Muchmore Douglas B, Gates Jeffrey R
Eli Lilly and Company, Indianapolis, IN 46285, USA.
Diabetes Obes Metab. 2006 Nov;8(6):634-42. doi: 10.1111/j.1463-1326.2006.00585.x.
Since 1925, when the concept of treating diabetes with inhaled insulin (INH) was originally published, a number of clinical challenges have been resolved through technological advancements. Efforts by pharmaceutical partnerships or individual companies have resulted in the development of both injection-free devices and novel insulin formulations. Four different INH systems are now in phase 3 of clinical development, and several other INH systems are in earlier stages of clinical study. Clinical data consistently demonstrate that INH therapy is comparable to subcutaneous (SC) therapy in improving glycaemic control in patients with either type 1 or type 2 diabetes, generally without greater risk of overall hypoglycaemia. INH is generally well tolerated and appears to be safe. Adverse-event profiles for INH therapies are similar to SC insulin therapy, with the majority of events being reported as being mild to moderate. Long-term safety studies are ongoing, with emphasis on evaluating the impact of INH therapy on pulmonary function and immune responses. Although small, reversible decreases in pulmonary diffusion capacity (DL(co)) and FEV1 have been reported in response to INH, pulmonary function and structure do not appear to be affected in any clinically significant way. While insulin antibodies are increased in INH therapy, these antibodies have not been correlated with haemoglobin A1c (HbA1c), insulin dosage, hypoglycaemia, pulmonary function or adverse events. Nevertheless, properly controlled, long-term studies will best answer any remaining concerns. From the patient's perspective, INH therapy is preferred by the majority of patients over conventional SC insulin therapy. Studies have shown that patients prefer INH therapy, because it provides greater lifestyle flexibility and social acceptability while at the same time avoiding the pain associated with injection. Thus, after more than 80 years during which the injection route has been the only means of administering insulin, patients and physicians may soon avail themselves of another valuable tool in management of diabetes.
自1925年吸入式胰岛素（INH）治疗糖尿病的概念首次发表以来，通过技术进步已解决了许多临床挑战。制药合作伙伴或个别公司的努力促成了无注射装置和新型胰岛素制剂的开发。目前有四种不同的INH系统处于临床开发的3期阶段，其他几种INH系统则处于临床研究的早期阶段。临床数据一致表明，在改善1型或2型糖尿病患者的血糖控制方面，INH疗法与皮下（SC）疗法相当，总体低血糖风险通常不会更高。INH一般耐受性良好，似乎是安全的。INH疗法的不良事件谱与SC胰岛素疗法相似，大多数事件报告为轻度至中度。长期安全性研究正在进行中，重点是评估INH疗法对肺功能和免疫反应的影响。尽管有报告称，INH会导致肺弥散能力（DL(co)）和第一秒用力呼气量（FEV1）出现小幅度、可逆的下降，但肺功能和结构似乎并未受到任何具有临床意义的影响。虽然INH疗法中胰岛素抗体增加，但这些抗体与糖化血红蛋白（HbA1c）、胰岛素剂量、低血糖、肺功能或不良事件均无关联。尽管如此，经过适当控制的长期研究将最好地回答任何遗留的问题。从患者的角度来看，大多数患者更喜欢INH疗法而非传统的SC胰岛素疗法。研究表明，患者更喜欢INH疗法，因为它提供了更大的生活方式灵活性和社会接受度，同时避免了注射带来的疼痛。因此，在注射途径一直是胰岛素给药唯一方式的80多年后，患者和医生可能很快就会有另一种治疗糖尿病的宝贵工具可供使用。
