Testa M A, Simonson D C
Department of Biostatistics, Harvard School of Public Health, Boston, Mass 02115, USA.
JAMA. 1998 Nov 4;280(17):1490-6. doi: 10.1001/jama.280.17.1490.
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.
To examine short-term outcomes of glycemic control in type 2 diabetes mellitus (DM).
Double-blind, randomized, placebo-controlled, parallel trial.
Sixty-two sites in the United States.
A total of 569 male and female volunteers with type 2 DM.
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.
Change from baseline in glucose and hemoglobin A1c (HbA1c) levels and symptom distress, QOL, and health economic indicators by questionnaires and diaries.
After 12 weeks, mean (+/-SE) HbA1c 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<.001). Quality-of-life treatment differences (SD units) for symptom distress (+0.59; P<.001), general perceived health (+0.36; P= .004), cognitive functioning (+0.34; P=.005), and the overall visual analog scale (VAS) (+0.24; P=.04) were significantly more favorable for active therapy. Subscales of acuity (+0.38; P=.002), VAS emotional health (+0.35; P=.003), general health (+0.27; P=.01), sleep (+0.26; P=.04), depression (+0.25; P=.05), disorientation and detachment (+0.23; P= .05), and vitality (+0.22; P=.04) were most affected. Favorable health economic outcomes for glipizide GITS included higher retained employment (97% vs 85%; P<.001), greater productive capacity (99% vs 87%; P<.001), less absenteeism (losses = $24 vs $115 per worker per month; P<.001), fewer bed-days (losses = $1539 vs $1843 per 1000 person-days; P=.05), and fewer restricted-activity days (losses = $2660 vs $4275 per 1000 person-days; P=.01).
Improved glycemic control of type 2 DM is associated with substantial short-term symptomatic, QOL, and health economic benefits.
尽管糖尿病患者良好的血糖控制对长期健康有益这一点已有充分记录，但据报道，短期内的生活质量（QOL）改善及经济节省通常很少或不存在。
研究2型糖尿病（DM）患者血糖控制的短期结果。
双盲、随机、安慰剂对照、平行试验。
美国的62个地点。
共有569名2型糖尿病男女志愿者。
经过3周的单盲安慰剂洗脱期后，参与者被随机分为接受饮食干预并滴定5至20毫克格列吡嗪胃肠治疗系统（GITS）（n = 377）或安慰剂（n = 192）治疗12周。
通过问卷和日记评估血糖和糖化血红蛋白（HbA1c）水平相对于基线的变化、症状困扰、生活质量和健康经济指标。
12周后，与安慰剂相比，积极治疗（格列吡嗪GITS）使平均（±SE）HbA1c和空腹血糖水平降低（分别为7.5%±0.1%对9.3%±0.1%以及7.0±0.1毫摩尔/升[126±2毫克/分升]对9.3±0.2毫摩尔/升[168±4毫克/分升]；P<0.001）。积极治疗在症状困扰（+0.59；P<0.001）、总体健康感知（+0.36；P = 0.004）、认知功能（+0.34；P = 0.005）和总体视觉模拟量表（VAS）（+0.24；P = 0.04）方面的生活质量治疗差异（标准差单位）明显更有利。敏锐度（+0.38；P = 0.002）、VAS情绪健康（+0.35；P = 0.003）（+0.27；P = 0.01）、睡眠（+0.26；P = 0.04）、抑郁（+0.25；P = 0.05）、定向障碍和脱离感（+0.上保留工作率更高（97%对85%；P<0.001）、生产能力更强（99%对87%；P<0.001）、旷工更少（损失为每名工人每月24美元对115美元；P<0.001）、卧床天数更少（损失为每1000人日1539美元对1843美元；P = 0.05）以及受限活动天数更少（损失为每1000人日2660美元对4275美元；P = 0.01）。
2型糖尿病患者血糖控制的改善与短期症状、生活质量和健康经济效益显著相关。
