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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。
　　
　　【人類胰島素口腔噴劑】
　　Napoli博士等人研究Generex製造的Oral-lyn這個胰島素口腔噴劑的效果與安全性。該裝置將胰島素噴到口咽黏膜，所以不會進入肺部、且吸收很好，給藥後10分鐘就達最高值。給藥器中，與注射劑同為中性pH值的緩衝液中，溶有常態型人類DNA胰島素。給藥器還含有吸收促進劑、穩定劑與非CFC推動劑。
　　
　　確認為IGT的31名病患，隨機分派接受分成2個劑量的4、6或12單位的口腔噴入型胰島素。在標準的75g口服葡萄糖耐受測試前給予1個劑量，測試後30分鐘給予另一次劑量。每一噴相當於1單位的胰島素。之後在30、60、90、120和180分鐘時檢測葡萄糖和胰島素值。
　　
　　【12噴獲得較低的血中葡萄糖值】
　　相較於沒接受治療的病患，使用4或6噴者的血中葡萄糖值沒有改變，使用12噴這一組則有影響。喝下葡萄糖後2小時，使用12噴這組病患的血中葡萄糖值平均比沒有接受任何治療者低29.6% (P< .05)。3小時的時候，使用12噴這組病患的血中葡萄糖值低26.8% (P<.05)。將所有時間點一起分析，相較於沒接受治療的病患，使用12噴這組病患的血中葡萄糖值平均減少15.8%。使用12噴的劑量也和各時間點之胰島素增加傾向有關，在30分鐘時達到統計上的顯著意義。研究中沒有低血糖或其他副作用事件。
　　
　　塔拉哈西(佛羅里達州首府)佛羅里達大學醫學院小兒內分泌專家Larry C. Deeb醫師表示認同，認為發現其他的胰島素給藥途徑是重要的。他表示，胰島素給藥是糖尿病患的一大問題。你必須克服恐懼，還有那些未按醫囑用藥也還不至於致命的人。漏給胰島素是第1和第2型糖尿病的重要問題之一。
　　
　　【口腔給藥的潛力】
　　他相信，口腔給藥很有潛力。藉由這種產品，你比較不會高血糖。血中血糖值與時間變化表的曲線下面積也減少。他指出，需要以有更多病患、研究期間更久的大型研究，來確認這種小型短期研究的結果。
　　
　　口腔噴劑已經在第1和第2型糖尿病的短期試驗中成功檢測。目前正在進行長期研究，Napoli博士等人目前對IGT病患進行1個這類型的長期研究。
　　
　　Napoli博士的研究接受Generex贊助。Deeb醫師宣告沒有相關財務關係。
　　
　　國際糖尿病聯盟(IDF)第20屆世界糖尿病研討會。摘要D-0965。發表於2009年10月21日。

Insulin Delivered by Buccal Spray Shows Promise

By Alison Palkhivala
Medscape Medical News

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.