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当前位置:药品说明书与价格首页 >> 药品专题 >> 肥胖症 >> 新药动态 >> 美国FDA批准AspireAssist为新肥胖治疗装置

美国FDA批准AspireAssist为新肥胖治疗装置

2016-06-15 06:40:54  作者:新特药房  来源:互联网  浏览次数:1  文字大小:【】【】【
简介: 2016年6月14日,美国食品和药品监管局(FDA)批准一种新肥胖治疗装置使用外科地放置管道在每餐后抽吸部分胃内容物。AspireAssist装置不应被对有进食障碍患者使用,而它不意向在中度地超重患者的短期使用。 ...

2016年6月14日,美国食品和药品监管局(FDA)批准一种新肥胖治疗装置使用外科地放置管道在每餐后抽吸部分胃内容物。
AspireAssist装置不应被对有进食障碍患者使用,而它不意向在中度地超重患者的短期使用。它是意向帮助年龄22和以上肥胖患者有体重指数减重,35至55,和通过非-手术减重治疗不能实现和维持减重的患者。
FDA的装置和辐射卫生中心中科学和首席科学家副主任William Maisel,M.D.,M.P.H. 说:“AspireAssist方法帮助提高有效控制热量吸收,它是体重处理治疗的关键原则” ,“患者需要被他们的卫生保健提供者定期监测和应随访生活方式程序帮助他们发展健康的饮食习惯和减少热量的摄入。”
为放置装置,外科医生在腹部一个小切口通过用内窥镜在胃中插入一根管子。机体外部有一个盘型端口阀,对腹部皮肤冲洗,是连接至管子和保持在位。进餐后约20至30分钟,患者附着装置外部连接器和管道至端口阀门,打开阀门和抽吸内容物。一旦打开,约5至10分钟通过管道抽吸食物物质和进入马桶。装置取出约30%的消耗热量。
FDA审评来自一项临床试验的结果111例患者用AspireAssist治疗和适当的生活方式治疗,和60对照患者仅接受生活方式治疗。一年后,用AspireAssist患者平均减重他们总体重的12.1%与之比较对照患者为3.6 %。
临床试验结果还提示两者患者组有经常伴随肥胖情况的小改善,例如糖尿病,高血压和生活质量。这些改善可能被归咎于生活方式治疗,其中包括营养和运动咨询。
患者需要被卫生保健提供者频繁监视以缩短管作为他们减重和腹围,所以盘保持对他们皮肤冲洗。频繁医学访问还需要监视装置使用和减重和以提供对生活方式治疗的咨询。装置还有有一个安全性特点,可以跟踪连接到端口的次数和115次循环后,自动停止工作(约治疗5至6周);患者必须返回一个医疗访问,以便继续治疗获得的装置更换部件。这个安全性特点帮助确保患者在治疗期间适当地使用。
与AspireAssist使用相关副作用包括偶尔消化不良,恶心,呕吐,便秘和腹泻。
内窥镜手术放置胃管是伴随风险,包括喉痛,疼痛,腹胀,消化不良,出血,感染,恶心,呕吐,镇静-相关呼吸问题,腹部衬里的炎症,胃的内侧溃疡,肺炎,胃或小肠壁意外刺破和死亡。
对端口阀腹部开口相关风险包括腹部不适或疼痛,放置管部位周围皮肤刺激,硬化或炎症,渗漏,出血和/或放置管处部位周围感染和装置移动进入胃壁。所有有潜在必要取出装置。取出装置后,可能有持久瘘管的风险,一个胃和腹壁间异常的通道。
有某些情况患者禁忌用AspireAssist,包括未控制的高血压,已诊断的贪食症,已诊断暴饮暴食症,夜间进食综合症,某些类型的以前腹部手术,妊娠或哺乳,炎症性肠道疾病或胃溃疡。在有严重肺火心血管病,凝血疾病,慢性腹痛病史患者或来自一个内窥镜操作医学并发症高危患者也禁忌AspireAssist。
AspireAssist系统是由位于宾州普鲁士国王Aspire Bariatrics公司制造。
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm506625.htm
The Aspire Assist Non-Surgical Weight Loss Procedure, alternative to Bariatric surgery with or gastric band, sleeve or balloon

AspireAssist”减肥仪
WEIGHT LOSS
The Aspire Assist A New Approach to Weight Loss 
The AspireAssist is a new weight loss solution for people with obesity. Unlike many other weight loss procedures, it’s minimally-invasive and reversible. Using the AspireAssist Patients can eat and drink normal amounts and types of food whilst learning healthier behaviours over time with lifestyle counselling, no sudden diet changes are required to achieve weight loss.
Aspiration Therapy
The AspireAssist works by reducing the calories absorbed in the body by removing 30% of the ingested meal. The AspireAssist enables obese patients to remove a portion of stomach contents through a specially designed PEG tube about 20 minutes after each meal and promotes slower eating by requiring thorough chewing and water consumption. Food must be chewed completely to fit through the tube, which gives patients time to feel satiated before overeating. Through the lifestyle modification programme, cognitive-based lifestyle therapy addresses overeating behaviours and discusses coping strategies.
Placing the device is a simple 15 minute Endoscopic  procedure that doesn’t require a general anaesthesia and patients can often return home within one to two hours. It can be an effective alternative for patients who do not want or are not candidates for more invasive surgical interventions. The AspireAssist Aspiration Therapy System is intended to facilitate weight reduction in morbidly obese adults with a Body Mass Index (BMI) over 35 and must be used concurrently with a weight management support programme.
The AspireAssist is now commercially available in selected regions in Europe and beyond, and is currently in clinical trials across the US.


Potential benefits of the AspireAssist include:
• Dramatic Results: In a U.S. Clinical Trial, patients lost an average of 46 pounds (21 kgs) during the first year with the AspireAssist.
• Quick Recovery: Placing the device is an outpatient procedure. Patients can often return home within one to two hours, and be back at work quickly.
• Simple Procedure: The quick, 20 minute procedure is performed under conscious sedation – no general anaesthesia is required. 
• Healthy, Normal Lifestyle: Patients can eat and drink normal amounts and types of food with the AspireAssist. Although patients will learn healthier behaviours over time with lifestyle counselling, no sudden diet changes are required to achieve weight loss.
• Reversible: The AspireAssist can be removed, at any time, through a 15-minute outpatient procedure. It is performed under conscious sedation.
• Affordable: Because the procedure and device are relatively simple, the AspireAssist may be affordable for patients who cannot afford bariatric surgery.

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