| Objective:In this study,we observed the changes of clinical symptoms and test items before and after treatment with Jianzhong tiaoqi decoction,compared with western medicine treatment,and evaluated the efficacy and safety of Jianzhong tiaoqi decoction in treating spleen deficiency and qi stagnation type FD.The aim was to provide evidence and clinical data for clinical treatment of FD.Methods:78FD patients with spleen deficiency and qi stagnation were randomly divided into treatment group and control group with 39 cases in each group.The treatment group was given Jianzhong tiaoqi decoction and the control group was treated with Mosapride Citrate Tablets.The treatment course lasted for 4 weeks.To observe the overall clinical efficacy after treatment,the main symptoms,the scores of TCM symptoms before and after treatment,plasma motilin levels and recurrence.All data were processed by SPSS22.0 statistical software.Results: There were 7 cases of abscission.A total of 71 cases participated in the final statistics,36 cases in the treatment group and 35 cases in the control group.1.Comparison of overall efficacy:After the course of treatment,the total effective rate of the treatment group was 91.67%,and that of the control group was 71.43%.The total effective rate of the treatment group was higher than that of the control group(P<0.05).2.Comparison of main symptoms:The disappearance rates of single symptoms of gastric distension and anorexia in the treatment group were 55.56% and 58.33% respectively,which were better than those in the control group(22.86% and 28.57%).The therapeutic effect of the treatment group on two main symptoms of gastric fullness and anorexia was higher than that of the control group(P<0.05).3.Comparisons of TCM symptom scores: After treatment,the scores of symptoms in the treatment group were significantly improved compared with those before treatment(P < 0.01);in the control group,except for loose stool,mental burnout and limb weakness,the scores of other symptoms after treatment were significantly different from those before treatment(P < 0.05).Compared between the two groups,the treatment group was better than the control group in the treatment of fullness of stomach,loss of appetite,thin stool,early satiety,limb weakness and mental burnout(P < 0.01,P < 0.05),but there was no difference in the treatment effect of hiccup(P > 0.05),indicating that the two groups had the same effect.The total score of the two groups after treatment was significantly lower than that before treatment(P < 0.05),and the total score of the treatment group after treatment was significantly lower than that of the control group(P < 0.05).4.Motilin level comparison: After treatment,the plasma motilin level in both groups was significantly higher than that before treatment(P<0.05);after treatment,the plasma motilin level in the treatment group was significantly higher than that in the control group(P<0.05).5.Drinking water load test analysis: After treatment,the threshold and the amount of sufficient drinking water in the two groups were significantly higher than before treatment(P<0.05).Inter-group analysis showed that after treatment,the threshold and the amount of sufficient drinking water in the treatment group were significantly higher than those in the control group(P< 0.05).6.Relapse rate: The recurrence rate of treatment group was 14.71%,which was significantly lower than that of control group(38.46%)(P<0.05).7.Safety indicators: The safety indicators of both groups were within the normal range.No adverse reactions were found during the course of taking the medicine.Conclusion:1.Jianzhong tiaoqi decoction is effective in the treatment of FD spleen deficiency qi stagnation syndrome.It can effectively alleviate clinical symptoms,thereby improving the quality of life of patients and improving the physical condition of the patients.Moreover,it has good safety and low recurrence rate,and is worthy of clinical application.2.The mechanism of Jianzhong tiaoqi decoction formula in treating spleen deficiency and qi stagnation type FD may be related to improving MTL level and improving the proximal gastric sensation function. |
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