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纳曲酮/安非他酮用于肥胖症及减肥手术后体重管理的真实世界疗效。

Real world efficacy of naltrexone/bupropion for weight management in obesity and after bariatric surgery.

作者信息

Yskout Marie, Steenackers Nele, Hoste Jarne, Pazmino Sofia, Simoens Caroline, Mattelaer Nele, Deleus Ellen, Lannoo Matthias, Mertens Ann, Van der Schueren Bart, Vangoitsenhoven Roman

机构信息

Endocrinology, University Hospitals, Leuven, Belgium.

Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.

出版信息

Int J Obes (Lond). 2025 Sep 2. doi: 10.1038/s41366-025-01870-x.

DOI:10.1038/s41366-025-01870-x
PMID:40897847
Abstract

BACKGROUND

Insufficient weight loss or weight regain after metabolic and bariatric surgery (MBS) is frequent, and evidence to support the use of pharmacotherapy for weight management is limited.

METHODS

In this single-centre retrospective cohort study, the effectiveness of naltrexone/bupropion (NB) for weight control in surgery-naive and post-MBS patients was evaluated. Data was collected between 2016 and 2022 on all patients started on NB after multidisciplinary consult. Patients received weekly dose escalation up to 32/360 mg daily per the manufacturer's protocol, with submaximal doses administered in cases of adverse effects or sufficient therapeutic response. Weight evolution, metabolic status, adherence and adverse events were analysed at 4 and 12 months after NB initiation. Data are presented as median (interquartile range).

RESULTS

A total of 151 patients were included, 111 were surgery-naive and 40 with prior MBS. The median time after MBS was 7.1 years (4.2, 14.9). Among the post-MBS patients, 18 (45%) patients had undergone Roux-en-Y gastric bypass and 11 (27.5%) sleeve gastrectomy. Four months after initiation of NB, 46.8% of the surgery-naive patients and 67.5% of the post-MBS patients continued using NB, with a median weight loss of 6.4% (3.0, 10.1) and 6.3% (2.3, 12.1) respectively. At 12-months, 38.5% of surgery-naive patients and 63.0% of post-MBS patients had continued NB, with median weight loss of 8.8% (5.0, 16.7) and 10.0% (4.5, 16.5) respectively. There was no statistically significant difference in weight loss between the surgery-naive and post-MBS group. Weight loss was not significantly influenced by whether the maximal dose was reached in both the surgery-naive patients (p = 0.38) and the post-MBS patients (p = 0.72).

CONCLUSION

Real-world data show that NB treatment is equally effective in surgery-naive patients and in patients experiencing weight regain after bariatric surgery, regardless of the maximal dose administered.

摘要

背景

代谢和减重手术后体重减轻不足或体重反弹的情况很常见,支持使用药物疗法进行体重管理的证据有限。

方法

在这项单中心回顾性队列研究中,评估了纳曲酮/安非他酮(NB)对未接受过手术的患者和代谢减重手术后患者体重控制的有效性。收集了2016年至2022年间所有经多学科会诊后开始使用NB的患者的数据。患者按照制造商的方案每周增加剂量,直至每日剂量达到32/360毫克,在出现不良反应或有足够治疗反应的情况下给予次最大剂量。在开始使用NB后的4个月和12个月分析体重变化、代谢状况、依从性和不良事件。数据以中位数(四分位间距)表示。

结果

共纳入151例患者,其中111例未接受过手术,40例曾接受过代谢减重手术。代谢减重手术后的中位时间为7.1年(4.2,14.9)。在接受过代谢减重手术的患者中,18例(45%)接受了Roux-en-Y胃旁路手术,11例(27.5%)接受了袖状胃切除术。开始使用NB后4个月,46.8%的未接受过手术的患者和67.5%的代谢减重手术后患者继续使用NB,体重中位数分别下降了6.4%(范围3.0,10.1)和6.3%(范围2.3,12.1)。在12个月时,38.5%的未接受过手术的患者和63.0%的代谢减重手术后患者继续使用NB,体重中位数分别下降了8.8%(范围5.0,16.7)和10.0%(范围4.5,16.5)。未接受过手术的患者组和代谢减重手术后的患者组之间的体重减轻没有统计学上的显著差异。在未接受过手术的患者(p = 0.38)和代谢减重手术后的患者(p = 0.72)中,是否达到最大剂量对体重减轻没有显著影响。

结论

实际数据表明,无论给予的最大剂量如何,NB治疗在未接受过手术的患者和减重手术后体重反弹的患者中同样有效。

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