Reduning injection for fever, rash, and ulcers in children with mild hand, foot, and mouth disease: a randomized controlled clinical study

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• 作者：Guoliang Zhang^a ; ^{zhang-guoliang61@sina.com" class="auth_mail} ; Jie Zhao^b ; Liyun He^c ; Shiyan Yan^c ; Ziqiang Zhuo^d ; Haojie Zheng^e ; Yongping Mu^f ; Shuangjie Li^g ; Xi Zhang^h ; Jihan Huangⁱ ; Xiuhui Li^j ; Jianping Liu^k ; Hehe Wan^b ; Chaoyu Wei^b ; Wei Xiao^l
• 关键词：Hand ; foot and mouth disease ; Symptomatic therapy ; Randomized controlled trial ; Treatment outcome ; Reduning injection
• 刊名：Journal of Traditional Chinese Medicine
• 出版年：December 2013
• 年：2013
• 卷：33
• 期：6
• 页码：733-742
• 全文大小：716 K

文摘

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 ≥0.5°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.