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目的 评价胰岛素口腔喷雾剂 (华中科技大学药物研究所制备 )治疗糖尿病的有效性及安全性。方法 采用开放、多中心、随机、自身交叉、阳性对照研究 ,共入选 61例糖尿病患者 ,随机分为两组 ,分别先用试验药胰岛素口腔喷雾剂或对照药短效胰岛素皮下注射剂 ,经 4周观察 (2周剂量调整期 ,2周维持期 )后交换药物种类 ,分别于试验前、交叉改用试验或对照药前、试验结束时测空腹和餐后 1h、2h血糖及安全性指标。结果 经一个月的胰岛素口腔喷雾剂治疗 ,能有效地降低空腹血糖、餐后 1、2h血糖、固定餐试验血糖曲线下面积 ,治疗前、后值分别为 (10 .7± 3 .2到 8.7± 2 .4,15.0± 4.3到 12 .5± 3 .2、15.7± 5.1到 11.9± 3 .5)mmol/L及 (2 8.2 4± 7.91到 2 2 .74± 5.74)mmol·L- 1·h ,其差异均有显著性 (P =0 .0 0 1) ;而与胰岛素皮下注射剂相比 ,治疗后空腹血糖差异无显著性〔(8.66± 2 .42对 8.55± 2 .3 6)mmol/L〕 ,而餐后1h、2h血糖差异有显著性〔分别为 (12 .48± 3 .15对 10 .93± 3 .0 3 )mmol/L ,P <0 .0 5;(11.87± 3 .48对 9.87± 3 .2 8)mmol/L ,P <0 .0 1〕 ,口腔喷雾剂降糖效果不如皮下注射 ,胰岛素口腔喷雾剂和胰岛素皮下注射剂的药量比约为 5.46:1。安全性指标治疗前后差异无显著性。两种?
Objective To evaluate the effectiveness and safety of insulin oral spray (prepared by Huazhong University of Science and Technology Institute of Materia Medica) in the treatment of diabetes. Methods A total of 61 patients with diabetes mellitus were enrolled in the study. They were randomly divided into two groups: experimental insulin oral buccal spray or control drug short-acting insulin subcutaneous injection respectively. After 4 weeks Before the test, before the crossover test, or before the control drug, the fasting and postprandial blood glucose and safety indexes at 1h and 2h were measured at the end of the experiment (2 weeks of dose adjustment and 2 weeks of maintenance). Results After a month of insulin oral spray treatment, can effectively reduce the fasting blood glucose, 1,2 h postprandial blood glucose, fixed blood glucose test under the test area, before and after treatment were (10.7 ± 3 .2 to 8.7 ± 2 .4, 15.0 ± 4.3 to 12.5 ± 3.2, 15.7 ± 5.1 to 11.9 ± 3.5, mmol / L, and (2 8.24 ± 7.91 to 2 2 · 74 ± 5.74) mmol·L -1 · H, the difference was significant (P = 0.010); while compared with insulin subcutaneous injection, fasting blood glucose after treatment was no significant difference (8.66 ± 2.42 vs 8.55 ± 2.36) mmol / L], while the differences of blood glucose between 1h and 2h after meal were significant (12.48 ± 3.15 vs 10.93 ± 3.30 mmol / L, P <0.05); (11.87 ± 3.48 vs 9.87 ± 3.28 mmol / L, P <0.01). The hypoglycemic effect of oral spray was not as good as that of subcutaneous injection. The dose ratio of insulin buccal spray and insulin subcutaneous injection was about 5.46: 1. Safety index before and after treatment was no significant difference. Two kinds?