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).

CONCLUSION:

Reduning injection with Western Medicine for symptomatic treatment is most effective for mild HFMD. No adverse reactions were observed.

• Authors: Guoliang Zhang, Jie Zhao, Liyun He, Shiyan Yan, Ziqiang Zhuo, Haojie Zheng, Yongping Mu, Shuangjie Li, Xi Zhang, Jihan Huang, Xiuhui Li, Jianping Liu, Hehe Wan, Chaoyu Wei, Wei Xiao
• Journal: Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan (J Tradit Chin Med) Vol. 33 Issue 6 Pg. 733-42 (Dec 2013) ISSN: 0255-2922 [Print] China
• PMID: 24660604 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Drugs, Chinese Herbal

Topics

• Adolescent
• Child
• Child, Preschool
• Drugs, Chinese Herbal (administration & dosage)
• Exanthema (drug therapy)
• Female
• Fever (drug therapy)
• Hand, Foot and Mouth Disease (drug therapy)
• Humans
• Infant
• Injections
• Male
• Treatment Outcome
• Ulcer (drug therapy)