| Objective:To evaluate the clinical efficacy and safety of Jianpi-Xiaopi decoction in the treatment of functional dyspepsia patients with spleen deficiency and qi stagnation,as well as its effect on the quality of life of patients,and to further explore the advantages of traditional Chinese medicine in the treatment of Functional dyspepsia.Methods:According to the inclusion and exclusion criteria,70 patients with FD of spleen deficiency and qi stagnation were randomly divided into control group and observation group.The control group was treated with mosapide citrate tablets,and the observation group was treated with Jianpi-Xiaopi prescription.Both groups were treated for 4 weeks.Collect and record clinical information such as the patient’s name,age,gender,height,weight and medical history.The efficacy indicators such as total TCM symptom score,individual TCM symptom score,nepean dyspep-sia symptom index(NDSI)and nepean dyspepsia life quality index(NDLQI)were observed and recorded before,2 weeks and 4 weeks after treatment.The safety indicators such as the three major routine tests,liver and kidney functions,12-lead ECG,etc.were observed and recorded before and after the treatment,and the adverse events were recorded,and the data of the experimental results were statistically analyzed,so as to evaluate the effectiveness and safety of Jianpi-Xiaopi prescription.Results:1.A total of 70 patients were included in this study.During the clinical trial,2patients dropped out,including 1 in the observation group and 1 in the control group.2.Comparison of research data: there was no significant difference in age,gender,course of disease and BMI distribution between the observation group and the control group,which were comparable.3.Analysis of curative effect of TCM symptoms:Compared before treatment,the total TCM symptom scores of the two groups decreased after 2 weeks and 4 weeks of treatment,but the total effective rate of the observation group was 88.24%,which was significantly better than 61.76% of the control group(P<0.05).After 2 weeks and 4weeks of treatment,the symptoms of stomach fullness,stomach distention and pain,less food,belching,fatigue,stool characteristics and other symptoms in the observation group were improved compared with those before treatment(P<0.05).In the control group,except for fatigue and stool characteristics symptoms,the other symptoms were also improved(P<0.05),indicating that the two treatment methods could improve the symptoms of patients(P < 0.05).At the same time,after 2 weeks and 4 weeks of treatment,the observation group was better than the control group in improving the symptoms of stomach fullness,stomach distention and pain,less food,fatigue,belching,stool characteristics and so on(P<0.05).4.Analysis of Nepin dyspeptic symptom index and quality of life index:Intra-group comparison:statistical analysis showed that after 2 weeks and 4 weeks of treatment,the differences in NDSI and NDLQI scores between the two groups were statistically significant(P < 0.05),indicating that the two treatment methods of Chinese medicine and western medicine could improve the NDSI and NDLQI scores of FD patients.There was no significant difference in NDSI and NDLQI scores between the two groups before treatment(P<0.05).After the treatment,the differences of NDSI and NDLQI scores between the two groups were statistically significant(P<0.05),indicating that Jianpi-Xiaopi prescription was more effective in improving the symptoms and quality of life of FD patients than the control group.5.Safety analysis:Before and after treatment,the relevant safety indicators of the two groups were in the normal range,and there were no significant positive changes in vital signs,electrocardiogram,stool routine and fecal OB.No adverse reactions or adverse events occurred in all subjects,indicating that Jianpi Xiaopi prescription had good safety.Conclusions:Jianpi-Xiaopi prescription can significantly improve the clinical symptoms of FD patients with spleen deficiency and qi stagnation,improve their quality of life,and has good safety. |
