米曲菌胰酶联合莫沙必利在FD患者中的临床研究OA

Objective To observe the clinical efficacy and safety of oryz-aspergillus enzyme and pancreatin tablets combined with mosapride tablets on functional dyspepsia(FD).Methods FD patients scheduled for treatment at our hospital were randomly assigned to either treatment group or control group using a randomized sequence method.The control group was treated with mosapride tablets at a dosage of 5 mg three times daily after meals.The treatment group received an additional dose of oryz-aspergillus enzyme and pancreatin tablets(1 tablet three times daily after meals)on bases of the control group's regimen.Both groups underwent treatment for 4 weeks.The clinical efficacy,gastric sensory function(gastric perceived water intake,gastric discomfort threshold),gastric electrical activity(fasting slow wave frequency variation coefficient and abnormal rhythm index,test-meal slow wave frequency variation coefficient and abnormal rhythm index),serum human Obestatin,serum calcitonin gene-related peptide(CGRP)and Nepean dyspepsia index(NDI)were compared between the two groups of patients,and the safety evaluation was performed.The patients were followed up for 6 months at the end of treatment and after drug withdrawal,and the recurrence rate was counted.Results A total of 257 cases were screened and 236 cases were enrolled,including 112 cases in control group and 124 cases in treatment group.After 4 weeks of treatment,16 cases in treatment group were lost due to loss of contact,poor compliance,presence of other diseases,drug intolerance and personal reasons.In control group,4 cases were lost due to loss of contact,active withdrawal from the study and poor compliance.Finally,108 cases were included in treatment group and 108 cases were enrolled as control group,respectively.After treatment,the total clinical effective rates in treatment group and control group were 89.81％(97 cases/108 cases)and 79.63％(86 cases/108 cases),respectively,with statistically significant difference(P＜0.05).After treatment,the gastric perceived water intakes in treatment group and control group were(621.73±28.05)and(611.91±25.86)mL,respectively;the gastric discomfort thresholds were(1 107.93±78.67)and(1 086.31±72.31)mL,respectively;the fasting slow wave frequency variation coefficients were 25.11±3.72 and 26.27±4.41,respectively;the fasting abnormal rhythm indexes were 25.28±3.62 and 26.59±4.03,respectively;CGRP levels were(68.74±10.19)and(73.67±14.52)pg·mL-1,and NDI scores were(19.26±2.29)and(20.51±3.35)points,respectively.Compared with control group,the differences of above indexes in treatment group were all statistically significant(all P＜0.05).After 6 months of follow-up at the end of treatment and after drug withdrawal,the recurrence rates in treatment group and control group were 3.77％(4 cases/106 cases)and 11.54％(12 cases/104 cases),respectively,revealing a statistical significant difference(P＜0.05).The adverse drug reactions in treatment group were dry mouth and dizziness,and dry mouth was observed in control group.The total incidence rates of adverse drug reactions in treatment group and control group were 1.89％(2 cases/106 cases)and 0.97％(1 case/104 cases),respectively,and the difference was not statistically significant(P＞0.05).Conclusion The combination of oryz-aspergillus enzyme and pancreatin tablets and mosapride tablets is more effective in improving gastric sensation and electrogastrographic activity in FD patients,while also reducing their risk of relapse.