Study On The Treatment Effect Increasing Mechanism Of Combining The Prescription Of Building Up Vital Energy And Nourishing The Blood With Omeprazole On Peptic Ulcer Based On The CYP2C19 Genetic Polymorphism

Objective:To observe the clinical effects of Yiqi Huoxue formula combined with omeprazole in treating patients with peptic ulcer,and to investigate the principle of the accelerating effects of this formula by using animal models.Methods:Clinical study:100 patients diagnosed with peptic ulcer according to the Traditional Chinese Medicine(TCM)diagnostic criteria were randomly divided into the Chinese-Western medicine group and Western medicine group.CYP2C19 gene sequencing was carried on all patients before treatment.The 50 patients in the Western medicine group took omeprazole(20 mg,twice per day),and the 50 patients in the Chinese-Western medicine group took omeprazole(20 mg,twice per day)and Yiqi Huoxue formula(1 dose/day)for 4 weeks.In both of the groups,patients with Hp infection were given omeprazole(20 mg,twice per day),amoxicillin(1000 mg,twice per day),clarithromycin(500 mg,twice per day)and Potassium citrate(220 mg,twice per day)for 2 weeks before treatment in order to eliminate Hp infectious.The clinical symptom scores,ulcer recovery condition under the microscope and Hp eradication rate were observed before and after treatment in the two groups.Animal experiments:analyzing the blood components after applying the Yiqi Huoxue formula to rats with peptic ulcer;observing the effects of Yiqi Huoxue formula on six subtypes(CYP2C9,CYP2C19,CYP2D6,CYP3A4,CYP2E1)of CYP450 enzyme(CYP1A2)by using the Cocktail method.Results:Clinical study:After the 4-weeks treatment,based on TCM diagnostic criteria,in the Chinese-Western medicine group,15 cases were cured,24 cases were markedly effective,9 cases were effective,2 cases were ineffective,and the total effective rate was 96%;in the Western medicine group,5 cases were cured,20 cases were markedly effective,18 cases were effective,7 cases were ineffective,and the total effective rate was 86%.The Chinese-Western medicine group was superior to the Western medicine group in improving the clinical symptoms(P<0.05).The retrospective gastroscopy showed that,in the Chinese-Western medicine group,18 cases were cured,18 cases were markedly effective,11 cases were effective,3 cases were ineffective,the ulcer recovery rate was 94%;in the Western medicine group,12 cases were cured,20 cases were markedly effective,8 cases were effective,10 cases were ineffective,and ulcer recovery rate was 80%.The ulcer recovery rate of the Chinese-Western medicine group was higher than the Western medicine group(P<0.05).The Hp eradication rate of the Chinese-Western medicine group was 88.6%,and which in the Western medicine group was 80.5%.The Chinese-Western medicine group was superior to the Western medicine group in the Hp eradication rate(P<0.05).The comparison of the efficacy of the above three aspects among the patients with different genotypes showed that strong metabolism<intermediate metabolism<poor metabolism(P<0.05).There was no significant differences in the efficacy of the three genotypes patients in the Chinese-Western medicine group(P>0.05).The treatment efficacy of patients with strong metabolism in the Chinese-Western medicine group was better than the Western medicine group in all of the above three aspects(P<0.05).The intermediate metabolite patients were better than the Western medicine group in the ulcer recovery rate and Hp eradication rate(P<0.05),but there was no significant difference in the clinical symptom score between the Chinese-Western medicine group and the Western medicine group(P>0.05).There were no significant differences in the above three aspects among patients with poor metabolism in the two groups(P>0.05).Animal experiment:The active ingredients(Formononetin,Calycosin,Glycyrrhizin and Gallic acid)of Yiqi Huoxue formula were detected in the blood of rats with peptic ulcer.After 2 weeks of continuous administration of Yiqi Huoxue formula,the activities of CYPlA2 and CYP3A4 enzymes were not significantly changed;the activities of CYP2C9 and CYP2El enzymes were enhanced;CYP2C19 enzyme was slightly inhibited;CYP2D6 enzyme was intermediately inhibited.Conclusion:Yiqi Huoxue formula has a significant curative effect on peptic ulcer patients with spleen stomach yang deficit cold,improving the clinical symptoms,promoting ulcer recovery and increasing the eradication rate of Hp.It may reduce the metabolic rate of omeprazole in the human body by inhibiting the activity of CYP2C19 enzyme,thereby enhancing the clinical efficacy of omeprazole.The active ingredients(Formononetin,Calycosin.Glycyrrhizin and Gallic acid)of Yiqi Huoxue formula have therapeutic effects on rat peptic ulcer.Yiqi Huoxue formula can affect the activity of rat P450 enzyme,slightly reduce the activity of rat CYP2C19 enzyme.