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益气活血法优化脓毒症早期目标导向性治疗疗效评价

The Curative Effect of Method of Supplementing Qi and Activating Blood Circulation on Optimizing the Early Goal-Directed Therapy of Sepsis

作者: 专业:中医学(专业学位) 导师:覃小兰 年度:2015 学位:硕士  院校: 广州中医药大学

Keywords

Sepsis, supplementing Qi and activating blood circulation, Integrative Medicine, Early goal-directed therapy

        目的:本研究是立足于脓毒症病程中出现的凝血功能紊乱的机制,再结合中药现代药理作用,在集束化方案的液体复苏早期目标导向性治疗中配合益气活血法治疗,探讨益气活血法对优化脓毒症早期目标导向性治疗中西医结合集束化方案干预后的疗效情况,评估益气活血法的中西医结合方案干预后对严重脓毒症目标导向性治疗达标情况及28天病死率的影响。同时评估益气活血法优化严重脓毒症早期目标导向性治疗的中西医集束化方案对患者外周血乳酸清除率、SOFA评分的影响,为中医药及中西医结合方案治疗严重脓毒症提供可参考的依据和思路。方法:本研究以在广东省中医院芳村急诊科及ICU住院治疗的68例严重脓毒症病人为研究对象,运用简单随机对照分组法,将病人随机分成治疗组和对照组,两组均采用《拯救脓毒症运动:2012严重脓毒症和脓毒症休克管理国际指南》推荐的治疗方法,予一致的标准治疗,而治疗组在进行液体复苏时使用参麦注射液60ml及丹参川芎嗪注射液lOml加入到补液中,仔细观察两组病人在开始治疗和治疗6小时、24小时以及72小时后的相关临床症状、体征、乳酸清除率、SOFA评分,并统计28天病死率。采用SPSS18.0软件包建立数据库,计量资料:计算各功能检测指标的均数及标准差,符合正态分布时,采用t检验,方差不齐时采用t’检验,组间比较采用独立样本t检验,治疗前、后组内比较采用配对样本t检验。不符合正态分布时,采用秩和检验,组间比较采用独立样本Mann-Whitney秩和检验,治疗前、后组内比较采用相关样本Wilcoxon符号秩和检验。计数资料:计算各指标的构成及分布,率的组间比较采用四格表x2检验,组间构成比较采用R×C表x2检验。以P<0.05为差异有统计学意义。结果:1.治疗组的6h早期目标导向性治疗(EGDT)达标率较对照组高(P<0.05);2.治疗组6h乳酸清除率、24h乳酸清除率及72h乳酸清除率均较对照组高(P<0.05);3.治组及对照组治疗后的SOFA评分均较前下降(P<0.05),但治疗组和对照组治疗后的SOFA评分差异无统计学意义(P>0.05);4.治疗组的死亡人数及28天死亡率均较对照组低,但差异无统计学意义(P>0.05);5.治疗组的ICU住院时间较对照组下降(P<0.05),而治疗组总住院时间较对照组稍下降,但差异无统计学意义(P>0.05)。结论:1.与单纯的目标导向性治疗相比,联合运用参麦注射液和丹参川芎嗪注射液组成的益气活血法能提高EGDT的达标率;2.与单纯的目标导向性治疗相比,联合运用参麦注射液和丹参川芎嗪注射液组成的益气活血法能提高乳酸的清除率,更有利于改善组织低灌注及微循环障碍;3.与单纯的目标导向性治疗相比,联合运用参麦注射液和丹参川芎嗪注射液组成的益气活血法能降低患者ICU住院时间;4.与单纯的目标导向性治疗相比,联合运用参麦注射液和丹参川芎嗪注射液组成的益气活血法无法降低患者的治疗72h的SOFA评分及28天病死率。
    ObjectivesThis research is mainly based on the pathogenesis of anomaly of coagulation system of sepsis, combines with the modern pharmacological effects of Chinese traditional medicine, and uses the method of supplementing Qi and activating blood circulation by Chinese medicine injection in EGDT to explore the therapeutic effect, the demonstrating compliance of EGDT and 28-day mortality rate of the sepsis bundle of intervention of traditional Chinese medicine and western medicine. Meanwhile, this research also explores the effect of blood lactate clearance rate and Sequential Organ Failure Assessment(SOFA) score by sepsis bundle of intervention of traditional Chinese medicine and western medicine, which can provides basis and train of thought in treatment of sepsis by the intervention of traditional Chinese medicine and western medicine.MethodsThe research object is 68 patients treating in the emergency department and ICU in Guangdong Provincial Hospital of Chinese Medicine. It is a simple, random and control study, which the patients were divided into two groups, the treatment group and the control group. The two groups will be treated with the same standard by international guidelines of severe sepsis and sepsis shock of SSC in 2012, but the treatment group will add using 60ml injection of shenmai and 10ml injection of salviaemiltiorrhizae and ligustrazine in liquid recovery treatment. The observation items are clinical symptoms, signs, blood lactate clearance rate, APACHEⅡ score, SOFA score and 28-day mortality rate before, the 6th hour, the 24th hour and the 72th hour of treatment. SPSS18.0 software package is adopted to establish the database. The measurement data is calculated the mean and standard deviation. Comparison between group is tested by t test when accorded with normal distribution, and is tested by t’ test when variance is not neat. Comparison between groups uses independent sample t test, Comparison between before and after treatment uses paired samples t test. Comparison between groups is tested by rank sum test when does not accord with normal distribution, comparison between groups uses independent sample the Mann-Whitney rank sum test. Comparison between before and after treatment is tested by Wilcoxon signed rank sum test. The enumeration data is calculated the index composition and distribution. The comparison of total effective rate between groups is tested by the four table chi-square test, and the form comparison made between group is tested by R * C table chi-square test. Difference is statistically significant when P<0.05.Results1. The rate of reaching the standard of treatment group in 6 hour is higher than the control group(P<0.05).2. The lactic acid clearances of treatment group in 6 h,24 h and 72 h are higher than the control group(P<0.05).3. After treatment, the SOFA scores of treatment group and control group are decreased than before(P<0.01), but after treatment, the SOFA scores of treatment group and control group are the difference of the posttreatment SOFA scores of treatment group and control group is no statistically significant(P>0.05).4. The death toll and 28-day mortality rate of treatment group is slightly lower than control group, but the difference is no statistically significant (P>0.05).5. The hospital stay of ICU of treatment group is significantly lower than control group(P<0.05), and the total hospital stay of treatment group is slightly decreased than control group, but the difference is no statistically significant(P>0.05).Conclusion1. Comparing with the simple therapy of EGDT, combining with the method of supplementing Qi and activating blood circulation by injection of shenmai and injection of salviae miltiorrhizae and ligustrazine can improve the rate of reaching the standard.2. Comparing with the simple therapy of EGDT, combining with the method of supplementing Qi and activating blood circulation by injection of shenmai and injection of salviae miltiorrhizae and ligustrazine can improve the clearance rate of lactate, and be more conducive to improve hypoperfusion of tissue and microcirculation dysfunction.3. Comparing with the simple therapy of EGDT, combining with the method of supplementing Qi and activating blood circulation by injection of shenmai and injection of salviae miltiorrhizae and ligustrazine can reduce the hospital stay of ICU.4. Comparing with the simple therapy of EGDT, combining with the method of supplementing Qi and activating blood circulation by injection of shenmai and injection of salviae miltiorrhizae and ligustrazine can not reduce the the posttreatment SOFA scores and 28-day mortality rate.
        

益气活血法优化脓毒症早期目标导向性治疗疗效评价

摘要3-5
Abstract5-7
引言10-12
第一章 文献综述12-24
    第一节 现代医学对脓毒症的研究现状12-19
        一、流行病学研究12
        二、发病机制12-16
        三、相关定义及诊断标准16-17
        四、治疗进展17-19
    第二节 中医学对脓毒症的研究概况19-24
        一、病因病机19-20
        二、辨证体系20-21
        三、中医药治疗21-24
第二章 临床研究24-32
    第一节 研究对象24
        一、病例来源24
        二、病例选择24
    第二节 研究方法24-27
        一、样本含量估算24-25
        二、研究设计及病例分组25
        三、治疗方法流程25-26
        四、观察内容26
        五、观察时点26-27
        六、有效性评估及安全性评估27
        七、数据整理及分析27
    第三节 研究结果27-32
        一、病人一般资料研究27
        二、治疗组和对照组基线比较27-29
        三、观察指标研究29-32
第三章 讨论32-36
    一、脓毒症与凝血功能紊乱32
    二、益气活血法与脓毒症32-33
    三、结果分析与疗效评价33-36
结语36-38
参考文献38-44
附录44-48
致谢48
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