Department of Surgery, Blekinge County Hospital, Lasarettsvägen, 371 85, Karlskrona, Sweden.
University Hospital Ostrava, Pionyru 690, 250 81, Nehvizdy, Czech Republic.
Obes Surg. 2018 Jul;28(7):1860-1868. doi: 10.1007/s11695-017-3096-5.
The objective of this post-market study was to evaluate long-term safety and efficacy of aspiration therapy (AT) in a clinical setting in five European clinics.
The AspireAssist® System (Aspire Bariatrics, Inc. King of Prussia, PA) is an endoscopic weight loss therapy utilizing a customized percutaneous endoscopic gastrostomy tube and an external device to aspirate approximately 30% of ingested calories after a meal, in conjunction with lifestyle counseling. A total of 201 participants, with body mass index (BMI) of 35.0-70.0 kg/m, were enrolled in this study from June 2012 to December 2016. Mean baseline BMI was 43.6 ± 7.2 kg/m.
Mean percent total weight loss at 1, 2, 3, and 4 years, respectively, was 18.2% ± 9.4% (n/N = 155/173), 19.8% ± 11.3% (n/N = 82/114), 21.3% ± 9.6% (n/N = 24/43), and 19.2% ± 13.1% (n/N = 12/30), where n is the number of measured participants and N is the number of participants in the absence of withdrawals or lost to follow-up. Clinically significant reductions in glycated hemoglobin (HbA1C), triglycerides, and blood pressure were observed. For participants with diabetes, HbA1C decreased by 1% (P < 0.0001) from 7.8% at baseline to 6.8% at 1 year. The only serious complications were buried bumpers, experienced by seven participants and resolved by removal/replacement of the A-Tube, and a single case of peritonitis, resolved with a 2-day course of intravenous antibiotics.
This study establishes that aspiration therapy is a safe, effective, and durable weight loss therapy in people with classes II and III obesity in a clinical setting.
ISRCTN 49958132.
本上市后研究的目的是评估在欧洲五家诊所的临床环境中，抽吸疗法（AT）的长期安全性和疗效。
AspireAssist®系统（Aspire Bariatrics，Inc.，King of Prussia，PA）是一种内镜减肥治疗方法，使用定制的经皮内镜胃造口管和外部设备，在饭后抽吸约 30%的摄入卡路里，同时结合生活方式咨询。共有 201 名体重指数（BMI）为 35.0-70.0kg/m 的参与者于 2012 年 6 月至 2016 年 12 月参加了这项研究。平均基线 BMI 为 43.6±7.2kg/m。
分别在 1、2、3 和 4 年时的平均总体重减轻百分比为 18.2%±9.4%（n/N=155/173）、19.8%±11.3%（n/N=82/114）、21.3%±9.6%（n/N=24/43）和 19.2%±13.1%（n/N=12/30），其中 n 是测量参与者的数量，N 是无退出或失访的参与者数量。观察到糖化血红蛋白（HbA1C）、甘油三酯和血压的临床显著降低。对于患有糖尿病的参与者，HbA1C 从基线时的 7.8%下降了 1%（P<0.0001），至 1 年时降至 6.8%。唯一的严重并发症是埋入式保险杠，7 名参与者出现该并发症，通过更换或重新放置 A 管得到解决，以及 1 例腹膜炎，通过 2 天的静脉内抗生素治疗得到解决。
本研究表明，在临床环境中，抽吸疗法是一种安全、有效且持久的 II 类和 III 类肥胖人群的减肥疗法。
ISRCTN49958132。
