Quinkler Marcus, Miodini Nilsen Roy, Zopf Kathrin, Ventz Manfred, Øksnes Marianne
Endocrinology in CharlottenburgStuttgarter Platz 1, 10627 Berlin, GermanyClinical EndocrinologyCharité Campus Mitte, Charité University Medicine Berlin, Berlin, GermanyCentre for Clinical ResearchHaukeland University Hospital, Bergen, NorwayDepartment of Clinical ScienceUniversity of Bergen, Bergen, NorwayDepartment of MedicineHaukeland University Hospital, Bergen, Norway Endocrinology in CharlottenburgStuttgarter Platz 1, 10627 Berlin, GermanyClinical EndocrinologyCharité Campus Mitte, Charité University Medicine Berlin, Berlin, GermanyCentre for Clinical ResearchHaukeland University Hospital, Bergen, NorwayDepartment of Clinical ScienceUniversity of Bergen, Bergen, NorwayDepartment of MedicineHaukeland University Hospital, Bergen, Norway
Endocrinology in CharlottenburgStuttgarter Platz 1, 10627 Berlin, GermanyClinical EndocrinologyCharité Campus Mitte, Charité University Medicine Berlin, Berlin, GermanyCentre for Clinical ResearchHaukeland University Hospital, Bergen, NorwayDepartment of Clinical ScienceUniversity of Bergen, Bergen, NorwayDepartment of MedicineHaukeland University Hospital, Bergen, Norway.
Eur J Endocrinol. 2015 May;172(5):619-26. doi: 10.1530/EJE-14-1114. Epub 2015 Feb 5.
Patients with adrenal insufficiency (AI) have impaired health-related quality of life (HRQoL), which is thought to be in part due to unphysiological glucocorticoid replacement therapy. The aim was to compare once-daily hydrocortisone (HC) dual-release tablet (modified-release) with conventional HC therapy regarding clinical data and HRQoL.
We conducted an open, prospective trial at one endocrine center. There were 15 of 26 patients with primary AI, nine of 18 patients with secondary AI, and six congenital adrenal hyperplasia patients switched to modified-release HC therapy by their own decision. We evaluated clinical outcome and disease-specific HRQoL by using AddiQoL questionnaire at baseline and at follow-up (median 202 days (85-498)).
Patients on modified-release HC (n=30) showed significant decreases in BMI (26.0±0.75-25.6±0.71, P for change=0.006) and HbA1c (6.04±0.29-5.86±0.28, P for change=0.005), whereas patients remaining on conventional HC (n=20) showed no change in these parameters (P for interaction=0.029 and 0.017 respectively). No significant change in AddiQoL score were found in the modified-release HC group (83.8 baseline and 84.9 at follow-up; P for change=0.629). In the conventional HC group, there was a significant decrease in scores (84.0 baseline and 80.9 at follow-up; P for change=0.016), with a between-treatment P for interaction of 0.066. The fatigue subscore of AddiQoL showed the same pattern with a significant decrease (P for change=0.024) in patients on conventional HC therapy (P for interaction=0.116).
Modified-release HC decreases BMI and HbA1c compared with conventional HC treatment. In addition, it seems to stabilize HRQoL over time.
肾上腺功能不全（AI）患者的健康相关生活质量（HRQoL）受损，这被认为部分归因于非生理性糖皮质激素替代疗法。本研究旨在比较每日一次的氢化可的松（HC）双相释放片（缓释片）与传统HC疗法在临床数据和HRQoL方面的差异。
我们在一个内分泌中心进行了一项开放性前瞻性试验。26例原发性AI患者中有15例、18例继发性AI患者中有9例，以及6例先天性肾上腺皮质增生患者自行决定改用缓释HC疗法。我们在基线和随访时（中位时间202天（85 - 498天））使用AddiQoL问卷评估临床结局和疾病特异性HRQoL。
使用缓释HC的患者（n = 30）的体重指数（BMI）显著下降（从26.0±0.75降至25.6±0.71，变化P值 = 0.006），糖化血红蛋白（HbA1c）也显著下降（从6.04±0.29降至5.86±0.28，变化P值 = 0.005），而继续使用传统HC的患者（n = 20）这些参数无变化（交互作用P值分别为0.029和0.017）。缓释HC组的AddiQoL评分无显著变化（基线时为83.8，随访时为84.9；变化P值 = 0.629）。在传统HC组中，评分显著下降（基线时为84.0，随访时为80.9；变化P值 = 0.016），组间交互作用P值为0.066。AddiQoL的疲劳子评分呈现相同模式，传统HC治疗的患者显著下降（变化P值 = 0.024）（交互作用P值 = 0.116）。
与传统HC治疗相比，缓释HC可降低BMI和HbA1c。此外，随着时间推移，它似乎能稳定HRQoL。
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