Objective:The study was to observe the clinical safety and efficacy of the Pingwei Capsule which is Hospital preparation treating Functional Dyspepsia with Liver Depression and Spleen Deficiency. And then, the study was to explore the mechanism of pathogenesis of functional dyspepsia and action mechanism of Pingwei capsule by observing the changes in plasma brain-gut peptide, lying a more solid theoretical basis for its further development and utilization.Methods:There were 80 patients who met the standard of diagnosis and the conditions to enter the experiment. They were divided randomly into two groups, 40 patients as the treatment group and 40 as the control group. Treatment group was given Pingwei Capsule, the control group used Domperidone Tablets, The course of treatment will last for 4 weeks.Observe TCM symptoms integration, the total change in efficiency, gastrointestinal motility and adverse reaction before and after treatment, and observe the recurrence rates two months later after the treatment. Objectively evaluate the efficacy, safety and recurrence rate of Pingwei Capsule. And to measure the content of brain-gut peptide in plasma before and after treatment. 20 cases of healthy from medical center were selected as the normal control group,exploring the mechanism of pathogenesis of functional dyspepsia with liver depression and spleen deficiency, so as to explore the action mechanism of Pingwei Capsule. This study used the SPSS19.0 statistical analysis software for statistical processing, On the level of P<0.05,the difference was statistically significant.Results:①General comparison: there were no statistically significant difference between the treatment group and the control group in terms of gender, age and course of the disease,(P>0.05), Two groups are comparable. ②Comparison of the efficacy of TCM symptoms. There was a significant reduction in the TCM symptom scores of patients from both the treatment group and the control group after the treatment compared with the scores before the treatment(P<0.05); total effective rate of the treatment group is better than the control group(P<0.05). ③Electrogastrogram comparison: post-meal average amplitude(VP),Postprandial and fasting power ratio and waveform reaction area(RA) are lower than healthy subjects significantly(P<0.05). post-meal average amplitude(VP), postprandial and fastingpower ratio and waveform reaction area(RA)after the treatment were increased significantly campared with before treatment(P<0.05); The difference between two groups electrogastrogram index has no statistically significant after treatment. ④Contents of brain-gut peptide in plasma: Content of Leptin and VIP increased significantly(P<0.05), content of Ghrelin and NPY decreased significantly(P<0.05). Content of Leptin and VIP decreased significantly,content of Ghrelin and NPY increased significantly campared with before treatment(P<0.05).content of Leptin and Ghrelin between the two groups has a statistically significant(P<0.05),content of VIP and NPY between the two groups has no statistically significant(P>0.05).Conclusion:①Gastric motility of FD patients is lower than healthy subjects, levels of brain-gut peptide in plasma are different from healthy persons. Pathogenesis of FD has some relevance with gastric motility disorder and changes of brain-gut peptide.②Pingwei capsules has an obvious effect on Functional Dyspepsia caused by liver depression and spleen deficiency. It can improve FD clinical symptoms significantly, improve quality of life, have no significant side effects and decrease the recurrence rate, And it also can significantly affect the levels of ghrelin, Leptin, NPY and VIP in the plasma.③The action mechanism of Pingwei capsule may be related to change of gastric motility and the influence on brain-gut peptide in plasma such as ghrelin, Leptin, NPY, VIP and so on. |