Clinical Observation On Qingyou Recipe Combined With Quadruple Therapy In The Treatment Of Helicobacter Pylori Infection

objective:To evaluate the clinical efficacy of self-made Chinese patent medicine Qingyou Recipe combined with quadruple regimen for the treatment of Helicobacter pylori.Methods:80 cases of Helicobacter pylori-positive patients diagnosed with chronic non-atrophic gastritis,syndromes of qi deficiency,blood stasis and damp heat were randomly divided into two groups using a random number table,with 40 cases in each group.The bismuth quadruple therapy was used in the control group,and the treatment group added Qingyou Recipe ol the basis of the control group.The course of treatment was 2 weeks,and 14C-UBT was reviewed after 4 and 16 weeks at end of treatment to observe the eradication rate and recurrence rate of Helicobacter pylori in the two groups.TCM symptom scores and clinical report outcome evaluation scale scores of patients with gastrointestinal diseases were recorded before and after treatment in both groups.Adverse reactions during the treatment of the two groups were observed.In this study,1 case was shed in the treatment group and 2 cases were shed in the control group.A total of 77 cases were included in the statistical description.Results:1.Symptom improvement:a.After treatment,the total scores of TCM symptoms in the two groups were lower than before,and both could significantly improve the TCM symptoms of the disease(P<0.01).b.After treatment,the total score of TCM symptoms in the treatment group was lower than that in the control group,showing that the curative effect of the treatment group was significantly better than that of the control group(P<0.01).c.After treatment,the scores of individual TCM symptoms in both groups were lower than before,showing that they could improve the symptoms of single TCM(P<0.05).d.The treatment group is better than the control group in improving stomach fullness or pain,food intake,heavy body trapped,bad breath,and fatigue(P<0.05),and it is significantly better in improving dry or bitter mouth than control group(P<0.01).The curative effects of the two groups were similar in terms of stool discomfort and improvement of gastric heartburn(P>0.05).2.Efficacy of TCM Syndrome:The total effective rate of the treatment group was 89.74%,and the total effec73.68%.The tive rate of the control group wasoverall clinical effect of the treatment group was significantly better than the control group(P<0.01).3.Helicobacter pylori eradication and recurrence:a.After 4 weeks of treatment,according to the intentionality analysis(ITT),the rate of eradication was 87.50%(35/40)in the treatment group and 77.50%(31/40)in the control group.Aaccording to the protocol analysis(PP),the rate of eradication was 89.74%(35/39)in the treatment group and 81.58%(31/38)in the control group.The efficacy of H.pylori eradication in the two groups was comparable(P>0.05)b.After 16 weeks of treatment,the recurrence rate in the treatment group was 2.86%(1/35),and the recurrence rate in the control group was 9.68%(3/31).The difference was not statistically significant(P>0.05).4.Quality of life improvement:a.After treatment,the scores of PRO scale in each dimension of the two groups were lower than before treatment.Both treatment options can effectively improve the quality of life of patients(P<0.01).b.The treatment group was better than the control group in the improvement of indigestion,systemic symptoms,and psychological emotions(P<0.05).In terms of the improvement of reflux,abnormal bowel movements,and social function in three dimensions,the two groups had comparable efficacy(P>0,05).5.Adverse reactions:The incidence of adverse reactions in the treatment group was 2.56%(1/39),and the incidence of adverse reactions in the control group was 15.79%(6/38).The difference was not statistically significant(P<0.05).The treatment group is lower than the control group.The adverse reactions in the two groups were mild and did not affect the patient’s treatmelt.Conclusion:The combination of Qingyou Recipe with the quadruple regimen has the same H.pylori eradication effect as the simple quadruple regimen,and the clinical symptoms and quality of life improvements are better than the latte,and it can reduce adverse reactions.It is suggested that the combination of Qingyou Recipe and quadruple therapy has a good clinical efficacy on treating Helicobacter pylori infection.