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氟氢可的松和氢化可的松在原发性肾上腺皮质功能不全中的盐皮质激素作用:欧盟肾上腺皮质功能不全注册研究患者数据

Mineralocorticoid effects of fludrocortisone and hydrocortisone in primary adrenal insufficiency: EU-AIR patient data.

作者信息

Ekman Bertil, Quinkler Marcus, Zhang Pinggao, Isidori Andrea M, Murray Robert D, Wahlberg Jeanette

机构信息

Department of Endocrinology and Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.

Department of Internal Medicine and Department of Health, Medicine and Caring Sciences, Linköping University, Norrköping, Sweden.

出版信息

J Endocrinol Invest. 2025 Sep 6. doi: 10.1007/s40618-025-02657-7.

Abstract

PURPOSE

Patients with primary adrenal insufficiency (PAI) require mineralocorticoid replacement therapy in addition to glucocorticoids. These therapies should be considered in combination because most glucocorticoids also possess mineralocorticoid activity. We aimed to investigate the relationship between fludrocortisone and hydrocortisone-equivalent dosing in patients with PAI.

METHODS

Data were obtained from the European Adrenal Insufficiency Registry (EU-AIR), a multinational, multicenter, observational study conducted between August 7, 2012, and October 31, 2020, in endocrinology centers in Germany, Italy, the Netherlands, Sweden, and the UK. Patients with PAI (excluding congenital adrenal hyperplasia or known hypertension) and treated with immediate-release hydrocortisone (IRHC), modified-release hydrocortisone (MRHC), or cortisone acetate were included. The relationship between hydrocortisone-equivalent and fludrocortisone doses and mineralocorticoid potency corrected for body surface area (BSA) was examined.

RESULTS

Overall, 670 (mean age: 46.2 years; 453 [67.6%] women) of 924 patients with PAI in EU-AIR were analyzed. Of those who received at least one dose of fludrocortisone (n = 350), 45 patients (12.9%) were receiving hydrocortisone-equivalent doses/BSA of ≤ 10 mg/day/m, 170 patients (48.6%) > 10-15 mg/day/m, and 133 patients (38.0%) > 15 mg/day/m. No clear associations were found between total daily fludrocortisone dose/BSA and hydrocortisone-equivalent dose/BSA, or between combined mineralocorticoid potency/BSA and systolic or diastolic blood pressure and sodium or potassium levels. Higher systolic blood pressure was found in IRHC than MRHC groups.

CONCLUSIONS

Fludrocortisone prescription in PAI appears to be independent of glucocorticoid replacement therapy. IRHC and MRHC might differ in mineralocorticoid effect owing to different pharmacokinetic profiles.

CLINICAL TRIAL REGISTRATION

NCT01661387.

摘要

目的

原发性肾上腺皮质功能减退症(PAI)患者除糖皮质激素外还需要盐皮质激素替代治疗。这些疗法应联合使用,因为大多数糖皮质激素也具有盐皮质激素活性。我们旨在研究PAI患者中氟氢可的松与氢化可的松等效剂量之间的关系。

方法

数据来自欧洲肾上腺皮质功能减退症注册研究(EU-AIR),这是一项于2012年8月7日至2020年10月31日在德国、意大利、荷兰、瑞典和英国的内分泌中心进行的跨国、多中心观察性研究。纳入PAI患者(不包括先天性肾上腺皮质增生症或已知高血压患者),并接受速释氢化可的松(IRHC)、缓释氢化可的松(MRHC)或醋酸可的松治疗。研究了氢化可的松等效剂量与氟氢可的松剂量以及校正体表面积(BSA)后的盐皮质激素效力之间的关系。

结果

总体而言,对EU-AIR中924例PAI患者中的670例(平均年龄:46.2岁;453例[67.6%]为女性)进行了分析。在接受至少一剂氟氢可的松的患者(n = 350)中,45例患者(12.9%)接受的氢化可的松等效剂量/BSA≤10mg/天/m²,170例患者(48.6%)>10 - 15mg/天/m²,133例患者(38.0%)>15mg/天/m²。未发现每日总氟氢可的松剂量/BSA与氢化可的松等效剂量/BSA之间,或联合盐皮质激素效力/BSA与收缩压或舒张压以及钠或钾水平之间存在明确关联。IRHC组的收缩压高于MRHC组。

结论

PAI患者中氟氢可的松的处方似乎与糖皮质激素替代治疗无关。由于药代动力学特征不同,IRHC和MRHC在盐皮质激素作用方面可能存在差异。

临床试验注册

NCT01661387。

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