Laube B L, Auci R M, Shields D E, Christiansen D H, Lucas M K, Fuchs H J, Rosenstein B J
Department of Environmental Health Sciences, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
Am J Respir Crit Care Med. 1996 Feb;153(2):752-60. doi: 10.1164/ajrccm.153.2.8564129.
We tested the hypothesis that recombinant human deoxyribonuclease 1 (rhDNase) reduces airflow obstruction and improves mucociliary clearance in patients with cystic fibrosis (CF), and that improvements seen in FEV1 and FVC after rhDNase treatment are independent of chest physical therapy (CPT). CF patients inhaled placebo (10 patients) or 2.5 mg rhDNAse aerosol (10 patients) twice a day for six consecutive days. Compared with baseline, there were no statistically significant differences between the two study groups by Day 6 for indices of airflow obstruction obtained from gamma-camera images of the right lung following inhalation of 99mTc aerosol, or for mucociliary clearance or the rate of clearance of the radioaerosol, quantified over a 6-h period. By Day 6, FEV1 and FVC were significantly higher in the rhDNase-treated group than in the placebo group, increasing by an average of 9.4 +/- 3.5% and 12.7 +/- 2.6%, respectively, as compared with a decrease of 1.8 +/- 1.7% and an increase of 0.4 +/- 1.1%, respectively (p < 0.05). There was no significant change in the FEV1/FVC ratio on Day 6 (0.68 +/- 0.05) compared with baseline (0.70 +/- 0.05) in the rhDNase group. On Day 6, FEV1 and FVC decreased after CPT in both study groups, but the decreases were not significant. Our results indicate that aerosolized rhDNase improves FEV1 and FVC independent of CPT. We were unable to demonstrate that rhDNase reduces airflow obstruction or improves mucociliary clearance.
重组人脱氧核糖核酸酶1（rhDNase）可减轻囊性纤维化（CF）患者的气流阻塞并改善黏液纤毛清除功能，且rhDNase治疗后第一秒用力呼气容积（FEV1）和用力肺活量（FVC）的改善与胸部物理治疗（CPT）无关。CF患者连续6天每天两次吸入安慰剂（10例患者）或2.5mg rhDNAse气雾剂（10例患者）。与基线相比，在第6天，两个研究组之间，从吸入99mTc气雾剂后右肺的γ相机图像获得的气流阻塞指标、黏液纤毛清除功能或放射性气雾剂在6小时内的清除率，均无统计学显著差异。到第6天，rhDNase治疗组的FEV1和FVC显著高于安慰剂组，分别平均增加9.4±3.5%和12.7±2.6%，而安慰剂组分别下降1.8±1.7%和增加0.4±1.1%（p<0.05）。rhDNase组第6天FEV1/FVC比值（0.68±0.05）与基线（0.70±0.05）相比无显著变化。在第6天，两个研究组CPT后FEV1和FVC均下降，但下降不显著。我们的结果表明，雾化rhDNase可独立于CPT改善FEV1和FVC。我们未能证明rhDNase可减轻气流阻塞或改善黏液纤毛清除功能。
