標題: 口腔噴入型胰島素顯示有用 [打印本頁] 作者: danny 時間: 2009-11-7 12:02 標題: 口腔噴入型胰島素顯示有用
作者：Alison Palkhivala
出處：WebMD醫學新聞
October 23, 2009 (蒙特婁) — 根據發表於國際糖尿病聯盟(International Diabetes Federation，IDF)第20屆世界糖尿病研討會的研究，每天經口腔噴入12單位的胰島素，有助於葡萄糖耐受異常(IGT)病患維持可接受的血糖值。這種胰島素給藥模式，為第1和第2型糖尿病的非注射型胰島素給藥方式帶來新希望。
發表人、第一作者Nicola Napoli博士向Medscape Diabetes and Endocrinology表示，我們實驗新的胰島素給藥途徑，因為糖尿病患最重要的問題是使用注射劑，這是胰島素治療的最大限制；並非所有病患都接受注射劑；注射時會痛且比較難管理。Napoli博士來自義大利羅馬Bio-Medico大學內分泌與代謝科。
October 23, 2009 (Montreal, Quebec) — Twelve puffs per day from a buccal spray unit can help individuals with impaired glucose tolerance (IGT) keep their blood glucose levels down, according to a study presented here at the International Diabetes Federation (IDF) 20th World Diabetes Congress. This insulin delivery method provides hope that a new noninjectable type of insulin delivery system is on the way for both type 1 and type 2 diabetes.
"We are experimenting with new routes for administering insulin because the most important problem in diabetic patients is injections," lead author and presenter Nicola Napoli, MD, PhD, told Medscape Diabetes and Endocrinology. "This is the biggest limitation of insulin treatment. [Injections are] not accepted by patients; they're painful and they're difficult to manage." Dr. Napoli is from the Division of Endocrinology and Metabolism, Universita Campus Bio-Medico di Roma in Rome, Italy.
Buccal Spray of Human Insulin
Dr. Napoli and colleagues investigated the safety and efficacy of a buccal spray insulin developed by Generex, called Oral-lyn. "The device delivers the insulin to the oropharyngeal mucosa, so it doesn't go to the lungs, . . . and the absorption is very good, giving a peak 10 minutes after administration." In the puffer, regular acting human DNA insulin is dissolved in a buffer at neutral pH, identical to injection. The puffer also contains absorption enhancers, stabilizers, and a non-CFC propellant.
Thirty-one patients, all with established IGT, were randomized to take 4, 6, or 12 buccal spray insulin puffs in 2 doses. One dose was taken before a standard 75 g oral glucose tolerance test, and the other was taken 30 minutes later. One puff is equivalent to 1 unit of insulin. Glucose and insulin levels were then measured at 30, 60, 90, 120, and 180 minutes.
Lower Blood Glucose With 12 Puffs
Although taking 4 or 6 puffs from the puffer did not change blood glucose levels, compared with patients who received no treatment, the 12-puff dose did have an impact. Two hours after ingestion of glucose, patients who had taken the 12-puff dose had blood glucose levels that were, on average, 29.6% lower than patients who did not receive any treatment (P < .05). At 3 hours, blood glucose was 26.8% lower in the 12-puff group (P <.05). Taking all time points together, there was a mean reduction in blood glucose of 15.8% with 12 puffs, compared with no treatment. The 12-puff dose was also associated with a trend toward increased insulin levels at all time points that reached statistical significance at 30 minutes. No hypoglycemia or other adverse events were noted during the study.
Larry C. Deeb, MD, a pediatric endocrinologist at the University of Florida College of Medicine in Tallahassee, agreed that finding an alternative route for insulin administration is crucial. "Insulin administration is a huge issue for people with diabetes," he said. "You have to appreciate the fear, particularly in a population like this that won't die tomorrow if they don't take it. . . . Insulin omission is one of the major issues in [type 1 and 2] diabetes."
Potential for Buccal Administration
He believes the buccal spray definitely has potential. "You are exposing yourself to less hyperglycemia over time [with this product]. . . . They've reduced the area under the curve [in the graph of blood sugar levels over time]." Such a small, short-term study does require replication, with a larger number of patients taking it for a longer period of time, he added.
The buccal spray has already been tested successfully in short-term trials among patients with type 1 and type 2 diabetes. Long-term studies are currently in the works. Dr. Napoli and his team are currently working on 1 such long-term study among patients with IGT.
Dr. Napoli's research was sponsored by Generex. Dr. Deeb has disclosed no relevant financial relationships.
International Diabetes Federation (IDF) 20th World Diabetes Congress. Abstract D-0965. Presented October 21, 2009.
