| Objective: to study the effect of Qingwei Xiaopi decoction on functional dyspepsia with Spleen-stomach Damp-heat Syndrome,and to examine the improvement of Qingwei Xiaopi decoction on the clinical symptoms of patients in this study,to evaluate the clinical efficacy and safety of Qingwei Xiaopi decoction for functional dyspepsia in order to provide a new reference for the clinical use and treatment of TCM.Methods: 96 patients who met the criteria of this study were randomly divided into Treatment Group(N = 48)and Control Group(N = 48).The treatment group was given the traditional Chinese Medicine Qingwei Xiaopi prescription with the following ingredients: Yinchen 15 g,houpu 15 g,Zhishi 15 g,Rhubarb 6G,Dandelion 30 g,forsythia15g,Sandalwood 6G,Rhizoma Curcumae 13 g,betel NUT 15 g,the Chinese medicine is made of undecocted granules provided by Jiangyin Tian Jiang Pharmaceutical Co.,Ltd..The control group was given Mosapride citrate dispersible tablets produced by Chengdu Kanghong Pharmaceutical Group Co.,Ltd..Method of Medication: Treatment Group Granules each dose of 400 ml of boiling water,a daily dose,half an hour after breakfast and evening meal warm 200 ml.In the control group,Mosapride citrate dispersible tablets(5mg)were given in warm water half an hour before breakfast,lunch and dinner respectively.Both groups were treated for 4 weeks.The general vital signs,routine examinations,individual symptoms and symptom scores were observed and statistically analyzed before and after treatment,to evaluate the clinical effect of the drug in this trial.The patients were followed up for 2 months after the course of treatment.The recurrence of the disease was observed and the long-term effect of the drug was evaluated.Results:(1)comparison of the overall curative effect of TCM Syndromes: The effective rate of Qingwei Xiaopi Fang group was 89.1%,and that of MOSAPRIDE CITRATE dispersible tablet group was 71.1%,it is suggested that Qingwei Xiaopi decoction is more effective in treating functional dyspepsia of spleen-stomach damp-heat Syndrome.(2)comparison of the total scores of TCM syndromes: Before treatment,the total score of TCM Syndrome of the two groups was tested by independent sample t test(p >0.05),the difference was not statistically significant,and the total score of TCM syndrome of the two groups after treatment was tested by independent sample t test(p < 0.05),the results showed that Qingwei Xiaopi prescription was superior to MOSAPRIDE CITRATE dispersible tablet in improving TCM Syndrome of damp-heat in spleen and stomach of FD.Before and after treatment,the total score of TCM syndromes in two groups was compared.T test of paired samples showed that both groups could improve the TCM syndromes of FD.(3)single symptom comparison of TCM: Qingweixiaopi decoction group was better than the control group in the improvement of epigastric fullness or pain,bitter and sticky mouth,short yellow urine(p < 0.05),compared with MOSAPRIDE citrate dispersible tablet group,there was no significant difference between the two groups in the improvement of symptoms(p > 0.05).(4)The recurrence rate was 12.2% in Qingwei xiaopi fang group and 34.4% in mosapride citrate dispersible tablets group,which suggested that Qingwei Xiaopi Fang was superior to Mosapride citrate dispersible tablets in long-term curative effect.(5)safety comparison: no significant adverse reactions were observed in the two groups during the course of the study.Conclusion: Qingweixiaopi decoction is superior to Mosapride citrate dispersible tablets in the treatment of functional dyspepsia of spleen and stomach damp-heat syndrome,which can effectively relieve the clinical symptoms of patients,improve the symptoms of TCM,reduce the recurrence rate,and is safe to use,the utility model is suitable for clinical popularization and application to treat the disease. |
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