A Multi-center,Prospective,Randomized Controlled And Animal Experimental Study Of Integrated Chinese And Western Medicine Treatment Of ARDS

Objective:Evaluate the clinical effect of Fusu Agent combined with Western medicine comprehensive treatment on patients with acute respiratory distress syndrome?ARDS?,and study the effect of resuscitation mixture on alveolar cells and inflammatory factors in ARDS rats.Provide scientific experimental basis for clinical diagnosis and treatment of ARDS in Chinese medicine,and use objective data to verify the efficacy of traditional Chinese medicine in treating ARDS,while also improving Participation of Chinese medicine in the treatment of ARDS.Method:Affiliated hospitals of Chengdu University of Traditional Chinese Medicine,Meishan Traditional Chinese Medicine Hospital,Neijiang Second People's Hospital and Suining Traditional Chinese Medicine Hospital were selected from August 2018to December 2019,and 105 patients with ARDS meeting the inclusion criteria were admitted.Inclusion criteria:In accordance with the 2012 European Critical Society's reformulation of the Berlin Definition of ARDS diagnostic criteria.A computer-generated random number table was used to divide the random number table into 53 cases in the control group and 52 cases in the treatment group.The two groups were given conventional western medicine treatment at the same time.The treatment group was added with the Fusu Agent?30 grams of aconite,15 grams of amomum,30 grams of turtle plate,10 grams of ephedra,10 grams of dried ginger,and 12 grams of licorice?on the basis of conventional western medicine Ultrafine powder,20g each time,three times a day,nasal or oral),the control group was given the same amount of placebo?provided by the Department of Pharmacy,Affiliated Hospital of Chengdu University of Traditional Chinese Medicine?.Both groups were treated for 14 days.Collect 28-day mortality,90-day mortality,ICU hospital stay,TCM curative effect evaluation,TCM syndrome score,ventilator parameters,oxygenation index,APACHE?score,ventilator use,antibiotic use,and hospital admissions in both groups Infection status,etc.,and observe the adverse reactions during the treatment of the two groups of patients.Data analysis was performed using SPSS 25.0 statistical software to evaluate its clinical efficacy and safety.Endotoxin?LPS?induced ARDS mouse model.After successful modeling,a blank group,a model group,a low-dose treatment group,and a high-dose treatment group were established.Except for the blank group,the rest of the groups were given a resuscitation mixture for 7 days of intervention.The number and morphology of alveolar type I and type II epithelial cells in different groups of mice were detected by histopathology,and the levels of marker proteins AQP-5,SP-C,DLK1 and Notch in alveolar epithelial cells were detected by immunohistochemistry.Inflammatory index detection in diabetic mice:Elisa detected serum IL-6 and TNF-?in mice of each group.The benign intervention effect and cytokine level changes of the resuscitation mixture on the proliferation of type I and type II alveolar epithelial cells in mice were clarified.Result:1. General information comparisonA total of 105 patients were enrolled.53 patients in the treatment group,26males?49.06%?,27 females?50.94%?,and a median age of 62.00 years;31 males?59.62%?and 21 females?40.38%?,with a median age of 58.00 years.In the treatment group and control group,the age,gender,and severity of the disease,the causes of ARDS,the underlying disease composition,the vital signs and oxygenation index at the time of admission,the initial TCM symptom score and APACHE?score,the initial ventilator model Comparing the set ventilator parameters and the treatments received,there was no significant difference between the two groups of patients?P>0.05?.2. Main outcome indicatorsAfter 28 days of treatment,the 28-day mortality rate was 26.42%in the treatment group and 46.15%in the control group.The difference was statistically significant?HR:0.502,95%CI:0.259-0.970,P=0.035<0.05?.During the 90-day follow-up,the mortality rate in the treatment group was 32.08%and the mortality rate in the control group was 55.77%.There was a statistically significant difference between the two groups?P<0.05?.3. Secondary outcome indicatorsAfter the first week of treatment,the patients in the two groups improved in terms of APACHE?score,PEEP,Pa O2/Fi O2,etc.,and the difference between the two groups was statistically significant?both P<0.05?.After the second week of treatment,the two groups of patients improved in TCM syndrome score,APACHE?score,Pa O2/Fi O2 and other aspects,and the difference between the two groups was statistically significant?both P<0.05?.In terms of TCM efficacy evaluation,there was a statistically significant difference in TCM efficacy between the two groups of patients?P<0.05?.The total effective rate of the treatment group was 79.25%,and the total effective rate of the control group was 61.54%.The total effective rates of the two groups were compared,and the difference was statistically significant?P<0.05?.In terms of mechanical ventilation time,the median time in the treatment group was 114.00h and the median time in the control group was 210.75h.The difference between the two groups was statistically significant?P<0.05?.In terms of ICU hospital stay,the median time in the treatment group was 182.00h and the control group was 328.00h.The difference between the two groups was statistically significant?P<0.05?.4. Comparison of hormone use and hospital infectionPatients in the control group received longer and larger doses of hormone therapy than those in the treatment group?7.00d vs.3.50d,480.00mg vs.180.00mg,P<0.05?.In the treatment group,8 patients?15.38%?developed hospital sensation,among which 7 patients?13.21%?developed VAP.In the control group,there were 11 patients?20.00%?who developed hospital sensation,among which 9 patients?17.31%? developed VAP.There was no statistically significant difference in nosocomial infection rate between the two groups?=1.362,P=1.00>0.05?.5. Adverse reactions and safetyIn the treatment group and control group,5 and 3 patients had nausea,10 and 4patients had vomiting symptoms,and 8 and 10 patients had diarrhea symptoms.The adverse reactions of the two groups were not statistically significant.P>0.05),suggesting that clinical use of the resuscitation mixture has better safety.6. Experimental researchAfter intervention in the model group,compared with the blank group and the model group,SP-C,AQP-5 and notch protein expression increased significantly;the model group's TNF-?and IL-6 were significantly higher than the blank group,after the intervention of resuscitation mixture IL-6 No obvious changes,but TNF-? decreased significantly.SP-C,AQP-5 and Notch protein were significantly higher than the blank tissue staining score?P<0.01?,with statistically significant significance;and SP-C,AQP-5 and Notch protein expression in the intervention group were higher than the model group,It is statistically significant?P<0.05?.SP-C,AQP-5 and Notch protein expressions gradually increased from"blank group?model group?intervention group",and the differences between the groups were statistically significant?P<0.05?.Conclusion:Clinical research shows:The comprehensive Chinese and western medicine scheme can reduce the 28-day mortality and 90-day mortality of patients with acute respiratory distress syndrome.Compared with the control group,it has curative effects in terms of TCM syndrome score,APACHE?score,PEEP and Pa O₂/Fi O₂,ventilator use time,ICU hospitalization time,and oxygenation index.Better than the control group.Animal experiments show that the resuscitation mixture can promote the proliferation of type?and type?alveolar epithelial cells and is related to Notch protein;it can reduce the level of TNF-?and has good lung protection.