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[二甲双胍用于 1 型糖尿病青少年及成人患者:缺乏循证依据]

[Metformin in adolescents and adults with type 1 diabetes mellitus: not evidence-based].

作者信息

Spaans E A J M Angelien, Kleefstra Nanne, van Hateren K J J Hans, Aanstoot Henk-Jan, Bilo Henk J G, Brand Paul L P

机构信息

Isala Klinieken, Diabetescentrum, Zwolle, the Netherlands.

出版信息

Ned Tijdschr Geneeskd. 2011;155(39):A3166.

PMID:21961686
Abstract

OBJECTIVE

Adolescents with type 1 diabetes mellitus (DM1) often have problems in achieving optimal glycaemic control. We investigated whether there is evidence of the beneficial effect of the addition of metformin to insulin therapy in adolescents with DM1.

DESIGN

Systematic literature study.

METHOD

Medline and Embase were searched for randomised double-blind trials in adolescents with DM1 up to May 2011 inclusive. Two reviewers selected relevant articles based on title, summary and, if necessary, the full text. The quality of the methodology was also assessed.

RESULTS

We found 2 studies in adolescents, of limited scope and duration. On this basis, it was decided that the search of the literature should be extended to adults with DM1, whereby 4 studies were found. All six trials were of good methodological quality, and included 196 patients in total. Clinical and statistical heterogeneity precluded pooling the results in a meta analysis. In one study in adolescents metformin treatment showed a reduction of HbA1c by 0.6% (95% CI: -1.16-0.04) and a slight decrease in daily total insulin dose. However, the treatment groups were not comparable at baseline. In the other studies, no significant changes in HbA1c were found. All studies showed decreased daily insulin dose; in four studies this was significant. Two studies showed a beneficial effect on weight or BMI. No serious side effects were recorded. One study showed an increase in hypoglycaemic episodes during metformin treatment.

CONCLUSION

The possible benefit of adding metformin to insulin in adolescents and adults with type 1 diabetes remains unclear. A well-designed double-blind randomised trial carried out over a longer time period is required to assess whether metformin is of added value.

摘要

目的

1型糖尿病(DM1)青少年患者在实现最佳血糖控制方面常常存在问题。我们调查了在DM1青少年患者中,胰岛素治疗基础上加用二甲双胍是否有证据显示有益效果。

设计

系统文献研究。

方法

检索Medline和Embase数据库,查找截至2011年5月(含)的DM1青少年患者随机双盲试验。两名评审员根据标题、摘要以及必要时的全文来选择相关文章。同时评估方法学质量。

结果

我们在青少年中发现了2项研究,范围和持续时间有限。在此基础上,决定将文献检索范围扩大至DM1成年患者,从而又发现了4项研究。所有6项试验方法学质量良好,总共纳入了196例患者。临床和统计学异质性使得无法将结果合并进行荟萃分析。在一项青少年研究中,二甲双胍治疗使糖化血红蛋白(HbA1c)降低了0.6%(95%可信区间:-1.16至0.04),每日总胰岛素剂量略有下降。然而,治疗组在基线时不具有可比性。在其他研究中,未发现HbA1c有显著变化。所有研究均显示每日胰岛素剂量减少;在4项研究中这一结果具有统计学意义。2项研究显示对体重或体重指数(BMI)有有益影响。未记录到严重副作用。一项研究显示二甲双胍治疗期间低血糖发作增加。

结论

在1型糖尿病青少年和成年患者中,胰岛素治疗基础上加用二甲双胍的潜在益处仍不明确。需要开展一项设计良好、为期更长的双盲随机试验,以评估二甲双胍是否具有附加价值。

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