Capani F, Carta Q, Vannini P, Ciaverella A, Consoli A, Fiocchi F, Monge L, Vitacolonna E, Sensi S
Diabetes Res. 1986 Jul;3(6):317-20.
A multicentric study has been carried out to compare the efficacy and the safety of monocomponent human insulins of different concentration (Novo Actrapid HM U-40 and U-100) in CSII-treated Type 1 diabetics. 15 males, all of whom had been diabetic for at least 2 yr, had been treated by CSII and were skillful in the self-monitoring of diabetes were selected for observation at 3 different clinical centres (Bologna, Chieti and Torino). After a 1-week period of insulin dose optimization, the patients were asked not to modify either basal or pre-prandial insulin infusion during the following 2 weeks in which they were treated alternately by U-40 or by U-100 insulin (7 days for each treatment in random sequence). Each day or at least every other day, patients recorded at home a 9-point blood glucose profile by means of glucose-sensitive strips and photometric reading (Reflocheck System-BOEHRINGER MANNHEIM, FRG). The patients used the microinfuser Miles Microjet Bolus 2 for the U-40 infusion and the same model with appropriate modifications for the U-100 infusion. On the last day of each study period, blood samples were drawn after the pre-breakfast insulin bolus. Paired Student's t-test analyses between blood glucose values obtained with different regimens did not show a significant difference in metabolic control. Similarly no difference could be observed in insulin absorption after an identical bolus of U-40 or U-100 insulin. In conclusion human U-100 insulin seems to be as effective and safe as U-40 and is recommended in order to reduce the size of microinfusers.
开展了一项多中心研究,比较不同浓度的单组分人胰岛素(诺和灵速效HM U-40和U-100)在持续皮下胰岛素输注(CSII)治疗的1型糖尿病患者中的疗效和安全性。选取了15名男性患者,他们均患有糖尿病至少2年,接受过CSII治疗且熟练掌握糖尿病自我监测,在3个不同临床中心(博洛尼亚、基耶蒂和都灵)接受观察。在为期1周的胰岛素剂量优化期后,要求患者在接下来的2周内不改变基础或餐前门静脉胰岛素输注量,在此期间他们交替接受U-40或U-100胰岛素治疗(每种治疗随机顺序进行7天)。患者每天或至少每隔一天在家中使用葡萄糖敏感试纸和光度读数(Reflocheck系统-德国宝灵曼)记录9点血糖谱。患者使用Miles Microjet Bolus 2微量注射器进行U-40输注,使用经过适当改装的同一型号微量注射器进行U-100输注。在每个研究期的最后一天,早餐前胰岛素推注后采集血样。不同治疗方案获得的血糖值之间的配对学生t检验分析未显示代谢控制方面有显著差异。同样,相同剂量的U-40或U-100胰岛素推注后的胰岛素吸收也未观察到差异。总之,人U-100胰岛素似乎与U-40一样有效和安全,为减小微量注射器尺寸,推荐使用U-100胰岛素。