Study On The Efficacy And Safety Of Compound Omeprazole Dry Suspension In Treating Duodenal Ulcer

OBJECTIVE:The effectiveness and safety of compound omeprazole dry suspension in the treatment of duodenal ulcer were evaluated by randomized,double-blind doublesimulation,parallel control of positive drugs,and multi-center studies.METHODS:240 cases were selected,120 cases in the experimental group and 120 cases in the control group.After screening,the actual number of participants was 221,the experimental group was 109,and the control group was 112.The experimental group took oral compound omeprazole dry suspension(specification: 6 g/bag;1 time/day,1bag/time),omeprazole magnesium enteric-coated tablets simulation agent(specification,20 mg/tablet;1 time/day,1 tablet/time),and the control group took oral compound omep-razole dry suspension simulation agent(specification : 6 g/bag,1 time/day,1bag/time),omeprazole magnesium enteric-coated tablets(Losec MUPS;specification,20mg/ta-blet;1 time/day,1 tablet/time),for all drugs Warm water to serve.After 4weeks of drug treatment,subjects were evaluated clinically using randomized,doubleblind,double-simulation,parallel control of positive drugs,and multicenter studies.RESULTS:(1)Effectiveness evaluation:(1)main efficacy indicators: gastroscopy ulcer healing rate,FAS data set,experimental group was 88.46%,control group was 89.29%;PPS data set,experimental group was 90.72%,control group was 94.29%.(2)sensitivity analysis: gastroscopy ulcer healing rate,FAS data set,97.12% in the test group and 91.96% in the control group;PPS data set,100.00% in the test group and97.14% in the control group.(3)the secondary efficacy indicators: the effectiveness of gastroscope ulcers,the FAS data set,the test group was 95.05% and the control group was 96.23%;the PPS data set,the test group was 94.85% and the control group was 96.19%.The FAS data set and the PPS data set showed that there was no statistically significant difference between the experimental group and the control group under gastroscopy ulcer effective groups(P> 0.05).(2)Safety evaluation:(1)the overall incidence of adverse events: the incidence rate in the experimental group was 35.58% and the incidence rate in the control group was 32.14%.There was no significant difference in the severity of adverse events between the groups(P> 0.05).(2)the incidence of adverse reactions: the incidence rate in the experimental group was 5.77% and the incidence rate in the control group was8.04%.There was no significant difference between the two groups(P> 0.05).The adverse reactions were classified according to the organs of each system.(3)vital signs:no clinically significant changes in vital signs related to the study drug occurred during the study period.There were no statistically significant differences between two groups before and after body temperature,heart rate,respiration,and blood pressure(P> 0.05).(4)ECG: during the study period,there were no clinically significant changes in abnormal ECG examination related to the study drug.(5)physical examination: during the study period,there were no clinically significant changes in physical examination abnormalities related to the study drug.(6)laboratory inspection:during the study period,one subject in the test group developed abnormally elevated ALT and AST after taking the drug,and it had clinical significance.It was judged to be an adverse reaction,the degree was mild,and the remission occurred after stopping the drug.The rate is 0.96%.During the study period,one subject in the control group had abnormally elevated Cr after taking the drug,and it had clinical significance.It was judged as an adverse reaction,the degree was mild,and the remission after stopping the drug was 0.89%.CONCLUSIONS:Compound omeprazole dry suspension for the treatment of duodenal ulcer,fasting and taking at least 1 hour before meals,6 g/d(omeprazole 20 mg;sodium bicarbonate 1680 mg),the course of treatment is 4 weeks,has a better efficacy and safety.Efficacy and safety are equivalent to omeprazole magnesium enteric-coated tablets(Losec MUPS,specification: 20 mg/tablet),which has broad clinical application prospects.