连续性肾脏替代治疗对硫酸黏菌素血药浓度和临床疗效及安全性的影响  

Effect of continuous renal replacement therapy on plasma concentration, clinical efficacy and safety of colistin sulfate

作　　者：彭丹阳 张帆[2] 李兆桢 吕品[4] 郭孜琦 陈银银 赵婧革 牛京京 郭波 贾文青 姜晓锋[6] 李晓召[7] 祁绍艳[8] 秦秉玉[2] 邵换璋[2] Peng Danyang;Zhang Fan;Li Zhaozhen;Lyu Pin;Guo Ziqi;Chen Yinyin;Zhao Jingge;Niu Jingjing;Guo Bo;Jia Wenqing;Jiang Xiaofeng;Li Xiaozhao;Qi Shaoyan;Qin Bingyu;Shao Huanzhang(Department of Critical Care Medicine,People's Hospital of Henan University,Zhengzhou 450003,Henan,China;Department of Critical Care Medicine,Henan Provincial People's Hospital,Zhengzhou 450003,Henan,China;Department of Respiratory and Critical Care Medicine,Henan Chest Hospital,Zhengzhou 450003,Henan,China;Department of Pharmacy,Henan Provincial People's Hospital,Zhengzhou 450003,Henan,China;Department of Clinical Research Center,Henan Province People's Hospital,Zhengzhou 450003,Henan,China;Department of Neurology,Henan Provincial People's Hospital,Zhengzhou 450003,Henan,China;Department of Cardiac Surgecal Intensive Care Unit,Henan Chest Hospital,Zhengzhou 450003,Henan,China;Department of Critical Care Medicine,the Second Affiliated Hospital of Zhengzhou University,Zhengzhou 450003,Henan,China)

机构地区：[1]河南大学人民医院重症医学科,郑州450003 [2]河南省人民医院重症医学科,郑州450003 [3]河南省胸科医院呼吸与危重症医学科,郑州450003 [4]河南省人民医院药学部,郑州450003 [5]河南省人民医院临床研究中心,郑州450003 [6]河南省人民医院神经内科,郑州450003 [7]河南省胸科医院心外重症监护病房,郑州450003 [8]郑州大学第二附属医院重症医学科,河南郑州45000

出　　处：《中华危重病急救医学》2023年第1期88-92,共5页Chinese Critical Care Medicine

基　　金：河南省自然科学基金面上项目(202300410458)。

摘　　要：目的:探讨连续性肾脏替代治疗(CRRT)对硫酸黏菌素血药浓度、临床疗效及安全性的影响。方法:从本课题组前期临床注册研究,即硫酸黏菌素治疗重症监护病房(ICU)重症感染患者的有效性和药代动力学特点的前瞻性、多中心观察研究中,收集接受硫酸黏菌素治疗患者的临床数据进行回顾性分析,根据是否接受血液净化治疗将患者分为CRRT组和非CRRT组。收集两组患者的基线资料(性别、年龄、是否合并糖尿病、慢性神经系统疾病等)、一般资料(感染病原菌及部位、稳态谷浓度、稳态峰浓度、临床有效率,28 d全因病死率等)以及不良事件(肾功能损伤、神经症状、皮肤色素沉着等)。结果:共纳入90例患者,其中CRRT组22例,非CRRT组68例。①两组患者在性别、年龄、基础疾病、肝功能、感染病原菌、感染部位、硫酸黏菌素剂量等资料比较差异均无统计学意义。与非CRRT组相比,CRRT组患者急性生理学与慢性健康状况评分Ⅱ(APACHEⅡ)、序贯器官衰竭评分(SOFA)更高〔APACHEⅡ(分):21.77±8.26比18.01±6.34,P<0.05;SOFA(分):8.5(7.8,11.0)比6.0(4.0,9.0),P<0.01〕,血肌酐水平更高〔μmol/L:162.0(119.5,210.5)比72.0(52.0,117.0),P<0.01〕。②血药浓度:CRRT组与非CRRT组患者稳态谷浓度差异未见统计学意义(mg/L:0.58±0.30比0.64±0.25,P=0.328),稳态峰浓度差异也未见统计学意义(mg/L:1.02±0.37比1.18±0.45,P=0.133)。③临床疗效:CRRT组与非CRRT组临床有效率差异无统计学意义〔68.2%(15/22)比80.9%(55/68),P=0.213〕。④安全性:仅非CRRT组患者中有2例(2.9%)发生急性肾损伤;两组患者均未发现明显的神经系统症状以及皮肤色素沉着等不良反应。结论:CRRT对硫酸黏菌素药物的消除影响较小。对于接受CRRT治疗的患者,常规的血药浓度监测(TDM)是有必要的。Objective To investigate the effects of continuous renal replacement therapy(CRRT)on plasma concentration,clinical efficacy and safety of colistin sulfate.Methods Clinical data of patients received with colistin sulfate were retrospectively analyzed from our group's previous clinical registration study,which was a prospective,multicenter observation study on the efficacy and pharmacokinetic characteristics of colistin sulfate in patients with severe infection in intensive care unit(ICU).According to whether patients received blood purification treatment,they were divided into CRRT group and non-CRRT group.Baseline data(gender,age,whether complicated with diabetes,chronic nervous system disease,etc),general data(infection of pathogens and sites,steady-state trough concentration,steady-state peak concentration,clinical efficacy,28-day all-cause mortality,etc)and adverse event(renal injury,nervous system,skin pigmentation,etc)were collected from the two groups.Results A total of 90 patients were enrolled,including 22 patients in the CRRT group and 68 patients in the non-CRRT group.①There was no significant difference in gender,age,basic diseases,liver function,infection of pathogens and sites,colistin sulfate dose between the two groups.Compared with the non-CRRT group,the acute physiology and chronic health evaluationⅡ(APACHEⅡ)and sequential organ failure assessment(SOFA)were higher in the CRRT group[APACHEⅡ:21.77±8.26 vs.18.01±6.34,P<0.05;SOFA:8.5(7.8,11.0)vs.6.0(4.0,9.0),P<0.01],serum creatinine level was higher[μmol/L:162.0(119.5,210.5)vs.72.0(52.0,117.0),P<0.01].②Plasma concentration:there was no significant difference in steady-state trough concentration between CRRT group and non-CRRT group(mg/L:0.58±0.30 vs.0.64±0.25,P=0.328),nor was there significant difference in steady-state peak concentration(mg/L:1.02±0.37 vs.1.18±0.45,P=0.133).③Clinical efficacy:there was no significant difference in clinical response rate between CRRT group and non-CRRT group[68.2%(15/22)vs.80.9%(55/68),P=0.213].④

关 键 词：硫酸黏菌素 血药浓度 连续性肾脏替代治疗 临床有效率 不良反应 

分 类 号：R969.1[医药卫生—药理学]