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比较糖尿病胰岛素输送和血糖监测方法的有效性和安全性:系统评价和荟萃分析。

Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis.

机构信息

The Johns Hopkins University, Baltimore, Maryland, USA.

出版信息

Ann Intern Med. 2012 Sep 4;157(5):336-47. doi: 10.7326/0003-4819-157-5-201209040-00508.

DOI:10.7326/0003-4819-157-5-201209040-00508
PMID:22777524
Abstract

BACKGROUND

Patients with diabetes mellitus need information about the effectiveness of innovations in insulin delivery and glucose monitoring.

PURPOSE

To review how intensive insulin therapy (multiple daily injections [MDI] vs. rapid-acting analogue-based continuous subcutaneous insulin infusion [CSII]) or method of monitoring (self-monitoring of blood glucose [SMBG] vs. real-time continuous glucose monitoring [rt-CGM]) affects outcomes in types 1 and 2 diabetes mellitus.

DATA SOURCES

MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials through February 2012 without language restrictions.

STUDY SELECTION

33 randomized, controlled trials in children or adults that compared CSII with MDI (n=19), rt-CGM with SMBG (n=10), or sensor-augmented insulin pump use with MDI and SMBG (n=4).

DATA EXTRACTION

2 reviewers independently evaluated studies for eligibility and quality and serially abstracted data.

DATA SYNTHESIS

In randomized, controlled trials, MDI and CSII showed similar effects on hemoglobin A1c (HbA1c) levels and severe hypoglycemia in children or adults with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. In adults with type 1 diabetes mellitus, HbA1c levels decreased more with CSII than with MDI, but 1 study heavily influenced these results. Compared with SMBG, rt-CGM achieved a lower HbA1c level (between-group difference of change, 0.26% [95% CI, 0.33% to 0.19%]) without any difference in severe hypoglycemia. Sensor-augmented insulin pump use decreased HbA1c levels more than MDI and SMBG did in persons with type 1 diabetes mellitus (between-group difference of change, 0.68% [CI, 0.81% to 0.54%]). Little evidence was available on other outcomes.

LIMITATION

Many studies were small, of short duration, and limited to white persons with type 1 diabetes mellitus.

CONCLUSION

Continuous subcutaneous insulin infusion and MDI have similar effects on glycemic control and hypoglycemia, except CSII has a favorable effect on glycemic control in adults with type 1 diabetes mellitus. For glycemic control, rt-CGM is superior to SMBG and sensor-augmented insulin pumps are superior to MDI and SMBG without increasing the risk for hypoglycemia.

PRIMARY FUNDING SOURCE

Agency for Healthcare Research and Quality.

摘要

背景

糖尿病患者需要了解胰岛素输送和血糖监测方面创新的有效性信息。

目的

回顾强化胰岛素治疗(多次皮下胰岛素注射[MDI]与基于速效类似物的连续皮下胰岛素输注[CSII])或监测方法(自我血糖监测[SMBG]与实时连续血糖监测[rt-CGM])如何影响 1 型和 2 型糖尿病患者的结局。

资料来源

MEDLINE、EMBASE 和 Cochrane 对照试验中心注册库,检索时间截至 2012 年 2 月,无语言限制。

研究选择

33 项随机对照试验,比较 CSII 与 MDI(n=19)、rt-CGM 与 SMBG(n=10)或传感器增强型胰岛素泵与 MDI 和 SMBG(n=4)的应用。

资料提取

2 位审查员独立评估研究的入选标准和质量,并进行连续数据提取。

资料综合

在随机对照试验中,MDI 和 CSII 在儿童或成人 1 型糖尿病患者以及成人 2 型糖尿病患者中,对糖化血红蛋白(HbA1c)水平和严重低血糖的影响相似。在成人 1 型糖尿病患者中,CSII 比 MDI 更能降低 HbA1c 水平,但 1 项研究严重影响了这些结果。与 SMBG 相比,rt-CGM 实现了更低的 HbA1c 水平(组间变化差异为 0.26%[95%CI,0.33%至 0.19%]),且严重低血糖发生率无差异。与 MDI 和 SMBG 相比,传感器增强型胰岛素泵使用使 1 型糖尿病患者的 HbA1c 水平降低更多(组间变化差异为 0.68%[CI,0.81%至 0.54%])。关于其他结局的证据很少。

局限性

许多研究规模较小、持续时间较短,且仅限于白种人 1 型糖尿病患者。

结论

CSII 和 MDI 对血糖控制和低血糖的影响相似,只是 CSII 对成人 1 型糖尿病患者的血糖控制有有利影响。在血糖控制方面,rt-CGM 优于 SMBG,传感器增强型胰岛素泵优于 MDI 和 SMBG,且不会增加低血糖风险。

主要资金来源

美国卫生保健研究与质量署。

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