P < .01），但纤维化分期无改善（-0.3±1.06 vs -0.59±1.25）。ESG组只有2例患者发生了需要住院治疗的不良事件；这些事件在72小时内保守治疗后得到缓解。
结论
ESG是一种有效且安全的方法，可促进体重减轻，同时使MASH和肥胖患者有显著改善。
临床试验
美国国立医学图书馆临床试验注册中心，编号：NCT03426111。
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