A Cochrane review [Abstract] 1 included 19 trials with a total of 2 565 patients. 15 studies compared dornase alfa to placebo or no dornase alfa treatment; one compared daily dornase alfa with hypertonic saline and alternate day dornase alfa; two compared daily dornase alfa to hypertonic saline; and one compared dornase alfa to mannitol and the combination of both drugs. Study duration varied from 6 days to 3 years. The number of deaths was not significant between treatment groups. Compared to placebo, forced expiratory volume at one second improved in the intervention groups, with significant differences at one month, three months, six months and two years. There was also a significant improvement in lung clearance index at one month and a decrease in pulmonary exacerbations in trials of longer duration. There was no excess of adverse effects except voice alteration and rash.
| Outcomes | Relative effect(95% CI) | Assumed risk - Control - Placebo or no dornase alfa | Corresponding risk - Intervention - Dornase alfa (95% CI) | No of Participants(studies) Quality of evidence |
|---|---|---|---|---|
| Relative mean percentage change in FEV1 (% predicted)at 3 mo | - | The relative mean change was 2.1 | The relative mean change was 7.3 higher(4.04 higher to 10.56 higher) | 320 (1) Moderate |
| Relative mean percentage change in FEV1 (% predicted)at 6 mo | - | The relative mean percentage change was 0 | The relative mean percentage change was 5.8 higher(3.99 higher to 7.61 higher) | 647 (1) High |
| Number of people experiencing exacerbationsat up to 2 years | 0.78 (0.62 to 0.96) | 252 per 1000 | 196 per 1000(156 to 242) | 1157(3) Moderate |
Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment).
Primary/Secondary Keywords