RT期刊文章SR电子T1重组人DNase I在患有严重肺部疾病的囊性纤维化患者中:一项短期,双盲研究,然后进行六个月的开放标签治疗JF欧洲呼吸杂志JO EUR RESSIR JO EUR RESSIR J FD欧洲呼吸道SP 954188bet官网地址OP 958 VO 8 IS 6 A1 SHAH,PI A1 BUSH,A1 CANNY,GJ A1 COLIN,AA A1 FUCHS,HJ A1 GEDDES,DM A1 JOHNSON,CA A1 LIGHT,MC A1 SCOTT,MC A1 SCOTT,SF A1 TULLIS,DE A1 ET,AL AL AL AL,AL AL。YR 1995 ul //www.qdcxjkg.com/content/8/6/6/954.abstract ab gronic慢性肺部感染是囊性纤维化(CF)发病率和死亡率的主要原因。体外重组人脱氧核糖核酸酶(Rhdnase)已显示可大大降低CF患者的痰液粘弹性。第二阶段和III期临床试验表明该药物是安全的,并且具有强迫生命力(FVC)> 40%的患者预测接受RHDNase时肺功能有所改善。当前的研究评估了RHDNase在最严重病重的CF患者中的安全性和功效(FVC <40%的预测)。一项双盲,随机,安慰剂对照试验,其中患者每天两次接受2.5 mg Rhdnase或安慰剂,为期14天,然后报告了6个月的开放延长期(OEP)。招募了70名患者进行双盲研究,有64名进入了OEP,其中38例完成了。在OEP期间,所有患者每天两次接受2.5 mg Rhdnase。在双盲时期和OEP中,药物似乎都是安全的。 During the double-blind study, forced expiratory volume in one second (FEV1) and FVC improved in both groups but there was no statistically significant difference between the groups. In the OEP, there was mean improvement in percentage predicted FEV1 and FVC, 9 and 18%, respectively, for all patients participating. In conclusion, DNase is safe when administered in conjunction with a rigorous regimen of chest physiotherapy to severely ill patients (FVC < 40% predicted) with CF. The double-blind, 14 day study showed no significant improvement in pulmonary function but some patients may have improved after longer administration of rhDNase.