内毒素吸附治疗腹腔内革兰氏阴性菌感染导致脓毒症或感染性休克的多中心随机对照研究  

Endotoxin adsorption therapy in patients with sepsis or infectious shock due to gram-negative bacterial infections in abdominal cavity:a multicenter randomized controlled trial

作　　者：唐新[1] 付平[1] 韩莉[2] 张凌[1] 常平[3] 于湘友[4] 冯永文[5] 王国恩[6] TANG Xin;FU Ping;HAN Li;ZHANG Ling;CHANG Ping;YU Xiangyou;FENG Yongwen;WANG Guoen(Department of Nephrology,China West Hospital,Sichuan University,Chengdu 610041,China;Department of Critical Care Medicine,China West Hospital,Sichuan University,Chengdu 610041,China;Department of Critical Care Medicine,Zhujiang Hospital of Southern Medical University,Guangzhou 510280,China;Department of Critical Care Medicine,The First Affiliated Hospital of Xinjiang Medical University,Urumqi 830011,China;Department of Critical Care Medicine,Shenzhen Second People's Hospital,Shenzhen 518028,Guangdong,China;Department of Critical Care Medicine,The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710004,China)

机构地区：[1]四川大学华西医院肾脏内科/肾脏病研究室,四川成都610041 [2]四川大学华西医院重症医学科,四川成都610041 [3]南方医科大学珠江医院重症医学科,广东广州510280 [4]新疆医科大学第一附属医院重症医学科,新疆乌鲁木齐830011 [5]深圳市第二人民医院重症医学科,广东深圳518028 [6]西安交通大学第二附属医院重症医学科,陕西西安710004

出　　处：《西部医学》2022年第5期729-734,共6页Medical Journal of West China

摘　　要：目的评估与只使用脓毒症常规治疗相比,使用常规治疗联合内毒素吸附治疗腹腔内革兰氏阴性菌感染导致的脓毒症或感染性休克患者的安全性及有效性。方法一项多中心随机对照研究,纳入2014年1月~2016年9月期间就诊于四川大学华西医院、新疆医科大学第一附属医院、南方医科大学珠江医院等5家医院的腹腔内革兰氏阴性菌感染导致的脓毒症或感染性休克患者19例。患者随机分为常规治疗联合内毒素吸附治疗的试验组8例和常规治疗的对照组11例。以治疗后第3天的序贯器官衰竭评分(SOFA)变化为主要评价指标,同时评价治疗后第3天、第7天及第14天的SOFA评分、平均动脉压(MAP)、血管活性药物使用量的变化以及急性肾损伤(AKI)的发生率、患者28天死亡率及不良事件发生率。结果观察组患者的SOFA评分与对照组相比降低的更明显,观察组和对照组患者治疗后第3天、第7天、第14天的SOFA评分没有统计学差异(P>0.05)。此外,观察组和对照组患者28天死亡率没有明显差异(P>0.05)。两组患者平均动脉压、血管活性药物使用量也没有明显差异。结论在腹腔内革兰氏阴性菌感染导致的脓毒症或感染性休克中,内毒素吸附治疗联合常规治疗相较于常规治疗,有降低患者SOFA评分的趋势,但没有统计学差异,目前还需要更多的大样本研究来验证内毒素吸附治疗在脓毒症患者治疗中的作用。Objective To evaluate the efficacy and safety of endotoxin adsorption therapy added to conventional therapy in patients with sepsis or infectious shock due to Gram-negative bacterial infections in abdominal cavity while compared with only conventional therapy.Methods From 2014.1 to 2016.9,a multicenter,randomized controlled trial included 19 patients with sepsis or infectious shock due to Gram-negative bacterial infections in abdominal cavity from West China hospital of Sichuan university,The First Affiliated Hospital of Xinjiang Medical University,Zhujiang Hospital of Southern Medical University and so on.Enrolled patients randomized to either endotoxin adsorption therapy added to conventional therapy(n=8)or conventional therapy(n=11).Primary outcome mainly included the change of Sequential Organ Failure Assessment scores(SOFA)on third day after treated and the changes of SOFA scores,mean arterial pressure(MAP)and vasoactive drugs on the third、7th、14th day after treated,the incidence rate of acute kidney injury(AKI),28-day mortality also were evaluated.Results Compared with conventional therapy only,SOFA may more obviously decrease in endotoxin adsorption therapy added to conventional therapy group.The SOFA in test group and control on the third day,7th,14th was(7.67±1.86 vs 9.88±4.73),(7.75±4.57 vs 9.33±6.74),and(4.67±2.08 vs 11.00±4.24)respectively.Due to the small sample size,statistical difference was not significant(P>0.05).28-day mortality also was no significant difference between the test group and control(35.7%VS.39.4%,P>0.05).Besides,the changes of MAP and vasoactive drugs also were no significant difference between the two groups.Conclusion Compared with only conventional therapy,there is a tendency to decrease SOFA for patients with sepsis or infectious shock due to Gram-negative bacterial infections in abdominal cavity treated by endotoxin adsorption therapy added to conventional therapy,however,there is no significance.More trials are needed to confirm the argument.

关 键 词：内毒素吸附治疗 脓毒症 感染性休克 疗效 不良事件 

分 类 号：R631.2[医药卫生—外科学]