Clinical research on Angongniuhuang pill adjuvant to haloperidol for the treatment of intensive care unit patients with postoperative delirium

Abstract

Objective To observe the clinical effects and safety of Angongniuhuang Pill(a traditional Chinese medical preparation) adjuvant to haloperidol for the treatment of Intensive Care Unit (ICU) patients in postoperative delirium. Methods A prospective study of 243 postoperative patients with delirium adimitted in Intensive Care Unit of Xinjiang Medical University First Affiliated Hospital (January 2013-December 2014), by using confusion assessment method of Intensive Care Unit(CAMICU). All of 243 patients with delirium were randomly divided into two groups by computer randomization software (SAS 9.1): group A in which patients were treated with Angongniuhuang Pill adjuvant to haloperidol and group Fin which patiets were treated with haloperidol alone. The end of two intervention methods was determined by two consecutive CAMICU showing negative or the treatment were ended up at seven days treatment.The data of general information, and the results of treatment were recorded and analized by statistical software SPSS 19.0. The measurement data was expressed as mean±standard deviation; the comparision between two groups was tested by t test; and repeated measurement was analised by variance. Count data was described as number and constitution ratio; and intergroup comparision was tested by Chi-square test. Results There was no significant difference in general information between two groups.The delirium duration and ICU treatment time in group A were shorter than those in group F[(3.0 ± 0.9)d vs.(3.8 ± 1.0)d, P= 0.010; (6.2 ± 1.4)d vs.(6.7 ± 1.5)d, P= 0.008]. When delirium was diagnosed (T0), all patients had EEG abnormalities. As treatment went on, EEG abnormal rate gradually declined. At day one (T1), there was no statistically significant difference in EEG findings between group A and group F (95.7% vs. 97.5%, P= 0.045). At day two (T2) and day three (T3), there was statistically significant difference in EEG findings between group A and group F (65.5% vs. 77.7%, P= 0.038; 42.2% vs. 56.2%, P= 0.032). The levels of S100β protein, interleukin-6 (IL-6), tumor necrosis factor α (TNF-α) in two groups at T0 were all elevated without noticeable difference. These markers were all deceased at T1, T2, T3, but the speed of descend in group A was relatively faster than that in group F. The differences were statistically significant (S100β: time effect P<0.01, inter-group effectp=0.002, interaction effectp=0.686; IL-6: time effect P<0.01, inter-group effectp=0.034, interaction effectp=0.01; TNF-α: time effect P<0.01, inter-group effectp=0.003, interaction effectp=0.516). The discharge rate in group A after improvement of general condition was higher than that in group F (89.7% vs. 79.3%, P= 0.029). The incidence of postoperative complications and mortality 28 days after operation in group A were lower than those in group F (45.7% vs. 58.7%P= 0.045; 12.9% vs. 24.0%, P= 0.028). Conclusion During the treatment of delirium, Angongniuhuang pill adjuvant to haloperidol was a better method compared with using haloperidol alone in respect of effectiveness and safety perspectives. It may be a novel approach to the treatment for delirium by the combination of Chinese and Western medicine. Key words: Angongniuhuang pill; Haloperidol; Postoperative delirium; ICU patient