Research Article

Improving the Efficacy of Conventional Therapy by Adding Andrographolide Sulfonate in the Treatment of Severe Hand, Foot, and Mouth Disease: A Randomized Controlled Trial

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.

VariableConventional therapy group ( )Andrographolide sulfonate combination therapy group ( )Treatment difference
(95% CI)
value

Primary
Major complications, (%)
14 (12.1)3 (2.6)9.4 (2.8 to 16.1)0.006
 Respiratory failure, (%)5 (4.3)2 (1.8)2.6 (−1.9 to 7.0)0.45
 Circulatory failure, (%)1 (0.9)0.9 (−0.8 to 2.5)1.00
 Purulent meningitis, (%)1 (0.9)0.9 (−0.8 to 2.5)1.00
 Brainstem encephalitis, (%)1 (0.9)0.9 (−0.8 to 2.5)1.00
 Encephalomyelitis, (%)1 (0.9)0.9 (−0.8 to 2.5)1.00
 Encephalitis, (%)2 (1.7)1 (0.9)0.9 (−2.1 to 3.8)1.00
Neurogenic pulmonary edema, (%)2 (1.7)1.7 (−0.6 to 4.1)0.50
 Pulmonary haemorrhage, (%)1 (0.9)0.9 (−0.8 to 2.5)1.00
Secondary
 Fever clearance time (SD), 96.9 (63.2)69.1 (62.4)27.8 (11.2, 44.4)0.001
 HFMD-cause deaths, (%)1 (0.86)0.9 (−0.8 to 2.5)1.00
 Duration of hospitalization (SD), 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), 5.2 (1.6)4.3 (1.5)1.0 (0.6 to 1.4)<.001
 Adverse event, (%)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.