FACTORS ASSOCIATED WITH EARLY REMISSION OF TYPE-I DIABETES IN CHILDREN TREATED WITH CYCLOSPORINE
FACTORS ASSOCIATED WITH EARLY REMISSION OF TYPE-I DIABETES IN CHILDREN TREATED WITH CYCLOSPORINE
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DOI：
10.1056/nejm198803173181103
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发表时间：
1988-03-17
影响因子：
158.5
通讯作者：
BACH, JF
中科院分区：
文献类型：
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作者：
BOUGNERES, PF;CAREL, JC;BACH, JF
为了提高未来免疫抑制试验的进入标准，我们招募了 40 名患有新发 I 型胰岛素依赖型糖尿病的儿童参加环孢菌素的试点试验。 27 名患者能够停止胰岛素治疗 48 .+-。免疫抑制开始后5天。四个月时，他们的空腹和餐后血糖浓度平均为 110 和 160 毫克每分升（6.1 和 8.9 毫摩尔每升），平均糖化血红蛋白水平为 6.15%。 这些早期缓解的患者中有 75% 在 12 个月时仍然不需要胰岛素，他们的血糖控制与 4 个月时相似。 27 例缓解患者与 13 例未缓解患者之间的主要差异是诊断前症状持续时间（26.8 与 48.0 天，P < 0.01）、体重减轻程度（3.2 与体重的 10%，P < 0.001）、初始糖化血红蛋白水平（10/7 与 13.2%，P < 0.001）以及出现症状的频率。酮症酸中毒（11% vs. 61.5%，P < 0.001）。体重减轻程度较小是缓解的最强独立预测因子。 C 肽对静脉注射胰高血糖素的反应（0.50 vs. 0.17 pmol 每毫升，P < 0.05）也是一个独立的预测因子。两组患者在年龄、性别、HLA 表型、胰岛素或胰岛细胞抗原自身抗体或环孢素的剂量或谷水平方面没有观察到差异。在观察期间仅检测到最小程度的毒性表现。我们的结论是，对新发的 I 型糖尿病儿童进行早期环孢素治疗可以缓解胰岛素依赖，半数患者在一整年后不需要胰岛素。
To improve criteria for entry into future trials of immunosuppression, we enrolled 40 children with recent-onset Type I insulin-dependent diabetes in a pilot trial of cyclosporine. Twenty-seven patients were able to discontinue insulin therapy 48 .+-. 5 days after the start of immunosuppression. At four months, their fasting and postprandial blood glucose concentrations averaged 110 and 160 mg per deciliter (6.1 and 8.9 mmol per liter) with a mean hemoglobin A1c level of 6.15 percent. Seventy-five percent of these patients with early remission still did not need insulin at 12 months, and their glycemic control was similar to that at 4 months. The major differences between the 27 patients with remission and the 13 without remission were the duration of symptoms before diagnosis (26.8 vs. 48.0 days, P < 0.01), the degree of weight loss (3.2 vs. 10 percent of body weight, P < 0.001), the initial hemoglobin A1c level (10/7 vs. 13.2 percent, P < 0.001), and the frequency of ketoacidosis (11 vs. 61.5 percent, P < 0.001). The lesser degree of weight loss was the strongest independent predictor of remission. The response of C-peptide to intravenous glucagon (0.50 vs. 0.17 pmol per milliliter, P < 0.05) was also an independent predictor. No differences were observed between the two groups of patients in age, sex, HLA phenotype, autoantibodies to insulin or islet-cell antigens, or doses or trough levels of cyclosporine. Only minimal manifestations of toxicity were detected over the period of observation. We conclude that early treatment with cyclosporine in children with recent-onset Type I diabetes can induce remission from insulin dependence, with half the patients not requiring insulin after a full year.