Background. Herb-derived compound
andrographolide sulfonate (called Xiyanping injection) recommended control measure for severe
hand, foot, and mouth disease (HFMD) by the Ministry of Health (China) during the 2010 epidemic. However, there is a lack of good quality evidence directly comparing the efficacy of
Andrographolide Sulfonate combination
therapy with conventional
therapy. Methods. 230 patients were randomly assigned to 7-10 days of
Andrographolide Sulfonate 5-10 mg/Kg/day and conventional
therapy, or conventional
therapy alone. Results. The major complications occurred less often after
Andrographolide Sulfonate (2.6% versus 12.1%; risk difference [RD], 0.94; 95% CI, 0.28-1.61; P = 0.006). Median
fever clearance times were 96 hours (CI, 80 to 126) for conventional
therapy recipients and 48 hours (CI, 36 to 54) for
Andrographolide Sulfonate combination-treated patients (χ(2) = 16.57, P < 0.001). The two groups did not differ in terms of HFMD-cause mortality (P = 1.00) and duration of hospitalization (P = 0.70). There was one death in conventional therapy group. No important adverse event was found in
Andrographolide Sulfonate combination therapy group. Conclusions. The addition of
Andrographolide Sulfonate to conventional
therapy reduced the occurrence of major complications,
fever clearance time, and the healing time of typical skin or oral mucosa lesions in children with severe HFMD.