摘要
目的评价枫蓼肠胃康颗粒治疗小儿急性腹泻(湿热泻)的临床有效性和安全性。方法采用随机、双盲、阳性药平行对照,多中心、非劣效试验设计。由全国12家医院共收集6个月~5岁患儿240例,随机分为对照组和治疗组各120例。对照组口服儿泻停颗粒,治疗组口服枫蓼肠胃康颗粒,两组均每日3次,共治疗5天,比较两组患儿5天止泻率、3天止泻率、治疗满3天大便次数及性状复常率、止泻时间、中医证候积分有效率及用药安全性。结果治疗组5天止泻率为87.29%,对照组为84.62%,差异无统计学意义(P>0.05);通过非劣分析显示,治疗组与对照组差值的95%CI(-0.0621,0.1155),95%CI区间下限值大于非劣介值-0.15,提示治疗组非劣于对照组成立。治疗组和对照组3天止泻率分别为60.50%、48.72%,差异无统计学意义(P>0.05)。两组大便次数及性状复常率差异无统计学意义(P>0.05)。治疗组和对照组中位止泻时间分别为92h、96h。两组中医证候积分及中医证候积分有效率比较差异无统计学意义。治疗期间治疗组未发生不良反应,对照组发生丙氨酸氨基转移酶升高、门冬氨酸氨基转移酶升高各1例次,组间不良反应发生率比较差异无统计学意义(P>0.05)。结论枫蓼肠胃康对6个月~5岁小儿急性腹泻(湿热泻)止泻率与儿泻停颗粒疗效相当且起效较快,临床应用安全。
Objective To evaluate the effectiveness and safety of Fengliaochangweikang Granule(枫蓼肠胃康颗粒)in the treatment of infantile acute diarrhea with damp-heat pattern.Methods A randomized,double-blind,multicenter clinical trial was conducted,and the non-inferiority design was used.A total of 240 children at the age of six months to five years old were recruited from 12 hospitals in China,and they were randomly divided to either receive Fengliaochangweikang Granule(treatment group)or Er Xie Ting Granule(儿泻停颗粒,control group),with 120 patients in each group.Both groups were treated threee times a day for five days.The 5-day diarrhea disappearance rate,3-day diarrhea disappearance rate,3-day normalization rate of defecation frequency and stool characteristics,duration of diarrhea,the effectiveness rate based on traditional Chinese medicine(TCM)syndrome scores,and safety outcomes were assessed.Results The 5-day diarrhea disappearance rate of the treatment group was 87.29%while that of the control group was 84.62%(P>0.05);the lower limit of 95%confidence interval(CI)(-0.0621,0.1155)was greater than the non-inferior margin-0.15,accepting that assumption that the treatment group was not inferior to the control.There were no significant differences between the treatment group(60.50%)and the control(48.72%)in the 3-day diarrhea disappearance rate(P>0.05),and in the normalization rate of defecation frequency and stool characteristics(P>0.05).The median duration of diarrhea stop in the treatment group and the control group was 92 hours and 96 hours respectively.The effectiveness rate based on TCM syndrome scores was not statistically different between groups.There were no adverse events in the treatment group,while one each case of elevated alanine aminotransferase and elevated aspartate aminotransferase appeared in the control group(P>0.05).Conclusion Fengliaochangweikang Granule is not inferior to Er Xie Ting Granule in improving the diarrhea disappearance rate for children at the age of six months to five years with acute diarrhea of damp-heat pattern,and is found to be safe.
作者
黄腾
王孟清
杜幼蕊
韩选明
王晓燕
孟永胜
张建红
鲁彩霞
冯自威
罗红芳
袁敏华
易文龙
高学敏
孙媛媛
许尤佳
HUANG Teng;WANG Mengqing;DU Yourui;HAN Xuanming;WANG Xiaoyan;MENG Yongsheng;ZHANG Jianhong;LU Caixia;FENG Ziwei;LUO Hongfang;YUAN Minhua;YI Wenlong;GAO Xuemin;SUN Yuanyuan;XU Youjia(Guangdong Provincial Hospital of Traditional Chinese Medical,Guangzhou,510120;The First Hospital of Hunan University of Chinese Medicine;Yuncheng Hospital of Traditional Chinese Medicine,Shanxi Province;The Second Affiliated Hospital of Shaanxi University of Chinese Medicine;Zhengzhou Hospital of Traditional Chinese Medicine,Henan Province;Kaifeng Central Hospital,Henan Province;Maternity and Child Health Care of Zaozhuang,Shandong Province;Changji Hui Autonomous Prefecture Hospital of Traditional Chinese Medicine,Xinjiang Uggur Autonomous Region;Luohe Hospital of Chinese Medicine,Henan Province;The Second Affiliated Hospital of Guizhou Medical University;Urumqi Hospital of Traditional Chinese Medicine,Xinjiang Uggur Autonomous Region;Tianyou Hospital Affiliated to Wuhan University of Science and Technology;Medical Research and Assessment Center,China Association of Traditional Chinese Medicine)
出处
《中医杂志》
CSCD
北大核心
2021年第4期318-323,共6页
Journal of Traditional Chinese Medicine
关键词
枫蓼肠胃康颗粒
儿泻停颗粒
小儿急性腹泻
湿热泻
有效性
安全性
Fengliaochangweikang Granule(枫蓼肠胃康颗粒)
Er Xie Ting Granule(儿泻停颗粒)
infantile acute diarrhea
damp-heat pattern
effectiveness
safety
作者简介
通讯作者:许尤佳,515498251@qq.com。
