Zych D, Pawlicka L, Zieliński J
Kliniki Chorób Płuc, Instytutu Gruźlicy i Chorób Płuc.
Pol Arch Med Wewn. 1992 Jul;88(1):30-7.
The aim of this investigation was to compare inhaled budesonide vs oral prednisone in the maintenance phase treatment of pulmonary sarcoidosis. Double-blind controlled study was performed in 40 patients with stage II or III pulmonary sarcoidosis. After initial systemic 6 weeks treatment with prednisone (40 reduced to 20 mg daily) patients were allocated either to systematically (P) or topically (B) treated group. P patients continued with 10 mg prednisone daily, B patients were given inhaled budesonide 1.6 mg daily. The progress of treatment was assessed by serial radiography, spirometry, serum ACE activity and plasma cortisol levels. All patients completed the 12 months treatment. Using a numerical score to assess changes on the chest radiograms P patients improved by 1.7 +/- 0.66 points; B patients improved by 1.15 +/- 0.81 points. Spirometric changes were insignificant. Serum ACE fell from 107 +/- 51 U/L in the P group and 92 +/- 40 U/L in the B group to 46 +/- 11 U/L and 38 +/- 21 U/L respectively during the initial phase of treatment. In the maintenance phase ACE levels remained lower than initial ones in both groups. Morning cortisol plasma levels studied in 10 patients (5 in each group) decreased significantly during the initial phase. Thereafter cortisol levels remained low in the P patients returning to the lower limit of normal values in the B patients. We conclude that inhaled budesonide may be a safe and effective alternative to oral steroids in the maintenance treatment of pulmonary sarcoidosis especially in the early, stage II, disease.
本研究的目的是比较吸入布地奈德与口服泼尼松在结节病维持期治疗中的效果。对40例II期或III期结节病患者进行了双盲对照研究。在用泼尼松进行初始6周全身治疗(每日剂量从40mg减至20mg)后,患者被分配至全身治疗组(P组)或局部治疗组(B组)。P组患者继续每日服用10mg泼尼松,B组患者每日吸入1.6mg布地奈德。通过系列胸部X线摄影、肺功能测定、血清血管紧张素转换酶(ACE)活性及血浆皮质醇水平评估治疗进展。所有患者均完成了12个月的治疗。采用数字评分法评估胸部X线片变化,P组患者改善了1.7±0.66分;B组患者改善了1.15±0.81分。肺功能变化不显著。治疗初期,P组血清ACE从107±51U/L降至46±11U/L,B组从92±40U/L降至38±21U/L。在维持期,两组ACE水平均低于初始水平。对10例患者(每组5例)晨间血浆皮质醇水平的研究显示,治疗初期显著下降。此后,P组患者的皮质醇水平持续较低,B组患者的皮质醇水平恢复至正常下限。我们得出结论,在结节病维持期治疗中,尤其是在疾病早期(II期),吸入布地奈德可能是口服类固醇的一种安全有效的替代药物。