美国批准首个治疗肥胖设备

 　　WASHINGTON, Jan. 14 (Xinhua) -- The U.S. Food and Drug Administration said Wednesday it had approved the first device to treat obesity¹ by targeting nerves between the brain and the stomach.

　　The device, known as the Maestro Rechargeable System, is approved to treat patients aged² 18 and older who have not been able to lose weight with a weight loss program, and who have a body mass index (BMI) of 35 to 45 with at least one other obesity- related condition, such as type 2 diabetes³.

　　BMI, which measures body fat based on an individual's weight and height, is used to define the obesity categories.

　　The Maestro Rechargeable System is the first obesity device to be approved by the FDA since 2007.

　　U.S. regulator approves first-of-kind device to treat obesity

　　"Obesity and its related medical conditions are major public health problems," said William Maisel, deputy director for science and chief scientist with the FDA's Center for Devices and Radiological Health, in a statement. "Medical devices can help physicians and patients to develop comprehensive obesity treatment plans."

　　The device, manufactured by EnteroMedics of St. Paul, Minnesota, consists of a rechargeable electrical pulse generator⁴, wire leads and electrodes implanted surgically⁶ into the abdomen⁷.

　　It works by sending intermittent⁸ electrical pulses to the trunks in the abdominal⁹ vagus nerve, which is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full.

　　In a 12-month clinical trial that included 233 patients with a BMI of 35 or greater, those who received the active Maestro device lost 8.5 percent more of the excess weight than who received the device that was not activated¹⁰.

　　Serious adverse¹¹ events reported in the clinical study included nausea¹², pain at the neuroregulator site, vomiting¹³, as well as surgical⁵ complications. Other adverse events included pain, heartburn, problems swallowing, belching¹⁴, mild nausea and chest pain, the FDA said.

　　The clinical study did not meet its original goal, which was that those who received the active Maestro device lose at least 10 percent more excess weight than the control group.

　　However, the FDA said its advisory¹⁵ committee found the study supportive of sustained weight loss, and agreed that the benefits of the device outweighed¹⁶ the risks for use in patients.

　　As part of the approval, the company must conduct a five-year post approval study that will follow at least 100 patients and collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity-related conditions, the agency added.

　　According to the U.S. Centers for Disease Control and Prevention, more than one-third of all U.S. adults are obese¹⁷, and people with obesity are at increased risk of heart disease, stroke, type 2 diabetes and certain kinds of cancer.

1 obesity   

n.肥胖，肥大

参考例句：

• One effect of overeating may be obesity.吃得过多能导致肥胖。
• Sugar and fat can more easily lead to obesity than some other foods.糖和脂肪比其他食物更容易导致肥胖。

2 aged   

adj.年老的，陈年的

参考例句：

• He had put on weight and aged a little.他胖了，也老点了。
• He is aged,but his memory is still good.他已年老，然而记忆力还好。

3 diabetes   

n.糖尿病

参考例句：

• In case of diabetes, physicians advise against the use of sugar.对于糖尿病患者，医生告诫他们不要吃糖。
• Diabetes is caused by a fault in the insulin production of the body.糖尿病是由体內胰岛素分泌失调引起的。

4 generator   

n.发电机，发生器

参考例句：

• All the while the giant generator poured out its power.巨大的发电机一刻不停地发出电力。
• This is an alternating current generator.这是一台交流发电机。

5 surgical   

adj.外科的，外科医生的，手术上的

参考例句：

• He performs the surgical operations at the Red Cross Hospital.他在红十字会医院做外科手术。
• All surgical instruments must be sterilised before use.所有的外科手术器械在使用之前，必须消毒。

6 surgically   

adv. 外科手术上, 外科手术一般地

参考例句：

• Unsightly moles can be removed surgically. 不雅观的痣可以手术去除。
• To bypass this impediment an almost mature egg cell is removed surgically. 为了克服这一障碍，通过手术，取出一个差不多成熟的卵细胞。

7 abdomen   

n.腹，下腹(胸部到腿部的部分)

参考例句：

• How to know to there is ascarid inside abdomen?怎样知道肚子里面有蛔虫？
• He was anxious about an off-and-on pain the abdomen.他因时隐时现的腹痛而焦虑。

8 intermittent   

adj.间歇的，断断续续的

参考例句：

• Did you hear the intermittent sound outside?你听见外面时断时续的声音了吗？
• In the daytime intermittent rains freshened all the earth.白天里，时断时续地下着雨，使整个大地都生气勃勃了。

9 abdominal   

adj.腹（部）的，下腹的；n.腹肌

参考例句：

• The abdominal aorta is normally smaller than the thoracic aorta.腹主动脉一般比胸主动脉小。
• Abdominal tissues sometimes adhere after an operation.手术之后腹部有时会出现粘连。

10 activated   

adj. 激活的 动词activate的过去式和过去分词

参考例句：

• The canister is filled with activated charcoal.蒸气回收罐中充满了活性炭。

11 adverse   

adj.不利的；有害的；敌对的，不友好的

参考例句：

• He is adverse to going abroad.他反对出国。
• The improper use of medicine could lead to severe adverse reactions.用药不当会产生严重的不良反应。

12 nausea   

n.作呕，恶心；极端的憎恶(或厌恶)

参考例句：

• Early pregnancy is often accompanied by nausea.怀孕期常有恶心的现象。
• He experienced nausea after eating octopus.吃了章鱼后他感到恶心。

13 vomiting   

吐

参考例句：

• Symptoms include diarrhoea and vomiting. 症状有腹泻和呕吐。
• Especially when I feel seasick, I can't stand watching someone else vomiting." 尤其晕船的时候，看不得人家呕。”

14 belching   

n. 喷出，打嗝 动词belch的现在分词形式

参考例句：

• The Tartars employed another weapon, the so-called Chinese dragon belching fire. 鞑靼人使用了另一种武器，所谓中国龙喷火器。
• Billows of smoke were belching from the chimney. 巨浪似的烟正从烟囱里喷出来。

15 advisory   

adj.劝告的，忠告的，顾问的，提供咨询

参考例句：

• I have worked in an advisory capacity with many hospitals.我曾在多家医院做过顾问工作。
• He was appointed to the advisory committee last month.他上个月获任命为顾问委员会委员。

16 outweighed   

v.在重量上超过( outweigh的过去式和过去分词 )；在重要性或价值方面超过

参考例句：

• This boxer outweighed by his opponent 20 pounds. 这个拳击选手体重比他的对手重20磅。 来自《简明英汉词典》
• She outweighed me by ten pounds, and sometimes she knocked me down. 她的体重超过我十磅，有时竟把我撞倒。 来自百科语句

17 obese   

adj.过度肥胖的，肥大的

参考例句：

• The old man is really obese,it can't be healthy.那位老人确实过于肥胖了，不能算是健康。
• Being obese and lazy is dangerous to health.又胖又懒危害健康。