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重度高血糖症患者新诊断的2型糖尿病的强化简化策略:多中心,开放标签,随机试验
Liehua Liu1, Weijian Ke1, Hai Li2
1The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China.
短期强化胰岛素治疗 (SIIT) 随后服用口服药物,特别是林格利平丁加上甲福明,有效改善了新诊断的2型糖尿病患者的长期血糖控制和β细胞功能.
科学领域:
- 内分泌学 在内分泌学.
- 代谢疾病 代谢疾病
- 临床试验 临床试验
背景情况:
- 患有严重高血糖的2型糖尿病 (T2DM) 需要有效的管理策略.
- 短期密集型胰岛素治疗 (SIIT) 接着口服药物是一种潜在的方法.
- 评估这一策略的长期血糖结果至关重要.
研究的目的:
- 评估SIIT之后的口服抗高血糖疗法是否改善了新诊断的T2DM患者的长期血糖控制,这些患者患有严重的高血糖症.
- 为了比较不同口服治疗方案 (林格利普丁,甲福林,组合) 与SIIT后的生活方式改变的疗效.
主要方法:
- 一个多中心的,开放的,随机的试验,涉及412名新诊断T2DM和HbA1c≥8.5%的患者.
- 所有参与者都接受了最初的SIIT (2-3周).
- 在SIIT后,参与者被随机分配到linagliptin,metformin,linagliptin加上metformin,或仅进行48周的生活方式修改.
主要成果:
- 在48周后,80%的林格利普丁加上甲福林的患者达到HbA1c<7.0%,明显高于对照组的60% (P=0.003).
- 组合组还显示出HbA1c<6.5% (70%对48%,P=0.005) 的优异性.
- 林格利普丁加上甲福明在禁食血葡萄糖和β细胞功能方面表现出最显著的改善.
结论:
- 随后的SIIT口服疗法,特别是林格利普丁加上甲福明,在患有严重高血糖症的T2DM患者中提供持续的血糖控制并改善β细胞功能.
- 这一策略代表了T2DM有前途的临床管理方法.
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