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随机、安慰剂对照试验研究地塞米松对肺结节病生活质量的影响。

Randomised, placebo-controlled trial of dexamethasone for quality of life in pulmonary sarcoidosis.

机构信息

Dept of Clinical Pharmacy, St Antonius Hospital, Nieuwegein, the Netherlands.

Dept of Clinical Pharmacy, St Antonius Hospital, Nieuwegein, the Netherlands.

出版信息

Respir Med. 2020 Apr-May;165:105936. doi: 10.1016/j.rmed.2020.105936. Epub 2020 Mar 16.

DOI:10.1016/j.rmed.2020.105936
PMID:32308204
Abstract

BACKGROUND

Many patients with pulmonary sarcoidosis experience reduced quality of life. Although oral corticosteroids are the most common agents used in sarcoidosis, very little is known on the effects on quality of life.

METHODS

In this double-blind, placebo-controlled trial, newly diagnosed patients without an indication for high dose immunosuppressive therapy were randomised to once-daily dexamethasone 1 mg (6.5 mg prednisone equivalent) or placebo for 6 months. The primary study parameter was the subscale physical functioning of the 36-item Short Form health survey (SF-36). Secondary parameters included five other patient reported outcome measures, disease activity markers and plasma cytokine profiles.

RESULTS

A total of 16 patients was randomised to dexamethasone (n = 7) and placebo (n = 9). During follow-up no significant difference for physical functioning was measured (p = 0.18). Dexamethasone treated patients showed a decrease in fatigue score (Checklist Individual Strength) from 106 (baseline) to 88 (3 months; p = 0.03); 86 (6 months; p = 0.05); 79 (9 months; p = 0.04); 90 (12 months; p = 0.03). Placebo treated patients showed no change: 96 (baseline) to 105 (3 months; p = 0.16); 91 (6 months; p = 0.48); 92 (9 months; p = 0.61); 95 (12 months; p = 0.90). During treatment with dexamethasone significant improvements in the SF-36 subscales vitality and pain, and a significant reduction in serum angiotensin-converting enzyme, soluble interleukin 2 receptor levels and serum cytokines and chemokines were measured.

CONCLUSIONS

Low-dose dexamethasone results in a reduction of the inflammatory profile and has the potential to improve quality of life parameters and fatigue.

摘要

背景

许多患有肺结节病的患者生活质量下降。虽然口服皮质类固醇是结节病最常用的药物,但对其对生活质量的影响知之甚少。

方法

在这项双盲、安慰剂对照试验中,新诊断为无高剂量免疫抑制治疗指征的患者被随机分为每日一次地塞米松 1mg(相当于 6.5mg 泼尼松龙)或安慰剂组,疗程为 6 个月。主要研究参数是 36 项简短健康调查(SF-36)的身体功能子量表。次要参数包括其他 5 项患者报告的结果测量指标、疾病活动标志物和血浆细胞因子谱。

结果

共有 16 名患者被随机分为地塞米松组(n=7)和安慰剂组(n=9)。在随访期间,身体功能没有显著差异(p=0.18)。地塞米松治疗组的疲劳评分(个体力量检查表)从 106(基线)下降至 3 个月时的 88(p=0.03);86(6 个月;p=0.05);79(9 个月;p=0.04);12 个月时的 90(p=0.03)。安慰剂治疗组无变化:96(基线)至 3 个月时的 105(p=0.16);91(6 个月;p=0.48);92(9 个月;p=0.61);95(12 个月;p=0.90)。地塞米松治疗期间,SF-36 子量表活力和疼痛显著改善,血清血管紧张素转换酶、可溶性白细胞介素 2 受体水平以及血清细胞因子和趋化因子显著降低。

结论

低剂量地塞米松可降低炎症谱,并有可能改善生活质量参数和疲劳。

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