Shun-wei Huang1, Xiang-dong Guan, Juan Chen, Bin Ou Yang. 1. Surgery Intensive Care Unit, the First Affiliated Hospital of Sun-Yat Sen University, Guangzhou 510080, Guangdong, China. huangshunwei@163.com
Abstract
OBJECTIVE: To study the clinical effect and long-term evaluation of immunomodulation therapy on trauma, severe sepsis and multiple organ dysfunction syndrome (MODS) patients. METHODS: Prospective, randomized, blind and controlled clinical analysis of 70 patients conforming to the enrolled standard was carried out. They were divided into two groups at random. One was control group (n=34) with regular therapy, and the treatment group (n=36) with ulinastatin plus thymosin-alpha1 on the base of regular therapy for 1 week. The immunological indexes were determined before and after therapy on the 1 st, 3 rd, 7 th, 14 th and 28 th day, including the changes in lymphocyte count, CD14(+) monocytes human leukocyte antigen (locus) DR (HLA-DR), clinical data and long-term follow-up. RESULTS: During hospitalization, 20 patients died in the control group and 13 patients died in the treatment group. There was significant difference between two groups (P<0.05). After 7 up to 28 days of therapy, the counts of lymphocyte and CD14(+) monocytes HLA-DR were significantly higher than those in control group (all P<0.05). The duration of using mechanical ventilation and pressor agent in the treatment group were shorter than those in the control group (both P<0.01). The length of stay and the cost in the intensive care unit (ICU) were not significantly increased in the treatment group (both P>0.05). The long-term survival time in the treatment group was much longer than that in the control group (P<0.05). CONCLUSION:Immunomodulation therapy can improve the prognosis of trauma, severe sepsis and MODS patients in a period of 28 days of observation, and lymphocyte counts and CD14(+) monocytes HLA-DR were increased significantly, showing that immunosuppression can be ameliorated. Immunomodulation therapy can shorten the time of mechanical ventilation and the use of pressor agent, and it does not increase the length of stay and the cost in ICU, and therefore the cost-effectiveness is high. It also can prolong the long-term survival time. The results show that immunomodulation therapy is one of successful therapeutic strategies in the care of critical illness.
RCT Entities:
OBJECTIVE: To study the clinical effect and long-term evaluation of immunomodulation therapy on trauma, severe sepsis and multiple organ dysfunction syndrome (MODS) patients. METHODS: Prospective, randomized, blind and controlled clinical analysis of 70 patients conforming to the enrolled standard was carried out. They were divided into two groups at random. One was control group (n=34) with regular therapy, and the treatment group (n=36) with ulinastatin plus thymosin-alpha1 on the base of regular therapy for 1 week. The immunological indexes were determined before and after therapy on the 1 st, 3 rd, 7 th, 14 th and 28 th day, including the changes in lymphocyte count, CD14(+) monocytes human leukocyte antigen (locus) DR (HLA-DR), clinical data and long-term follow-up. RESULTS: During hospitalization, 20 patients died in the control group and 13 patients died in the treatment group. There was significant difference between two groups (P<0.05). After 7 up to 28 days of therapy, the counts of lymphocyte and CD14(+) monocytes HLA-DR were significantly higher than those in control group (all P<0.05). The duration of using mechanical ventilation and pressor agent in the treatment group were shorter than those in the control group (both P<0.01). The length of stay and the cost in the intensive care unit (ICU) were not significantly increased in the treatment group (both P>0.05). The long-term survival time in the treatment group was much longer than that in the control group (P<0.05). CONCLUSION: Immunomodulation therapy can improve the prognosis of trauma, severe sepsis and MODSpatients in a period of 28 days of observation, and lymphocyte counts and CD14(+) monocytes HLA-DR were increased significantly, showing that immunosuppression can be ameliorated. Immunomodulation therapy can shorten the time of mechanical ventilation and the use of pressor agent, and it does not increase the length of stay and the cost in ICU, and therefore the cost-effectiveness is high. It also can prolong the long-term survival time. The results show that immunomodulation therapy is one of successful therapeutic strategies in the care of critical illness.