Hypoglycemia in the diabetes control and complications trial
Hypoglycemia in the diabetes control and complications trial
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在糖尿病控制和并发症试验（DCCT）中，共有1，441例IDDM患者被随机分配接受强化（n = 711）或常规（n = 730）糖尿病治疗。患者平均随访6.5年。指导受试者向其医疗保健团队报告所有疑似重度低血糖发作。此外，在季度随访访视时，询问每例受试者重度低血糖的发生情况。有3，788次重度低血糖发作（需要帮助）;其中1，027次发作与昏迷和/或癫痫发作相关。到研究结束时，强化治疗组中共有65%的患者与常规治疗组中35%的患者至少发生一次重度低血糖;强化治疗组和常规治疗组中重度低血糖的总体发生率分别为61.2/100患者-年与18.7/100患者-年，相对风险（RR）为3.28。强化治疗组发生昏迷和/或癫痫发作的相对危险度为3.02。在DCCT的9年随访期间和研究进行期间的1984-1993日历年，强化治疗的风险增加持续存在。当检查基线患者特征对重度低血糖风险的影响时，所有亚组中强化治疗与常规治疗的低血糖相对风险均大于或等于2。根据基线特征定义的几个亚组，包括男性、青少年和无残留C肽或有低血糖既往史的受试者，在两个治疗组中重度低血糖的风险特别高。对连续发作累积发生率的分析表明，强化治疗也与同一患者多次发作的风险增加有关（例如，在随访的前5年内，22%的患者发生了5次或5次以上的严重低血糖发作，而常规组为4%。在两个治疗组中，发生重度低血糖的患者后续发作的风险增加。每组中约30%的患者在重度低血糖首次发作后4个月内发生第二次发作。在每个治疗组中，既往低血糖发作次数是未来发作风险的最强预测因素，其次是当前HbA（1c）值。调整当前季度HbA（1c）水平后，强化治疗仍与低血糖风险显著增加相关，表明强化治疗的风险增加不能完全由HbA（1c）值的差异解释。
A total of 1,441 patients with IDDM were randomly assigned to receive either intensive (n = 711) or conventional (n = 730) diabetes therapy in the Diabetes Control and Complications Trial (DCCT). The patients were followed for an average of 6.5 years. Subjects were instructed to report all episodes of suspected severe hypoglycemia to their health care team. In addition, at quarterly follow-up visits, each subject was asked about the occurrence of severe hypoglycemia. There were 3,788 episodes of severe hypoglycemia (requiring assistance); 1,027 of these episodes were associated with coma and/or seizure. A total of 65% percent of patients in the intensive group vs. 35% of patients in the conventional group had at least one episode of severe hypoglycemia by the study end; the overall rates of severe hypoglycemia were 61.2 per 100 patient-years vs. 18.7 per 100 patient-years in the intensive and conventional treatment groups, respectively, with a relative risk (RR) of 3.28. The relative risk for coma and/or seizure was 3.02 for intensive therapy. The increased risk with intensive treatment persisted over each of the 9 years of follow-up in the DCCT and over the calendar years 1984-1993 during which the study was conducted. When baseline patient characteristics were examined for effects on the risk of severe hypoglycemia, the relative risk of hypoglycemia for intensive versus conventional treatment was greater than or equal to 2 for all subgroups. Several subgroups defined by baseline characteristics, including males, adolescents, and subjects with no residual C-peptide or with a prior history of hypoglycemia, had a particularly high risk of severe hypoglycemia in both treatment groups. Analyses of the cumulative incidence of successive episodes indicated that intensive treatment was also associated with an increased risk of multiple episodes within the same patient (e.g., 22% experienced five or more episodes of severe hypoglycemia within the first 5 years of follow-up vs. 4% in the conventional group). Within both treatment groups, patients who experienced severe hypoglycemia were at increased risk of subsequent episodes. Approximately 30% of patients in each group experienced a second episode within the 4 months following the first episode of severe hypoglycemia. Within each treatment group, the number of prior episodes of hypoglycemia was the strongest predictor of the risk of future episodes, followed closely by the current HbA(1c) value. After adjustment for the current quarterly HbA(1c) level, intensive treatment was still associated with a significantly increased risk of hypoglycemia, indicating that the increased risk with intensive treatment is not completely explained by differences in HbA(1c) values.