儿童、青少年糖尿病最终版__培训课件.ppt

* 1415 – Danne et al. Data on File This was a multi-centre, randomised, open-label, 24-week cross-over study (two 12-week periods) safety and efficacy study. There was no washout-period between the treatments. After randomisation, during the first 2 weeks (of 12 weeks), insulin doses were titrated for dose optimisation. After 12 weeks, patients transferred to the alternative meal-time insulin. After crossover, there was a further 2-week titration period. * 1415 – Danne et al. Data on File This slide shows mean seven-point blood glucose profiles for postprandial NovoRapid? and preprandial HI. There were no significant differences between the treatments. * 1415 – Danne et al. Data on File Glycaemic control (changes in HbA1c and fructosamine) showed no significant differences between treatments The number of hypoglycaemic episodes (a rate of 140 episodes per year) was high in both groups in this study. (The rate in a recent study of biphasic NovoRapid? versus HI in children and adolescents was approximately 50 episodes per year1). The number of adverse events was similar with both treatments. There were 112 adverse events (55 with NovoRapid? , 57 with HI). The majority of adverse events were mild or moderate. There were three serious adverse events (all with HI). They were not considered to be treatment-related. No deaths occurred. 1. Mortensen et al. Pediatr Diabetes. 2006 Feb;7(1):4-10. (study 1240 ) * 1415 – Danne et al. Data on File Satisfaction to continue with NovoRapid? was significantly greater than with HI (p = 0.045). There was a trend to preference for recommending NovoRapid? treatment to others compared with HI (p = 0.051). * 1200 – Danne et al. Diabetes Care. 2003 Aug;26(8):2359-64. This study demonstrated the feasibility of mealtime dosing of NovoRapid? without compromising glycaemic control in adolescents and children. * 从上表中我们可以看出三种胰岛素的等电点不同，诺和锐的等电点最低， 这意味着只有在更低的pH值时，诺和锐才能形成沉淀 ，也说明了诺和锐在泵中出现结晶的 可能性会低于其它产品。 * 这时另一个体外研究的结果： 横坐标为pH值，纵坐标为沉淀的百分比。 测定三种产品