title: Reduning injection for fever, rash, and ulcers in children with mild hand, foot, and mouth disease: a randomized controlled clinical study.
abstract: OBJECTIVE
  To assess the efficacy and safety of Reduning injection for fever, rash, and ulcers in children with mild hand, foot, and mouth disease (HFMD).
  
  
  METHODS
  A stratified-block randomized, double-blind, parallel-controlled, and multicenter clinical trial was conducted with 360 patients in five hospitals across China: Quanzhou Children's Hospital, Shijiazhuang No. 5 Hospital, Shanghai Public Health Centre, Hunan Provincial Children's Hospital, and Kaifeng Children's Hospital. Patients were randomized into three groups with 120 in each. Group A was treated with Western Medicine, group B with Reduning injection, a Chinese herbal medicine, and group C with both Reduning injection and Western Medicine. Results were compared for treatment efficacy and safety on HFMD. The clinical outcomes were observed as follows: fever and onset time of antifebrile effect (time to bring the body temperature down > or = 0.5 degrees C after medication); cumulative time for fever recovery (body temperature recovering to normal and lasting more than 24 h without medication); cumulative time for rash disappearance (without new rashes or ulcers appearing and the original ones fading away); and cumulative time for mouth ulcer disappearance.
  
  
  RESULTS
  For the onset time of the antifebrile effect, there was no statistical difference between groups A and B (P > 0.05) and groups B and C (P > 0.05). However, there was a statistical difference between groups A and C (P < 0.05), and the effect in group C was the best. For the cumulative time for rash disappearance, there was no statistical difference between groups A and B (P > 0.05). There were statistical differences between groups A and C, and groups B and C (P < 0.05), and the effect in group C was the best. For the cumulative time for mouth ulcers disappearance, there were no statistical differences among the three groups (P > 0.05).
  
  
  CONCLUSIONS
  Reduning injection with Western Medicine for symptomatic treatment is most effective for mild HFMD. No adverse reactions were observed.
authors.forename: Guoliang
authors.initials: G
authors.lastname: Zhang
authors.forename: Jie
authors.initials: J
authors.lastname: Zhao
authors.forename: Liyun
authors.initials: L
authors.lastname: He
authors.forename: Shiyan
authors.initials: S
authors.lastname: Yan
authors.forename: Ziqiang
authors.initials: Z
authors.lastname: Zhuo
authors.forename: Haojie
authors.initials: H
authors.lastname: Zheng
authors.forename: Yongping
authors.initials: Y
authors.lastname: Mu
authors.forename: Shuangjie
authors.initials: S
authors.lastname: Li
authors.forename: Xi
authors.initials: X
authors.lastname: Zhang
authors.forename: Jihan
authors.initials: J
authors.lastname: Huang
authors.forename: Xiuhui
authors.initials: X
authors.lastname: Li
authors.forename: Jianping
authors.initials: J
authors.lastname: Liu
authors.forename: Hehe
authors.initials: H
authors.lastname: Wan
authors.forename: Chaoyu
authors.initials: C
authors.lastname: Wei
authors.forename: Wei
authors.initials: W
authors.lastname: Xiao
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage*; D005076:Exanthema / Q000188:drug therapy*; D005260:Female; D005334:Fever / Q000188:drug therapy*; D006232:Hand, Foot and Mouth Disease / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007267:Injections; D008297:Male; D016896:Treatment Outcome; D014456:Ulcer / Q000188:drug therapy*
chemical_list: D004365:Drugs, Chinese Herbal