两种胰岛素类似物治疗2型糖尿病的比较

摘要

目的 探讨预混胰岛素类似物门冬胰岛素30注射液(诺和锐30)和长效胰岛素类似物甘精胰岛素注射液(来得时)治疗2型糖尿病的疗效和安全性.方法 83例初诊2型糖尿病随机分成2组,分别给予诺和锐30每天2次及来得时每天1次治疗12周,观察治疗前后空腹血糖(FPG)、餐后2小时血糖(PPG),糖化血红蛋白(HbA1c)的变化,比较两组血糖达标率、低血糖的发生率.结果 诺和锐30组HbA1c较来得时治疗组明显下降,HbA1c(7.42±1.38)% vs(8.31±1.82)%(P<0.05).诺和锐30组PPG显著低于来得时组,(7.82±4.18)mmol/L vs(8.21±3.90)mmol/L(P <0.05).诺和锐30组PPG达标率更高,83.0% vs 56.1%(P <0.05),达标时间更短,(7.85±1.48)天vs(8.25±2.46)天,但低血糖事件较来得时组略高,26.2% vs 12.2%(P <0.05).诺和锐30组胰岛素用量高于来得时组,(0.61±0.24)U/kg vs(0.50±0.27)U/kg(P <0.05),体质量增加也较明显,(5.6±4.6)kg vs(3.0±4.3)kg(P<0.05),结论 诺和锐30每天2次治疗比来得时每天1次治疗能更有效地降低血糖,血糖达标时间更短,但低血糖发生率略高.%Objective To compare the efficacy and safety of biphasic insulin aspart 30(BIAsp30) given twice daily with once-daily insulin glargine in type 2 diabetes mellitus. Methods 83 patients with newly diagnosed type 2 diabetes mellitus were randomized to receive either aspart 30 twice daily or glargine once daily for 12 weeks. The level of fasting plasma glucose ( FPG), 2 hour postprandial glucose (PPG), glycosylated hemoglobin A)C(HbAic) were compared before and after treatment. At the end of the trial,the difference in the proportion of patients who reached a target of FPG<7. 0 mmol/L and PPG<10. 0 mmol/L was observed. Hypoglycemic episodes were recorded. Results HbA1C change was significantly greater in BIAsp 30 group than glargine group. (7. 42±1. 38)% vs (8. 31 ±1. 82)% ( P <0. 05). PPG was significantly lower for BIAsp 30 compared with glargine group,(7. 82±4.18) mmol/L vs (8. 21± 3.90) mmol/L( P <0. 05). At the end of the trial, more patients using BIAsp 30 reached a target of PPG<10. 0 mmol/L,83. 3% vs 56.1 % ( P <0.05). 26. 2% and 12. 2% of patients experienced minor hypoglycemic episodes in BIAsp 30 and glargine groups,respectively( P <0. 05). At the end of the trial,mean daily insulin doses were (0. 61 ± 0. 24) U/kg vs (0. 50±0. 27) U/kg in BIAsp 30 and glargine groups,respectively( P <0. 05). Body mass gain with BIAsp 30 was more than with glargine, (5. 6 ±4. 6) kg vs (3.0±4. 3)kg( P <0. 05). Conclusion BIAsp 30, given twice daily was more effective than insulin glargine,given once daily in patients with type 2 diabetes mellitus, but was associated with increased minor hypoglycemic and body mass gain.