重组赖脯胰岛素与赖脯胰岛素治疗T2DM的疗效比较

A comparison of effects between recombinant insulin lispro and insulin lispro in treating type 2 diabetes mellitus

目的探讨重组赖脯胰岛素注射液与赖脯胰岛素注射液在2型糖尿病(T2DM)治疗中的临床疗效和安全性。方法将血糖控制不佳的T2DM患者48例按2∶1比例随机分为重组赖脯胰岛素组(观察组,n=32)和赖脯胰岛素组(对照组,n=16),在睡前给予1次重组甘精胰岛素注射的基础上,三餐前分别给两组患者进行1次重组赖脯胰岛素或赖脯胰岛素注射,治疗周期16周。比较两组患者治疗前、后糖化血红蛋白(HbA1c)、空腹血糖(FPG)、餐后2h血糖(2hPG)变化水平,并评估不良事件。结果 44例完成研究,其中观察组28例,对照组16例。治疗16周后,两组患者HbA1c、FPG和2hPG水平均明显降低(P<0.05),观察组和对照组HbA1c下降幅度分别为(1.55±1.50)%、(1.06±1.30)%,FPG下降幅度分别为(2.07±5.01)、(1.09±3.18)mmol/L,2hPG下降幅度分别为(3.28±5.71)、(3.60±5.89)mmol/L。以HbA1c为主要评价指标,0.40为非劣效界值,重组赖脯胰岛素注射液非劣效于赖脯胰岛素注射液(P<0.05)。观察组HbA1c≤6.50%的达标率为14.29%,HbA1c<7.00%的达标率为28.57%;对照组HbA1c≤6.50%的达标率为18.75%,HbA1c<7.00%的达标率为43.75%,两组患者在HbA1c两个水平达标率比较差异无统计学意义(P>0.05)。结论重组赖脯胰岛素注射液治疗T2DM患者在有效性方面非劣效于赖脯胰岛素注射液,且具有相同的安全性。

Objective To compare the efficacy and safety of recombinant insulin lispro and insulin lispro in the treatment of type 2 diabetes mellitus（T2DM ） .Methods Forty‐eight T2DM patients with poor blood glucose control were randomly assigned to the recombinant insulin lispro group （observation group ,n=32） and insulin lispro group （control group ,n=16） according to the ratio of 2∶1 .On the basis of injection of the recombinant insulin glargine once daily before sleep ,the two groups were given the re‐combinant insulin lispro injection or insulin lispro injection once before each meal .The period of treatment was 16 weeks .The levels of HbA1c ,2 h postprandial blood glucose（2hPG） and fasting plasma glucose（FPG） before and after treatment were measured and compared between the two groups .The adverse events were evaluated at the end of treatment .Results Forty‐four cases finished the study ,28 cases in the observation group and 16 cases in the control group .The levels of HbA1c ,FPG and 2hPG after 16‐week treatment in the two groups were decreased significantly （P〈0 .05） .The decrease amplitudes of HbA1c in the observation group and the control group were （1 .55 ± 1 .50）% and（1 .06 ± 1 .30）% respectively ,which of FPG were （2 .07 ± 5 .01）mmol/L and （1 .09 ± 3 .18）mmol/L respectively ,and which of 2hPG declined （3 .28 ± 5 .71）mmol/L and（3 .60 ± 5 .89）mmol/L respectively . With HbA1c as the main evaluation index and 0 .40 as the non‐inferiority critical value ,non‐inferiority was found in the recombi‐nant insulin lispro injection as compared with the insulin lispro injection （P〈0 .05） .The standard‐reaching rate of HbA1c less than 6 .50% in observation group was 14 .29% ,and which of HbA1c less than 7 .00% was 28 .57% ;in control group ,these two stand‐ard‐reaching rates were 18 .75% and 43 .75% respectively ,and there were no statistically significant differences between two groups （P〉0 .05） .Conclusion The recombinant insulin lispro injection has non‐inferiority effects in the aspect of effectiveness compared with the lispro insulin injection ,moreover they have the same safety .