联合维生素D、布洛芬和谷氨酸脱羧酶-明矾治疗近期发病的1型糖尿病：DIABGAD随机先导试验的经验教训

Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type I diabetes: lessons from the DIABGAD randomized pilot trial.

作者信息

Ludvigsson Johnny, Routray Indusmita, Elluru Sriramulu, Leanderson Per, Larsson Helena E, Rathsman Björn, Hanås Ragnar, Carlsson Annelie, Ek Torben, Samuelsson Ulf, Torbjörnsdotter Torun, Åman Jan, Örtqvist Eva, Badwal Karun, Beam Craig, Casas Rosaura

机构信息

Department of Biomedical & Clinical Sciences, Crown Princess Victoria Children´s Hospital & Div of Pediatrics, Linköping University, SE-58185, Linköping, Sweden.

Department of Biomedical & Clinical Sciences, Division of Pediatrics, Linköping University, SE 58185 Linköping, Sweden.

出版信息

Future Sci OA. 2020 Jun 23;6(7):FSO604. doi: 10.2144/fsoa-2020-0078.

AIM

Double-blind placebo-controlled intervention using glutamic acid decarboxylase (GAD)-alum, vitamin D and Ibuprofen in recent onset Type I diabetes (T1D).

METHODS

64 patients (T1D since <4 months, age 10-17.99, fasting sC-peptide ≥0.12 nmol/l, GADA-positive) were randomized into Day(D) 1-90 400 mg/day Ibuprofen, D1-450 vitamin D 2000 IU/day, D15, 45 sc. 20 μg GAD-alum; as A but placebo instead of Ibuprofen; as B but 40 μg GAD-alum D15, 45; placebo.

RESULTS

Treatment was safe and tolerable. No C-peptide preservation was observed. We observed a linear correlation of baseline C-peptide, HbA1c and insulin/per kilogram/24 h with change in C-peptide AUC at 15 months (r = -0.776, p < 0.0001).

CONCLUSION

Ibuprofen, vitamin D + GAD-alum did not preserve C-peptide. Treatment efficacy was influenced by baseline clinical and immunological factors and vitamin D concentration. Clinical Trial Registration: NCT01785108 (ClinicalTrials.gov).

目的

使用谷氨酸脱羧酶（GAD）-明矾、维生素D和布洛芬对近期发病的I型糖尿病（T1D）进行双盲安慰剂对照干预。

方法

64例患者（T1D病程<4个月，年龄10 - 17.99岁，空腹sC肽≥0.12 nmol/l，GADA阳性）被随机分为：第1 - 90天，每天服用400 mg布洛芬，第1 - 45天，每天服用2000 IU维生素D，第15天和第45天皮下注射20 μg GAD-明矾；方案A，但用安慰剂替代布洛芬；方案B，但第15天和第45天皮下注射40 μg GAD-明矾；安慰剂组。