摘要
目的评价小儿化食口服液治疗儿童功能性消化不良(积滞食积化热证)的有效性与安全性。方法采用计算机分层区组随机、安慰剂平行对照、双盲、多中心临床研究的方法,共纳入受试者240例,其中试验组160例,对照组80例。对照组给予小儿化食口服液模拟剂口服,试验组给予小儿化食口服液口服,2组均治疗2周为1个疗程。结果2组中医证候有效率比较,经以中心分层的CMHχ~2法统计,差异有统计学意义(P<0.05)。各年龄段受试者的有效率,试验组均大于对照组,整体2组间有效率的比较,经以年龄分段的CMHχ~2法统计,差异无统计学意义(FAS:CMHχ~2=3.2339,P=0.0721;PPS:CMHχ~2=2.8547,P=0.0911);其中8~14岁年龄段,2组有效率比较,经χ~2检验统计,差异有统计学意义(P<0.05)。2组中医证候积分和比较,经成组t检验统计,差异有统计学意义(P<0.05)。2组各症状比较,经χ2检验统计,试验组的心烦易怒症状的消失率高于对照组,差异有统计学意义(P<0.05)。除22例剔除和脱落病例外,其余218例依从性均在80%~120%,依从性良好,2组比较,差异无统计学意义(P>0.05)。试验中,试验组发现临床不良事件1例次,对照组3例次,2组比较,差异无统计学意义(P>0.05)。结论小儿化食口服液治疗儿童功能性消化不良(积滞食积化热证)有效,临床应用安全性好。
Objective To evaluate the efficacy and safety of Xiao’er Huashi Koufuye in the treatment of functional dyspepsia in children(dyspepsia with syndrome of retention of food transforming into heat).Methods Computer stratified group randomized,placebo-parallel control,double-blind,and multi-center trial were used.Totally240 subjects were included,including 160 in the trial group and 80 in the control group.The control group was given Xiao’er Huashi Koufuye mimetic agent,while the trial group was given oral Xiao’er Huashi Koufuye(小儿化食口服液),and the 2 groups were both given 2 weeks as a course of treatment.Results Statistics by central stratification of the CMHχ~2 method,there was statistical significance in the effective rate of TCM syndrome between the two groups(P<0.05).The effective rates of the subjects of all ages in the trial group were all higher than those in the control group.Statistics by age segmented CMHχ~2 method,there was no statistical significance in comparison of the effective rate between the two groups as a whole(FAS:CMHχ~2=3.2339,P=0.0721;PPS:CMHχ~2=2.8547,P=0.0911).Of these,by statistical testing,there was statistical significance in the effective rate between the two groups in the 8-14 age bracket(P<0.05).Statistics by group t test,there was statistical significance in TCM syndrome integral sum between the two groups(P<0.05).Comparison of symptoms in the two groups byχ~2 statistical testing,the disappearance rate of susceptibility to rage due to dysphoria syndrome of the trial group was higher than that of the control group,and there was statistical significance(P<0.05).Except for 22 cases excluded and lost,the compliance of the rest 218 cases was 80%-120%,and the compliance appeared quite well,there was no significant difference between the two groups(P>0.05).In the trial,1 case of clinical adverse event was found in the trial group and 3 cases in the control group.There was no statistical significance between the two groups(P>0.05).Conclusion Xiao’er Huashi Koufuye is effective in treating functional dyspepsia in children(dyspepsia with syndrome of retention of food transforming into heat),with good security in clinical application.
作者
胡思源
陈馨雨
丁樱
白晓红
王建新
洪丽君
苏保玲
颜云盈
严明
潘树强
HU Siyuan;CHEN Xinyu;DING Ying;BAI Xiaohong;WANG Jianxin;HONG Lijun;SU Baoling;YAN Yunying;YAN Ming;PAN Shuqiang(Clinical Trial Center,The First Affiliated Hospital of Tianjin University of TCM,Tianjin,300193,China;Department of TCM,Tianjin Children’s Hospital,Tianjin,300134,China;Department of Pediatrics,The First Affiliated Hospital of Henan University of TCM,Zhengzhou,Henan,450000,China;Department of Pediatrics,Affiliated Hospital of Liaoning University of TCM,Liaoning,Shenyang,110033,China;Department of Gastroenterology,Harbin Children’s Hospital,Harbin,Heilongjiang,150010,China;Department of Pediatrics,Mudanjiang Hospital of TCM,Mudanjiang,Heilongjiang,157005,China;Department of Pediatrics,Heji Hospital Affiliated to Changzhi Medical College,Changzhi,Shanxi,046000,China;Department of Pediatrics,Nanning Maternal and Child Health Care Hospital,Nanning,Guangxi,530011,China;Department of Pediatrics,Ezhou Hospital of TCM,Ezhou,Hubei,436000,China;Emergency Department,Qinzhou Maternal and Child Health Care Hospital,Qinzhou,Guangxi,535000,China)
出处
《中医儿科杂志》
2018年第6期29-34,共6页
Journal of Pediatrics of Traditional Chinese Medicine
关键词
功能性消化不良
小儿
积滞
食积化热证
小儿化食口服液
临床研究
functional dyspepsia
children
dyspepsia
symptom of retention of food transforming into heat
Xiao’er Huashi Koufuye(小儿化食口服液)
clinical study
