Norén Erik, Forssell Henrik
Department of Surgery, Blekinge County Hospital, Lasarettsvägen, Karlskrona, S-371 85 Sweden.
Department of Surgery, Blekinge County Hospital, Lasarettsvägen, Karlskrona, S-371 85 Sweden ; Blekinge Center of Competence, Blekinge County Council, Karlskrona, Sweden.
BMC Obes. 2016 Dec 28;3:56. doi: 10.1186/s40608-016-0134-0. eCollection 2016.
This study evaluated the efficacy and safety of the novel AspireAssist® Aspiration Therapy System for treatment of obesity, and its effect on patient's quality of life.
A prospective observational study with 25 obese subjects, mean age 48 years (range 33-65), was performed. A custom gastrostomy tube (A-tube, Aspire Bariatrics) was percutaneously inserted during a gastroscopy performed under conscious sedation. Drainage and irrigation of the stomach were performed 3 times daily, 20 min after each meal, for 1-2 years. Efficient aspiration required thorough chewing of ingested food. Treatment included a cognitive behavioral weight loss program.
Mean body mass index (BMI) at inclusion was 39.8 kg/m (range 35-49). After 1 year mean (SD) BMI was 32.1 kg/m (5.4), < 0.01, and excess weight loss was 54.4% (28.8), < 0.01. Quality of life, as measured with EQ-5D, improved from 0.73 (0.27) to 0.88 (0.13), < 0.01. After 2 years BMI was 31.0 kg/m (5.1), < 0.01, and excess weight loss was 61.5% (28.5), < 0.01. There were no serious adverse events or electrolyte disorders. Compliance was 80% after 1 year and 60% after 2 years.
Aspiration therapy is an efficient and safe treatment for obesity, and weight reduction improves quality of life. Excess weight was approximately halved in a year, with weight stability if treatment was continued.
Trial Register ISRCTN 49958132. Retrospectively registered 28/02/2014.
本研究评估了新型AspireAssist®抽吸治疗系统治疗肥胖症的有效性和安全性，及其对患者生活质量的影响。
对25名肥胖受试者进行了一项前瞻性观察性研究，受试者平均年龄48岁（范围33 - 65岁）。在清醒镇静下进行胃镜检查时，经皮插入一根定制的胃造口管（A管，Aspire Bariatrics公司生产）。每天饭后20分钟对胃进行3次引流和冲洗，持续1 - 2年。有效的抽吸需要充分咀嚼摄入的食物。治疗包括认知行为减肥计划。
纳入时平均体重指数（BMI）为39.8kg/m²（范围35 - 49）。1年后平均（标准差）BMI为32.1kg/m²（5.4），P < 0.01，超重减轻了54.4%（28.8），P < 0.01。用EQ - 5D量表测量的生活质量从0.73（0.27）提高到0.88（0.13），P < 0.01。2年后BMI为31.0kg/m²（5.1），P < 0.01，超重减轻了61.5%（28.5），P < 0.01。未发生严重不良事件或电解质紊乱。1年后依从性为80%，2年后为60%。
抽吸治疗是一种有效且安全的肥胖治疗方法，体重减轻可改善生活质量。1年内超重约减半，若继续治疗体重可保持稳定。
试验注册编号ISRCTN 49958132。2014年2月28日追溯注册。
