J Tradit Chin Med. 2013 Dec;33(6):733-42. doi: 10.1016/s0254-6272(14)60005-4.
To assess the efficacy and safety of Reduning injection for fever, rash, and ulcers in children with mild hand, foot, and mouth disease (HFMD).
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.
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).
Reduning injection with Western Medicine for symptomatic treatment is most effective for mild HFMD. No adverse reactions were observed.
评估热毒宁注射液治疗儿童手足口病（HFMD）轻症发热、出疹、溃疡的疗效和安全性。
采用分层区组随机、双盲、平行对照、多中心临床试验，在中国五家医院（泉州儿童医院、石家庄市第五医院、上海市公共卫生临床中心、湖南省儿童医院、开封市儿童医院）共纳入 360 例患儿，将患儿分为三组，每组 120 例，A 组给予西医常规治疗，B 组给予热毒宁注射液，C 组给予热毒宁注射液+西医常规治疗。比较三组治疗手足口病的疗效和安全性。临床疗效观察指标为：退热起效时间（用药后体温下降≥0.5℃的时间）、退热总疗程（体温恢复正常且停药 24 h 以上的时间）、出疹消退总疗程（无新出疹或溃疡且原有皮损消退的时间）、口腔疱疹消退总疗程。
退热起效时间 A 组与 B 组比较差异无统计学意义（P＞0.05），B 组与 C 组比较差异无统计学意义（P＞0.05），A 组与 C 组比较差异有统计学意义（P＜0.05），C 组起效最快；出疹消退总疗程 A 组与 B 组比较差异无统计学意义（P＞0.05），A 组与 C 组、B 组与 C 组比较差异均有统计学意义（P＜0.05），C 组消退最快；口腔疱疹消退总疗程三组间比较差异均无统计学意义（P＞0.05）。
热毒宁注射液联合西医常规对症治疗手足口病轻症发热、出疹、溃疡疗效确切，未见不良反应。
