双时相门冬胰岛素50与双时相人胰岛素50治疗2型糖尿病的临床对比研究

目的 比较双时相门冬胰岛素和双时相人胰岛素治疗2型糖尿病（T2DM）的有效性和安全性.方法 选取2012年2月至2013年2月于江苏省盐城市亭湖区人民医院住院的T2DM患者50例为研究对象,按分层随机化分为2组,分别应用门冬胰岛素50（A组,25例）和人胰岛素50R（B组,25例）治疗.观察两组不同治疗方案患者2周和12周后空腹血糖（FPG）、餐后2h血糖（2 hPG）、糖化血红蛋白（HbA1c）、每日胰岛素（INS）用量、低血糖发生及体质指数（BMI）变化的情况.计量资料的比较采用成组t检验,计数资料比较用χ^2检验.结果 治疗2周后,两组患者血糖都明显下降,其中A组在早餐后、中餐后、晚餐后下降更明显,差异有统计学意义（t=3.342、3.393、2.504,均P＜0.05）;而B组在晚餐前、睡前下降更明显,差异亦有统计学意义（t=2.532、3.066,均P＜0.05）.治疗12周后,A组在HbA1c及2 hPG方面较B组下降更明显,A组HbA1c由治疗前的（10.6±1.9）％降至治疗后的（6.7±0.5）％,B组HbA1c由治疗前的（10.5±1.5）％降至治疗后的（7.1±0.6）％,组间比较差异有统计学意义（t=3.808,P＜0.05）,A组2 hPG由治疗前的（21±5）mmol/L降至治疗后的（7.1 ±0.9） mmol/L,B组2 hPG由治疗前的（21±5）mmol/L降至治疗后的（8.4±1.6） mmol/L,组间比较差异有统计学意义（t=3.331,P＜0.05）,而在空腹血糖方面差异无统计学意义（均P＞0.05）;在胰岛素用量方面,12周后两组胰岛素用量都明显减少,部分患者胰岛素停用,其中A组较B组减少更明显,A组胰岛素用量由治疗2周时的（50±13） U/d降至治疗12周时的（32±12） U/d,B组胰岛素用量由治疗2周时的（59±10） U/d降至治疗12周时的（39±6） U/d,组间比较差异有统计学意义（t =3.399,P＜0.05）;治疗前两组患者体重差异无统计学意义,治疗12周后两组患者体重与治疗前比较差异亦无统计学意义（均P ＞0.05）,但组间比较差异有统计学意义（t=2.319,均P＜0.05）;在低血糖发生方面,两组均无严重低血糖发生,A组低血糖发生率明显低于B组（χ^2=4.500,P＜0.05）.结论 双时相门冬胰岛素能更平稳地降低T2DM患者的血糖水平,特别是控制餐后血糖而不增加低血糖的风险及日胰岛素的用量,体重增加亦不明显.

Comparative study on biphasic insulin aspart50 and biphasic human insulin50 in the treatment of type 2 diabetic patients

Objective To compare the clinical efficacy of biphasic insulin aspart50 and biphasic human insulin50 in the treatment of type 2 diabetic patients.Methods Selecting the type 2 diabetic clinical in-patients of 50 cases in Department of Endocrinology,Tinghu District People＆#39;s Hospital,Yancheng,Jiangsu Province from February of 2012 to February of 2013 for study subjects,which all meet the criterion of WHO diabetes mellitus diagnosis in 1999.Fifty patients were divided into two groups randomly.The patients were treated with Biphasic Insulin AspartS0 in group A （n =25）,and Biphasic Human Insulin50 in group B （n =25）.Fasting plasma glucose （FPG）,2 h postprandial plasma glucose （2 hPG）,HbA1c,BMI,dosage of insulin,and incidence of hypoglycemia were observed at the baseline and the end of 2 weektreatment and 12 week-treatment.The analysis was done using SPSS 17.0 statistical software and the measurement data was compared using group t-test and the count data was compared by χ^2 test.Results After 2 week-treatment,the levels of FPG and 2 hPG decreased significantly from baseline in the two groups,the decrease in group A of blood glucose after breakfast,lunch and dinner was significantly more than that in group B.The differences have statistical significance （t =3.342,3.392 and 2.504 respectively,P 〈 0.05 all above）.But the decrease of pre-dinner and pre-sleep in group B was significantly more than that in group A.The differences have statistical significance （t =2.532,3.066,respectively,P 〈0.05 all above）.After treatment for 12 weeks,the decrease of HbA1c,2 hPG and insulin dosage in group A was significantly more than that in group B （P 〈0.05）.HbA1c in group A falled from （10.6 ± 1.9）% before treatment to （6.7 ± 0.5）% after treatment and HbA1c in group B falled from （10.5± 1.5）% before treatment to （7.1 ± 0.6）% after treatment.The differences between two groups have statistical significance （t =3.808,P 〈 0.05）.2 hPG in group A falled from （21 ± 5） mmol/L before treatment to （7.1 ± 0.9） mmol/L after treatment and 2 hPG in group B falled from （21 ± 5） mmol/L before treatment to （8.4 ± 1.6） mmol/L after treatment.The differences have statistical significance （t =3.331,P 〈0.05）.No statistical differences were observed in FBG （P 〉 0.05）.Insulin dosage significantly decreased in two groups after 12 week-treatment.Some patients stopped using insulin.In group A,insulin dosage falled from （50 ± 13） U/d after 2 week-treatmet to （32 ± 12） U/d after 12 week-treatment and in group B,insulin dosage falled from （59 ± 10） U/d after 2 week-treatmet to （39 ± 6） U/d after 12-week treatment.The differences have statistical significance （t =3.399,P 〈 0.05）.Before treatment body weight has no statistical difference between two groups,and the body weight has no statistical difference between before and after 12 week-treatment （P 〉0.05 all above）.The gain of weight in group B was more than that in group A （t =2.319,P 〈 0.05）.No severe hypoglucemia happened in two groups.The rate of hypoglycemia in group B was significantly more than that in group A （χ^2 =4.500,P 〈 0.05）.Conclusion Biphasic Insulin Aspart50 is superior to Biphasic Human Insulin50 in the reduction of HbA1c,2 hPG and the dosage of insulin and dose not increase hypoglycemic episodes and weight gaining significantly.