美国梅奥诊所Barham K Abu Dayyeh团队研究了内镜下袖状胃成形术治疗1级和2级肥胖的疗效。2022年7月28日，《柳叶刀》杂志发表了这一成果。
内镜下袖状胃成形术（ESG）是一种治疗肥胖的腔内、器官保留疗法，在全球范围内得到广泛采用。该研究旨在探讨ESG与生活方式改变相比的疗效和安全性。
研究组在美国九个中心进行了一项随机临床试验，纳入21-65岁的1级或2级肥胖患者，他们同意遵守终身饮食限制。参与者被随机分配（1:1.5）到生活方式改变的ESG（ESG组）或单独生活方式改变（对照组），分别在52周时再收紧或交叉到ESG。生活方式的改变包括低热量饮食和体育活动。
对主要ESG组的参与者进行了104周的随访。52周时的主要终点是超重部分减重的百分比（EWL），超重是指超过体重指数为25 kg/m2的理想体重。次要终点包括两组之间代谢共病的变化。研究组使用多输入意图处理混合效应模型的分析。该分析在按方案与改良意向治疗的基础上进行。安全人群定义为接受ESG（主要和交叉ESG）达52周的所有参与者。
2017年12月20日至2019年6月14日，共有209名参与者被随机分配到ESG组（85例）或对照组（124例）。52周时，ESG组的主要终点EWL平均百分比为49.2%，显著高于对照组的3.2%。ESG组的平均总体重减轻13.6%，显著大于对照组的0.8%；ESG组77名参与者中有59名（77%）在52周时达到EWL为25%及以上，而对照组110名中有13名（12%），组间差异亦显著。
52周时，ESG组51名参与者中的41名（80%）在一种或多种代谢性共病方面有所改善，而6名（12%）恶化；对照组62名参与者中有28名（45%）有类似改善，而31名（50%）恶化。在104周时，ESG组60名参与者中有41名（68%）维持25%及以上的EWL。131名参与者中有3名（2%）发生ESG相关的严重不良事件，但无死亡或需要重症监护或手术。
研究结果表明，ESG是一种安全的干预措施，可显著减轻体重，可维持至104周，并显著改善代谢性共病。ESG应被视为1级或2级肥胖患者的协同减肥干预。
附：英文原文
Title: Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial
Author: Barham K Abu Dayyeh, Fateh Bazerbachi, Eric J Vargas, Reem Z Sharaiha, Christopher C Thompson, Bradley C Thaemert, Andre F Teixeira, Christopher G Chapman, Vivek Kumbhari, Michael B Ujiki, Jeanette Ahrens, Courtney Day, Andres J Acosta, Dilhana Badurdeen, Navtej S Buttar, Matthew M Clark, Laura Eaton, Omar Ghanem, Karen Grothe, Pichamol Jirapinyo, Todd Kellogg, Connie L Klein, Manpreet Mundi, Andrew C Storm, Angielyn R Rivera, Todd D Wilson, Manoel Galvao Neto, Natan Zundel, Erik B Wilson
Issue&Volume: 2022-07-28
Abstract:
Background
Endoscopic sleeve gastroplasty (ESG) is an endolumenal, organ-sparing therapy for obesity, with wide global adoption. We aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone.
Methods
We conducted a randomised clinical trial at nine US centres, enrolling individuals aged 21–65 years with class 1 or class 2 obesity and who agreed to comply with lifelong dietary restrictions. Participants were randomly assigned (1:1·5; with stratified permuted blocks) to ESG with lifestyle modifications (ESG group) or lifestyle modifications alone (control group), with potential retightening or crossover to ESG, respectively, at 52 weeks. Lifestyle modifications included a low-calorie diet and physical activity. Participants in the primary ESG group were followed up for 104 weeks. The primary endpoint at 52 weeks was the percentage of excess weight loss (EWL), with excess weight being that over the ideal weight for a BMI of 25 kg/m2. Secondary endpoints included change in metabolic comorbidities between the groups. We used multiple imputed intention-to-treat analyses with mixed-effects models. Our analyses were done on a per-protocol basis and a modified intention-to-treat basis. The safety population was defined as all participants who underwent ESG (both primary and crossover ESG) up to 52 weeks.
Findings
Between Dec 20, 2017, and June 14, 2019, 209 participants were randomly assigned to ESG (n=85) or to control (n=124). At 52 weeks, the primary endpoint of mean percentage of EWL was 49·2% (SD 32·0) for the ESG group and 3·2% (18·6) for the control group (p<0·0001). Mean percentage of total bodyweight loss was 13·6% (8·0) for the ESG group and 0·8% (5·0) for the control group (p<0·0001), and 59 (77%) of 77 participants in the ESG group reached 25% or more of EWL at 52 weeks compared with 13 (12%) of 110 in the control group (p<0·0001). At 52 weeks, 41 (80%) of 51 participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, compared with the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 (68%) of 60 participants in the ESG group maintained 25% or more of EWL. ESG-related serious adverse events occurred in three (2%) of 131 participants, without mortality or need for intensive care or surgery.
Interpretation
ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities. ESG should be considered as a synergistic weight loss intervention for patients with class 1 or class 2 obesity. This trial is registered with ClinicalTrials.gov, NCT03406975.
DOI: 10.1016/S0140-6736(22)01280-6
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01280-6/fulltext
LANCET：《柳叶刀》，创刊于1823年。隶属于爱思唯尔出版社，最新IF：202.731
官方网址：http://www.thelancet.com/
投稿链接：http://ees.elsevier.com/thelancet
本期文章：《柳叶刀》：Online/在线发表
