中国实用儿科杂志2024，Vol.39Issue(5)：380-385,6.DOI:10.19538/j.ek2024050613
涩肠止泻散治疗儿童急性水样便腹泻多中心随机对照临床研究
Randomized controlled,multi-center clinical study of Sechangzhixiesan in the treatment of acute watery diarrhea in children
郭圣璇 1邓成俊 2赵瑞芹 3方莹 4王丽波 5张葆青 6冯晓纯 7任常军 8李在玲 9郭荣彦 10李学明 11马融 1韩慧彬 12赵立敏 13陈月月 1胡思源 1李振江 14王杰民 15邓朝晖 16李小芹 17王玉梅 18徐俊杰19
作者信息
- 1. 天津中医药大学第一附属医院 国家中医针灸临床医学研究中心,天津 300381
- 2. 昆明市儿童医院,云南昆明 650100
- 3. 河北省儿童医院,河北 石家庄 050030
- 4. 西安市儿童医院,陕西 西安 710003
- 5. 吉林大学第一医院,吉林长春 130021
- 6. 山东中医药大学附属医院,山东济南 250011
- 7. 长春中医药大学附属医院,吉林长春 130021
- 8. 河北医科大学第一医院,河北石家庄 050030
- 9. 北京大学第三医院,北京 100191
- 10. 石家庄市栾城人民医院,河北石家庄 051430
- 11. 邯郸市中医院,河北邯郸 056001
- 12. 定州市妇幼保健院,河北定州 073000
- 13. 定州市人民医院,河北定州 073000
- 14. 河北省经典名方与现代中药质量过程控制重点实验室,河北石家庄 051430
- 15. 陕西省人民医院,陕西西安 710068
- 16. 上海交通大学医学院附属上海儿童医学中心,上海 200127
- 17. 河南省儿童医院,河南郑州 450000
- 18. 郑州大学第三附属医院,河南郑州 450000
- 19. 济南市儿童医院,山东济南 250022
- 折叠
摘要
Abstract
Objective To evaluate the clinical efficacy and safety of Sechangzhixiesan in the treatment of acute watery diarrhea in children.Methods Stratified block randomized,double-blind method was adopted.A total of 248 children with acute watery diarrhea were enrolled in 17 research centers from December 2020 to March 2023.They were divided into an experimental group of 123 cases and a control group of 125 cases.They were given Sechangzhixiesan and montmorillonite powder respectively to test the non-inferiority of the drugs.The effectondiarrhea,duration of diarrhea,abdominal pain duration,onset time of drug effect in stopping diarrhea,onset time of abdominal pain relief,and safety indicators were compared between the two groups.Results A total of 245 cases were included in the full analysis set(FAS),including 122 cases in the experimental group and 123 cases in the control group.The main efficacy index was the efficacy(effective rate)of diarrhea for 3 days,which was 83.61％in the experimental group and 85.37％in the control group.The rate ratio of the two groups and the 95％CI(experimental group/control group)was 0.979(0.879～1.09);the non-inferiority test was established,the experimental group was not inferior to the control group,and the FAS and PPS analysis conclusions were consistent.There were no statistically significant differences in the duration of diarrheaor or onset time of drug effect in stopping diarrhea;the duration of abdominal pain and the onset time of abdominal pain were shorter in the experimental groups than in the control group,and the difference was statistically significant;the conclusions of FAS and PPS analysis were consistent.In terms of safety,there was no statistically significant difference in the incidence of adverse events/adverse reactions between the two groups.Adverse reactions occurred in 1 case in each group,both of which were constipation,and it was a known adverse reaction in the species.Conclusion Sechangzhixiesan is non-inferior to montmorillonite powder in treating acute watery diarrhea in children,having obvious analgesic effect,and it exhibits good safety,implying its promising clinical application value.关键词
涩肠止泻散/急性水样便腹泻/儿童/随机对照试验/多中心Key words
Sechangzhixiesan/acute watery diarrhea/child/randomized controlled trial/multicenter分类
医药卫生引用本文复制引用
郭圣璇,邓成俊,赵瑞芹,方莹,王丽波,张葆青,冯晓纯,任常军,李在玲,郭荣彦,李学明,马融,韩慧彬,赵立敏,陈月月,胡思源,李振江,王杰民,邓朝晖,李小芹,王玉梅,徐俊杰..涩肠止泻散治疗儿童急性水样便腹泻多中心随机对照临床研究[J].中国实用儿科杂志,2024,39(5):380-385,6.
