| Objective:Through the clinical trial of the radical treatment of helicobacter pylori(HP)infection with Saccharomyces boulardii sachets and Jinghuaweikang capsule on the basis of the standard gastric tetrad,to observe the efficacy and safety,to explore a more effective way of the radical treatment of HP related gastritis,and to solve the current problem of intestinal flora disorder caused by a large number of antibiotics and the decrease of eradication rate caused by HP strain resistance.Method:230 cases of Hp positive patients with chronic gastritis and dyspepsia(mixed cold and heat syndromes)who visited the outpatient department of shanxi hospital of traditional Chinese medicine from November 2017 to July 2018 were collected.The optimal clinical trial design method of randomized and parallel control of positive drugs was adopted.Patients were divided into the experimental group and the control group according to the same proportion and completely random method,with 115 patients in each group.Control group: western medicine quadruple therapy(Esomeprazole magnesium enteric-coated tablets(E),Colloidal Bismuth Pectin Capsules(Bi),Amoxicillin capsules(A),Clarithromycin sustained-release tablets(C))+ Banxiaxiexin decoction for 2 weeks;Experimental group: on the basis of the control group,Saccharomyces boulardii sachets and Jinghuaweikang capsules were used for 2 weeks at the same time.all patients underwent 13 C breath test at the end of 2 weeks and 6 weeks of treatment to reexamine helicobacter pylori and observe the negative conversion rate of Hp;The clinical improvement of TCM symptoms and the occurrence of adverse reactions were observed during the treatment;Follow-up and review were conducted for those who successfully eradicated HP,to observe the rate of HP positive recurrence at 6 months later.Results : 115 patients in the experimental group,3 patients did not follow the prescribed course of medication,4 patients lost follow-up,finally,108 subjects were tested;115 patients in the control group,5 patients lost follow-up,and finally 108 subjects were tested.1.Two groups of patients were examined for HP(clearance rate)2 weeks after taking the western medicine sequential therapy(the end of the second week from the begining of the course): 99 patients in the experimental group were converted to negative HP,with a clearance rate of 91.67%;89 patients in the control group were converted to negative HP,with a clearance rate of 75.46%,The clearance rate in the experimental group was higher than that in the control group,P<0.05,the difference was statistically significant.2.After the patients in the two groups stopped the western medicine quadruple therapy for one month(at the end of the sixth week from the begining of the course),the HP(eradication rate)was reviewed: 95 cases of HP became negative in the experimental group,the eradication rate was 87.96%;83 cases of HP became negative in the control group,the eradication rate was 75.46%;the eradication rate in the experimental group was significantly higher than that in the control group,P < 0.05,the difference was significant;3.Clinical improvement of TCM syndromes in the two groups: after the treatment of 2weeks,the experimental group and the control group showed no statistical difference in each individual symptom.Except “belching”,the other syndromes improvement groups were superior to the control group(P < 0.05).Compared with the control group,the total score of TCM syndromes and curative effect of TCM syndrome in the experimental group was superior to the control group,the difference was statistically significant(P < 0.05).4.Follow up patients successful eradicated HP in the two groups to reexamine HP(recurrence rate)after 6 months(i.e.,week 30): 95 cases were followed up in the experimental group,and 3 cases were positive,with a recurrence rate of 3.16%;In the control group,83 cases were followed up,9 cases were positive,and the recurrence rate was 10.84%.The recurrence rate of the experimental group was significantly lower than that of the control group(P < 0.05).5.Analysis of adverse reactions in the two groups: during the study,1 patient in the experimental group had headache,and the incidence of adverse reactions was 0.93%;In the control group,diarrhea occurred in 4 patients,nausea in 2 patients,abdominal pain in 1patient,and rash in 1 patient,the incidence of adverse reactions was 7.27%.The incidence of adverse reactions in the experimental group was lower than that in the control group,and the difference was statistically significant(P < 0.05).6.Before and after the treatment,routine examination of blood,urine,and stool,liver function ALT,AST,renal function Cr,BUN,and electrocardiogram of the two groups of patients showed no obvious abnormalities,and no serious adverse events related to medication occurred during the treatment process.The treatment plan of the two groups was safe.Conclusion:The clearance and eradication rates of Jinghuaweikang capsules,Saccharomyces boulardii sachets united standard quadruple therapy(E+A+C+Bi)including Esomeprazole magnesium enteric-coated tablets,Amoxicillin capsules,Clarithromycin sustained-release tablets,and Colloidal Bismuth Pectin Capsules are higher than standard quadruple therapy(E+A+C+Bi)at the first time,TCM syndrome integral improvement and efficient syndromes are superior to E+A+C+Bi quadruple therapy,and can significantly reduce the incidence of adverse reactions and the recurrence rate. |
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