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成年早期胰岛素依赖型糖尿病患者个体缓解的概率。来自法国环孢素糖尿病研究组的结果。

Probability of remission in individual in early adult insulin dependent diabetic patients. Results from the Cyclosporine Diabetes French Study Group.

作者信息

Papoz L, Lenegre F, Hors J, Assan R, Vague P, Tchobroutsky G, Passa P, Charbonnel B, Mirouze J, Feutren G

机构信息

INSERM Unité 21, Villejuif, France.

出版信息

Diabete Metab. 1990 Jul-Aug;16(4):303-10.

PMID:2265735
Abstract

The aim of this study was to determine which candidates were suitable for immunotherapy among adult insulin dependent diabetic patients of recent onset. A statistical analysis was performed using the results of a multicentre randomized trial of cyclosporine versus placebo after nine months of treatment. When the baseline characteristics of the patients in remission were compared with those not in remission, there was no difference observed either in initial residual beta-cell function (glucagon stimulated C-peptide level), or in immunological markers (T4 and T8 lymphocytes counts, Interleukin 2). The parameters showing the most difference were, in addition to treatment group, the duration of diabetes symptoms and body mass index at inclusion, and the HLA-DR phenotype. This was confirmed using a logistic regression analysis, in which these variables were found to be significantly related to remission. The probability of remission in each individual patient was then calculated using these variables in the mathematical function provided by the logistic model. Ninety eight out of 110 patients were correctly classified using this method. In addition, it must be noted that only subjects adequately treated by cyclosporine were still in complete remission after a one year follow-up. Conversely, it appeared that immunosuppression in subjects having a predicted probability of remission lower than 0.35 using the mathematical function, and being non-DR3, non-DR4 has to be avoided. These results will be useful in optimizing the recruitment of patients in on-going or future trials of immunotherapy in early diabetes.

摘要

本研究的目的是确定哪些近期发病的成年胰岛素依赖型糖尿病患者适合免疫治疗。使用环孢素与安慰剂的多中心随机试验九个月后的治疗结果进行了统计分析。将缓解患者与未缓解患者的基线特征进行比较时,在初始残余β细胞功能(胰高血糖素刺激的C肽水平)或免疫标志物(T4和T8淋巴细胞计数、白细胞介素2)方面均未观察到差异。除治疗组外,显示差异最大的参数是糖尿病症状持续时间、纳入时的体重指数以及HLA-DR表型。使用逻辑回归分析证实了这一点,其中发现这些变量与缓解显著相关。然后使用逻辑模型提供的数学函数中的这些变量计算每个患者的缓解概率。使用此方法对110名患者中的98名进行了正确分类。此外,必须指出的是,只有接受环孢素充分治疗的受试者在一年随访后仍完全缓解。相反,对于使用数学函数预测缓解概率低于0.35且非DR3、非DR4的受试者,似乎必须避免免疫抑制。这些结果将有助于优化正在进行的或未来早期糖尿病免疫治疗试验中的患者招募。

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