Health economic benefits and quality of life during improved glycemic control in patients with type 2 diabetes mellitus - A randomized, controlled, double-blind trial
Health economic benefits and quality of life during improved glycemic control in patients with type 2 diabetes mellitus - A randomized, controlled, double-blind trial
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DOI：
10.1001/jama.280.17.1490
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发表时间：
1998-11-04
影响因子：
120.7
通讯作者：
Simonson, DC
中科院分区：
文献类型：
--
作者：
Testa, MA;Simonson, DC
背景。虽然糖尿病患者良好血糖控制的长期健康益处已得到充分证明，但据报道，短期生活质量（QOL）和经济节省通常很少或不存在。研究2型糖尿病（DM）血糖控制的短期结果。双盲、随机、安慰剂对照、平行试验。设置。-在美国有62个站点。共有569名男性和女性志愿者与2型DNI. Intervention。在3周的单盲安慰剂洗脱期后，参与者被随机分配至饮食和5至20 mg格列吡嗪胃肠道治疗系统（GITS）（n=377）或安慰剂（n=192）滴定12周。通过问卷调查和日记分析血糖和血红蛋白A（1c）（HbA（1c））水平、症状困扰、QOL和健康经济指标较基线的变化。12周后，与安慰剂相比，活性治疗（格列吡嗪控释片）组的平均（+/-SE）HbA（1c）和空腹血糖水平降低（分别为7.5%+/-0.1% vs 9.3%+/-0.1%和7.0+/-0.1 mmol/L [126+/-2 mg/dL] vs 9.3 +/-0.2 mmol/L [168 +/-4 mg/dL]; P
Context.-Although the long-term health benefits of good glycemic control in patients with diabetes are well documented, shorter-term quality of life (QOL) and economic savings generally have been reported to be minimal or absent.Objective.-To examine short-term outcomes of glycemic control in type 2 diabetes mellitus (DM).Design.-Double-blind, randomized, placebo-controlled, parallel trial.Setting.-Sixty-two sites in the United States.Participants.-A total of 569 male and female volunteers with type 2 DNI.Intervention.-After a 3-week, single-blind placebo-washout period, participants were randomized to diet and titration with either 5 to 20 mg of glipizide gastrointestinal therapeutic system (GITS) (n=377) or placebo (n=192) for 12 weeks.Main Outcome Measures.-Change from baseline in glucose and hemoglobin A(1c) (HbA(1c)) levels and symptom distress, QOL, and health economic indicators by questionnaires and diaries.Results.-After 12 weeks, mean (+/-SE) HbA(1c) and fasting blood glucose levels decreased with active therapy (glipizide GITS) vs placebo (7.5%+/-0.1% vs 9.3%+/-0.1% and 7.0+/-0.1 mmol/L [126+/-2 mg/dL] vs 9.3 +/- 0.2 mmol/L [168 +/- 4 mg/dL], respectively; P