Multicenter clinical study on the efficacy and safety of inhalable insulin aerosol in the treatment of type 2 diabetes.
Multicenter clinical study on the efficacy and safety of inhalable insulin aerosol in the treatment of type 2 diabetes.
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DOI：
10.1097/00029330-200807010-00002
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发表时间：
2008-07
影响因子：
6.1
通讯作者：
Z. Liao;Ying-li Chen;Fang-ping Li;Xiang Yan;Hai Lu;Li Yan;Zhiguang Zhou;Dalong Zhu;L. Ji;J. Weng
中科院分区：
文献类型：
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作者：
Z. Liao;Ying-li Chen;Fang-ping Li;Xiang Yan;Hai Lu;Li Yan;Zhiguang Zhou;Dalong Zhu;L. Ji;J. Weng
背景：我国研制了一种新型的可吸入胰岛素气雾剂（Inh-Ins）。这项多中心临床研究的目的是评估这种新型Inh-Ins治疗2型糖尿病的有效性和安全性。常规猪胰岛素（RI）用作对照。方法本研究是一项前瞻性、随机、开放性、平行组、多中心临床试验，其中253例符合条件的2型糖尿病患者接受甘精胰岛素每日睡前加餐前Inh-Ins或餐前皮下RI治疗12周。检测空腹血糖（FPG）、餐后1h血糖（1hPBG）、餐后2 h血糖（2 hPBG）、糖化血红蛋白（HbA 1c）。监测事件的不良反应。结果治疗12周后，两组患者的HbA 1c均较治疗前显著下降，但两组间差异无统计学意义。在Inh-Ins组中，FPG、1hPBG和2 hPBG在治疗第8周和第12周后均较基线显著下降。两组间FPG或1hPBG的降低值显示Inh-Ins的降糖作用比RI更显著。12周后，Inh-Ins组肺一氧化碳弥散量（DLco）显著低于RI组。Inh-Ins的主要不良反应为咳嗽、多痰和低血糖。结论Inh-Ins与RI一样具有降低HbA 1c的作用。在降低FPG和1hPBG方面优于RI。主要不良反应为咳嗽、痰多、低血糖。此外，Inh-Ins轻微损害DLco。
BACKGROUND A new inhalable insulin aerosol (Inh-Ins) was developed in China. The aim of this multicenter clinical study was to evaluate the efficacy and safety of this new Inh-Ins as a treatment of type 2 diabetes. Regular porcine insulin (RI) was used as a control. METHODS This study is a prospective, randomized, open-label, parallel-group multicenter clinical trial in which 253 qualified patients with type 2 diabetes received the insulin Glargine daily at bedtime plus either a pre-meal Inh-Ins or a pre-meal subcutaneous RI for 12 weeks. HbA1c, fasting plasma glucose (FPG), the 1-hour-postprandial blood glucose (1hPBG) and the 2-hour-postprandial blood glucose (2hPBG) were measured. Events were monitored for adverse effects. RESULTS After 12 weeks, the HbA1c decreased significantly from baseline in both treatment groups, with no significant difference between the two regimens. In the Inh-Ins group, FPG, both 1hPBG and 2hPBG significantly declined from baseline after the 8th- and 12th-weeks of treatment. The reduced values of FPG or 1hPBG between the two groups showed a more significant hypoglycemic effect with the Inh-Ins than the RI. After 12 weeks, the pulmonary carbon monoxide diffusing capacity (DLco) was significantly lower in Inh-Ins group than in the RI. The main side effects of Inh-Ins were coughing, excessive sputum, and hypoglycemia. CONCLUSIONS Inh-Ins was effective in decreasing HbA1c like the RI. It was better in lowering the FPG and the 1hPBG than the RI. Its main side effects were coughing, excessive sputum, and hypoglycemia. Also, Inh-Ins slightly impaired DLco.