與注射相比,胰島素噴劑可能更容易被接受

噴劑優於注射的胰島素;吸入式也是一種可行的選擇

  2002年6月17日─對於大多數的糖尿病病人,口腔噴入或者吸入給藥胰島素比重覆注射方式讓人感覺更舒服。在6月15日美國糖尿病協會年會上好幾個報告讓這些病人有了新的希望。不像經皮膚吸收和口服膠囊現在還處於試驗於健康的志願者階段,噴劑或吸入劑在糖尿病病人早期試驗中就已經出現很好的效果。

  「對於口服降血糖藥無效的第二型糖尿病人注射給藥方式會給他們帶來痛苦,致使大多數病人不願繼續注射。」來自多倫多Generex 生物技術公司的Pankaj Modi和他的同事寫到。「對此選用另一種方法─噴劑(RapidMist)一種新型利用胰島素在口腔中形成單一氣溶膠顆粒的噴劑形式(Oralin)的糖尿病給藥系統。

  Oralin是胰島素的口腔噴劑形式,通過口腔粘膜吸收,能夠準確計量。在這項對11位第二型糖尿病人單盲,隨機,交互的研究中,在攝入360卡路里後10分鐘採取每次用噴劑裝置噴15下Oralin給藥,或通過皮下注射胰島素0.11u/k。研究證明Oralin在胰島素快速地吸收或清除方面、降低葡萄糖、C胂以及增高胰島素水準方面優於皮下注射。

  Modi研究組的第二項研究通過對13列病人單盲、隨機、交互實驗,比較了Oralin和口服的降血糖藥物聯合使用與單獨使用降血糖藥物治療糖尿病的效果。「Oralin在控制餐後血糖水準能安全地和其他口服降血糖藥聯合使用。」他們寫到。

  Modi研究小組進一步進行了第三項對22位第二型糖尿病人的研究,發現在進食中使用Oralin噴劑產生比口服降糖藥的病人的內源性胰島素濃度更高的胰島素峰,並且餐後葡萄糖濃度比單獨使用口服降糖藥降低了9%到27%。「Oralin通過增高餐後胰島素水準改善了口服降糖藥無效的第二糖尿病人的葡萄糖控制能力,這是單憑病人內源性的胰島素是無法達到的。」他們總結說。

  然而另一種方法對於厭倦了胰島素注射的病人來說就像呼吸了一口新鮮空氣。另外兩項研究發現,肺部吸入胰島素(Exubera)的給藥也是安全有效的控制進餐時間的方式。

  在三個月第三期多中心的研究中, 309位口服降糖藥無效的第二型糖尿病人,隨機分三組,第一組單獨快速吸入胰島素乾粉,第二組吸入胰島素聯合口服降糖藥,第三組單獨使用口服降糖藥。

  「在病情很難控制的第二型糖尿病人中,單獨使用胰島素吸入治療或聯合口服降糖藥比單獨使用降血糖藥或使用抗體A1在血糖控制方面明顯地好。」來自Exubera三期研究小組的Julio Rosenstock和他的同事寫到。

  胰島素吸入療法是另一種可供選擇的方式,Christoph Kapitza和他的同事們說,它是一種AERx胰島素糖尿病給藥系統,當吸入參數最有利於進入肺時,它能夠利用氣溶膠使液態的胰島素到達肺的深部被吸收。

  在這項平行的隨機的被告知的實驗中,17位不吸菸第一型糖尿病的男性病人在進食前肺部吸入普通劑量胰島素和餐前30分鐘皮下注射普通劑量胰島素後給予標準的早餐。肺部給藥安全,耐受性好,而肺部給藥在每個病人中的差異性和皮下注射胰島素類似。

Compared With Shots, Insulin Spray May Be Easier to Swallow

Oralin Outperforms SC Insulin; Inhalers May Be Viable Alternative

By Laurie Barclay, MD
WebMD Medical News

Reviewed by Gary D. Vogin, MD

June 17, 2002 -- Buccal spray or inhaled insulin may be more palatable for most diabetics than repeated injections, and several presentations on June 15 at the American Diabetic Association annual meeting offer new hope to these patients. Unlike transdermal or oral capsule forms of insulin, which are still being tested in healthy volunteers, the oral spray and insulin inhaler seem to be effective in early trials with diabetics.

"The painful nature of injections is a major problem for Type-2 diabetics failing on oral agents and most patients are reluctant to go on injections," write Pankaj Modi and colleagues from Generex Biotechnology Corporation in Toronto. "The alternative to this is the RapidMist, a novel Diabetes Management System based on a unique liquid aerosol formulation of oral insulin (Oralin)."

Oralin is an oral spray form of insulin that is absorbed through the buccal mucosa, allowing precise dosing. In this single-blind, randomized, crossover study, 11 patients with type 2 diabetes received Oralin, 15 puffs from the RapidMist device, or subcutaneous insulin injection, 0.11u/kg, followed in 10 minutes by a 360-calorie Ensure meal. Oralin outperformed subcutaneous insulin in rapidity of absorption and elimination, in glucose and C-peptide lowering capacity, and in rise in insulin levels.

A second study by Modi's group compared the efficacy of Oralin in combination with oral hypoglycemic agents vs. oral hypoglycemic agents alone in a single-blind, randomized, crossover design with 13 subjects. "Oralin can be used safely in combination with oral hypoglycemic agents to control post-prandial glucose levels," the authors write.

Taking it a step further, a third study by Modi's group evaluated 22 patients with type 2 diabetes and found that Oralin spray at meals produced insulin peaks significantly greater than endogenous insulin production in patients on oral hypoglycemics and less post-prandial glucose elevation compared with oral agents alone (9% vs. 27%). "Oralin may have a role in improving glucose control in Type-2 patients with failing oral agents, by increasing post-prandial insulin peaks beyond what can be accomplished by endogenous insulin production alone," they conclude.

Yet another approach may seem like a breath of fresh air for diabetics weary of insulin injections. Two additional studies found that pulmonary delivery of inhaled insulin was safe and effective for mealtime control.

In a three-month phase III multicenter study, 309 patients with type 2 diabetes failing oral hypoglycemics were randomized to treatment with inhaled, rapid-acting, dry powder insulin (Exubera) alone, inhaled insulin combined with continued oral hypoglycemics, or continued oral hypoglycemics alone.

"In poorly controlled patients with type 2 diabetes, insulin inhaler either alone or in combination with oral agent therapy provided significantly better glycemic control compared with oral agent therapy alone and achieved target HbA1c in significantly more patients," write Julio Rosenstock and colleagues from the Exubera Phase III Study Group.

An alternate form of inhaled insulin, described by Christoph Kapitza and colleagues, is the AERx insulin Diabetes Management System, which delivers an aerosol of liquid human insulin to the deep lung for systemic absorption when inspiratory parameters are optimal for deep lung delivery.

In this parallel, randomized, open-label trial, 17 nonsmoking male subjects with type 1 diabetes received a standard breakfast on four identical treatment days followed by their usual insulin dose either as pulmonary insulin immediately before the meal or as subcutaneous insulin injection 30 minutes before the meal. Pulmonary insulin delivery was safe and well tolerated, and the intrasubject variability of pulmonary delivery was similar to that of subcutaneous insulin.

© 2002 WebMD Inc. All rights reserved.

    
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