化纤胶囊1号方对瘀毒内阻型脓毒症患者T细胞亚群的影响
发布时间：2019-06-05 11:15
【摘要】：目的:探讨化纤胶囊1号方对瘀毒内阻型脓毒症(sepsis)免疫抑制患者临床疗效及T细胞亚群的影响,为中医益气活血解毒法治疗瘀毒内阻型脓毒症免疫抑制奠定临床研究基础。方法:本研究采取的研究方式为随机对照临床研究,纳入符合标准的瘀毒内阻型脓毒症患者80例,病例来自于黑龙江中医药大学附属第一医院ICU病房,将患者随机分为治疗组和对照组各40例。对照组患者参照《2012年版脓毒症国际指南》予以治疗,治疗组患者在西医治疗的基础上予以化纤胶囊1号方水煎剂治疗,疗程为7日。观察用药前后APACHE-‖评分、SOFA评分、中医证候积分、炎症指标、T细胞亚群等治疗指标,并记录治疗过程中不良反应及不良事件,评价化纤胶囊1号方对瘀毒内阻型脓毒症患者的临床疗效及对T细胞亚群的影响。结果:1.治疗前一般基线资料比较:两组患者之间的性别、年龄、APACHE-‖评分、SOFA评分、中医证候积分、WBC、CRP、PCT、T细胞亚群之间的差异无统计学意义(P0.05)。2.治疗前后组间比较:两组患者之间APACHE-‖评分、SOFA评分、CRP、PCT之间的差异有统计学意义(P0.05),CD4+T细胞、中医证候积分之间的差异具有显著统计学意义(P0.01),两组患者之间WBC、CD8+T细胞、CD4+/CD8 +的差异无统计学意义(P0.05)。3.治疗前后组内比较:治疗后第7天治疗组APACHE-‖评分、SOFA 评分、WBC、CRP、PCT、CD4+T、CD4+/CD8 +与治疗前变化均有显著统计学意义(P0.01)。治疗后第7天治疗组CD8+T细胞的变化与治疗前变化有显著统计学意义(P0.01),而对照组中CD8+T细胞的变化虽有统计学意义但统计学意义不显著(P0.05)。4.中医瘀毒内阻症状疗效评价:治疗后第7天两组患者瘀毒内阻症状均得到改善,但治疗组患者的改善程度优于对照组。5.安全性观察:两组患者均未出现不良反应。结论化纤胶囊1号方能够改善瘀毒内阻型脓毒症患者APACHE-‖评分、SOFA评分,减少中医证候积分,降低炎症指标,改善免疫功能,起到益气扶正、活血解毒作用,恢复瘀毒内阻型脓毒症患者CD4+T细胞数目,改善免疫抑制。
[Abstract]:Objective: to investigate the effect of Huaxian capsule No. 1 on (sepsis) immunosuppression and T cell subsets in patients with sepsis caused by blood stasis and internal obstruction, and to lay a foundation for clinical research on immunosuppression of sepsis treated with Yiqi Huoxue jiedu method. Methods: a randomized controlled clinical study was conducted in this study. 80 patients with sepsis of stasis toxin were included in this study. The cases were from ICU ward, the first affiliated Hospital of Heilongjiang University of traditional Chinese Medicine. The patients were randomly divided into treatment group (n = 40) and control group (n = 40). The patients in the control group were treated with reference to the 2012 edition of the International guidelines for sepsis, and the patients in the treatment group were treated with Huaxian capsule No. 1 decoction on the basis of western medicine. The course of treatment was 7 days. The APACHE- score, SOFA score, TCM syndrome score, inflammation index and T cell subgroup were observed before and after treatment, and the adverse reactions and adverse events were recorded. To evaluate the clinical effect of Huaxian capsule No. 1 on patients with sepsis with internal obstruction of blood stasis and its effect on T cell subsets. Result: 1. Comparison of general baseline data before treatment: there was no significant difference in sex, age, APACHE- score, SOFA score, TCM syndrome score and WBC,CRP,PCT,T cell subsets between the two groups (P 0.05). Comparison between the two groups before and after treatment: there were significant differences in APACHE- score, SOFA score and CRP,PCT between the two groups (P 0.05), and there were significant differences in CD4 T cells and TCM syndrome scores between the two groups (P 0.01). There was no significant difference in WBC,CD8 T cells and CD4 / CD8 between the two groups (P 0.05). Comparison before and after treatment: on the 7th day after treatment, there were significant changes in APACHE- score, SOFA score, WBC,CRP,PCT,CD4 T, CD 4 / CD8 and pre-treatment (P 0.01). On the 7th day after treatment, the changes of CD8 T cells in the treatment group were significantly different from those before treatment (P 0.01), while the changes in CD8 T cells in the control group were statistically significant but not statistically significant (P 0.05). Evaluation of the curative effect of internal obstruction of blood stasis in traditional Chinese medicine: on the 7th day after treatment, the symptoms of internal obstruction of blood stasis in both groups were improved, but the improvement degree of the patients in the treatment group was better than that in the control group. 5. Safety observation: there were no adverse reactions in both groups. Conclusion Huaxian capsule No. 1 can improve the APACHE- score and SOFA score, reduce the score of TCM syndromes, reduce the inflammatory index, improve the immune function, and play the role of invigorating qi and promoting blood circulation and detoxification. The number of CD4 T cells in patients with sepsis was restored and immunosuppression was improved.
【学位授予单位】：黑龙江中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R278
[Abstract]:Objective: to investigate the effect of Huaxian capsule No. 1 on (sepsis) immunosuppression and T cell subsets in patients with sepsis caused by blood stasis and internal obstruction, and to lay a foundation for clinical research on immunosuppression of sepsis treated with Yiqi Huoxue jiedu method. Methods: a randomized controlled clinical study was conducted in this study. 80 patients with sepsis of stasis toxin were included in this study. The cases were from ICU ward, the first affiliated Hospital of Heilongjiang University of traditional Chinese Medicine. The patients were randomly divided into treatment group (n = 40) and control group (n = 40). The patients in the control group were treated with reference to the 2012 edition of the International guidelines for sepsis, and the patients in the treatment group were treated with Huaxian capsule No. 1 decoction on the basis of western medicine. The course of treatment was 7 days. The APACHE- score, SOFA score, TCM syndrome score, inflammation index and T cell subgroup were observed before and after treatment, and the adverse reactions and adverse events were recorded. To evaluate the clinical effect of Huaxian capsule No. 1 on patients with sepsis with internal obstruction of blood stasis and its effect on T cell subsets. Result: 1. Comparison of general baseline data before treatment: there was no significant difference in sex, age, APACHE- score, SOFA score, TCM syndrome score and WBC,CRP,PCT,T cell subsets between the two groups (P 0.05). Comparison between the two groups before and after treatment: there were significant differences in APACHE- score, SOFA score and CRP,PCT between the two groups (P 0.05), and there were significant differences in CD4 T cells and TCM syndrome scores between the two groups (P 0.01). There was no significant difference in WBC,CD8 T cells and CD4 / CD8 between the two groups (P 0.05). Comparison before and after treatment: on the 7th day after treatment, there were significant changes in APACHE- score, SOFA score, WBC,CRP,PCT,CD4 T, CD 4 / CD8 and pre-treatment (P 0.01). On the 7th day after treatment, the changes of CD8 T cells in the treatment group were significantly different from those before treatment (P 0.01), while the changes in CD8 T cells in the control group were statistically significant but not statistically significant (P 0.05). Evaluation of the curative effect of internal obstruction of blood stasis in traditional Chinese medicine: on the 7th day after treatment, the symptoms of internal obstruction of blood stasis in both groups were improved, but the improvement degree of the patients in the treatment group was better than that in the control group. 5. Safety observation: there were no adverse reactions in both groups. Conclusion Huaxian capsule No. 1 can improve the APACHE- score and SOFA score, reduce the score of TCM syndromes, reduce the inflammatory index, improve the immune function, and play the role of invigorating qi and promoting blood circulation and detoxification. The number of CD4 T cells in patients with sepsis was restored and immunosuppression was improved.
【学位授予单位】：黑龙江中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R278
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