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. 2018 Sep 6;2018(9):CD001127. doi: 10.1002/14651858.CD001127.pub4

Comparison 1. Dornase alfa versus placebo.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Relative mean % change in FEV1 (% predicted) 7   Mean Difference (IV, Random, 95% CI) Subtotals only
1.1 At 1 month 4 248 Mean Difference (IV, Random, 95% CI) 9.51 [0.67, 18.35]
1.2 At 3 months 1 320 Mean Difference (IV, Random, 95% CI) 7.30 [4.04, 10.56]
1.3 At 6 months 1 647 Mean Difference (IV, Random, 95% CI) 5.8 [3.99, 7.61]
1.4 At 12 months 1 19 Mean Difference (IV, Random, 95% CI) 0.70 [‐11.26, 12.66]
2 Relative mean % change in FEV1 (% predicted) at one month ‐ subgroup analysis by disease severity 4   Mean Difference (IV, Fixed, 95% CI) Subtotals only
2.1 Moderate 3 183 Mean Difference (IV, Fixed, 95% CI) 14.26 [10.79, 17.74]
2.2 Severe 1 65 Mean Difference (IV, Fixed, 95% CI) ‐2.81 [‐8.77, 3.15]
3 Absolute mean % change in FEV1 (% predicted) 1   Mean difference (Fixed, 95% CI) Subtotals only
3.1 At 1 month 1   Mean difference (Fixed, 95% CI) 0.08 [‐5.59, 5.74]
4 Absolute mean % change in FEV1 (% predicted) 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
4.1 At 2 years 1 410 Mean Difference (IV, Fixed, 95% CI) 3.24 [1.03, 5.45]
5 Relative mean % change in FEV1 (in participants with acute exacerbations) 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
5.1 Up to 1 month 1 80 Mean Difference (IV, Fixed, 95% CI) 1.0 [‐13.93, 15.93]
6 Relative mean % change in FVC (% predicted) 6   Mean Difference (IV, Random, 95% CI) Subtotals only
6.1 At 1 month 4 248 Mean Difference (IV, Random, 95% CI) 7.52 [1.34, 13.69]
6.2 At 3 months 1 318 Mean Difference (IV, Random, 95% CI) 5.10 [1.23, 8.97]
6.3 At 12 months 1 19 Mean Difference (IV, Random, 95% CI) ‐5.70 [‐15.87, 4.47]
7 Relative mean % change in FVC (% predicted) 1   Mean Difference (Random, 95% CI) Subtotals only
7.1 At 6 months (once daily) 1 2 Mean Difference (Random, 95% CI) 3.80 [2.62, 4.98]
7.2 At 6 months (twice daily) 1 2 Mean Difference (Random, 95% CI) 3.00 [1.82, 4.18]
8 Relative mean % change in FVC at one month ‐ subgroup analysis by disease severity 4 248 Mean Difference (IV, Fixed, 95% CI) 9.49 [6.34, 12.63]
8.1 Moderate 3 183 Mean Difference (IV, Fixed, 95% CI) 10.98 [7.68, 14.29]
8.2 Severe 1 65 Mean Difference (IV, Fixed, 95% CI) ‐4.90 [‐15.15, 5.35]
9 Absolute mean % change in FVC (% predicted) 1   Mean Difference (Fixed, 95% CI) Subtotals only
9.1 At 1 month 1   Mean Difference (Fixed, 95% CI) ‐3.61 [‐10.02, 2.80]
10 Absolute mean % change in FVC (% predicted) 1   Mean Difference (IV, Random, 95% CI) Subtotals only
10.1 At 2 years 1 410 Mean Difference (IV, Random, 95% CI) 0.70 [‐1.24, 2.64]
11 Absolute mean change in LCI 1   Mean Difference (Fixed, 95% CI) Subtotals only
11.1 At 1 month 1 34 Mean Difference (Fixed, 95% CI) ‐0.9 [‐1.87, 0.07]
12 Absolute change in FEV0.5 (z score) 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
12.1 At 6 months 1 38 Mean Difference (IV, Fixed, 95% CI) 0.1 [‐0.57, 0.77]
13 Quality of life ‐ CFQ‐R respiratory 1   Mean Difference (Fixed, 95% CI) Subtotals only
13.1 At 1 month 1   Mean Difference (Fixed, 95% CI) 0.84 [‐10.74, 12.42]
14 Quality of life ‐ CFQ‐R Parent respiratory 1   Mean Difference (Fixed, 95% CI) Subtotals only
14.1 At 1 month 1   Mean Difference (Fixed, 95% CI) 9.78 [‐2.58, 22.14]
15 Number of people experiencing exacerbations 3 1151 Risk Ratio (M‐H, Fixed, 95% CI) 0.78 [0.62, 0.96]
16 Number of deaths 7 1690 Risk Ratio (M‐H, Fixed, 95% CI) 1.70 [0.70, 4.14]
16.1 At 1 month 4 253 Risk Ratio (M‐H, Fixed, 95% CI) 5.0 [0.25, 100.53]
16.2 At 3 months 1 320 Risk Ratio (M‐H, Fixed, 95% CI) 1.54 [0.56, 4.22]
16.3 At 6 months 1 647 Risk Ratio (M‐H, Fixed, 95% CI) 1.01 [0.06, 16.07]
16.4 At 2 years 1 470 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
17 Mean number of days IV antibiotics used 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
17.1 At 3 months 1 320 Mean Difference (IV, Fixed, 95% CI) ‐2.96 [‐7.29, 1.37]
18 Mean number of days inpatient treatment 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
18.1 At 3 months 1 320 Mean Difference (IV, Fixed, 95% CI) 0.93 [‐2.19, 4.05]
19 Mean change in weight from baseline 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
19.1 At 2 years 1 470 Mean Difference (IV, Fixed, 95% CI) ‐0.20 [‐2.42, 2.02]
20 Adverse event ‐ haemoptysis (blood‐stained sputum) 3 788 Risk Ratio (M‐H, Fixed, 95% CI) 0.88 [0.50, 1.55]
21 Adverse event ‐ dyspnoea (shortness of breath) 4 1108 Risk Ratio (M‐H, Fixed, 95% CI) 1.00 [0.85, 1.18]
22 Adverse event ‐ pneumothorax 3 788 Risk Ratio (M‐H, Fixed, 95% CI) 0.60 [0.08, 4.50]
23 Adverse event ‐ pneumothorax (in participants with acute exacerbations) 1 80 Risk Ratio (M‐H, Fixed, 95% CI) 2.59 [0.11, 61.75]
24 Adverse event ‐ voice alteration 6 1670 Risk Ratio (M‐H, Fixed, 95% CI) 1.69 [1.20, 2.39]
25 Adverse event ‐ voice alteration (1x versus 2x daily treatment) 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
26 Adverse event ‐ voice alteration (in participants with acute exacerbations) 1 80 Risk Ratio (M‐H, Fixed, 95% CI) 2.58 [0.55, 12.03]
27 Adverse event ‐ rash 2 1117 Risk Ratio (M‐H, Fixed, 95% CI) 2.40 [1.16, 4.99]
28 Adverse event ‐ chest pain 3 1151 Risk Ratio (M‐H, Fixed, 95% CI) 1.00 [0.59, 1.70]
29 Adverse event ‐ cough (new or increased) 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
30 Adverse event ‐ increased sputum production 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
31 Adverse event ‐ dry throat 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
32 Adverse event ‐ pharyngitis 6 1612 Risk Ratio (M‐H, Fixed, 95% CI) 1.15 [0.91, 1.46]
33 Adverse event ‐ laryngitis 3 1187 Risk Ratio (M‐H, Fixed, 95% CI) 1.58 [0.68, 3.68]
34 Adverse event ‐ conjunctivitis 2 1117 Risk Ratio (M‐H, Fixed, 95% CI) 1.25 [0.50, 3.13]
35 Adverse event ‐ wheeze 3 175 Risk Ratio (M‐H, Fixed, 95% CI) 0.59 [0.15, 2.41]
36 Adverse event ‐ facial oedema 1 92 Risk Ratio (M‐H, Fixed, 95% CI) 7.62 [0.40, 143.52]