中国实验方剂学杂志2025,Vol.31Issue(1) :55-63.DOI:10.13422/j.cnki.syfjx.20250696

大柴胡汤辅助治疗"阳证"脓毒症的随机对照试验

Da Chaihutang for Treatment of Sepsis with Yang Syndrome:A Randomized Controlled Trial

黄娜 陈广美 考星宇 杨震 许伟贤 袁康 雷俊娜 陈景利 何明丰
中国实验方剂学杂志2025,Vol.31Issue(1) :55-63.DOI:10.13422/j.cnki.syfjx.20250696

大柴胡汤辅助治疗"阳证"脓毒症的随机对照试验

Da Chaihutang for Treatment of Sepsis with Yang Syndrome:A Randomized Controlled Trial

黄娜 1陈广美 1考星宇 1杨震 1许伟贤 1袁康 1雷俊娜 1陈景利 1何明丰1
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作者信息

  • 1. 广州中医药大学第八临床医学院,佛山 528000
  • 折叠

摘要

目的:探索大柴胡汤辅助治疗脓毒症"阳证"患者的临床疗效及安全性.方法:纳入70例脓毒症"阳证"患者,根据随机数字法将其分为观察组和对照组各35例,均予脓毒症西医标准治疗,观察组加服大柴胡汤一剂,分2次服,每次100 mL;对照组加服等体积等次数温开水,疗程均为3d.比较两组患者28 d全因死亡率,以及治疗前后以下指标的变化:序贯性器官功能衰竭评分(SOFA)、急性生理和慢性健康评分(APACHE Ⅱ)、白细胞(WBC)、中性粒细胞百分比(NEU%)、C反应蛋白(CRP)、降钙素原(PCT)、丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、总胆红素(TBil)、肌酐(Cr)、血尿素氮(BUN)、急性胃肠损伤(AGI)分级、胃肠功能障碍评分(GDS)、血清肠型脂肪酸结合蛋白(iFABP)、血清瓜氨酸(CR)、血小板(PLT)、凝血酶原时间(PT)、活化部分凝血酶原时间(APTT)、纤维蛋白原(Fib)、国际化标准比值(INR)、D-二聚体(D-D).结果:两组患者28 d死亡率差异无统计学意义.与本组治疗前比较,对照组患者治疗后SOFA、WBC、PCT、Cr明显降低,PLT明显升高(P<0.05);观察组患者 SOFA、APACHE Ⅱ、NEU%、CRP、PCT、ALT、AST、Cr、BUN、AGI 分级、GDS 评分、血清 iFABP、CR均明显改善(P<0.05).与对照组治疗后比较,观察组APACHE Ⅱ、PCT、AGI分级、GDS评分、血清iFABP明显降低,CR、PLT 明显升高(P<0.05,P<0.01).两组患者 SOFA、APACHE Ⅱ、AST、TBil、AGI 分级、GDS 评分、iFABP、CR、PLT 治疗前后差值差异具有统计学意义(P<0.05,P<0.01).两组患者PT、APTT、Fib、INR、D-D稍有差异,但均在临床允许范围内.结论:在西医标准治疗上给予大柴胡汤可以显著减轻脓毒症严重程度,改善多器官功能障碍,疗效确切且安全,但其对脓毒症预后的影响仍待进一步研究.

Abstract

Objective:To explore the clinical efficacy and safety of Da Chaihutang(DCH)for the treatment of sepsis with Yang syndrome.Methods:A total of 70 patients suffering from sepsis with Yang syndrome were randomly divided into an observation group and a control group,with 35 cases in each group.They both received standard Western medicine treatment.The observation group was additionally given a dose of DCH,which was boiled into 100 mL and taken twice.The control group was additionally given an equal volume and dosage of warm water.The intervention lasted for three days.The 28-day all-cause mortality and the changes in the following indicators before and after intervention were compared between the two groups,including sequential organ failure assessment(SOFA),acute physiology and chronic health evaluation Ⅱ(APACHE Ⅱ)score,white blood cell(WBC),the percentage of neutrophils(NEU%),C-reactive protein(CRP),procalcitonin(PCT),alanine transaminase(ALT),aspartate transaminase(AST),total bilirubin(TBil),creatinine(Cr),blood urea nitrogen(BUN),acute gastrointestinal injury(AGI)grade,gastrointestinal dysfunction score(GDS),serum intestinal fatty acid-binding protein(iFABP),citrulline(CR),platelet(PLT),prothrombin time(PT),activated partial thromboplastin time(APTT),fibrinogen(Fib),international normalized ratio(INR),and D-dimer(D-D).Results:There was no significant difference between the two groups regarding 28-day all-cause mortality.After the intervention,SOFA,WBC,PCT,and Cr were significantly decreased,and PLT was significantly increased in the control group(P<0.05).SOFA,APACHE Ⅱ,NEU%,CRP,PCT,ALT,AST,Cr,BUN,AGI grade,GDS,and serum iFABP and CR were significantly improved in the observation group(P<0.05).After the intervention,APACHE Ⅱ,PCT,AGI grade,GDS,and serum iFABP in the observation group were significantly lower than those in the control group,while CR and PLT were higher(P<0.05,P<0.01).There were significant differences regarding the gap of SOFA,APACHE Ⅱ,AST,TBil,AGI grade,GDS,iFABP,CR,and PLT between the two groups(P<0.05,P<0.01).There were slight differences regarding PT,APTT,Fib,INR,and D-D between the two groups,which were in the clinical normal range.Conclusion:On the basis of Western medicine,DCH helped to reduce sepsis severity and improved multiple organ dysfunction with high clinical efficacy and safety,but further research on its impact on the prognosis of patients with sepsis is still required.

关键词

脓毒症/多器官功能障碍/大柴胡汤/随机对照试验

Key words

sepsis/multiple organ dysfunction/Da Chaihutang/randomized controlled trial

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出版年

2025
中国实验方剂学杂志
中国中医科学院中药研究所 中国中西医结合学会中药专业委员会

中国实验方剂学杂志

北大核心
影响因子:1.62
ISSN:1005-9903
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