原创力文档a phase ii study on safety and efficacy of high-dose n-acetylcysteine in patients with cystic fibrosis第二阶段研究安全性和有效性的囊性纤维化患者大剂量防治作用.pdfVIP
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a phase ii study on safety and efficacy of high-dose n-acetylcysteine in patients with cystic fibrosis第二阶段研究安全性和有效性的囊性纤维化患者大剂量防治作用
352 EUROPEAN J OURNAL OF MEDICAL RESEARCH August 12, 2009
Eur J Med Res (2009) 14: 352-358 © I. Holzapfel Publishers 2009
A PHASE II STUDY ON SAFETY AND EFFICACY OF HI H-DOSE
N-ACETYLCYSTEINE IN PATIENTS WITH CYSTIC FIBROSIS
1 1 1 2 3 2 1
N. Dauletbaev , P. Fischer , B. Aulbach , J. ross , W. Kusche , U. Thyroff-Friesinger , T. O. F. Wagner ,
J. Bargon 1, 4
1University Hospital, Frankfurt/Main, 2Hexal A , Holzkirchen, 3A.CRO Clinical Research Services GmbH, Wiesbaden,
4Hospital St. Elisabeth, Frankfurt/Main, ermany
Abstract fore, antioxidant drugs may be useful to control both
Obje ctive: We conducted a single-centre, randomised, oxidative stress and excessive inflammation in CF air-
double-blinded, placebo-controlled phase II clinical ways.
study to test safety and efficacy of a 12-week therapy While the safety and clinical efficacy of corticos-
with low-dose (700 mg/daily) or high-dose (2800 teroids and high-dose ibuprofen have been thoroughly
mg/daily) of NAC. tested in clinical studies, NAC has not been studied as
M ethods: Twenty-one patients (∆F508 homo/hetero- extensively. To date, only one short-term, open, un-
zygous, FEV1 40% pred.) were included in the controlled, phase I study on NAC in CF has been pub-
study. Afte
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