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Evidence-Based Complementary and Alternative Medicine
Volume 2013, Article ID 316250, 7 pages
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

1You’an Hospital, Capital Medical University, Beijing, Fengtai 100069, China
2China Academy of Chinese Medical Sciences, Beijing 100700, China
3Handan Maternal and Child Health Hospital, Handan, Hebei 056001, China
4The People’s Hospital of Liuzhou, Liuzhou, Guangxi 545006, China
5Children’s Hospital of Jiangxi Province, Nanchang, Jiangxi 330006, China

Received 15 October 2012; Accepted 20 December 2012

Academic Editor: Zhao Xiang Bian

Copyright © 2013 Xiuhui Li et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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; ). 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 ( , ). The two groups did not differ in terms of HFMD-cause mortality ( ) and duration of hospitalization ( ). 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.