Siebenhofer A, Plank J, Berghold A, Horvath K, Sawicki P T, Beck P, Pieber T R
Division of Diabetes and Metabolism, Department of Internal Medicine, Medical University, Leopold Auenbrugger University Hospital, Auenbruggerplatz 15, 8036 Graz, Austria.
Diabetologia. 2004 Nov;47(11):1895-905. doi: 10.1007/s00125-004-1545-x. Epub 2004 Nov 25.
AIMS/HYPOTHESIS: This study aimed to compare the effect of treatment with short-acting insulin (SAI) analogues versus structurally unchanged short-acting insulin (regular insulin) on glycaemic control and on the risk of hypoglycaemic episodes in type 1 diabetic patients using different insulin treatment strategies.
We performed a meta-analysis of 27 randomised controlled trials that compared the effect of SAI analogues with regular insulin in patients with type 1 diabetes mellitus. The treatments were administered either via continuous subcutaneous insulin infusion (CSII) or by conventional intensified insulin therapy (IIT) with short-acting insulin injections before meals and basal insulin administered once or twice daily in most cases.
HbA(1)c levels were reported for 20 studies. For studies using CSII, the weighted mean difference between values obtained using SAI analogues and regular insulin was -0.19% (95% CI: -0.27 to -0.12), whereas the corresponding value for injection studies was -0.08% (95% CI: -0.15 to -0.02). For the analysis of overall hypoglycaemia, we used the results from nine studies that reported the mean frequency of hypoglycaemic episodes per patient per month. For studies using CSII, the standardised mean difference between SAI analogues and regular insulin was -0.07 (95% CI: -0.43 to 0.28), whereas for IIT studies the corresponding value was -0.04 (95% CI: -0.24 to 0.16).
CONCLUSIONS/INTERPRETATION: Taking into consideration the low quality of the trials included, we can conclude that use of a short-acting insulin analogue in CSII therapy provides a small, but statistically significant improvement in glycaemic control compared with regular insulin. An even smaller effect was obtained with the use of ITT. The rate of overall hypoglycaemic episodes was not significantly reduced with short-acting insulin analogues in either injection regimen.
目的/假设：本研究旨在比较使用不同胰岛素治疗策略的1型糖尿病患者中，短效胰岛素（SAI）类似物与结构未改变的短效胰岛素（常规胰岛素）治疗对血糖控制及低血糖发作风险的影响。
我们对27项随机对照试验进行了荟萃分析，这些试验比较了SAI类似物与常规胰岛素对1型糖尿病患者的治疗效果。治疗方式为持续皮下胰岛素输注（CSII）或常规强化胰岛素治疗（IIT），大多数情况下，IIT是在饭前注射短效胰岛素，并每日注射一次或两次基础胰岛素。
20项研究报告了糖化血红蛋白（HbA₁c）水平。对于使用CSII的研究，使用SAI类似物和常规胰岛素获得的值之间的加权平均差为-0.19%（95%置信区间：-0.27至-0.12），而注射研究的相应值为-0.08%（95%置信区间：-0.15至-0.02）。对于总体低血糖分析，我们使用了9项研究的结果，这些研究报告了每位患者每月低血糖发作的平均频率。对于使用CSII的研究，SAI类似物与常规胰岛素之间的标准化平均差为-0.07（95%置信区间：-0.43至0.28），而对于IIT研究，相应值为-0.04（95%置信区间：-0.24至0.16）。
结论/解读：考虑到纳入试验的质量较低，我们可以得出结论，与常规胰岛素相比，在CSII治疗中使用短效胰岛素类似物可在血糖控制方面带来虽小但具有统计学意义的改善。使用IIT时效果更小。在任何一种注射方案中，短效胰岛素类似物均未显著降低总体低血糖发作率。
