| Objective: To investigate the clinical effect of jianshenxiaodao granules on functional dyspepsia(FD)in children.The aim of our studies is to explore a safe and effective treatment method which can effectively alleviate or relieve the main clinical symptoms of FD in children and improve the quality of life and improve the mental state.Methods: From December 2016 to November 2018,120 patients met Rome Ⅳ criteria were enrolled and divided into jianshenxiaodao granule treatment group(observation group)and domperidone control group by random number table method.There are 60 cases in each group.Treatment group: jianshenxiaodao granules plus Lglutamine gualenate granules and proper dietary guidance.The method of take jianshenxiaodao granules: < 1 year old,half pack each time,twice a day;1 to 6 years old,1 pack each time,2 times a day;> 6 years old,one pack each time,3 times daily.Rinsed with boiling water after a meal or meal and treated for 14 days.Control group:domperidone suspension plus L-glutamine gualenate granules and proper dietary guidance.The method of take domperidone suspension: 0.3mg/kg for 3 times/d rinsed30 min before meal and treated for 14 days.Subjects received three times visiting at baseline(before treatment),2 weeks after treatment,and follow-up f8 weeks after the drugs were stopping.We evaluated the main clinical symptoms of above two groups(epigastric fullness,abdominal pain,acid reflux,belching,nausea and vomiting,eating less,inhibited defecate)score before and after treatment,symptoms improvement time,the levels of gastrointestinal hormone,serum electrogastrogram parameters and drug adverse reactions.The above indexes were statistically analyzed.Results: There were no significant difference in sex,age,course of disease,symptoms on baseline between treatment group and control group,which indicated that two group had comparability(P>0.05).There were no statistically significant differences in clinical symptoms,the level of serum gastrointestinal hormone,occurrence of bradygastria and irregular gastric electric rhythm between two groups before treatment(P>0.05),indicating that two groups were comparable.The clinical symptom scores of two groups post-treatment were lower than pretherapy,moreover,treatment group were better than control group,and the differences within groups and between two groups had statistically significant(P<0.05).The time of clinical symptom improvement in treatment group was significantly shorter than control group,the differences between two groups were significant(P<0.05).After treatment,the level of gastrointestinal hormone in serum between two groups were improved in varying degree,the level of above hormones in treatment group were improved and superior to control group before and after treatment.In control group,there were statistical differences in levels of other five gastrointestinal hormones(motilin,gastrin,somatostatin,neuropeptide Y and vasoactive peptide)except serotonin before and after treatment(P<0.05).Both two groups had significantly lower incidence of bradygastria and irregular gastric electric rhythm both preprandial and postprandial than before treatment(P<0.05),moreover,jianshenxiaodao granules treatment group had significantly lower incidence of bradygastria and irregular gastric electric rhythm than that of domperidone group(P<0.05).The results of clinical efficacy evaluation as following: the significant healing efficiency was 80% and the total effective rate was 95% in the treatment group,and 61.67% and 90% in the control group with domperidone.The significant healing efficiency of the two groups was statistically significant(P<0.05),and the total effective rate of the two groups was not statistically significant(P > 0.05).After8 weeks of drug withdrawal and follow-up,the significant healing efficiency of the children in the jianshenxiaodao granule treatment group was 78.33%,and the total effective rate was 90%,while that of the domperidone control group was 60% and the total effective rate was 75%.The significant healing efficiency and total effective rate were statistically different between groups(P<0.05).Conclusion: Compared with domperidone suspension,the treatment of jianshenxiao dao granule can significantly improve the clinical symptoms of children with FD,enhance the gastric motility,and improve the clinical efficacy,which lasts for two weeks after discontinuation. |