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来自阿尔及利亚的 2 型糖尿病患者使用胰岛素类似物的安全性和有效性:A₁chieve 研究的亚组分析。

Safety and effectiveness of insulin analogues in type 2 diabetic patients from Algeria: a sub-analysis of the A₁chieve study.

机构信息

Internal Medicine Department, Saâdna University Hospital, Setif, Algeria.

出版信息

Diabetes Res Clin Pract. 2013 Aug;101 Suppl 1:S15-26. doi: 10.1016/S0168-8227(13)70015-9.

DOI:10.1016/S0168-8227(13)70015-9
PMID:23958568
Abstract

AIM

To determine the safety and effectiveness of insulin analogues in type 2 diabetes (T2D) patients in the Algerian cohort of the A₁chieve study and to examine the status of T2D management across different regions in Algeria.

METHODS

Patients starting therapy with biphasic insulin aspart 30, insulin detemir, insulin aspart (IAsp) or IAsp + basal insulin at their physicians' decision were included. The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia. Secondary outcomes included changes from baseline to Week 24 in hypoglycaemia, glycated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), weight and quality of life (QoL, evaluated using the EQ-5D questionnaire).

RESULTS

Overall, 1494 patients (mean ± SD age: 60.1 ± 10.3 years; body mass index: 28.1 ± 4.9 kg/m(2); HbA1c: 9.2 ± 1.8%) were enrolled. Poor baseline glucose control was revealed across the different Algerian regions with mean HbA1c varying from 8.9% to 9.6%. Two SADRs were reported during the study. The proportion of patients reporting major hypoglycaemic events decreased from 1.1% at baseline to 0.2% at Week 24 (p = 0.0017). Significant improvements in mean HbA1c (-1.3 ± 2.0%), FPG (-38.8 ± 79.9 mg/dL) and post-breakfast PPPG (-51.4 ± 97.1 mg/dL) were observed in the entire cohort (all p < 0.001). The mean body weight increased by 0.9 ± 3.8 kg, while QoL increased by 9.2 ± 16.7 points after 24 weeks.

CONCLUSIONS

Insulin analogue therapy was well-tolerated and significantly improved blood glucose control over 24 weeks in the Algerian cohort.

摘要

目的

评估在阿尔及利亚 A₁chieve 研究的人群中,2 型糖尿病(T2D)患者使用胰岛素类似物的安全性和有效性,并考察不同地区 T2D 管理现状。

方法

纳入起始接受门冬胰岛素 30、地特胰岛素、门冬胰岛素或门冬胰岛素+基础胰岛素治疗的患者。主要终点为严重药物不良反应(SADR)发生率,包括严重低血糖。次要终点包括从基线至 24 周时低血糖、糖化血红蛋白(HbA1c)、空腹血糖(FPG)、餐后血糖(PPPG)、体重和生活质量(QoL,采用 EQ-5D 问卷评估)的变化。

结果

共纳入 1494 例患者(平均年龄±标准差:60.1±10.3 岁;体重指数:28.1±4.9 kg/m2;HbA1c:9.2±1.8%)。不同阿尔及利亚地区基线血糖控制不佳,HbA1c 均值从 8.9%到 9.6%不等。研究期间报告了 2 例 SADR。报告有严重低血糖事件的患者比例从基线时的 1.1%下降至 24 周时的 0.2%(p=0.0017)。整个队列的平均 HbA1c(-1.3±2.0%)、FPG(-38.8±79.9 mg/dL)和早餐后 PPPG(-51.4±97.1 mg/dL)显著改善(均 p<0.001)。24 周后,平均体重增加 0.9±3.8 kg,QoL 增加 9.2±16.7 分。

结论

在阿尔及利亚人群中,胰岛素类似物治疗耐受性良好,治疗 24 周可显著改善血糖控制。

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