A Randomized Controlled Study Of Fusu Agent In The Treatment Of Acute Respiratory Distress Syndrome(Sudden Yang Collapse)

Objective:To evaluate the clinical efficacy of Fusu Agent combined with western medicine in the treatment acute respiratory distress syndrome?ARDS?of the Syndrome Sudden Yang Collapse,and to provide scientific experimental basis for the clinical diagnosis and treatment of ARDS by traditional Chinese medicine,and to improve the level of diagnosis and treatment of ARDS by traditional Chinese medicine.Method:Using randomized,single-center,controlled,and double-blind clinical research methods,60 patients who met the inclusion criteria were randomly divided into a test group and a control group.According to the predetermined treatment plan,both groups of patients received conventional Western medicine treatment.The experimental group was treated with the traditional Chinese medicine Fusu Agent?20g oral or nasal feeding tid?,and the control group was given placebo?20g oral or nasal feeding tid?.The expected treatment period was 14 days.The main observation indicators are invasive/non-invasive mechanical ventilation support time,oxygenation index?Pa O₂/Fi O₂?and positive end-expiratory pressure?PEEP?on the seventh and fourteenth days of treatment.The secondary observation indicators were the 28th-day mortality,in-hospital mortality,total hospital stay,evaluation of the effectiveness of Traditional Chinese Medicine?TCM?after 14 days of treatment,the reduced TCM symptom scores in the first and second weeks,and the APACHE II score.And observe the adverse reactions of two groups of patients during the treatment.Data analysis was performed using SPSS 26.0 statistical software to evaluate its clinical efficacy and safety.Result:A total of 68 patients were included in the trial,8 of whom were fell off,and 30patients in each of the test group and the control group.There were 28 males and 40females,with an average age of 57.59±12.77 years.13 patients with mild ARDS?19.12%?,32 patients with moderate ARDS?47.06%?,and 23 patients with severe ARDS?33.82%?.Comparison of baseline characteristics between the two groups of patients and the difference was not statistically significant?P>0.05?,indicating that the baseline of the two groups of patients is balanced and comparable between groups.?1?Mechanical ventilation time:The median time required for the test group was207.50 h,and the control group was 234.50 h.Compared with the two groups of patients,the test group required less support time,and the difference was statistically significant?Z=2.225,P=0.026<0.05?.?2?PEEP and Pa O₂/Fi O₂:After the first and second weeks of treatment,the PEEP and Pa O2/Fi O2 of the two groups of patients improved significantly,and the difference between the two groups was statistically significant?8.60±3.83 vs.11.28±3.66,5.14±2.12 vs.8.64±3.18?216.15±60.68 vs.177.01±57.36,272.80±81.46 vs.224.36±98.55,P<0.05?.?3?On day 28,the case fatality rate was 30.00%in the experimental group and43.33%in the control group.12 patients in the experimental group had an in-hospital death,a mortality rate of 40.00%,and 14 patients in the control group died,a mortality rate of 46.67%.There was no significant difference in the 28-day mortality and in-hospital mortality between the two groups?P>0.05?;however,the total length of hospital stay in the experimental group was less than that in the control group,and the difference was statistically significant?16.27±6.70dvs.21.52±9.96d,P<0.05?.?4?Evaluation of TCM:On the 14th day,the total effective rate of TCM in the experimental group was 86.67%,and the total effective rate of TCM in the control group was 63.33%.There was a statistically significant difference in the total effective rate and TCM effect between the two groups of patients?P<0.05?.?5?TCM symptom score:After one week of treatment,the TCM symptom score in the test group decreased by 7.00 points compared with the initial treatment,and the control group decreased by 4.50 points.After two weeks of treatment,the TCM symptom score in the test group decreased by 5.00 compared with the first week,and the control group decreased by 1.00.There was a statistically significant difference in the TCM symptom scores of the two groups of patients?P<0.05?.?6?Safety and adverse events:No serious adverse events occurred in the two groups.The most common adverse reactions were diarrhea,nausea,and vomiting.There was no significant difference in adverse reactions between the two groups?P<0.05?.Conclusion:Fusu agent combined with conventional western medicine for the treatment of patients with the Acute Respiratory Distress Syndrome of Sudden Yang Qi Collapse type is more effective than conventional western medicine.Fusu agent can reduce the mechanical ventilation support time of ARDS patients,improve the oxygenation index,PEEP,reduce the TCM symptom score and APACHE II score.And to a certain extent,it reduces the patient's mortality,improves the patient's prognosis,and has good safety.