| ObjectiveTo objectively evaluate the effectiveness and safety of Qingzhong Yunpi Decoction by observing the changes of TCM syndromes and main symptoms of western medicine before and after the treatment on Postprandial Distress Syndrome of Functional Dyspepsia of spleen deficiency and damp-heat syndrome and provide new ideas and basis for clinical treatment.Methods80 patients with PDS of spleen deficiency and damp-heat syndrome were selected from the Department of Gastroenterology,Guangdong Integrated Traditional Chinese and Western Medicine Hospital during January 2020 to December 2020,and divided into observation group and control group using the principle of randomized control,40 patients in each group.The observation group was given Qingzhong Yunpi Decoction,and the control group was treated with itopride dispersible tablets.The course of treatment in both groups was 4 weeks.After the treatment,the changes in the patient’s symptoms scores were recorded in detail,and the clinical efficacy,symptom improvement and recurrence rate were analyzed and compared.Results(1)Comparison of the efficacy of TCM syndromes:After the treatment,the total effective rate of the observation group is 91.67%,and that of the control group is 72.22%.Compared by the rank sum test,there is a significant difference(P<0.01),showing that the efficacy of observation group is better than that of the control group.(2)Comparison of TCM syndrome scores:After treatment,the total points of TCM syndromes of two groups were lower than before(P<0.01),but the decline of the observation group was better(P<0.01).In terms of individual TCM syndrome scores,all of the individual TCM syndrome scores in the observation group decreased significantly after treatment(P<0.01).In the control group,the scores of gastric swelling or pain,anorexia,dry mouth or bitter mouth,fatigue,nausea and vomiting syndromes decreased significantly(P<0.01),but there was no statistical significance in the changes of drowsiness,loose stools,and yellow urine(P>0.05).In the two groups with improved scores of individual syndromes,The improvement of gastric swelling or pain in the observation group was significantly better than that in the control group(P<0.01).In terms of anorexia,dry mouth or bitter mouth and fatigue,the scores of observation group was better than that of the control group(P<0.05).In terms of nausea and vomiting,there was no significant difference between two groups(P>0.05).(3)Comparison of western medicine overall symptom scoreL:After treatment,the overall symptom scores of Western medicine decreased in the two groups,but the observation group decreased more significantly than the control group(P<0.01).(4)Long-term efficacy comparison:Follow-up 4 weeks after the end of treatment,the recurrence rate of observation group was 12.12%,and that of control group was 34.62%.Compared by Fisher chi-square test,there is a statistical difference(P<0.05),indicating that Qingzhong Yunpi Decoction has better long-term efficacy in the treatment of PDS patients.(5)Safety:There were no adverse safety events in two groups of patients during the test,and there was no abnormality in the safety indicators after the recheck,indicating that the trial drug has good safety.ConclusionQingzhong Yunpi Decoction has good therapeutic effect on Postprandial Distress Syndrome of Functional Dyspepsia of spleen deficiency and damp-heat syndrome.It can significantly improve the clinical symptoms of PDS patients,reduce the recurrence rate,and have no obvious adverse reactions,which is worthy of clinical application. |