EPIDEMIOLOGY OF SEVERE HYPOGLYCEMIA IN THE DIABETES CONTROL AND COMPLICATIONS TRIAL
EPIDEMIOLOGY OF SEVERE HYPOGLYCEMIA IN THE DIABETES CONTROL AND COMPLICATIONS TRIAL
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DOI：
10.1016/0002-9343(91)80085-z
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发表时间：
1991-04-01
影响因子：
5.9
通讯作者：
中科院分区：
文献类型：
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目得：本研究描述了严重低血糖的流行病学，并确定患者的特征或行为与严重低血糖的胰岛素依赖型糖尿病（IDDM）患者参与糖尿病控制和并发症试验（DCCT）。患者和方法：DCCT是一个多中心随机临床试验，旨在比较的好处和危险的密集治疗与传统的管理IDDM。DCCT的可行性阶段表明，强化治疗的目的是使血糖水平尽可能接近非糖尿病范围，与常规治疗相比，严重低血糖的发生率增加了3倍。这份报告是基于第一个817名受试者进入DCCT，平均随访21 months.RESULTS：216名受试者报告了714次严重低血糖发作，549（77%）发生在集中治疗的受试者。强化治疗组中严重低血糖的发生率为常规治疗组的2 - 6倍。严重低血糖更常发生在睡眠期间（55%）; 43%的事件发生在午夜至上午8点之间。在清醒时发生的事件中，36%没有伴随警告症状。在接受强化治疗的受试者中，重度低血糖的预测因素包括重度低血糖病史、较长的IDDM持续时间、较高的基线糖化血红蛋白（HbA 1c）水平和较低的近期HbA 1c。多变量分析未能产生预测模型与高sensitivity.CONCLUSIONS：在DCCT，密集治疗的IDDM增加严重低血糖的频率相对于常规治疗。在临床实践环境中，当应用于选择较少和动机较低的人群时，强化治疗可能导致更频繁的重度低血糖。这些发现强调了确定密集型和标准治疗的获益风险比的重要性。
PURPOSE: The present study describes the epidemiology of severe hypoglycemia and identifies patient characteristics or behaviors associated with severe hypoglycemia in patients with insulin-dependent diabetes mellitus (IDDM) participating in the Diabetes Control and Complications Trial (DCCT).PATIENTS AND METHODS: The DCCT is a multicenter randomized clinical trial designed to compare the benefits and risks of intensive therapy with those of conventional management of IDDM. The DCCT's feasibility phase demonstrated that intensive therapy, with the aim of achieving glucose levels as close to the non-diabetic range as possible, was accompanied by a threefold increase in severe hypoglycemia compared with conventional therapy. This report is based on the first 817 subjects who entered the DCCT, with a mean follow-up of 21 months.RESULTS: Two hundred sixteen subjects reported 714 episodes of severe hypoglycemia; 549 (77%) occurred in intensively treated subjects. The incidence of severe hypoglycemia in the intensive treatment group ranged from two to six times that observed with conventional treatment. Severe hypoglycemia occurred more often during sleep (55%); 43% of all episodes occurred between midnight and 8 AM. Of episodes that occurred while subjects were awake, 36% were not accompanied by warning symptoms. In intensively treated subjects, predictors of severe hypoglycemia included history of severe hypoglycemia, longer duration of IDDM, higher baseline glycosylated hemoglobin (HbA1c) levels, and a lower recent HbA1c. Multivariate analyses failed to yield predictive models with high sensitivity.CONCLUSIONS: In the DCCT, intensive treatment of IDDM increased the frequency of severe hypoglycemia relative to conventional therapy. Intensive treatment may cause even more frequent severe hypoglycemia when applied to less selected and less motivated populations in the clinical practice setting. These findings underscore the importance of determining the benefit-risk ratio of intensive and standard therapy of IDDM.