【摘要】 目的评价胰岛素粉雾剂治疗2型糖尿病患者胰岛素自身抗体(IAA)的发生情况。方法保持原口服降糖药不变,试验组加吸入型胰岛素治疗,对照组加sc胰岛素治疗,疗程均为13周。比较治疗前后两组糖化血红蛋白(HbA1c)、空腹及餐后2h血糖和IAA,并在试验结束后6个月随访复查IAA。结果两组的HbA1c分别下降了0.73%、1.19%,两组均未发现呼吸道的不良反应;试验组较对照组IAA阳性率更高(28.5%比18.2%),但停止使用吸入胰岛素后6个月,所有患者抗体滴度明显下降,1例抗体转阴,2/3的患者抗体滴度降至接近正常。试验组抗体滴度与吸入剂量和使用疗程相关,但与疗效无关。结论胰岛素粉雾剂与sc胰岛素的降糖疗效相当,但吸入胰岛素后产生胰岛素抗体的几率更高,所产生的抗体与吸入的剂量、疗程相关。因此,长期使用吸入胰岛素的糖尿病患者应监测是否有胰岛素自身抗体的产生。更多还原

【Abstract】 OBJECTIVE To compare antibody response to pre-meal inhaled insulin vs pre-meal subcutaneous(sc) Regular insulin injection in poor-controlled type 2 diabetic patients by oral anti-diabetic drug(OAD).METHODS The patients were randomized into two groups:inhaled insulin group(oral agent + insulin dry powder inhalation,INH group:n=21) and regular insulin group(oral agent+subcutancous insulin regimen,sc group:n=22) for 13 weeks.All the patients continued their oral agent therapy.Fasting blood glucose(FBG),postprandial 2-hour blood glucose(PG2h) after 100 g carbohydrate load,glycosylated hemoglobin A1c (HbA1c) and insulin antibody binding (indicated insulin auto-antibody (IAA)) were measured from the beginning baseline up to 13 weeks as a course for both groups.IAA was also assessed at the mean 6th-month follow-up.RESULTS After 13 weeks’ treatment,HbA1c decreased significantly(0.73% vs 1.19%) in INH and sc groups,but no statistical difference between the two groups(P>0.05).There was no statistical significant difference of FBG,PG2h before and after the trial between two groups(P>0.05).No respiratory adverse reaction was found in the enrolled patients.For the INH and sc groups,titration values of IAA were 3.28%±1.22% and 5.15%± 6.22% at baseline,respectively,compared with 12.89%± 17.91% and 6.84%±11.93% at the 13th week,and 6.17%±6.82% and 8.97%±14.67% at about 6th month after treatment stopping.Higher insulin antibody binding was observed in patients with inhaled insulin than that of sc insulin patients(28.5% vs 18.2%),but percentage of antibody binding in the former reduced greatly at about the 6th month after stopping inhaled insulin.One patient’s IAA was negative and the two thirds decreased closely to normal.IAA level was positively correlated with insulin dry powder inhaled dose(P<0.01) and time of inhaling the drug (P<0.01),but no relationship with glycemic control. CONCLUSION Insulin dry powder inhalation provides glycemic control with effectiveness,compared to that with a conventional subcutaneous regular insulin injection regimen.But insulin dry powder inhalation produced a larger response than sc insulin and insulin antibody binding correlated with inhaled insulin dose and time of using inhaled insulin.6 months after treatment stopping,insulin antibody binding in most of the patients could decrease to normal.We suggested that monitoring IAA titration was necessary in the diabetic patients with long-term inhaled insulin therapy.更多还原