International Centre for Skin Diseases DermAllegra, Coimbra Protocol Certified Center, Am Markgrafenpark 6, 91224 Pommelsbrunn-Hohenstadt, Germany.
The Wellcome-Wolfson Institute for Experimental Medicine, Queens University of Belfast, Belfast BT7 1NN, UK.
Nutrients. 2022 Apr 10;14(8):1575. doi: 10.3390/nu14081575.
In 2013, the group of Cicero Coimbra, Brazil, reported the clinical efficacy of high doses of vitamin D3 in patients suffering from autoimmune skin disorders ("Coimbra protocol", CP). However, hypercalcemia and the subsequent impaired renal function may be major concerns raised against this protocol.
We report for the first time for a broad spectrum of autoimmune diseases in 319 patients (mean age (±SD) 43.3 ± 14.6 years, 65.5% female, 34.5% male) safety data for high doses of orally applied vitamin D3 (treatment period: up to 3.5 years) accompanied by a strict low-calcium diet and regular daily fluid intake of at least 2.5 L.
Mean vitamin D3 dose was 35,291 ± 21,791 IU per day. The measurement of more than 6100 single relevant laboratory parameters showed all mean values (±SD) within the normal range for total serum calcium (2.4 ± 0.1 mmol/L), serum creatinine (0.8 ± 0.2 mg/dL), serum creatinine associated estimated GFR (92.5 ± 17.3 mL/min), serum cystatin C (0.88 ± 0.19 mg/L), serum TSH (1.8 ± 1 mIU/L), and for 24 h urinary calcium secretion (6.9 ± 3.3 mmol/24 h). We found a very weak relationship between the dosage of oral vitamin D3 and the subsequent calcium levels, both in serum and in urinary excretion over 24 h, respectively.
Our data show the reliable safety of the CP in autoimmune patients under appropriate supervision by experienced physicians.
2013 年，巴西西库拉·科因布拉（Cicero Coimbra）小组报道了大剂量维生素 D3 治疗自身免疫性皮肤疾病的临床疗效（“科因布拉方案”，CP）。然而，高钙血症和随后的肾功能受损可能是反对该方案的主要关注点。
我们首次报告了 319 例自身免疫性疾病患者（平均年龄（±SD）43.3±14.6 岁，65.5%为女性，34.5%为男性）应用大剂量口服维生素 D3（治疗期：长达 3.5 年）的安全性数据，同时严格控制低钙饮食和每日规律饮水至少 2.5 升。
平均维生素 D3 剂量为 35291±21791IU/天。超过 6100 个相关实验室参数的测量值显示所有均值（±SD）均在总血清钙（2.4±0.1mmol/L）、血清肌酐（0.8±0.2mg/dL）、血清肌酐相关估计肾小球滤过率（92.5±17.3mL/min）、血清胱抑素 C（0.88±0.19mg/L）、血清 TSH（1.8±1mIU/L）和 24 小时尿钙排泄量（6.9±3.3mmol/24h）的正常范围内。我们发现，口服维生素 D3 的剂量与血清和 24 小时尿液中的钙水平之间存在非常微弱的关系。
我们的数据表明，在经验丰富的医生的适当监督下，CP 对自身免疫性疾病患者是可靠安全的。
