Efremova N V, Bolotskaya L L, Atarshchikov D S, Bondarenko O N, Ilyin A V, Shestakova M V
Endocrinology Research Centre, Ministry of Health of Russia, Moscow, Russia.
Ter Arkh. 2015;87(10):42-49. doi: 10.17116/terarkh2015871042-49.
To implement in 2009-2012 the RESULT observational program on the use of insulin glargine (Lantus) in combination with insulin glulisine (Apidra) as a basal-bolus regimen in patients with type 1 diabetes mellitus (DM) to evaluate the efficiency and safety of therapy with human insulin analogues.
The program covered 100 patients aged 19 to 25 years from 7 regions of the Russian Federation, who had had DM onset at the age of 9-13 years, were using human recombinant insulins as continuous insulin therapy, and had glycated hemoglobin (HbA1c) levels of 7 to 9%. The main inclusion criterion was switching to insulin therapy with the human insulin analogues Lantus and Apidra.
A total 41 men and 59 women were followed up. Their mean baseline HbA1c level was 8.3±0.7%. After 24 months of therapy, HbA1c was significantly decreased to 7.7±0.7%; its change compared with that at Visit 1 was -0.6±0.6% (p<0.001). There was a significant reduction in fasting and postprandial blood glucose levels at 3 months of a follow-up. The number of symptomatic and asymptomatic glycemic episodes declined. No nocturnal or severe hypoglycemic episodes were recorded at 24 months of therapy. Microvascular complications did not progress during the follow-up.
The use of human insulin analogues is effective and safe in treating young diabetic patients, improves their quality of life and confers no risk of asymptomatic or nocturnal hypoglycemic states.
在2009 - 2012年实施RESULT观察项目，该项目针对1型糖尿病患者使用甘精胰岛素（来得时）联合门冬胰岛素（诺和锐）作为基础 - 餐时胰岛素治疗方案，以评估人胰岛素类似物治疗的有效性和安全性。
该项目涵盖了来自俄罗斯联邦7个地区的100名年龄在19至25岁之间的患者，他们在9至13岁时发病，一直使用人重组胰岛素进行持续胰岛素治疗，糖化血红蛋白（HbA1c）水平为7%至9%。主要纳入标准是改用甘精胰岛素和门冬胰岛素类似物进行胰岛素治疗。
共随访了41名男性和59名女性。他们的平均基线HbA1c水平为8.3±0.7%。治疗24个月后，HbA1c显著降至7.7±0.7%；与第1次就诊时相比，其变化为 - 0.6±0.6%（p<0.001）。随访3个月时，空腹和餐后血糖水平显著降低。有症状和无症状的血糖波动次数减少。治疗24个月时未记录到夜间或严重低血糖事件。随访期间微血管并发症未进展。
人胰岛素类似物用于治疗年轻糖尿病患者有效且安全，可改善他们的生活质量，且无无症状或夜间低血糖状态的风险。
