| Objective: Helicobacter pylori(H.pylori) infection is closely associated with the upper gastrointestinal disease. The World Health Organization International Agency for Research on Cancer defined H.pylori as the human class I carcinogen in 1994. Therefore, the detection and eradication therapy of H.pylori is very important. However, after many years of research on the eradication of H.pylori, still have not found the best therapy. In fact, after the first-line treatment regimen is still about 20%of patients need further treatment. This increases the cost of treatment, the psychological burden of patients, etc. Thus, looking for factors, whichcan predict eradication success, is very important to H.pylori eradication. The detection value of 13C- urea breath test(13C-UBT) reflects the totalurease activity in the stomach. Its DOB(delta over baseline) values can be used as a indicator of H.pylori colonization density in gastric. Moreover, some studies have elucidated DOB values canpredict whether the first-line treatment can eradicate success, they think, the higher the DOB values, the lower eradication rate. But some studies have found no relationship between DOB values and eradicate effect.The aim of this study was to study if there is a correlation between13C-urea breath test values prior to treatment and the response to triple therapy and quadruple therapy. Does the 13C-urea breath test values prior to treatment is useful to predict the success or failure of eradicating therapy?Methods: 1 Patient selection: A total of 200 by 13C-UBT detect H.pylori-positive patients were chooseed from December 2013 to December 2014 in the Third Hospital of Hebei Medical University, Department of Gastroenterology. 1.1 Inclusion Criteria: ①Between the ages of 18 to 70 years, able and willing to be followed up;②13C-UBT had results for H.pylori positive; ③Patients had not previous history of regular H.pylori eradication therapy; ④All patients were informed and consent before enrolling the study protocol. 1.2 Exclusion criteria: ①Patients had not received antibiotics, bismuth agents in the 4 weeks before treatment and had not received proton pump inhibitors, H2 receptor antagonists(H2RA) in recently 2 weeks; ②There is a history of gastrectomy surgery;③Patients with serious brain, lung, liver, kidney dysfunction; ④Pregnant or lactating women;⑤Patients who were allergic to the study drugs.2 Methods 2.1 Grouping: All patients met the inclusion criteria were randomly divided into A, B two groups for H.pylori eradication therapy, respectively. Group A was triple therapy group, 100 cases; Group B was quadruple therapy group, 100 cases.2.2 Methods:All patients were treated with 13C-UBT testing, and the results are positive for H.pylori, DOB values were recorded, and were following theeradication of H.pylori eradication therapy be:Group A(Triple therapy group, n=100): Received esomeprazole(20mg bid) + amoxicillin(1000mg bid) + furazolidone(100mg bid), for 10 day;Group B(quadruple therapy group, n=100): Received esomeprazole(20mg bid) +bismuth 220mg+ amoxicillin(1000mg bid) + furazolidone(100mg bid), for 10 day.Esomeprazole and Bismuth potassium citrate were taken half an hourbefore meals, antibiotics in each groups were taken immediately after meals. After the eradication of H.pylori, duodenal ulcer patients continuedto give esomeprazole 20 mg qd, rebamipide 100 mg tid orally four weeks, gastric ulcer patients continued to give esomeprazole 20 mg qd, rebamipide 100 mg tid orally six weeks. 2.3 Efficacy: H.pylori eradication rate was assessed by 13C-UBT, four weeks after the course of treatment. The adverse reactions and the compliance were observed and recorded during the therapy. 2.4 Statistical Analysis: Application SPSS13.0 statistical software for analysis. Measurement data are expressed as Minimum or Maximum or Mean ±Standard, Median+Quartile Range deviation. The comparison of the rate was analyzed by χ2 test. Homogeneity of variance of the normal distribution of information between the two groups using independent samples t test. Non-normal distribution of information between the two groups using Wilcoxon rank sum test. P<0.05 was considered statistically significant.Results:1 General information: A total of 200 patients enrolled, 100 cases of group A, 53 males and 47 females, aged 18~70 years, mean age(44.82±14.39), 23 cases of peptic ulcer, chronic active gastritis 49 cases, 28 casesof functional dyspepsia; Group B 100 cases, 52 males and 48 females, aged 18~70 years, mean age(44.98±15.81), 32 cases of peptic ulcer, chronic active gastritis 44 cases, 24 cases of functional dyspepsia. Patientsin each group showed no significant difference in age, gender, disease classification(P>0.05)(Table 1-2).2 H.pylori eradication rate: Five were lost to follow-up in total, 150 cases of successful eradication. Two patients were lost in group A, 63casesof successful eradication; 3 patients were lost in group B, 87 cases successfully eradicated. The H.pylori eradication rates by Per-protocol(PP) analysis were 64.3%(63/98), 89.7%(87/97), respectively, by intention-to-treat(ITT)analysis in groups A, B were 63.0%(63/100), 87.0%(87/100), respectively. The H.pylori eradication rate in group B was significantly higher than that in group A by PP and ITT analysis(P=0.000,P=0.000)(Table 3).3 DOB values: Basal DOB values were categorized as low(<16), intermediate(16–35), or high(>35), as suggested in previous studies[9,10].Bysubgrouping patients into the three DOB classes, a trend to higher eradication rates was found when comparing the DOB <16 group and those two with higher values, although the difference was not statisticallysignificant(P>0.05)(Table 4).4 DOB values in the eradication failure and successful cured patients: Although basal DOB values tended to be higher in the eradication failurethan in the successful cured patients, the difference was not statistically significant(P>0.05)(Table 5).5 In addition, the difference in age was not statistically significant(P>0.05); similar H.pylori eradication rate were observed in male and femalepatients, drinkers and nondrinkers patients; H.pylori eradication rate in peptic ulcer was significantly higher than that in non-ulcer dyspepsiapatients, as well as in nonsmokers and smokers(Table 6-7).Conclusion:This study failed to demonstrate a role for DOB value in H.pylori eradication with either atriple therapy or quadruple therapy. Therefore, theeffect of H.pylori eradication can not be predicted based on DOB values before treatment. |
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