Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus

  • Review
  • Intervention

Authors


Abstract

Background

Short acting insulin analogue use for diabetic patients is still controversial, as reflected in many scientific debates.

Objectives

To assess the effects of short acting insulin analogues versus regular human insulin.

Search methods

The Cochrane Library, MEDLINE and EMBASE were searched.

Selection criteria

Randomised controlled trials with an intervention duration of at least four weeks.

Data collection and analysis

Trial selection and evaluation of study quality was done independently by two reviewers.

Main results

Altogether 8274 participants took part in 49 randomised controlled studies. Most studies were of poor methodological quality.
In patients with type 1 diabetes, the weighted mean difference (WMD) of HbA1c was -0.1% (95% CI: -0.2 to -0.1) in favour of insulin analogue, whereas in patients with type 2 diabetes the WMD was 0.0% (95% CI: -0.1 to 0.0).
In subgroup analyses of different types of interventions in type 1 diabetic patients, the WMD in HbA1c was -0.2% (95% CI: -0.3 to -0.1) in favour of insulin analogue in studies using continuous subcutaneous insulin injections (CSII), whereas for conventional intensified insulin therapy (IIT) studies the WMD in HbA1c was -0.1% (95% CI: -0.1 to 0.0).
The WMD of the overall mean hypoglycaemic episodes per patient per month was -0.2 (95% CI: -1.1 to 0.7) and -0.2 (95% CI: -0.5 to 0.1) for analogues in comparison to regular insulin in patients with type 1 diabetes and type 2 diabetes, respectively.
For studies in type 1 diabetes patients the incidence of severe hypoglycaemia ranged from 0 to 247.3 (median 21.8) episodes per 100 person-years for insulin analogues and from 0 to 544 (median 46.1) for regular insulin, in type 2 the incidence ranged from 0 to 30.3 (median 0.3) episodes per 100 person-years for insulin analogues and from 0 to 50.4 (median 1.4) for regular insulin.
No study was designed to investigate possible long term effects (e.g. mortality, diabetic complications), in particular in patients with diabetes related complications.

Authors' conclusions

Our analysis suggests only a minor benefit of short acting insulin analogues in the majority of diabetic patients treated with insulin. Until long term efficacy and safety data are available we suggest a cautious response to the vigorous promotion of insulin analogues. For safety purposes, we need a long-term follow-up of large numbers of patients and well designed studies in pregnant women to determine the safety profile for both the mother and the unborn child.

摘要

背景

比較短效胰島素類似物及常規型人體胰島素用於糖尿病患

短效胰島素類似物用於糖尿病患仍有爭議,反應在許多科學的討論。

目標

評估短效胰島素類似物及常規型人體胰島素的效果。

搜尋策略

The Cochrane Library (Issue 3, 2005), MEDLINE, EMBASE 至2005年九月的資料。

選擇標準

隨機對照試驗,參與時間至少四星期。

資料收集與分析

由兩個獨立的作者決定試驗的選擇及評估試驗的品質

主要結論

共選取四十九個隨機對照試驗參與八千二百七十四個人。大部分的研究有不良的統計方式。在第一型糖尿病患,糖化血色素的加權平均數(WMD)為 −0.1%(95% CI:−0.2 to −0.1)傾向使用胰島素類似物,然而在第二型糖尿病患,WMD為0.0%(95% CI: −0.1 to 0.0)。在第一型糖尿病患不同的治療的次組分析中,連續型皮下胰島素注射(CSII)的研究顯示糖化血色素的WMD是 −0.2%(95% CI: −0.3 to −0.1)傾向使用胰島素類似物,而胰島素強化治療(IIT)的研究顯示糖化血色素的WMD是 −0.1%(95% CI: −0.1 to 0.0)。若以胰島素類似物比較常規型人體胰島素整體平均每個人個月低血糖發生次數,在第一型糖尿病患的WMD為 −0.2 (95% CI: −1.1 to 0.7),在第二型糖尿病患為 −0.2 (95% CI: −0.5 to 0.1)。在第一型糖尿病患的研究中,使用胰島素類似物嚴重低血糖的發生次數為每百人年0到247.3次(平均21.8次),使用常規型胰島素則為為0到544次(平均46.1次);在第二型糖尿病患的研究中,使用胰島素類似物嚴重低血糖的發生次數為每百人年0到30.3次(平均0.3次),使用常規型胰島素則為為0到50.4次(平均1.4次)。沒有研究設計探討長期效果(如:死亡率、糖尿病併發症),特別是糖尿病相關的併發症。

作者結論

我們的分析顯示對於大部分使用胰島素的糖尿病患使用短效胰島素類似物只有些許的好處。在有長期的效果及安全性的資料之前,我們建議小心的回應胰島素類似物的推展。為了安全性的考量,我們需要長期大型研究及對懷孕婦女良好設計的研究來決定孕婦及胎兒的安全性。

翻譯人

本摘要由臺灣大學附設醫院賴瑩純翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

在糖尿病患,短效胰島素類似物(Lispro, Aspart, Glulisine)的作用比常規型人體胰島素快。它可以在飯前直接施打而降低於飯後高血糖。我們的分析顯示短效胰島素類似物比起常規型人體胰島素對於長期的血糖控制定有幾乎相同的效果,而且在低血糖的發生也是類似。沒有研究資料計對晚期的併發症,如眼睛、腎臟、或足部。在有長期的效果及安全性的資料之前,我們建議小心的回應胰島素類似物的推展。

Plain language summary

Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus

Short acting insulin analogues (Lispro, Aspart, Glulisine) act more quickly than regular human insulin. It can be injected immediately before meals and leads to lower blood sugar levels after food intake. Our analysis showed that short acting insulin analogues were almost identically effective to regular human insulin in long term glycaemic control and were associated with similar episodes of low blood sugar (hypoglycaemia). No information on late complications such as problems with the eyes, kidneys or feet are existing. Until long term safety data are available we suggest a cautious response to the vigorous promotion of insulin analogues.

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