| Purpose: Based on clinical perspective of the improvement of endoscopic performance and bacterial overgrowth in small intestinal before and after the treatment of reflux esophagitis(RE)patients,we determined and evaluated the effect of oral esomeprazole magnesium combined with two strains of live bacillus subtilis on clinical clinical therapy and recurrence of related diseasesMethod:From January 2015 to December 2015,select 240 patients who met the inclusion criteria from outpatient department or digestive wards of a level 3 first-class hospital in the eastern Shandong province(Criteria for diagnosis and classification of RE identified in accordance with the 2015 ASGE guidelines for endoscopic management and the Losangeles classification criteria).The RE grade is in A-D level,the age of patients if 20-65 years old,duration of disease is 2 weeks of to 1 year,and did not take PPI or disable PPI for at least 6 months.The 240 patients with RE were randomly divided into treatment group(n=120 cases)and control group(n=120 cases).The control group received PPI and placebo: patients were given oral esomeprazole(Nexium)20mg twice a day;placebo(white capsules),2 tablets each time,3 times daily for 8 weeks.The treatment group was given PPI and Bacillus subtilis enteric capsule: orally given esomeprazole(Nexium)20mg,2 times daily;Bacillus subtilis enteric capsule(treatment group)500mg,3 times daily for 8 weeks.Before medication,we checked the injury status of mucosa of RE patients by gastroscopy(Olympus HQ290),performed lactulose hydrogen breath test(Lactulose hydrogen Breath Test;LHBT)by application of hydrogen breath test instrument(Gastrolyzer type EC60),recorded the gas value,and calculated the positive rate of small intestinal bacterial overgrowth(SIBO).Within 3-4 days after the standard treatment(8 weeks),all patients of the control group and the experimental group went back to our hospital and underwent LHBT,gastroscope and completed the reflux disease questionnaire(RDQ Chinese gastroesophageal reflux disease study group made Nexium scale RDQ,also known as Nexium scale)and scored it.We did the follow-up to the patients.They were endoscopic cured and their RDQ was under 12.Patients completed the RDQ,if RDQ integral >12.It was believed that there was reflux recurrence,follow-up end point is defined as that the reflux symptoms happened again or the end of the follow-up(8 weeks).During follow-up,patients stop taking the antisecretory drugs and prokinetic drugs.All the patients were followed up once a week by telephone or outpatient service.We recorded the compliance of patients.The compliance was classified to “bad”if patients neglected taking the medicine for 3 days.Before treatment of after treatment for 8,blood and urine routine,stool routine,liver function,renal function,blood glucose were detected respectively for the two groups using biochemical methods.The adverse reactions such as headache,dizziness,nausea and diarrhea were observed and recorded.The formula is: healing rate of the mirror = the number of cases of healing under the microscope / the total number of cases × 100%,SIBO positive rate of =SIBO positive cases / total number of cases ×100%.Data was processed by SPSS21.0 software.Results:There was no statistically significant difference(p > 0.05)about age(44.8 + 13.88,45.2 + 14.43 years),sex ratio(61/52,58/52),duration(6.5 + 1.3,7.1 + 1.1 months),fasting glucose(5.02±0.45mmol/l,5.08±0.43 mmol/l),body mass index(23.2 + 2.4 kg/m2 23.4 + 2.2 kg/,M2),waist circumference(79.5 + 8.3cm,81 + 7.8cm),current smoking percentage(35,30.1%,28,25.5%),percentage of drinking >50g/week(31.7%,30,27.3%)of the patients in the treatment group and the control group;Before treatment,there was no significant difference between the two groups in endoscopic RE classification(p > 0.05);For 8 weeks after standard therapy,the endoscopic healing rate of treatment group was 91.2%,the value of control group was 91.2%.There was no significant difference between the two groups(p =0.873);the ratio of RDQ < 12 was 95.6%;95.5% respectively;no significant difference between the two groups(p =0.981).Before treatment,SIBO positive rate of the treatment group was 8.9%(10/113),the positive ratio of the control group was 9.1%(10/110),there was no statistically significant difference(p > 0.05),after 8 weeks standard treatment,SIBO positive rate of treatment group was 25.7%the control group was 43.6%(48/110),p =0.005.After stopping medication for 8 weeks,the SIBO positive rate of the treatment group was 24.7%(28/113),and the SIBO positive rate of the control group was 42(38.2%),P<0.05.The results showed that the SIBO positive rate in the treatment group and the control group after 8 weeks treatment was higher than that before treatment,but the SIBO positive rate in the treatment group was significantly lower than that in the control group,the difference between the two groups was statistically significant.The SIBO positive rate was decreased in two groups after standard treatment for 8 weeks,but the SIBO positive rate in the treatment group was lower than that in the control group,and the difference between the two groups was statistically significant.The positive rate of SIBO was decreased in two groups at the end of the drug withdrawal for 8 weeks,but the positive rate of SIBO in the treatment group was lower than that in the control group,and the difference between the two groups was statistically significant.All patients who received standard treatment stopped taking medicine for 8 weeks,went back to our hospital fill in the RDQ paralleled with LHBT.Our research found that in the treatment group,patient ratio with RDQ score >12 points was more than 9.7%(11/113),the SIBO positive rate was 24.7%(28/113);In control group,patient ratio with RDQ score >12 is 20%(22/110),the SIBO positive rate is 38.2%(42/110).The treatment group RDQ score(>12)was significantly lower than that of control group(9.7%,11/113,20%,22/110),reflux symptoms recurrence rate was lower than that of control group(p =0.031),the SIBO positive rate was significantly lower than that of control group(24.7%,28/113,38.2%,42/110).The results showed that esomeprazole combined with viable Bacillus subtilis for the treatment of RE can reduce the incidence of SIBO,and reduce the recurrence rate of RE.Conclusion:We compared oral esomeprazole 20 mg 2 times daily together with viable Bacillus subtilis enteric capsules 500 mg 3 times daily for 8 weeks with esomeprazole 20 mg 2 times daily for 8 weeks only.Endoscopic cure rate had no significant difference,but can reduce the reflux esophagitis recurrence rate.The recurrence rate was only 9.7% which may be related with that esomeprazole combined with live Bacillus subtilis can reduce the incidence of SIBO. |
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