| Objective To investigate changes of immune function in patients with sepsis, as well as feasibility and clinical efficacy of Shenqi Fuzheng Injection-based integrative immune regulation in the treatment of sepsis.Methods The experiment was a prospective, randomized and controlled clinical study.32patients with sepsis and36cases of non-septic patients were selected as the research subjects after they were admitted to general surgery16A district of Tianjin Medical University General Hospital from December2012to March2014. The patients with sepsis were randomly divided into sepsis group (group A, n=15) and Shenqi Fuzheng injection group (group B, n=17), non-septic patients were classified as control group (group C, n=36). We collected clinical variables of all patients at day1, day3, day7, day10after they were diagnosed, and calculated APACHE-Ⅱ score. Simultaneously, T lymphocyte subsets of peripheral blood and their respective proportion of apoptosis were detected by flow cytometry, immunoglobulin and complement levels detected by immunology laboratory of Tianjin Medical University General Hospital, serum endotoxin and cytokine levels detected by ELISA. Compare group A to group B and group C on these indicators. Statistical analysis was performed through the statistical software SPSS19.0. Independent samples T-test was applied for comparison of variable between two groups; and in the same group, Least-significant difference test was applied. The significance level of5%of probability (P<0.05) was adopted.Results Group A and group C:(1)APACHE-Ⅱ score:There was statistical difference in APACHE-Ⅱ score between group A and group C at day1, day3, day7, day10after they were diagnosed, the former was significantly higher than the latter; APACHE-Ⅱ scores of group A and group C showed a downward trend, there were statistical differences within the group.(2)T lymphocyte subsets:At day1, day3, day7after they were diagnosed, the percentage of CD4+T lymphocytes and CD4+/CD8+ratio were higher in the group C than those in the group A, and the difference was statistically significant; at day7, day10after they were diagnosed, the percentage of CD4+T lymphocytes and CD4+/CD8+ratio were higher than those at day1in the group A, and the difference was statistically significant.(3)The percentage of apoptotic T lymphocytes:At day1, day3, day7after they were diagnosed, the percentages of apoptotic CD4+T lymphocytes were higher in the group A than those in the group C, and the difference was statistically significant; at day3after they were diagnosed, the percentage of apoptotic CD4+T lymphocytes was higher than that at day1in the group A, but the difference was statistically insignificant, whereas lower at day7, day10and the difference was statistically significant.(4)Immunoglobulin:At dayl, day3after they were diagnosed, immunoglobulin IgG, IgA, IgM levels were higher in the group C than those in the group A, and the difference was statistically significant; after they were diagnosed, the levels of IgG, IgM at day7, day10as well as the levels of IgA at day3, day7, day10were higher than those at day1in the group A, and the difference was statistically significant; at day3, day7, day10after they were diagnosed, the levels of IgA were higher than that at day1in the group C, and the difference was statistically significant.(5)Complement:At day1, day3after they were diagnosed, the complement C3, CH50levels were higher in the group C than those in the group A, and the difference was statistically significant; after they were diagnosed, the levels of C3at day7, day10as well as the level of CH50at day10were higher than those at day1in the group A,’the difference was statistically significant.(6)Endotoxin and cytokines:At day1, day3, day7, day10after they were diagnosed, the cytokine IL-6, IL-8, TNF-a as well as endotoxin levels were higher in the group A than those in the group C, and the difference was statistically significant; after they were diagnosed, the levels of IL-6, IL-8, TNF-a at day7, day10and the levels of endotoxin at day3, day7, day10were lower than those at day1in the group A, the difference was statistically significant; At day3, day7, day10after they were diagnosed, the cytokine IL-6, IL-8, TNF-a and endotoxin levels were lower than those at day1in the group C, and the difference was statistically significant.Group A and group B:(1)APACHE-Ⅱ score:There was statistical difference in APACHE-Ⅱ score between group A and group B at day7, day10after they were diagnosed, the former was significantly higher than the latter; APACHE-Ⅱ scores of group A and group B showed a downward trend, there were statistical differences within the group.(2)T lymphocyte subsets:At day7after they were diagnosed, the percentage of CD4+T lymphocytes and CD4+/CD8+ratio were higher in the group B than those in the group A, and the difference was statistically significant; at day7, day10after they were diagnosed, the percentage of CD4+T lymphocytes and CD4+/CD8+ratio were higher than those at dayl in the group A as well as group B, and the difference was statistically significant.(3)The percentage of apoptotic T lymphocytes:At day7after they were diagnosed, the percentages of apoptotic CD4+T lymphocytes was higher in the group A than that in the group B, and the difference was statistically significant; at day3after they were diagnosed, the percentages of apoptotic CD4+T lymphocytes were higher than those at day1in the group A as well as group B, but the difference was statistically insignificant, whereas lower at day7, day10and the difference was statistically significant.(4)Immunoglobulin:At day3after they were diagnosed, immunoglobulin IgM level was higher in the group B than that in the group A, and the difference was statistically significant; after they were diagnosed, the levels of IgG and IgM at day7, day10as well as the levels of IgA at day3, day7, day10were higher than those at day1in the group A, and the difference was statistically significant; after they were diagnosed, the levels of IgG at day10and the levels of IgA at day3, day7, day10as well as the levels of IgM at day7,day10were higher than those at dayl in the group B, and the difference was statistically significant.〤omplement:At day3after they were diagnosed, the complement C3level was higher in the group B than that in the group A, and the difference was statistically significant; after they were diagnosed, the levels of C3at day7, day10as well as the level of CH50at day10were higher than those at day1in the group A, the difference was statistically significant; after they were diagnosed, the levels of C3at day3, day10as well as the levels of CH50at day3, day7, day10were higher than those at dayl in the group B, and the difference was statistically significant.(6)Endotoxin and cytokines:After they were diagnosed, the levels of IL-8, TNF-a at day7and the levels of IL-6at day7,day10as well as the levels of endotoxin at day3, day7, day10were higher in the group A than those in the group B, and the difference was statistically significant; after they were diagnosed, the levels of IL-6, IL-8, TNF-a at day7, day10as well as the levels of endotoxin at day3, day7, day10were lower than those at day1in the group A, the difference was statistically significant; after they were diagnosed, the levels of IL-6, IL-8and endotoxin at day3, day7, day10as well as the levels of TNF-a at day7, day10were lower than those at day1in the group B, and the difference was statistically significant.Conclusion1.Compared with non-septic patients, the condition and immune dysfunction of patients with sepsis are more serious. Specifically in the following areas, APACHE-II score increases; the percentage of CD4+T lymphocytes and the CD4+/CD8+ratio decrease, the percentage of apoptotic CD4+T lymphocytes increases; the levels of immunoglobulin IgG, IgA, IgM and complement C3, CH50decrease; the levels of proinflammatory cytokine IL-6, IL-8, TNF-a as well as bacterial endotoxin increase.2.On the basis of conventional western medicine treatment, early application of Shenqi Fuzheng Injection in the treatment of patients with sepsis can improve the condition and reduce the APACHE-II score; can inhibit the apoptosis of CD4+T lymphocytes, improve the percentage of CD4+T lymphocytes and the CD4+/CD8+ratio, enhance cellular immune function and correct the fettle of immunosuppression; can increase the secretion of immunoglobulin IgM, promote the generation of complement C3and enhance humoral immune function; can reduce the levels of proinflammatory cytokine IL-6, IL-8, TNF-a and bacterial endotoxin, and recuperate the disorder of immune system. |
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