Marianne Skov1, Tacjana Pressler1, Jens Lykkesfeldt2, Henrik Enghusen Poulsen3, Peter Østrup Jensen4, Helle Krogh Johansen5, Tavs Qvist1, Dorthe Kræmer6, Niels Høiby7, Oana Ciofu8. 1. Copenhagen Cystic Fibrosis Center, University Hospital Rigshospitalet, Copenhagen, Denmark. 2. Department of Veterinary Disease Biology, Faculty of Health Science, University of Copenhagen, Denmark. 3. Laboratory of Clinical Pharmacology, Bispebjerg/Frederiksberg Hospitals, Copenhagen, Denmark. 4. Department of Clinical Microbiology, University Hospital Rigshospitalet, Copenhagen, Denmark. 5. Department of Clinical Microbiology, University Hospital Rigshospitalet, Copenhagen, Denmark; The Novo Nordisk Foundation Center for Biosustainability, Technical University of Denmark, Hørsholm, Denmark. 6. General practice, Nørre Farimagsgade 54, Copenhagen, Denmark. 7. Department of Clinical Microbiology, University Hospital Rigshospitalet, Copenhagen, Denmark; Department of International Health, Immunology and Microbiology, Costerton Biofilm Center, Faculty of Health Science, University of Copenhagen, Denmark. 8. Department of International Health, Immunology and Microbiology, Costerton Biofilm Center, Faculty of Health Science, University of Copenhagen, Denmark. Electronic address: ociofu@sund.ku.dk.
Abstract
BACKGROUND:Patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa lung infection have increased oxidative stress as a result of an imbalance between the production of reactive oxygen species caused by inflammation and their inactivation by the impaired antioxidant systems. Supplementation with anti-oxidants is potentially beneficial for CF patients. METHODS: The effect of 4 weeks of oral N-acetylcysteine (NAC) treatment (2400 mg/day divided into two doses) on biochemical parameters of oxidative stress was investigated in an open-label, controlled, randomized trial on 21 patients; 11 patients in the NAC group and 10 in the control group. Biochemical parameters of oxidative burden and plasma levels of antioxidants were assessed at the end of the study and compared to the baseline values in the two groups. RESULTS: A significant increase in the plasma levels of the antioxidant ascorbic acid (p=0.037) and a significant decrease in the levels of the oxidized form of ascorbic acid (dehydroascorbate) (p=0.004) compared to baseline were achieved after NAC treatment. No significant differences were observed in the control group. The parameters of oxidative burden did not change significantly compared to baseline in either of the groups. A better lung function was observed in the NAC treated group with a mean (SD) change compared to baseline of FEV1% predicted of 2.11 (4.6), while a decrease was observed in the control group (change -1.4 (4.6)), though not statistically significant. CONCLUSION: Treatment with N-acetylcysteine 1200 mg×2/day for 30 days significantly decreased the level of oxidized vitamin C and increased the level of vitamin C (primary end-points) and a not statistically significant improvement of lung function was observed in this group of patients.
RCT Entities:
BACKGROUND:Patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa lung infection have increased oxidative stress as a result of an imbalance between the production of reactive oxygen species caused by inflammation and their inactivation by the impaired antioxidant systems. Supplementation with anti-oxidants is potentially beneficial for CFpatients. METHODS: The effect of 4 weeks of oral N-acetylcysteine (NAC) treatment (2400 mg/day divided into two doses) on biochemical parameters of oxidative stress was investigated in an open-label, controlled, randomized trial on 21 patients; 11 patients in the NAC group and 10 in the control group. Biochemical parameters of oxidative burden and plasma levels of antioxidants were assessed at the end of the study and compared to the baseline values in the two groups. RESULTS: A significant increase in the plasma levels of the antioxidant ascorbic acid (p=0.037) and a significant decrease in the levels of the oxidized form of ascorbic acid (dehydroascorbate) (p=0.004) compared to baseline were achieved after NAC treatment. No significant differences were observed in the control group. The parameters of oxidative burden did not change significantly compared to baseline in either of the groups. A better lung function was observed in the NAC treated group with a mean (SD) change compared to baseline of FEV1% predicted of 2.11 (4.6), while a decrease was observed in the control group (change -1.4 (4.6)), though not statistically significant. CONCLUSION: Treatment with N-acetylcysteine 1200 mg×2/day for 30 days significantly decreased the level of oxidized vitamin C and increased the level of vitamin C (primary end-points) and a not statistically significant improvement of lung function was observed in this group of patients.