| Objective:To objectively evaluate the efficacy and safety of Xiaopibaohe Decoction by observing the clinical cure rate,FDDQL score,recurrence rate and safety index in the treatment of Postprandial Distress Syndrome of Functional Dyspepsia of Spleen-deficiency and Qi-stagnation Syndrome and explore a new treatment of the disease.Method:1.68 patients with PDS of Spleen-deficiency and Qi-stagnation Syndrome were selected from the Outpatient Department of Spleen and Stomach in the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine during December 2018 to June 2019.The experimental group and the control group were divided by using random number table method,34 patients each group.2.The patients in the two groups were instructed to eat regularly,no smoking,alcohol,tea,hot,cold,greasy and other irritants,to conduct psychological counseling,health education and proper physical exercise.Then the experimental group was treated with Xiaopibaohe Decoction while the control group was given Domperidone tablets,both groups' therapy continued for 4 weeks.The experimental data was to evaluate efficacy and safety of the decoction,including TCM symptom scores before and after the treatment,FDDQL score and safety index.After the treatment,the subjects were followed up by telephone or returning to the hospital,and the recurrence rate was counted to evaluate the long-term efficacy of the side.3.All experimental statistics were analysed by SPSS23.0 software.Results:A total of 68 patients were included in this study,and 65 patients completed the observation,including 33 in the experimental group and 32 in the control group.There was no significant difference in general data between the two groups before treatment(P> 0.05),which was comparable.1.Comparison of efficacy of TCM syndromes: The total effective rate of the experimental group(93.9%)was significantly higher than that of the control group(78.1%)(P<0.01).This indicates that the efficacy of Xiaopibaohe Decoction is significantly better than that of Domperidone Tablets.2.Comparison of single symptom score: Before treatment,there was no significant difference in the scores of individual symptoms between the two groups(P>0.05).After treatment,the scores of each single symptom in the two groups were lower than before(P<0.05),indicating that the two treatment schemes could improve the patients' discomfort symptoms;compared with the control group,the scores of fullness or pain after eating,early saturation and little appetite were significantly lower in the experimental group(P<0.01),and the scores of belching,fatigue and loose stools were lower(P<0.05).It is suggested that the Xiaopibaohe Decoction has a significant advantage in improving the symptoms of fullness or distention after eating,early saturation and little nostalgia,and has a certain advantage in improving belching,fatigue and loose stools.3.Quality of life comparison: before treatment,there was no significant difference in FDDQL score between the two groups(t=-0.076,P=0.940>0.05),which could be compared.After treatment,the FDDQL scores of the two groups increased(P<0.05).Compared with the control group,the scores of the experimental group were significantly higher(t=3.565,P=0.001<0.01),indicating that the two treatment schemes can improve the quality of life of patients,and the effect of Xiaopibaohe Decoction is better.4.Recurrence rate comparison: Two weeks after treatment,there was no significant difference in the recurrence rate between the two groups(P>0.05).Four weeks after treatment,the recurrence rate of the control group was higher than that of the experimental group(P<0.05).Twelve weeks after treatment,the recurrence rate of the control group was significantly higher than that of the experimental group(P<0.01),indicating that the short-term effect of the two treatment schemes was not significantly different,but the long-term effect of Xiaopibaohe Decoction in the treatment of PDS of Spleen-deficiency and Qi-stagnation Syndrome was significantly better than that of Domperidone Tablets.5.Safety comparison: There were no adverse reactions in the two groups during the treatment,and the safety indexes of the two groups were within the normal range before and after the treatment,indicating that Xiaopibaohe Decoction and domperidone tablet are safe and reliable in the treatment of PDS of Spleen-deficiency and Qi-stagnation Syndrome.Conclusion:Xiaopibaohe Decoction has a significant effect on the treatment of PDS of Spleen-deficiency and Qi-stagnation Syndrome.It is superior to domperidone tablet in the total effective rate,improving the symptoms of patients' discomfort,improving the quality of life and long-term curative effect.And high security,no obvious adverse reaction... |
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