Clinical Study On Treatment Of ICU Delirium With The Method Of Warming Kidney And Subsiding Yang

Objective:To evaluate the clinical efficacy and safety of traditional Chinese medicine based on the method of warming kidney(The particle of Modified Ningshen Pellet)and subsiding yang combined with western medicine in the treatment of ICU delirium.Methods:A randomized controlled trial was conducted in which patients enrolled through screening were randomly assigned to the treatment group and the control group,and both groups were given basic standard treatment by western medicine,and the treatment group was treated with traditional Chinese medicine(20g po tid)and the control group was treated with placebo(20g po tid),the treatment period was 14 days,and the follow-up was 28 days.The diagnosis of delirium was performed with CAM-ICU,and the severity score of DRS-R-98 scale(D score)and TCM syndrome score were used to evaluate delirium severity.The primary end point was the number of days with delirium and the cure rate during the 14-day intervention period.Secondary outcome indicators were D score,TCM syndrome score,total efficiency rate,TCM syndrome improvement rate,delirium recurrence rate,the time without mechanical ventilation in the first 28 days,the 28-day mortality,length of stay in ICU and length of stay.Results : A total of 76 patients were included,38 in each group,2 patients were excluded from the treatment group,and 2 patients were lost from the control group.each group ended up with 36 patients.Subjects in both groups had the same baseline and were comparable.The number of days with delirium in the treatment group during the 14-day intervention period was shorter than that of the control group [5.0(3,8)d vs 7.5(5,10)d,P<0.05],the cure rate in the first 14 days of the treatment group was higher than that of the control group [78% vs 50%,P<0.05],and the difference was statistically significant.The D score of the treatment group after treatment was lower than that of the control group [1(0,4)vs 2(1,11),P < 0.05],and the difference of D score before and after treatment in the treatment group was greater than that of thecontrol group [16(15,19)vs 15(7,18),P < 0.05],with statistically significant differences.The TCM syndrome score of the treatment group after treatment was lower than that of the control group [0(0,3)vs 1(0,6),P < 0.05],and the difference was statistically significant.The total efficiency rate and the total improvement rate of TCM syndromes in the treatment group were 94% while in the control group were89%,and the incidence of adverse reactions in the treatment group was 5.6% while in the control group was 7.9%,there was no statistical difference between the two groups(P > 0.05).There were no statistically significant differences between the two groups indifference of TCM syndrome score before and after treatment,number of days without mechanical ventilation in the first 28 days,the 28-day mortality,length of stay in ICU and length of stay(P > 0.05).Conclusions: 1.Traditional Chinese medicine based on traditional Chinese medicine combined with warming kidney combined with Western medicine comprehensive treatment of ICU delirium can shorten the duration of delirium,reduce the severity of delirium,have a higher cure rate.The total effective rate is greater than 90% and the safety is good;2.The treatment plan of this study could not reduce the 28-day fatality rate,number of days without mechanical ventilation in the first 28 days,delirium recurrence rate,length of stay in ICU,and length of stay in ICU.