胰岛素粉雾剂与注射剂治疗2型糖尿病的随机对照临床研究

目的:评价胰岛素粉雾剂治疗2型糖尿病的疗效及安全性。方法:232例18～70a的2型糖尿病病人随机分为2组。保持原口服降糖药不变,试验组加用吸入性胰岛素治疗;对照组加用胰岛素皮下注射治疗,疗程均为13 wk。比较治疗前后2组糖化血红蛋白、空腹及餐后2 h血糖、常规实验室检查、胸片变化及不良事件的发生率。结果:治疗后,试验组糖化血红蛋白、空腹和餐后2 h血糖均下降,分别为(0.8±s 1.2)%、(1.1±2.1)mmol·L~(-1)、(3±4)mmol·L~(-1),对照组下降了(1.2±1.6)%、(0.9±2.2)mmol·L~(-1)、(2±4)mmol·L~(-1);均下降明显(P>0.01),下降幅度2组无显著差异(P>0.05)。试验组低血糖发生率14.0%(16/114),低于对照组24.6%(29/118),P<0.05。呼吸道不良反应试验组发生1例,对照组无(P>0.05)。结论:胰岛素粉雾剂能安全有效地控制2型糖尿病病人的血糖水平,是临床医生和病人的一个新选择。

Insulin dry powder inhalation comparing with subcutaneous insulin injection in patients with type 2 diabetes: a randomized, controlled clinical trial

AIM:To evaluate the efficacy and safety of insulin dry powder inhalation for patients with type 2 diabetes.METHODS:Two hundred and thirty-two patients (age 18-70 a) with type 2 diabetes were randomized into two groups:inhaled insulin group (oral agent+insulin dry powder inhalation) and regular insulin group (oral agent+subcutaneous insulin regimen).All the patients continued their oral agent therapy. The primary efficacy end point was checked by the changes in glycosylated hemoglobin (HbA_(1c)),fasting blood glucose (FBG) and 2 h postprandial blood glucose (2hPG) from the beginning baseline up to 13 weeks as a course for both groups.For safety,blood routine,urine routine,X-ray of chest and the incidence of adverse reaction were undertaken and recorded.RESULTS:After 13 weeks' treatment,HbA_(1c),FBG and 2hPG in inhaled insulin group and regular insulin group decreased significantly ((0.8±s 1.2) %,(1.1±2.1) mmol·L~(-1) and (3±4) mmol·L~(-1) vs (1.2±1.6) %,(0.9±2.2) mmol·L~(-1) and (2±4) mmol·L~(-1)),but there was no significant difference between the two groups (P>0.05).Hypoglycemia occurred slightly less in inhaled insulin group than that of the regular insulin group,14.0 % (16/119) vs 24.6 % (29/118),P<0.05. Respiratory adverse reaction occurred in 1 patient of inhaled insulin group,but none in the other (P>0.05). CONCLUSION:Insulin dry powder inhalation provides glycemic control with safety and effectiveness, competitive to the conventional subcutaneous regimen and appears to be an alternative treatment for patients with type 2 diabetes.