2型糖尿病患者转换德谷门冬双胰岛素和门冬胰岛素30的安全性比较:一项倾向性评分匹配研究

Safety comparison of switching to insulin degludec and insulin aspart vs.insulin aspart 30 in patients with type 2 diabetes mellitus:a propensity score matching study

目的研究由其他胰岛素治疗转换为每日2次德谷门冬双胰岛素(IDegAsp)或门冬胰岛素30(IAsp30)在2型糖尿病患者中的安全性及血糖控制效果。方法采用回顾性队列研究方法,选择本院2021年1月1日至6月30日期间由其他胰岛素转换为IDegAsp(IDegAsp组)或IAsp30(IAsp30组)治疗的2型糖尿病住院患者资料,胰岛素剂量调整使早餐前和晚餐前血糖达4.4~7.2 mmol·L^(-1)。收集胰岛素转换前(基线)和转换12周后(终点)胰岛素剂量、血糖及低血糖发生数据。采用倾向性评分匹配(PSM),根据2组患者的基线资料进行11匹配,并统计PSM后胰岛素剂量、血糖及低血糖发生情况。结果PSM前IDegAsp组患者48例,IAsp30组103例,2组年龄、体重指数、胰岛素剂量比较有显著差异(P<0.05)。PSM后2组患者各43例,基线资料比较无显著差异(P>0.05)。PSM后,观察终点IDegAsp组餐前胰岛素、总胰岛素剂量均显著低于IAsp30组(P<0.05);2组均无严重低血糖事件发生,虽IDegAsp组非严重低血糖事件和夜间低血糖事件发生数、频次低于IAsp30组,但发生风险组间比较无显著差异(RR=0.55,95%CI:0.30~1.04,P>0.05和RR=0.60,95%CI:0.14~2.51,P>0.05);IDegAsp组空腹血糖(FPG)、早餐前、早餐后2 h血糖、午餐后2 h血糖、晚餐前和凌晨300血糖均低于IAsp30组(P<0.05);2组患者体重变化无显著差异(P>0.05)。结论与IAsp30相比,由其他胰岛素转换为IDegAsp,患者低血糖发生次数降低,但低血糖风险无显著差异,应用IDegAsp患者的胰岛素剂量更低,FPG改善更佳,血糖曲线更平稳。

AIM To investigate the safety and blood glucose control effect of transforming from other insulin treatment to twice daily insulin degludec and insulin aspart(IDegAsp)or insulin aspart 30(IAsp30)in patients with type 2 diabetes.METHODS A retrospective cohort study was conducted.The hospitalization data of type 2 diabetes patients admitted to our hospital from January 1,2021 to June 30,2021 who switching from other insulin to IDegAsp(IDegAsp group)or IAsp30(IAsp30 group)were selected and the insulin dose was adjusted to make the blood glucose before breakfast and dinner reaching 4.4 to 7.2 mmol·L^(-1).The data of insulin dose,blood glucose and hypoglycemia before insulin conversion(baseline)and 12 weeks after insulin conversion(end point)were collected.The propensity score matching(PSM)was used to match 11 according to the baseline data of the two groups,and the insulin dose,blood glucose and hypoglycemia after PSM were counted.RESULTS There were 48 patients in IDegAsp group and 103 patients in IAsp30 group before PSM.There were significant differences in age,body mass index and insulin dose between the two groups(P<0.05).There were 43 patients in each group after PSM,and there was no significant difference in the baseline data between the two groups(P>0.05).After PSM,the pre-prandial insulin and total insulin doses in the IDegAsp group were significantly lower than those in the IAsp30 group(P<0.05).There were no serious hypoglycemia events in both groups.Although the number and frequency of nonserious hypoglycemia events and nocturnal hypoglycemia events in the IDegAsp group were lower than those in the IAsp30group,there was no significant difference in the hypoglycemia risk between two groups(RR=0.55,95%CI:0.30 to 1.04,P>0.05 and RR=0.60,95%CI:0.14 to 2.51,P>0.05).The fasting blood glucose(FPG),blood glucose before breakfast,blood glucose 2 h after breakfast,blood glucose 2 h after lunch,blood glucose before dinner,and at 300 am in the IDegAsp group were lower than those in the IAsp30 group(P<0.05).There was no significant difference in weight change between the two groups(P>0.05).CONCLUSION Compared with other insulin converted to IAsp30,the patient who switching to IDegAsp has lower frequency of hypoglycemia,but there was no significant difference in the risk of hypoglycemia.And patient treated with IDegAsp has lower insulin dose,better FPG improvement,and smoother blood glucose curve.