Auerbach H S, Williams M, Kirkpatrick J A, Colten H R
Lancet. 1985 Sep 28;2(8457):686-8. doi: 10.1016/s0140-6736(85)92929-0.
A randomised, double-blind, placebo-controlled study examined the effects of alternate-day prednisone therapy on morbidity and progression of lung disease in cystic fibrosis (CF). At baseline the patients (aged 1-12 years) had mild to moderate lung disease, and the prednisone group did not differ significantly from the placebo group for any values measured. After 4 years, the prednisone-treated group had significant advantages over the placebo group for height, weight, vital capacity, forced expiratory volume in 1 s, peak flow rate, erythrocyte sedimentation rate, and serum IgG. The prednisone-treated group required 9 admissions to hospital for CF-related pulmonary disease compared with 35 for the placebo group. There were no steroid-induced side-effects. To rule out bias in case selection, 69 CF clinic patients comparable in age and clinical status but not included in the study were compared with the placebo group at 4 years; no significant differences between the groups were found.
一项随机、双盲、安慰剂对照研究考察了隔日泼尼松疗法对囊性纤维化(CF)患者肺部疾病发病率和病情进展的影响。在基线时,患者(年龄1至12岁)患有轻度至中度肺部疾病,泼尼松组与安慰剂组在任何测量值上均无显著差异。4年后,泼尼松治疗组在身高、体重、肺活量、1秒用力呼气量、峰值流速、红细胞沉降率和血清IgG方面比安慰剂组具有显著优势。泼尼松治疗组因CF相关肺部疾病需住院9次,而安慰剂组为35次。未出现类固醇诱导的副作用。为排除病例选择中的偏差,将69名年龄和临床状况与研究对象可比但未纳入研究的CF门诊患者在4年后与安慰剂组进行比较;未发现两组之间存在显著差异。