| ObjectiveThe eradication of Helicobacter pylori is of great significance to peptic ulcer, H.pylori-induced chronic gastritis with indigestion, mucosa-associated lymphoid tissue(MALT) lymphoma,chronic gastritis with gastric mucosa atrophy or erosion, early gastric cancer, unexplained iron-deficiency anemia and idiopathic thrombocytopenic purpura. The antimicrobial resistant rate of H.pylori has been increasing rapidly because of non-standard eradication therapy and many kinds of antimicrobial agents being used in clinical treatment, which leading to the decreasing of eradication rate year by year. Antibiotics resistance has become the main factor affecting treatment options and their effects. Due to the unsatisfactory curative effect, standard triple therapy has been replaced by a high eradication rate plan gradually.In this context, the bismuth-containing quadruple therapy and accompanying therapy showed a better efficacy and higher drug safety. But the antibiotics resistance spectrum of H.pylori in the area of Zhengzhou and the difference in therapeutic effect of the two regimens in this area remain to be unknown, without a systematic clinical research so far. This study was designed to evaluate the efficiency and safety of bismuth-containing quadruple therapy and accompanying therapy. And the susceptibility of the commonly used antibiotics referred in the eradication therapy was tested. Then conduct a correlation analysis between antimicrobial resistance and the efficacy of the mentioned two regimens, providing evidence for the treatment options of this area. Methods1. H.pylori resistance analysis: Randomly selected 284 patients who visited the Gastroenterology of the First Affiliated Hospital of Zhengzhou University from July 1, 2014 to July 1, 2015. All these patients were diagnosed as chronic erosive gastritis or peptic ulcer by gastroscopy. And their C13 breath tests were positive. All patients were taken biopsies in gastric antrum tissue in the gastroscopy. Then isolate and culture the H.pylori of their biopsy tissue. All patients were Zhengzhou residents and long-term residence in the region, and signed informed consent before enrollment. Using E-test(Epsilome test) method to isolate and culture the H.pylori strains, then test the susceptibility of metronidazole, clarithromycin, amoxicillin.2. Clinical study: Enrolled patients were randomly divided into four groups and used four therapies respectively.Group A Esomeprazole magnesium enteric-coated tablets 20 mg, metronidazole tablets 400 mg, clarithromycin tablets 500 mg, amoxicillin 1000 mg, 1 twice a day, 7 days treatment.Group B Esomeprazole magnesium enteric-coated tablets 20 mg, bismuth potassium citrate capsules 220 mg, clarithromycin tablets 500 mg, amoxicillin 1000 mg, 1 twice a day, 7 days treatment.Group C Esomeprazole magnesium enteric-coated tablets 20 mg, metronidazole tablets 400 mg, clarithromycin tablets 500 mg, amoxicillin 1000 mg, 1 twice a day, 14 days a course of treatment.Group D Esomeprazole magnesium enteric-coated tablets 20 mg, bismuth potassium citrate capsules 220 mg, clarithromycin tablets 500 mg, amoxicillin 1000 mg, 1 twice a day, the course of 14 days.Observe and record possible adverse reactions and the remission of gastrointestinal symptoms in the course of treatment. And give the C13 breath test after eradication treatment for 4 weeks. Results1. H.pylori culture resultsThis study collected 270 patients with their gastric mucosa, including 98 cases of H.pylori culture-positive. The overall culture positive rate was 36.3%. The culture-positive rate in male and female patients was 37.1% and 35.4% respectively. And the rate in the group A, B, C, D was 40.6%, 36.4%, 33.8% and 34.3%, respectively. Comparing the H.pylori strain culture positive rate between different genders and different groups, there was no statistically significance according to the statistical analysis(P> 0.05).2. Susceptibility test resultsIn 98 cases of H.pylori culture positive specimens after susceptibility testing, the resistance rate of metronidazole, clarithromycin, and amoxicillin was 60.2%, 25.5% and 3.1% respectively. Besides, the metronidazole and clarithromycin dual resistant strains were found in this test, whose resistance rate was 13.3%. And then comparing the antibiotics resistance rate in different genders, the difference was not statistically significant(P> 0.05).3. Resistance patterns of different diseasesIn 98 patients with culture-positive, 61 cases were erosive gastritis and 37 cases were peptic ulcer. In these 61 cases of erosive gastritis, the resistance rate of metronidazole, clarithromycin and amoxicillin was 67.2%, 27.9% and 3.3% respectively. And in the 37 cases of peptic ulcer, the resistance rate of the above three antibiotics was 48.6%, 21.6% and 2.7%. We also found that the resistance rate of these three antibiotics was no statistical difference between erosive gastritis and peptic ulcer(P >0.05).4. Comparison of H.pylori eradication rates, adverse reactions incidence rates and gastrointestinal symptoms remission rates in different regimens and coursesThis study included 284 patients. By using Per-protocol(PP) analysis, the H.pylori eradication rate of group A, B, C and D was 84.06%, 83.33%, 94.12% and 97.91% respectively. While the H.pylori eradication rate of group A, B, C and D was 81.69%, 77.46%, 92.96% and 91.55% respectively by using Intention-to-treat(ITT) analysis. The differences of H.pylori eradication rates between group A and group B, group C and group D were not statistically significant(P> 0.05) after PP and ITT analysis. However, the differences of H.pylori eradication rates between group A and group C, group B and group D had statistically significance(P< 0.05) after PP and ITT analysis. Besides, the differences of adverse reactions incidence rates and gastrointestinal symptoms remission rates between these four groups were not statistically significant(P> 0.05).5. The influence on eradication rate of H.pylori resistance to antimicrobial agents with different courses of accompany therapy and bismuth-containing quadruple therapyIn group A, 28 cases were culture-positive. 13 patients were resistant to metronidazole and sensitive to clarithromycin at the same time, including 11 cases of successful eradication. 5 patients were dually resistant to metronidazole and clarithromycin, including 4 cases of successful eradication. 7 patients were both sensitive to metronidazole and clarithromycin, including 6 cases of successful eradication. 3 patients were sensitive to metronidazole and resistant to clarithromycin at the same time, including 2 cases of successful eradication. Above different patients, the differences of H.pylori eradication rates had no statistical significance by intra-group comparison.(P>0.05);In group B, 24 cases were culture-positive. 6 patients were resistant to clarithromycin, including 4 cases of successful eradication. 18 patients were sensitive to clarithromycin, including 15 cases of successful eradication. Both H.pylori eradication rates had no significant difference statistically(P> 0.05).In group C, 23 cases were culture-positive. 12 patients were resistant to metronidazole and sensitive to clarithromycin at the same time, including 11 cases of successful eradication. 2 patients were dually resistant to metronidazole and clarithromycin, and all cases were successfully eradicated. 6 patients were both sensitive to metronidazole and clarithromycin, and all cases were successfully eradicated. 3 patients were sensitive to metronidazole and resistant to clarithromycin at the same time, and all cases were successfully eradicated. Above different patients, the H.pylori eradication rates had no significant difference statistically by intra-group comparison(P> 0.05).In group D, 23 cases were culture-positive. 6 patients were resistant to clarithromycin, including 5 cases of successful eradication. 17 patients were sensitive to clarithromycin, and all patients were successfully eradicated. Both H.pylori eradication rates had no significant difference statistically(P> 0.05). Conclusion1. In Zhengzhou area, the H.pylori resistance rate of metronidazole and clarithromycin is high. And it exists the double resistant strains those are resistant to metronidazole and clarithromycin. However, the H.pylori resistance rate of amoxicillin is low.2. In Zhengzhou area, the bismuth-containing quadruple therapy for two weeks may be considered as the best eradication regimen. However, if bismuth is contraindicated for patients, we may also choose the accompany therapy.3. The H.pylori resistance to antimicrobial drugs has no significant correlation with diseases types both in erosive gastritis or peptic ulcer. |
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