| Objective:To observe the clinical efficacy of early oral administration of Oryzae oryzae pancreas e tablets on acute pancreatitis dyspepsia and the influence of pancreatic exocrine function,detect the change of fecal elastase-1 level,and evaluate the safety of oryzae oryzae pancrease tablets in patients with acute pancreatitis,so as to provide reference for clinical rational drug use.Methods:1.Basic data From May 2022 to March 2023,in the Department of Gastroenterology of Yichun People’s Hospital,75 patients with acute pancreatitis with dyspepsia during early eating were randomly assigned to the experimental group and the control group in a ratio of 2:1.The drug regimen was as follows:control group:conventional treatment;Experimental group:on the basis of conventional treatment,early oral administration of Aspergillus oryzae pancrease tablets was added,one tablet three times a day,taken during eating,swallowed whole tablet without chewing,for 14 days in patients with mild acute pancreatitis(MAP),for 28 days in patients with moderate and severe acute pancreatitis(MSAP)and severe acute pancreatitis(SAP).The scores of dyspepsia,remission rate of dyspepsia,quality of life score,incidence of adverse events and fecal elastinase-1 level of the two groups were compared before and after treatment.Meanwhile,stool of 20 healthy adults was collected for fecal elastinase-1 detection.2.Statistical method All the data in this study were summarized,summarized and sorted out,accurately input into Excel,and statistical analysis of the data was carried out with spss22.0 statistical software.Measurement data were expressed as mean ± standard deviation((?)±s),and all measurement data were subject to normal distribution test.If they were consistent with normal distribution,independent sample t test was used for data comparison between two groups,and one-way analysis of variance was used for data comparison between multiple groups.If the normal distribution was not consistent,the Mann-Whitney U nonparametric test was used for comparison of data between two groups,and Kruskal-Wallis H nonparametric test was used for comparison of data between multiple groups.Counting data were represented by frequency(n)and percentage(%),and Chi-square test or Fisher’s exact test was used according to data characteristics.Observation index values obtained from multiple measurements of subjects were used by repeated measurement analysis of variance or multivariate analysis of variance.P<0.05 was considered statistically significant.Results:1.A total of 75 patients with acute pancreatitis were included in this study,which were randomly assigned to the experimental group and the control group in a ratio of 2:1.During the treatment process,2 male patients in the experimental group withdrew from the study,and 73 patients participated in the whole study.2.Comparison of baseline data between the two groups:there were no significant differences in age,gender and severity of acute pancreatitis between the two groups(P>0.05).3.Comparison of dyspepsia symptom score between the two groups:dyspepsia symptom score in MAP patients of test group and control group changed at different time periods,the difference was statistically significant(P<0.05),dyspepsia symptom score in MAP patients of test group was lower than control group on the 14th day of treatment,the difference was statistically significant(P<0.05);Dyspepsia symptom score in MSAP and SAP patients,experimental group and control group were changed at different time periods,the difference was statistically significant(P<0.05),dyspepsia symptom score in MSAP and SAP patients,experimental group were lower than control group on the 14th and 28th day of treatment,the difference was statistically significant(P<0.05).4.Comparison of remission of dyspepsia between the two groups:relief of dyspepsia after 14 days of treatment in MAP patients,the relief rate of dyspepsia in test group was higher than that in control group,and the difference was statistically significant(P<0.05).After 28 days of treatment in MSAP and SAP patients,the remission rate of dyspepsia in test group and control group was higher than that in control group,and the difference was statistically significant(P<0.05).5.Comparison of changes in FE-1 value between the two groups:there was no significant difference in FE-1 value between MAP patients in test group and control group on day 1,day 7 and day 14(P>0.05).There was no significant difference in FE-1 value between test group and control group in MSAP and SAP patients on day 1,day 7,day 14 and day 28(P>0.05).The value of FE-1 in MAP test group and control group on day 1,day 7 and day 14 was lower than that in healthy group,and the difference was statistically significant(P<0.05).FE-1 value in MSAP and SAP patients in test group and control group on day 1,day 7,day 14 and day 28 was lower than that in healthy group,and the difference was statistically significant(P<0.05).6.Comparison of quality of life scores between the two groups:After 14 days of treatment,the scores of test group and control group in five dimensions of physiological function,general health status,energy,social function and mental health were higher than those of control group,and the difference was statistically significant(P<0.05).However,there was no significant difference in the three dimensions of physiological function,physical pain and emotional function(P>0.05).After 28 days of treatment for MSAP and SAP patients,test group and control group scored higher than control group in seven dimensions of physiological function,physiological function,general health status,energy,social function,emotional function and mental health,with statistical significance(P<0.05).However,there was no significant difference in the dimension of physical pain(P>0.05).7.Safety comparison between the two groups:there was 1 case of adverse reaction in the experimental group,and there was no statistical significance in the incidence of adverse reaction between the two groups(P>0.05).Conclusion:1.Early oral administration of Aspergillus oryzae pancrease tablets can improve the dyspepsia symptom score and improve the quality of life of patients with acute pancreatitis.2.Early oral administration of Aspergillus oryzae pancrease tablets has high safety and is expected to be a new treatment for acute pancreatitis dyspepsia.3.The detection of fecal elastase-1 has certain reference value in the diagnosis of pancreatic exocrine insufficiency in patients with acute pancreatitis.4.Aspergillus oryzae pancreatic enzyme tablets may have no significant effect on pancreatic exocrine function in patients with acute pancreatitis. |
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