联合参附注射液对高乳酸水平脓毒症患者器官保护作用的前瞻性、多中心、随机、对照初步临床研究  

Effect of Shenfu injection on organ protection in patients of sepsis withhigh lactate levels: a preliminary report of prospective, multicenter,randomized, controlled clinical study

作　　者：杨苏仪 陈瑞 闫春江 陈国聪 高益锐 邓雅文 曾瑞峰 唐光华 叶烨 刘云涛 奚小土 李俊 YANG Suyi;CHEN Rui;YAN Chunjiang;CHEN Guocong;GAO Yirui;DENG Yawen;ZENG Ruifeng;TANG Guanghua;YE Ye;LIU Yuntao;XI Xiaotu;LI Jun(The Second School of Clinical Medicine,Guangzhou University of Traditional Chinese Medicine,Guangzhou 510405,Guangdong,China;Department of Emergency,Guangdong Hospital of Traditional Chinese Medicine,The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine,Guangzhou 510120,Guangdong,China;Guangdong Provincial Key Laboratory for Research on Emergency of Traditional Chinese Medicine,Guangzhou 510120,Guangdong,China;Administration Office,The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine,Guangzhou 510405,Guangdong,China)

机构地区：[1]广州中医药大学第二临床医学院,广东广州510405 [2]广州中医药大学第二附属医院广东省中医院急诊科,广东广州510120 [3]广东省中医急症研究重点实验室,广东广州510120 [4]广州中医药大学第一附属医院医院办公室,广东广州510405

出　　处：《暨南大学学报（自然科学与医学版）》2023年第4期423-430,共8页Journal of Jinan University(Natural Science & Medicine Edition)

基　　金：广东省自然科学基金面上项目(2020A1515010512);广东省中医院中医药科学技术研究专项(YN2018ZD03);广东省中医院临床研究专项(YN10101908);广东省中医药局科研专项课题(20213007);广东省中医急症研究重点实验室(2017B030314176)。

摘　　要：目的:探索联合参附注射液对高乳酸水平脓毒症患者的器官保护作用。方法:本试验为多中心、随机、对照研究,纳入基线乳酸大于4.0 mmol/L的脓毒症患者进行统计分析,按1∶1比例以随机信封法分配到治疗组和对照组。对照组按照指南要求接受常规的西医治疗,治疗组在对照组治疗的基础上联合使用参附注射液,疗程为5天,比较两组治疗前及治疗后第5天相关临床指标、住院天数、血管活性药物使用天数的差异。结果:共28例病例纳入本研究统计分析,其中14例为治疗组,14例为对照组。两组之间性别、年龄、基础疾病、感染部位等基线数据均衡可比(P>0.05)。治疗后,两组患者心率、序贯器官衰竭评分(SOFA)评分、急性生理学与慢性健康状况评分系统Ⅱ(APACHEⅡ)评分、乳酸水平均较治疗前有所改善,治疗组在治疗后第5天平均动脉压(MAP)、Glasgow评分较治疗前改善,差异均有统计学意义(P<0.05)。治疗组MAP的改善较对照组差异具有统计学意义(P<0.05),两组间其余指标、住院天数及血管活性药物使用天数比较差异均无统计学意义(P>0.05)。结论:联合参附注射液治疗能降低高乳酸水平脓毒症患者的乳酸水平。与西医常规治疗相比,西医联合参附注射液治疗可改善患者MAP水平,并有改善患者SOFA评分、APACHEⅡ评分的趋势。Objective:To explore the organ protective effect of combined Shenfu injection on patients with high lactate level sepsis.Methods:This trial is a multicenter,randomized,controlled study that included sepsis patients with baseline lactate levels greater than 4.0 mmol/L for statistical analysis.They were randomly assigned to the treatment group and control group in a 1∶1 ratio using a random envelope method.The control group received routine Western medicine treatment,while the treatment group received a combination of Shenfu Injection on the basis of routine Western medicine treatment for a period of 5 days.The differences in clinical indicators,hospitalization days,and days of vasoactive drug use between the two groups before and on the fifth day after treatment were compared.Results:A total of 28 cases were included in this study for statistical analysis,14 of which were in the treatment group and 14 in the control group.Baseline data such as gender,age,underlying disease and site of infection were balanced and comparable between the two groups(P>0.05).After treatment,the heart rate,SOFA score,APACHEⅡscore,and lactate level of the two groups of patients improved compared to before treatment.The treatment group showed statistically significant improvements in Mean Arterial Pressure(MAP)and Glasgow score on the fifth day after treatment(P<0.05).The improvement of MAP in the treatment group was statistically significant compared to the control group(P<0.05),while there was no statistically significant difference in other indicators,hospitalization days,and days of vasoactive drug use between the two groups(P>0.05).Conclusion:The combination of Shenfu Injection in the treatment of sepsis patients with high lactate levels can reduce their lactate levels.Compared with conventional Western medicine treatment,the combination of Western medicine and Shenfu injection can improve patients MAP levels,and there is a trend towards improving patients SOFA score and APACHEⅡscore.

关 键 词：参附注射液 脓毒症 脓毒性休克 乳酸 平均动脉压 

分 类 号：R278[医药卫生—中医学] R969.4