EFFECT OF HIGH-DOSE IBUPROFEN IN PATIENTS WITH CYSTIC-FIBROSIS
EFFECT OF HIGH-DOSE IBUPROFEN IN PATIENTS WITH CYSTIC-FIBROSIS
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DOI：
10.1056/nejm199503303321303
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发表时间：
1995-03-30
影响因子：
158.5
通讯作者：
DAVIS, PB
中科院分区：
文献类型：
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作者：
KONSTAN, MW;BYARD, PJ;DAVIS, PB
背景由于对慢性感染的炎症反应导致囊性纤维化患者的肺破坏，我们假设，抗病毒治疗可能会减缓肺部疾病的进展。在一项双盲试验中，85名年龄在5 - 39岁之间的轻度肺病患者（一秒用力呼气量[FEV（1）]大于或等于预测值的60%）被随机分配接受布洛芬或安慰剂口服，每天两次，持续4年。单独调整剂量以达到50 - 100 μ g/ml的血浆峰浓度。评估肺功能、理想体重百分比、胸片评分和住院频率的变化。随机分配到布洛芬组的患者FEV（1）的年变化率比分配到安慰剂组的患者慢（平均[+/-SE]斜率，-2.17+/-0.57% vs. -3.60+/-0.55%安慰剂组;体重）在前一组中保持得更好（P = 0.02），在服用布洛芬四年且依从率至少为70%的患者中，FEV（1）年变化率甚至更慢（-1.48+-0.69% vs.安慰剂组-3.57+/-0.65%，P=0.03），这组患者的用力肺活量（理想体重的百分比）下降速度也明显较慢，和胸片评分布洛芬组和安慰剂组的住院频率没有显著差异。1例患者因结膜炎退出研究，1例患者因与布洛芬相关的鼻出血退出研究。在囊性纤维化和轻度肺部疾病的患者中，持续服用高剂量布洛芬四年，显着减缓肺部疾病的进展，而没有严重的副作用。
Background. Since the inflammatory response to chronic infection contributes to lung destruction in patients with cystic fibrosis, we hypothesized that antiinflammatory therapy might slow the progression of lung disease.Methods. In a double-blind trial, 85 patients, 5 to 39 years of age, with mild lung disease (forced expiratory volume in one second [FEV(1)], greater than or equal to 60 percent of the predicted value) were randomly assigned to receive ibuprofen or placebo orally twice daily for four years. Doses were adjusted individually to achieve peak plasma concentrations of 50 to 100 mu g per milliliter. Changes in pulmonary function, the percentage of ideal body weight, the chest-radiograph score, and the frequency of hospitalization were assessed.Results. Patients randomly assigned to ibuprofen had a slower annual rate of change in FEV(1) than the patients assigned to placebo (mean [+/-SE] slope, -2.17+/-0.57 percent vs. -3.60+/-0.55 percent in the placebo group; weight) was better maintained in the former group (P = 0.02), Among the patients who took ibuprofen for four years and had at least a 70 percent rate of compliance, the annual rate of change in FEV(1) was even slower (-1.48+-0.69 percent vs. -3.57+/-0.65 percent in the placebo group, P=0.03), and this group of patients also had a significantly slower rate of decline in forced vital capacity, the percentage of ideal body weight, and the chest-radiograph score. There was no significant difference between the ibuprofen and placebo groups in the frequency of hospitalization. One patient was withdrawn from the study because of conjunctivitis, and one because of epistaxis related to ibuprofen.Conclusions. In patients with cystic fibrosis and mild lung disease, high-dose ibuprofen, taken consistently for four years, significantly slows the progression of the lung disease without serious adverse effects.