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目的:研究小牛脾提取物注射液对多器官功能障碍综合征(multiple organ dysfunction syndrome,MODS)患者的疗效和作用机制。方法:采用随机、对照、单盲的设计方案,三峡大学第一临床医学院48例MODS患者随机分为用药组(24例)和对照组(24例)。对照组常规治疗,用药组常规治疗联合小牛脾提取物注射液治疗(每次10mL,每日1次),疗程7d。观察两组治疗前后淋巴细胞亚群比例、淋巴细胞核因子(nuclear factor,NF)κB的主要亚基P65蛋白的表达,血浆细胞因子浓度的变化。结果:用药组患者发热时间,机械通气时间低于对照组(P<0.05)。用药组淋巴细胞亚群比例较治疗前明显升高(P<0.05),对照组无显著变化(P>0.05)。两组患者细胞因子浓度较用药前明显下降(P<0.05),但用药组细胞因子浓度下降较对照组更为显著(P<0.05)。两组患者淋巴细胞的主要亚基P65蛋白表达均下降,第7天用药组NF-κB P65蛋白表达较对照组低(P<0.05)。回归分析提示CD4~+T细胞百分比、CD4~+/CD8~+、IL-1、IL-6、TNF-α浓度是预测死亡的危险因素,其中CD4~+/CD8~+对预后影响最大。结论:小牛脾提取物注射液可改善免疫功能及生存质量。其机制可能为调控淋巴细胞NF-κB的表达,阻断细胞因子瀑布。
Objective: To study the curative effect and mechanism of calf spleen extract injection on patients with multiple organ dysfunction syndrome (MODS). Methods: Forty-eight MODS patients in the First Clinical College of China Three Gorges University were randomly divided into medication group (24 cases) and control group (24 cases) with randomized, controlled and single-blind design. Control group conventional treatment, the treatment group with conventional calf spleen extract injection treatment (each 10mL, day 1), the course of treatment 7d. The proportion of lymphocyte subsets, the expression of P65 protein, the major subunit of nuclear factor (NF) κB, and the changes of plasma cytokines were observed before and after treatment. Results: The fever time and the time of mechanical ventilation in the medication group were lower than those in the control group (P <0.05). The proportion of lymphocyte subsets in the treatment group was significantly higher than that before treatment (P <0.05), while there was no significant change in the control group (P> 0.05). The concentrations of cytokines in both groups were significantly lower than those before treatment (P <0.05), but the concentrations of cytokines in the two groups were significantly lower than those in the control group (P <0.05). P65 protein expression of the major subunit of lymphocytes decreased in both groups. On the 7th day, the expression of NF-κB P65 protein in the two groups was lower than that in the control group (P <0.05). Regression analysis showed that the percentage of CD4 ~ + T cells, CD4 ~ + / CD8 ~ +, IL-1, IL-6 and TNF-α levels were the risk factors for predicting death. CD4 ~ + / CD8 + Conclusion: Ma spleen extract injection can improve immune function and quality of life. The mechanism may be to regulate the expression of NF-κB in lymphocytes and block the apoptosis of cytokines.