Table 2.
Postdosing Responses
| Time Point of Maximal Effect | 20 ml | 10 ml | 5 ml | P Value | |
|---|---|---|---|---|---|
| Systemic | |||||
| Fever, % of group >38°C | 6-8 h | 93.3 | 50 | 0 | 0.0003 |
| Maximum temperature, mean (SD) | 6-8 h | 38.6 (0.5) | 38.0 (0.7) | 37.4 (0.3) | 0.0002 |
| Blood leukocytes, mean (SD) | 8 h | 15.8 (3.2) | 14.1 (4.5) | 12.8 (3.8) | 0.22 |
| Blood neutrophils, mean (SD) | 8 h | 13.9 (3.4) | 11.3 (4.1) | 9.8 (3.5) | 0.06 |
| Serum C-reactive protein, median (IQR) | Day 2 | 59 (36-73) | 51 (25-88) | 38 (5-78) | 0.4 |
| Pulmonary | |||||
| FEV1, % of group with >20% relative drop | 66.6 | 33.3 | 0 | 0.02 | |
| FEV1 relative % drop, mean (SD) | ∼6 h | 24.6 (9.3) | 17.5 (7.8) | 16.8 (4.0) | 0.08 |
| FVC relative % drop, mean (SD) | ∼6 h | 20.7 (2.9) | 13.7 (2.2) | 14.7 (2.2) | 0.22 |
| FEV1/FVC ratio, absolute % | ∼6 h | −3.1 | −2.7 | −1.7 | 0.85 |
Definition of abbreviation: IQR = interquartile range.
Postdosing responses reported only for patients not receiving adjunctive treatments (20 ml, n = 15; 10 ml, n = 6; 5 ml, n = 6).
Results for two 20-ml patients receiving prednisolone and ibuprofen, respectively, lay within group spread. Data from six patients receiving paracetamol (10 ml, n = 4; 5 ml, n = 2) showed a trend to a reduction in systemic responses, but as numbers are small they have not been subjected to formal statistical analysis. Paracetamol was included in the future protocol to mitigate against the possibility that a patient might experience an influenza-like response and become unblinded. Three-group data were compared with analysis of variance, Kruskall-Wallis, or Fisher’s exact tests, as appropriate.