主页 > 医学新闻 >
【drug-news】FDA Approves New Treatment for Diabetes (FDA批准
FOR IMMEDIATE RELEASE
P06-169
October 17, 2006 Media Inquiries:
Laura Alvey, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Approves New Treatment for Diabetes
First in a New Class of Diabetes Drugs
FDA批准用于糖尿病的新的治疗方法
首次应用于治疗糖尿病的新药
The Food and Drug Administration (FDA) announced today the approval of Januvia (sitagliptin phosphate) Tablets, the first diabetes treatment approved in a new class of drugs known as DPP-4 inhibitors that enhances the body's own ability to lower elevated blood sugar.
美国食品与药品监督管理局（FDA）今天宣布正式批准了Januvia（二肽基肽酶Ⅳ（DDPIV）抑制剂磷酸盐）的片剂，首次批准用于糖尿病的治疗，是一种名为二肽基肽酶DPP-4抑制剂的新药，用来增强身体自身机能而达到降低高血糖的目的。
FDA approved Januvia for use in addition to diet and exercise to improve blood sugar levels in patients with type 2 diabetes, alone or in combination with two other commonly prescribed oral diabetes medications, metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist, when either of these drugs alone, along with diet and exercise, don't provide adequate blood sugar control.
FDA批准Januvia适用于结合饮食和锻炼改善2型糖尿病患者血糖水平，单方使用或和２个常用口服处方药二甲双胍和PPAR (γ过氧化物酶体增殖因子活化受体)增效剂复方使用，在任一的这些药物单方使用并结合饮食和锻炼不足够控制血糖的时侯。
"For the millions of Americans with type 2 diabetes, who continue to have inadequate blood sugar control, the approval of Januvia marks an important advance in the fight against diabetes," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "We now have another new option that treats the disease in an entirely new way that can be added to existing treatment regimens to help patients gain more control over their blood sugar levels."
“对于数百万长期血糖控制不稳定的患有二型糖尿病的美国人来说，Januvia批准标志着抵制糖尿病战斗的重大进步，“FDA药物评价和研究中心主任：Steven Galson博士说，“我们现在有了另一个新的治疗二型糖尿病的选择，它是一个完全的新的治疗方法，它能够增加现有的治疗方法，用来帮助患者以得到更多的控制他们的高血糖水平的方法。"。
Type 2 diabetes is the most common form of the disease, accounting for about 90 percent to 95 percent of all diagnosed cases of diabetes (20.8 million in 2005). In type 2 diabetes, the body does not produce enough insulin or the cells ignore the insulin. Insulin is necessary to take sugar, the basic fuel for cells, from the blood into the cells. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, nerve damage, and kidney damage.
二型糖尿病是糖尿病中最普遍的形式，在2005年全美所有的诊断确定为糖尿病的病案中2型的大约占90%-95%的比例。在这些二型糖尿病案中，病理表现为身体不能够产生足够的胰岛素或细胞对胰岛素不应答。 胰岛素是人体必需的用来捕获糖份（用于细胞燃烧）从血液进入细胞，随着时间的过去，高血糖水平能增加患严重并发症风险，包括心脏病、失明、神经损害和肾脏损伤。
Januvia prolongs the activity of proteins that increase the release of insulin after blood sugar rises, such as after a meal. Januvia does this by blocking an enzyme (dipeptidyl peptidase IV or DPP-IV) which breaks down these proteins, leading to better blood sugar control.
Januvia可以在血糖上升以后延长蛋白质的活跃水平以增加胰岛素的释放，例如进餐以后，Januvia通过阻碍缩氨酸肽酶IV（DPP-IV)终止这些蛋白质来达到更好的血糖控制。
Januvia was examined in a total of 2,719 patients with type 2 diabetes, in studies lasting from 12 weeks to more than a year. These studies demonstrated improved blood sugar control when Januvia was used alone or in patients not satisfactorily managed with metformin or a PPAR agonist.
Januvia的临床研究总共调查了患有二型糖尿病的2,719名病人， 用药时间持续12个星期至超过一年的病人。这些研究证明改善血糖控制在Januvia单方使用效果不满意的可与二甲双胍或PPAR增效剂复方使用。
The most common side effects in clinical studies were upper respiratory tract infection, sore throat, and diarrhea.
临床研究中最常见的副作用是上呼吸道感染，喉咙痛和腹泻。
Januvia is manufactured by Merck and Co., Inc., Whitehouse Station, N.J.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01492.html
水平有限,有不合适之处请多多指教,翻译目的,一来多些咨询,二来可进步英语. 昨天发的帖子供参考：
阅读本文的人还阅读：
作者:admin@医学,生命科学 2010-11-11 05:11
医学,生命科学网