摘要
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 ev al uate the efficacy and safety of insulin buccal spray preparation in diabetic pat ients. Methods In this open, multiple-center, positive control with regular insulin injection and cross design study, 61 diabe tic patients (26 men, 35 women; 8 cases of type 1, 53 type 2) aged (50.3±10.3)y ears, body mass index (23.4±3.1)kg/m 2, were recruited from 3 clinical centers and were randomized to two groups: one group received the insulin buccal spray administration three times per day one hour before each meal for one month, and then shifted to adopt three daily subcutaneous insulin injections; the other gro up received a reverse treatment sequence. The patients monitored their blood glu cose at home and outpatient clinics and adjusted their insulin dosage per three days to attain postprandial glycaemic levels at 5.5-10.0 mmol/L during the firs t two weeks, and then to fix the dosage of the two kinds of insulin preparations . Fasting blood glucose (FBG), one hour and two hours postprandial blood glucose (PBG) levels after fixed breakfast were determined at the beginning and end of one month treatment. Results After one month in sulin buccal spray treatment, FBG, 1hPBG, 2hPBG and area under blood glucose cur ve (AUC BG ) were significantly decreased from (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 (28.24±7.91 to 22.74±5.7 4)mmol·L -1 ·h, respectively (P=0.001). There was no s ignificant difference in FBG (buccal spray vs. injection, 8. 66±2.42 vs 8.55±2.36)mmol/L after treatment but there were significantly differencies in 1hPBG 〔(12.48±3.15 vs 10.93 ±3.03)mmol/L, P<0.05〕 and 2hPBG 〔(11.87±3.48 vs 9.87±3.28)mmol/L,P<0.01〕 after treatment bet ween insulin buccal spray group and insulin injection group. The ratio of the fi xed dosages of insulin buccal spray and regular insulin were 5.46:1. No signific ant weight gain and no severe events were observed.Conclusion Insulin buccal spray preparation is efficacious and safe in treati ng diabetes, although its initial action seems a little slower than that of subc ulaneous administration.
出处
《中华内分泌代谢杂志》
CAS
CSCD
北大核心
2003年第5期354-357,共4页
Chinese Journal of Endocrinology and Metabolism
