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胰岛素强化治疗对新诊断的2型糖尿病患者β细胞功能和血糖控制的影响:一项多中心、随机、平行临床试验 |
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Effect of intensive insulin therapy on β-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial |
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Weng J., Li Y., Xu W., Shi L., Zhang Q., Zhu D., Hu Y., Zhou Z., Yan X., Tian H., Ran X., Luo Z., Xian J., Yan L., Li F., Zeng L., Chen Y., Yang L., Yan S., Liu J., Li M., Fu Z., Cheng H. 2009/5/29 18:39:20 |
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The Lancet, 2008, Volume 371, Issue 9626
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Background: Early intensive insulin therapy in patients with newly diagnosed type 2 diabetes might improve β-cell function and result in extended glycaemic remissions. We did a multicentre, randomised trial to compare the effects of transient intensive insulin therapy (continuous subcutaneous insulin infusion [CSII] or multiple daily insulin injections [MDI]) with oral hypoglycaemic agents on β-cell function and diabetes remission rate. Methods: 382 patients, aged 25-70 years, were enrolled from nine centres in China between September, 2004, and October, 2006. The patients, with fasting plasma glucose of 7·0-16·7 mmol/L, were randomly assigned to therapy with insulin (CSII or MDI) or oral hypoglycaemic agents for initial rapid correction of hyperglycaemia. Treatment was stopped after normoglycaemia was maintained for 2 weeks. Patients were then followed-up on diet and exercise alone. Intravenous glucose tolerance tests were done and blood glucose, insulin, and proinsulin were measured before and after therapy withdrawal and at 1-year follow-up. Primary endpoint was time of glycaemic remission and remission rate at 1 year after short-term intensive therapy. Analysis was per protocol. This study was registered with ClinicalTrials.gov, number NCT00147836. Findings: More patients achieved target glycaemic control in the insulin groups (97·1% [133 of 137] in CSII and 95·2% [118 of 124] in MDI) in less time (4·0 days [SD 2·5] in CSII and 5·6 days [SD 3·8] in MDI) than those treated with oral hypoglycaemic agents (83·5% [101 of 121] and 9·3 days [SD 5·3]). Remission rates after 1 year were significantly higher in the insulin groups (51·1% in CSII and 44·9% in MDI) than in the oral hypoglycaemic agents group (26·7%; p=0.0012). β-cell function represented by HOMA B and acute insulin response improved significantly after intensive interventions. The increase in acute insulin response was sustained in the insulin groups but significantly declined in the oral hypoglycaemic agents group at 1 year in all patients in the remission group. Interpretation: Early intensive insulin therapy in patients with newly diagnosed type 2 diabetes has favourable outcomes on recovery and maintenance of β-cell function and protracted glycaemic remission compared with treatment with oral hypoglycaemic agents. Funding: 973 Programme from the Chinese Government, the Natural Science Foundation of Guangdong Province Government, Novo Nordisk (China), and Roche Diagnostics (Shanghai). © 2008 Elsevier Ltd. All rights reserved. |
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Correspondence Address: Weng, J.; Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China; email: wjianp@mail.sysu.edu.cn |
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疾病资源中心
摘自:《西氏内科学》,第23版
患者女性,21岁,因干咳、间歇性气促2个月到急诊科就诊。开始症状为上呼吸道感染引起的鼻塞、流涕和咳嗽。医生检查后开了抗生素。服药后鼻部症状缓解,但仍有轻微干咳和呼吸困难。其他症状包括疲劳和焦虑。否认发热、体重减轻、胸痛、端坐呼吸、气喘、鼻后滴漏、胃灼热以及神经系统症状。
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