束带装置有了更广泛的指征： FDA降低了减肥手术的BMI要求

Lap-Band Device Gets Wider Indication: FDA Lowers BMI Requirements for Weight-Loss Surgery

束带装置有了更广泛的指征： FDA降低了减肥手术的BMI要求

 

February 22, 2011 (Irvine, California) ? Less obese individuals are now candidates for laparoscopic gastric banding surgery, with the Food and Drug Administration (FDA) lowering the body-mass index (BMI) requirements for those eligible to undergo surgery using the Lap-Band Adjustable Gastric Banding System (Allergan, Irvine, CA) [1].海南医学院附属医院内分泌科王新军

2011年2月22日（Irvine, California）----随者美国食品和药物管理局（FDA）降低了波段可调式胃束带系统（Allergan, Irvine, CA）手术对体重指数（BMI）的要求，以后更少的肥胖者需要进行腹腔镜胃束带手术了。

 

 

 

The FDA approved the expanded use of the gastric band for obese adults who have failed to lose weight with diet, exercise, and pharmacotherapy and who have a BMI of 30 to 40 kg/m2and one additional obesity-related comorbid condition, such as diabetes or hypertension.

美国FDA批准了胃束带扩大适应症：成年肥胖患者BMI在30~30 kg/m2且有一个额外的肥胖相关合并症如糖尿病或高血压，经饮食、运动和药物治疗减肥失败者。

 

The expanded approval is based on a December 2010 advisory panel hearing in which committee members vote 8 to 2 in favor of widening the pool of patients eligible for the banding surgery. Previously, the gastric surgery was indicated only for patients with a BMI >35 kg/m2and additional risk factors or >40 kg/m2in those without any other conditions. 

扩大适应症的批准是基于2010年12月咨询小组听取了委员会成员在表决胃束带手术扩大患者群的投票后做出决定的（8票对2票赞成）。以前，胃手术的适应症仅限于BMI≥35 kg/m2且有额外危险因素或BMI≥40 kg/m2无危险因素的患者。

 

According to the Los Angeles Times, reporters citing company officials say the expanded indication means that approximately 25 million more Americans would be eligible for the Lap-Band surgery, with roughly 45 million Americans, or one in seven, now eligible for the weight-loss procedure [2].

根据洛杉矶时报，记者援引公司官方观点说，扩大适应症意味者大约2500万美国人将有进行Lap-Band手术的资格，大约4500万美国人，或七分之一，现在可以进行减肥治疗。

 

During the surgery, a band is placed around the upper part of the stomach, and this creates a small pouch that holds only a small amount of food. As a result of the narrowed opening, food passes slowly from the pouch to the rest of the stomach, helping the patient eat less and increasing the amount of time needed for digestion.

在手术过程中，将一个束带放置在胃的上部，这样将产生一个小袋，只能容纳少量的食物。由于开口较狭窄，食物从这个小袋进入胃的其他部分比较缓慢，所以可帮助患者吃得更少，增加消化所需的时间。

 

Just a couple of weeks ago, the FDA rejected the diet drug Contrave, the third weight-loss drug to be turned away by the agency in the past year. The agency was concerned about blood-pressure and heart-rate changes with Contrave, a combination of naltrexone and bupropion HCL--specifically, that most patients who lost weight with the drug failed to see significant improvements in blood pressure. As heartwire reported recently, clinicians who treat obesity were disappointed by the FDA decision.

就在几个星期前，美国FDA拒绝了减肥药Contrave上市，这是去年该机构拒绝的第三个减肥药品。FDA关注的是应用Contrave后血压和心率的变化，Contrave是纳曲酮和盐酸安非他酮的复合物----特别是，大多数用此药减轻体重的患者没有血压显著改善。就像heartwire近日报道的，治疗肥胖的医生由于FDA的决定而感到失望