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Recombinant human deoxyribonuclease for cystic fibrosis.

Abstract

BACKGROUND

Recombinant human deoxyribonuclease (rhDNase) is currently used to treat pulmonary disease (the major cause of morbidity and mortality) in cystic fibrosis.

OBJECTIVES

To determine whether the use of rhDNase in cystic fibrosis is associated with improved mortality and morbidity compared to placebo or other mucolytics and to identify any adverse events associated with its use.

SEARCH STRATEGY

We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and abstracts from conferences. Date of the most recent search of the Group's register: January 2003.

SELECTION CRITERIA

All randomized and quasi-randomized controlled trials where rhDNase was compared to either placebo, standard therapy or another mucolytic.

DATA COLLECTION AND ANALYSIS

Trials were independently assessed for inclusion criteria and the lead reviewer and a colleague carried out analysis of methodological quality and data extraction.

MAIN RESULTS

The searches identified 38 trials, of which 12 trials met our inclusion criteria, including a total of 2294 participants. Three additional studies examined the health care cost from one of the clinical trials. Ten studies compared rhDNase to placebo; one compared daily rhDNase with hypertonic saline and alternate day rhDNase; and one compared daily rhDNase to hypertonic saline. Study duration varied from six days to two years. The number of deaths was not significant between treatment groups. Lung function improved in the treated groups, with significant differences at one month, three months, six months and two years. The mean percentage change in FEV1in the two largest trials were 5.80 (95% CI 3.99 to 7.61) and 3.24 (95% CI 1.03 to 5.45). There was no excess of adverse effects except voice alteration (and rash, which were reported more frequently in one trial in the treated groups. Insufficient data were available to analyse differences in antibiotic treatment, inpatient stay and quality of life.

REVIEWER'S CONCLUSIONS

There is evidence to show that therapy with rhDNase over a one month period is associated with an improvement in lung function in CF, results from a trial lasting six months also showed the same effect. Therapy over a two year period (based on one trial) significantly improved FEV1 in children and there was a non-significant reduction in the risk of infective exacerbations. Voice alteration and rash appear to be the only adverse events reported with increased frequency in randomised controlled trials.

Authors+Show Affiliations

Institute of Child Health, University of Liverpool, Alder Hey Children's Hospital, Eaton Road, Liverpool, UK, L12 2AP.No affiliation info available

Pub Type(s)

Journal Article
Review
Systematic Review

Language

eng

PubMed ID

12917899

Citation

Jones, A P., and C E. Wallis. "Recombinant Human Deoxyribonuclease for Cystic Fibrosis." The Cochrane Database of Systematic Reviews, 2003, p. CD001127.
Jones AP, Wallis CE. Recombinant human deoxyribonuclease for cystic fibrosis. Cochrane Database Syst Rev. 2003.
Jones, A. P., & Wallis, C. E. (2003). Recombinant human deoxyribonuclease for cystic fibrosis. The Cochrane Database of Systematic Reviews, (3), CD001127.
Jones AP, Wallis CE. Recombinant Human Deoxyribonuclease for Cystic Fibrosis. Cochrane Database Syst Rev. 2003;(3)CD001127. PubMed PMID: 12917899.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Recombinant human deoxyribonuclease for cystic fibrosis. AU - Jones,A P, AU - Wallis,C E, PY - 2003/8/15/pubmed PY - 2003/9/26/medline PY - 2003/8/15/entrez SP - CD001127 EP - CD001127 JF - The Cochrane database of systematic reviews JO - Cochrane Database Syst Rev IS - 3 N2 - BACKGROUND: Recombinant human deoxyribonuclease (rhDNase) is currently used to treat pulmonary disease (the major cause of morbidity and mortality) in cystic fibrosis. OBJECTIVES: To determine whether the use of rhDNase in cystic fibrosis is associated with improved mortality and morbidity compared to placebo or other mucolytics and to identify any adverse events associated with its use. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and abstracts from conferences. Date of the most recent search of the Group's register: January 2003. SELECTION CRITERIA: All randomized and quasi-randomized controlled trials where rhDNase was compared to either placebo, standard therapy or another mucolytic. DATA COLLECTION AND ANALYSIS: Trials were independently assessed for inclusion criteria and the lead reviewer and a colleague carried out analysis of methodological quality and data extraction. MAIN RESULTS: The searches identified 38 trials, of which 12 trials met our inclusion criteria, including a total of 2294 participants. Three additional studies examined the health care cost from one of the clinical trials. Ten studies compared rhDNase to placebo; one compared daily rhDNase with hypertonic saline and alternate day rhDNase; and one compared daily rhDNase to hypertonic saline. Study duration varied from six days to two years. The number of deaths was not significant between treatment groups. Lung function improved in the treated groups, with significant differences at one month, three months, six months and two years. The mean percentage change in FEV1in the two largest trials were 5.80 (95% CI 3.99 to 7.61) and 3.24 (95% CI 1.03 to 5.45). There was no excess of adverse effects except voice alteration (and rash, which were reported more frequently in one trial in the treated groups. Insufficient data were available to analyse differences in antibiotic treatment, inpatient stay and quality of life. REVIEWER'S CONCLUSIONS: There is evidence to show that therapy with rhDNase over a one month period is associated with an improvement in lung function in CF, results from a trial lasting six months also showed the same effect. Therapy over a two year period (based on one trial) significantly improved FEV1 in children and there was a non-significant reduction in the risk of infective exacerbations. Voice alteration and rash appear to be the only adverse events reported with increased frequency in randomised controlled trials. SN - 1469-493X UR - https://www.unboundmedicine.com/medline/citation/12917899/Recombinant_human_deoxyribonuclease_for_cystic_fibrosis_ L2 - https://doi.org/10.1002/14651858.CD001127 DB - PRIME DP - Unbound Medicine ER -