| Objective:In this study,a randomized controlled clinical trial was conducted to evaluate the efficacy of Jinhong Decoction on sepsis and acute gastrointestinal injury caused by sepsis by retention enema.Methods:This is a randomized,controlled,double-blind study that was conducted on the inpatients from July 2021 to February 2023 in Dongzhimen Hospital of Beijing University of Chinese Medicine who received retention enema using traditional Chinese medicine granules.A total of 35 subjects were included at the beginning of the study,one of which fell off,and 34 were eventually included,all of whom and were≥18 years old.All of them met the diagnostic criteria for sepsis and acute gastrointestinal injury caused by sepsis,and did not meet the exclusion criteria.Gender,age,initial infection site and past medical history of the subjects were collected as general baseline data.Gastrointestinal symptoms,diet,excretion and absorption of the subj ects were used as therapeutic evaluation indexes for acute gastrointestinal injury.SOFA score,APACHE Ⅱ score and inflammation index were collected as therapeutic evaluation indexes for sepsis.Excel was used to establish a database,grade evaluation of each index was carried out,and statistical analysis was carried out with Spss 26.0.Chi-square test,t test and non-parametric test were used to compare the differences among different data types.Repeated measurement analysis of variance and generalized linear model were used for repeated measurement analysis.Results:At the beginning of this study,a total of 35 subjects were included,one of which fell off,and 34 subj ects were eventually included,which were divided into experimental group and control group,with 17 subjects in each group1.General information and baseline informationThere were no differences in gender,age,initial infection site,past medical history and severity of sepsis and acute gastrointestinal injury between the two groups,which were comparable.2.Main therapeutic indexes2.1 Classification of acute gastrointestinal injuryThe overall grade of acute gastrointestinal injury showed a decreasing trend,and the decreasing trend was more obvious in experimental group.For intra group comparison,compared with D0,D3 and D5,the grade of acute gastrointestinal injury in experimental group D8 showed statistical difference,while the grade of acute gastrointestinal injury in control group showed no difference over time.For inter group comparison,the difference between the two groups was statistically significant.2.2 Classification of appetiteThe overall grade of appetite showed a decreasing trend,and the decreasing trend of experimental group was more obvious.There was no difference in appetite grading for intra group comparison over time.There was statistical difference between the two groups for inter group comparison(P=0.05).2.3 Classification of diarrheaThe diarrhea grade of the experimental group showed a downward trend,while that of the control group showed an upward trend.There was no difference in diarrhea grading for intra group comparison over time.For inter group comparison,there was a statistically significant difference in D5 between the two groups.2.4 Classification of bowel soundsThe grade of bowel sound in the experimental group showed a downward trend,while that of in the control group(grade 3,grade 4)showed a downward trend.For intra group comparison,compared with D0,the grading of bowel sound in experimental group D8 showed statistical difference,while that in control group showed no difference over time.For inter group comparison,there was a statistically significant difference in D 8 between the two groups.2.5 Enteral nutrition tolerance scoreThe overall enteral nutrition tolerance score decreased gradually,and the decreasing range was more obvious in experimental group.For intra group comparison,the enteral nutrition tolerance scores of D5-D0,D8-D0 and D8-D3 in experimental groups were statistically different,while that in control group showed no difference over time.There were significant differences in enteral nutrition tolerance scores in D8 between the two groups for inter group comparison.2.6 Total lymphocyte count and classification of malnutrition2.6.1 Total lymphocyte countThe overall total lymphocyte count increased gradually.For intra group comparison,there was no difference in total lymphocyte count over time.There were significant differences in total lymphocyte count between the two groups for inter group comparison.2.6.2 Classification of malnutritionThe overall nutrient grade showed a downward trend.For intra group comparison,there was no difference in nutrient grading over time.For inter group comparison,the difference between the two groups was statistically significant3 Secondary efficacy indicatorsSOFA score,APACHE Ⅱ score and the levels of WBC,NE%,CRP and PCT showed an overall decreasing trend,and the decreasing trend of experimental group was more obvious.There was significant difference in WBC level between the two groups for inter group comparison,but no significant difference in other secondary efficacy indexes.Conclusions:1.Jinhong Decoction by retention enema has a good effect on reducing the grade of acute gastrointestinal injury caused by sepsis and improving intestinal nutritional tolerance and nutritional status.2.Jinhong Decoction by retention enema has a certain effect on improving the symptoms of acute gastrointestinal injury caused by sepsis such as loss of appetite,abnormal bowel sounds and diarrhea.3.Jinhong Decoction by retention enema has a certain effect on controlling and improving the inflammation level of sepsis patients,and has a certain effect on reducing SOFA score and APACHE Ⅱ score of sepsis patients. |