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标准糖皮质激素替代疗法对主观幸福感的影响:继发性肾上腺功能不全患者的随机、双盲、交叉研究。

Effects of standard glucocorticoid replacement therapies on subjective well-being: a randomized, double-blind, crossover study in patients with secondary adrenal insufficiency.

机构信息

Institute of Medical Psychology and Behavioural Immunobiology, Essen, Germany.

出版信息

Eur J Endocrinol. 2012 Nov;167(5):679-85. doi: 10.1530/EJE-12-0351. Epub 2012 Aug 28.

DOI:10.1530/EJE-12-0351
PMID:22930487
Abstract

OBJECTIVE

For secondary adrenal insufficiency (SAI), established biochemical parameters for dosage control are lacking and no optimal substitution dosage and daily distribution have been determined yet. Therefore, in clinical practice, the individual total dose is often adjusted based on patients' subjective well-being.

DESIGN

Effects of three standard glucocorticoid replacement regimens on psychological variables were assessed in patients with SAI based on a randomized double-blind study design.

METHODS

SAI patients (n=18) were treated with three different established glucocorticoid replacement regimens in a randomized, double-blind, crossover study (treatment A, hydrocortisone 10 mg-placebo-5 mg-placebo; treatment B, hydrocortisone 10 mg-5 mg-placebo-5 mg; and treatment C, prednisone 5 mg-placebo-placebo-placebo). Following each 4-week replacement regimen, quality of life (SF-36) and emotional distress (brief symptom inventory (BSI)) were assessed along with diurnal changes in current well-being (Bf-S) and alertness (Stanford Sleepiness Scale (SSS)) using validated questionnaires, and additionally compared with patient (patients with pituitary disease and adrenal sufficiency) and healthy control groups.

RESULTS

SAI patients showed improvements in physical quality of life (i.e. SF-36 physical function, P<0.05; physical role function, P<0.05) and current well-being (at 1800 h, P<0.05) under treatment A (hydrocortisone 10-0-5-0 mg) compared with the other replacement regimens. Quality of life and current well-being were significantly impaired compared with healthy controls but did not differ from patient controls.

CONCLUSIONS

Although the observed improvements in psychological parameters were comparatively small, our results indicate beneficial effects of a 10-0-5-0 mg hydrocortisone replacement regimen. Nevertheless, treatment effects were insufficient to restore subjective health compared with healthy controls, indicating the need for improved replacement regimens and supportive psychosocial interventions in SAI patients.

摘要

目的

对于继发性肾上腺功能不全(SAI),缺乏确定剂量控制的既定生化参数,也尚未确定最佳替代剂量和每日分配。因此,在临床实践中,个体总剂量通常根据患者的主观舒适度进行调整。

设计

根据随机双盲研究设计,评估了三种标准糖皮质激素替代方案对 SAI 患者心理变量的影响。

方法

SAI 患者(n=18)按随机、双盲、交叉研究(治疗 A,氢可的松 10 mg-安慰剂-5 mg-安慰剂;治疗 B,氢可的松 10 mg-5 mg-安慰剂-5 mg;治疗 C,泼尼松 5 mg-安慰剂-安慰剂-安慰剂)接受三种不同的既定糖皮质激素替代方案治疗。在每个 4 周的替代方案后,使用经过验证的问卷评估生活质量(SF-36)和情绪困扰(简明症状量表(BSI)),以及当前幸福感的昼夜变化(Bf-S)和警觉性(斯坦福嗜睡量表(SSS)),并与患者(患有垂体疾病和肾上腺功能正常的患者)和健康对照组进行比较。

结果

与其他替代方案相比,治疗 A(氢可的松 10-0-5-0 mg)下,SAI 患者的生理生活质量(即 SF-36 生理功能,P<0.05;生理角色功能,P<0.05)和当前幸福感(1800 h,P<0.05)得到改善。与健康对照组相比,生活质量和当前幸福感明显受损,但与患者对照组无差异。

结论

尽管观察到的心理参数改善相对较小,但我们的结果表明 10-0-5-0 mg 氢可的松替代方案具有有益的作用。然而,与健康对照组相比,治疗效果不足以恢复主观健康,这表明 SAI 患者需要改进替代方案和支持性的心理社会干预。

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