Romanello C, Grossi F, Radillo L, Betterle C, Marinoni S, Agosti E, Pocecco M, Boehm P
Clinica Pediatrica, Ospedale Infantile B. Garofolo, Via dell'Istria, Trieste, Italia.
Pediatr Med Chir. 1991 Jul-Aug;13(4):355-8.
A controlled trial was carried out on type I diabetic children to evaluate and to compare the clinical effects of two different kinds of immunotherapy: high doses intravenous gammaglobulin (IVIgG) and cyclosporine A (CyA). 30 newly diagnosed patients were admitted to the trial, 10 of whom served as controls (group A), 10 received 400 mg/kg b.w. of IVIgG on 5 consecutive alternate days and subsequently after 15 days and monthly thereafter for up to six months (group B), 10 patients received CyA 5-10/kg b.w. by mouth in two daily doses for a period comprised between 6 and 18 months (group C). Serum post-prandial C-peptide level was significantly higher after 6 months in group B and C than in group A; after 12 months, only group C showed significantly higher values. This difference was no longer significative at 18 and 24 months. Insulin requirement in the treated groups was significantly lower than in control group at 6 months, this difference was no longer significative at 12 months. We didn't find any difference concerning insulin requirement during the study comparing the two groups treated with the two different immunosuppressive therapies. In 3 patients in group B and in 3 patients in group C we didn't observe any appreciable response to immunosuppressive therapy (defined as insulin requirement greater than 0.5 UI/kg b.w. at 6 months and/or greater than 0.8 UI/kg b.w. at 12 months). We couldn't find any significant difference between responders and not responders to the immunosuppressive therapies regarding age, symptoms lasting before the diagnosis, weight loss, ketoacidosis intensity and serum post-prandial C-peptide level at the onset.(ABSTRACT TRUNCATED AT 250 WORDS)
对 I 型糖尿病儿童进行了一项对照试验,以评估和比较两种不同免疫疗法的临床效果:大剂量静脉注射丙种球蛋白(IVIgG)和环孢素 A(CyA)。30 名新诊断的患者被纳入试验,其中 10 名作为对照组(A 组),10 名连续 5 个隔日接受 400mg/kg 体重的 IVIgG,随后在 15 天后每月一次,持续 6 个月(B 组),10 名患者口服 CyA 5-10mg/kg 体重,分两次每日服用,疗程为 6 至 18 个月(C 组)。6 个月后,B 组和 C 组餐后血清 C 肽水平显著高于 A 组;12 个月后,只有 C 组显示出显著更高的值。在 18 个月和 24 个月时,这种差异不再显著。治疗组在 6 个月时的胰岛素需求量显著低于对照组,在 12 个月时这种差异不再显著。在研究期间,比较接受两种不同免疫抑制疗法的两组患者的胰岛素需求量,我们没有发现任何差异。B 组有 3 名患者和 C 组有 3 名患者对免疫抑制疗法没有任何明显反应(定义为 6 个月时胰岛素需求量大于 0.5UI/kg 体重和/或 12 个月时大于 0.8UI/kg 体重)。在免疫抑制疗法的反应者和无反应者之间,我们没有发现年龄、诊断前症状持续时间、体重减轻、酮症酸中毒强度和发病时餐后血清 C 肽水平有任何显著差异。(摘要截断于 250 字)