Yamada Satoru, Watanabe Mari, Kitaoka Akira, Shiono Kaoru, Atsuda Koichiro, Tsukamoto Youko, Kawana Yukiko, Irie Junichiro
Department of Internal Medicine, Kitasato Institute Hospital, Tokyo.
Intern Med. 2007;46(18):1513-7. doi: 10.2169/internalmedicine.46.0236. Epub 2007 Sep 14.
To evaluate the clinical effects of switching from premixed human insulin to a premixed rapid-acting insulin analogue in type 2 diabetic patients.
Thirty patients, who were treated with a twice-daily injection of premixed human insulin, were enrolled and randomized to (i) 50/50 premixed insulin lispro twice-daily at the same daily dose as premixed human insulin (analogue mix group), or (ii) continued premixed human insulin (control group). The doses of insulin were adjusted every month by registered diabetologists to achieve adequate blood glucose levels. At the beginning of the study, and again 4 months later, HbA1c and blood glucose levels were measured, and the amount of insulin required and BMI were recorded in both groups. Insulin therapy-related quality of life (ITR-QOL) and the diabetes treatment satisfaction questionnaire (DTSQ) were also assessed in the analogue mix group at the beginning of the study and again 4 months later.
Although HbA1c levels did not change significantly over the duration of the study in the control group (7.33 +/- 0.58 vs 7.29 +/- 0.65%), HbA1c did improve significantly in the analogue mix group (7.59 +/- 0.44 vs 7.24 +/- 0.49%; p<0.05). The dose of insulin required in the analogue mix group did not change significantly (0.37 +/- 0.11 vs 0.38 +/- 0.14 U/kg/day), but increased in the control group from 0.34 +/- 0.15 to 0.37 +/- 0.16 U/kg/day (p<0.05). The switch to the premixed insulin analogue did not affect ITR-QOL and DTSQ scores.
This study showed that switching from premixed human insulin to 50/50 premixed insulin lispro improved blood glucose control without compromising QOL. This finding suggests that a premixed rapid-acting insulin analogue is more effective than human insulin for Japanese type 2 diabetic patients.
评估2型糖尿病患者从预混人胰岛素转换为预混速效胰岛素类似物的临床效果。
选取30例每日两次注射预混人胰岛素的患者,将其随机分为两组:(i)每日两次注射50/50预混赖脯胰岛素,剂量与预混人胰岛素相同(类似物混合组);(ii)继续使用预混人胰岛素(对照组)。由注册糖尿病专家每月调整胰岛素剂量,以达到足够的血糖水平。在研究开始时以及4个月后,测量两组患者的糖化血红蛋白(HbA1c)和血糖水平,并记录所需胰岛素量和体重指数(BMI)。在研究开始时以及4个月后,还对类似物混合组进行了胰岛素治疗相关生活质量(ITR-QOL)和糖尿病治疗满意度问卷(DTSQ)评估。
虽然对照组在研究期间糖化血红蛋白水平无显著变化(7.33±0.58%对7.29±0.65%),但类似物混合组的糖化血红蛋白水平显著改善(7.59±0.44%对7.24±0.49%;p<0.05)。类似物混合组所需胰岛素剂量无显著变化(0.37±0.11对0.38±0.14U/kg/天),但对照组从0.34±0.15增加至0.37±0.16U/kg/天(p<0.05)。转换为预混胰岛素类似物未影响ITR-QOL和DTSQ评分。
本研究表明,从预混人胰岛素转换为50/50预混赖脯胰岛素可改善血糖控制,且不影响生活质量。这一发现提示,预混速效胰岛素类似物对日本2型糖尿病患者比人胰岛素更有效。