Table 2.
Outcomes for participants with severe HFMD involved in a randomized trial comparing the efficacy of Andrographolide Sulfonate combination therapy with conventional therapy alone.
| Variable | Conventional therapy group (n = 116) | Andrographolide sulfonate combination therapy group (n = 114) | Treatment difference (95% CI) |
P value |
|---|---|---|---|---|
| Primary Major complications, n (%) |
14 (12.1) | 3 (2.6) | 9.4 (2.8 to 16.1) | 0.006 |
| Respiratory failure, n (%) | 5 (4.3) | 2 (1.8) | 2.6 (−1.9 to 7.0) | 0.45 |
| Circulatory failure, n (%) | 1 (0.9) | — | 0.9 (−0.8 to 2.5) | 1.00 |
| Purulent meningitis, n (%) | 1 (0.9) | — | 0.9 (−0.8 to 2.5) | 1.00 |
| Brainstem encephalitis, n (%) | 1 (0.9) | — | 0.9 (−0.8 to 2.5) | 1.00 |
| Encephalomyelitis, n (%) | 1 (0.9) | — | 0.9 (−0.8 to 2.5) | 1.00 |
| Encephalitis, n (%) | 2 (1.7) | 1 (0.9) | 0.9 (−2.1 to 3.8) | 1.00 |
| Neurogenic pulmonary edema, n (%) | 2 (1.7) | — | 1.7 (−0.6 to 4.1) | 0.50 |
| Pulmonary haemorrhage, n (%) | 1 (0.9) | — | 0.9 (−0.8 to 2.5) | 1.00 |
| Secondary | ||||
| Fever clearance time (SD), h* | 96.9 (63.2) | 69.1 (62.4) | 27.8 (11.2, 44.4) | 0.001 |
| HFMD-cause deaths, n (%) | 1 (0.86) | — | 0.9 (−0.8 to 2.5) | 1.00 |
| Duration of hospitalization (SD), d † | 7.6 (2.0) | 7.7 (1.7) | −0.1 (−0.5 to 0.4) | 0.70 |
| The healing time of typical skin or oral mucosa lesions (SD), d ‡ | 5.2 (1.6) | 4.3 (1.5) | 1.0 (0.6 to 1.4) | <.001 |
| Adverse event, n (%) | 1 (0.86) | — | 0.9 (−0.8 to 2.5) | 1.00 |
*Values are means with standard deviations.
†Surviving patients only.
‡defined as the number of days in the total-contact cast until the skin or oral mucosa completely closed.