改良缓释氢化可的松胶囊与泼尼松龙在治疗先天性肾上腺皮质增生症方面的比较。

IF 2.6 3区 医学 Q3 ENDOCRINOLOGY & METABOLISM Endocrine Connections Pub Date : 2024-07-18 Print Date: 2024-08-01 DOI:10.1530/EC-24-0150
Dafydd Aled Rees, Deborah P Merke, Wiebke Arlt, Aude Brac De La Perriere, Angelica Linden Hirschberg, Anders Juul, John Newell-Price, Alessandro Prete, Nicole Reisch, Nike M Stikkelbroeck, Philippe A Touraine, Alex Lewis, John Porter, Helen Coope, Richard J Ross
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引用次数: 0

摘要

背景:泼尼松龙和泼尼松是先天性肾上腺皮质增生症(CAH)成人患者的推荐治疗方案;然而,目前还没有泼尼松龙与氢化可的松的随机比较:评估17-羟孕酮(17OHP)水平和糖皮质激素剂量:方法:48例基线服用泼尼松(OL)1的患者的氢化可的松剂量当量和9:00时的17OHP:基线时,氢化可的松剂量当量中位数为30毫克/天,17OHP为结论:与泼尼松(奥利司酮)相比,MRHC可降低9:00时的17OHP,大多数患者的MRHC剂量可随着时间的推移而降低。
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Comparison of modified-release hydrocortisone capsules versus prednisolone in the treatment of congenital adrenal hyperplasia.

Background: Prednisolone and prednisone are recommended treatment options for adults with congenital adrenal hyperplasia (CAH); however, there is no randomised comparison of prednis(ol)one with hydrocortisone.

Design: Six-month open-label randomised phase 3 study and interim analysis of a single-arm extension study was the design of the study.

Methods: The method of the study was hydrocortisone dose equivalent and 09:00-h 17-hydroxyprogesterone (17OHP) from 48 patients taking prednis(ol)one at baseline.

Results: At baseline, the median hydrocortisone dose equivalent was 30 mg/day and 17OHP was < 36 nmol/L (3× upper limit of normal) in 56% of patients. Patients were randomised to continue prednis(ol)one or switch to modified-release hydrocortisone capsule (MRHC) at the same hydrocortisone-equivalent dose. At 4 weeks, 94% on MRHC and 71% on prednis(ol)one had 17OHP < 36 nmol/L. At 18 months in the extension study of MRHC, the median MRHC dose was 20 mg/day and 82% had 17OHP < 36 nmol/L. The per cent of patients with 17OHP < 36 nmol/L on a hydrocortisone dose equivalent ≤ 25 mg/day was greater at 18 months in the extension study on MRHC than while on prednis(ol)one at baseline: 57% vs 27%, P = 0.04. In the randomised study, no patients had an adrenal crisis on MRHC and one on prednisolone. In the extension study (221 patient years), there were 12 adrenal crises in 5 patients (5.4/100 patient years).

Conclusion: MRHC reduces 17OHP at 09:00 h compared to prednis(ol)one and the dose of MRHC can be down-titrated over time in the majority of patients.

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来源期刊
Endocrine Connections
Endocrine Connections Medicine-Internal Medicine
CiteScore
5.00
自引率
3.40%
发文量
361
审稿时长
6 weeks
期刊介绍: Endocrine Connections publishes original quality research and reviews in all areas of endocrinology, including papers that deal with non-classical tissues as source or targets of hormones and endocrine papers that have relevance to endocrine-related and intersecting disciplines and the wider biomedical community.
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