OBJECTIVE： To assess the efficacy and safety of Re- duning injection for fever, rash, and ulcers in chil- dren with mild hand, foot, and mouth disease （HFMD）. METHODS： A stratified-block randomized, dou- ble-blind...OBJECTIVE： To assess the efficacy and safety of Re- duning injection for fever, rash, and ulcers in chil- dren with mild hand, foot, and mouth disease （HFMD）. METHODS： A stratified-block randomized, dou- ble-blind, parallel-controlled, and multicenter clini- cal trial was conducted with 360 patients in five hospitals across China： Quanzhou Children＇s Hospi- tal, Shijiazhuang No. 5 Hospital, Shanghai Public Health Centre, Hunan Provincial Children＇s Hospi- tal, 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 medi- cine, 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 on- set time of antifebrile effect （time to bring the body temperature down 〉0.5~C after medication）; cumu- lative time for fever recovery （body temperature re- covering to normal and lasting more than 24 h without medication）; cumulative time for rash dis- appearance （without new rashes or ulcers appear- ing and the original ones fading away）; and cumula- tive time for mouth ulcer disappearance. RESULTS： For the onset time of the antifebrile ef- fect, there was no statistical difference between groups A and B （P〉O.05） and groups B and C （P〉 0.05）. However, there was a statistical difference be- tween groups A and C （P〈0.05）, and the effect ingroup C was the best. For the cumulative time for rash disappearance, there was no statistical differ- ence 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 ul- cers disappearance, there were no statistical differ- ences among the three groups （P〉0.05）. CONCLUSION： Reduning injection with Western Medicine for symptomatic treatment is most effec- tive for mild HFMD. No adverse reactions were ob- served.展开更多
基金Supported by Grants from the Special Planning Project of the State Administration of Traditional Medicine in 2009(200907001-3)
文摘OBJECTIVE： To assess the efficacy and safety of Re- duning injection for fever, rash, and ulcers in chil- dren with mild hand, foot, and mouth disease （HFMD）. METHODS： A stratified-block randomized, dou- ble-blind, parallel-controlled, and multicenter clini- cal trial was conducted with 360 patients in five hospitals across China： Quanzhou Children＇s Hospi- tal, Shijiazhuang No. 5 Hospital, Shanghai Public Health Centre, Hunan Provincial Children＇s Hospi- tal, 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 medi- cine, 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 on- set time of antifebrile effect （time to bring the body temperature down 〉0.5~C after medication）; cumu- lative time for fever recovery （body temperature re- covering to normal and lasting more than 24 h without medication）; cumulative time for rash dis- appearance （without new rashes or ulcers appear- ing and the original ones fading away）; and cumula- tive time for mouth ulcer disappearance. RESULTS： For the onset time of the antifebrile ef- fect, there was no statistical difference between groups A and B （P〉O.05） and groups B and C （P〉 0.05）. However, there was a statistical difference be- tween groups A and C （P〈0.05）, and the effect ingroup C was the best. For the cumulative time for rash disappearance, there was no statistical differ- ence 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 ul- cers disappearance, there were no statistical differ- ences among the three groups （P〉0.05）. CONCLUSION： Reduning injection with Western Medicine for symptomatic treatment is most effec- tive for mild HFMD. No adverse reactions were ob- served.
