不同诊断标准对肝硬化轻微型肝性脑病判定的影响:一项基于前瞻性、多中心、真实世界研究的分析  

Impact of different diagnostic criteria for assessing mild micro-hepatic encephalopathy in liver cirrhosis:an analysis based on a prospective,multicenter,real-world study

作　　者：李晓燕 刘尚豪 刘川 祖红梅 郭小青[6] 向慧玲[7] 黄燕[8] 严兆兰 李雅静 孙佳 宋瑞欣 闫俊卿[7] 叶青[7] 刘菲[8] 黄磊 孟繁平 张晓宁 杨少奇[9] 呼圣娟[10] 阮继刚 李异玲[12] 王宁宁[12] 崔会鹏 王滟萌 雷创[13] 汪清海[13] 田宏玲 瞿章书 袁敏 石瑞春 杨小婷 金丹 苏丹 刘益军[16] 陈颖 夏玉香 李勇忠[17] 杨巧华 李淮[17] 赵学兰 田泽敏 余洪吉 张晓娟 吴晨曦 吴志坚 李胜强 沈迁 刘雪梅 胡建平[21] 武曼群[21] 党彤[22] 王晶[22] 孟宪梅[22] 王海英 江振宇[22] 刘娅媛 刘莹[23] 曲素萱 陶弘 鄢冬梅 刘君 付巍 于杰 王福生 祁小龙 福军亮 Li Xiaoyan;Liu Shanghao;Liu Chuan;Zu Hongmei;Guo Xiaoqing;Xiang Huiling;Huang Yan;Yan Zhaolan;Li Yajing;Sun Jia;Song Ruixin;Yan Junqing;Ye Qing;Liu Fei;Huang Lei;Meng Fanping;Zhang Xiaoning;Yang Shaoqi;Hu Shengjuan;Ruan Jigang;Li Yiling;Wang Ningning;Cui Huipeng;Wang Yanmeng;Lei Chuang;Wang Qinghai;Tian Hongling;Qu Zhangshu;Yuan Min;Shi Ruichun;Yang Xiaoting;Jin Dan;Su Dan;Liu Yijun;Chen Ying;Xia Yuxiang;Li Yongzhong;Yang Qiaohua;Li Huai;Zhao Xuelan;Tian Zemin;Yu Hongji;Zhang Xiaojuan;Wu Chenxi;Wu Zhijian;Li Shengqiang;Shen Qian;Liu Xuemei;Hu Jianping;Wu Manqun;Dang Tong;Wang Jing;Meng Xianmei;Wang Haiying;Jiang Zhenyu;Liu Yayuan;Liu Ying;Qu Suxuan;Tao Hong;Yan Dongmei;Liu Jun;Fu Wei;Yu Jie;Wang Fusheng;Qi Xiaolong;Fu Junliang(Senior Department of Infectious Diseases,the Fifth Medical Center of Chinese PLA General Hospital,National Clinical Research Center for Infectious Diseases,Beijing 100039,China;Medical School of Chinese PLA,Beijing 100853,China;The First School of Clinical Medicine of Lanzhou University,Lanzhou 730000,China;Department of Radiology,Affiliated Zhongda Hospital,Southeast University,Nanjing 210000,China;Department of Gastroenterology,Qinghai Provincial Fourth People's Hospital,Xining 810000,China;Department of Hepatology,the Third People's Hospital of Taiyuan,Taiyuan 030000,China;Department of Gastroenterology and Hepatology,Tianjin Third Central Hospital,Tianjin Key Laboratory of Extracorporeal Life Support for Critical Diseases,Artificial Cell Engineering Technology Research Center,Institute of Hepatobiliary Disease,Tianjin 300000,China;Department of Infectious Diseases,Hunan Key Laboratory of Viral Hepatitis,Xiangya Hospital,Central South University,Changsha 410000,China;Department of Gastroenterology,General Hospital of Ningxia Medical University,Yinchuan 750000,China;Department of Gastroenterology,People's Hospital of Ningxia Hui Autonomous Region,Yinchuan 750000,China;Branch Hospital for Diseases of the Heart,Brain,and Blood Vessels of General Hospital of Ningxia Medical University,Yinchu

机构地区：[1]解放军总医院第五医学中心感染病医学部国家感染性疾病临床医学研究中心,北京100039 [2]解放军医学院,北京100853 [3]兰州大学第一临床医学院,兰州730000 [4]东南大学附属中大医院放射科,南京210000 [5]青海省第四人民医院消化内科,西宁810000 [6]太原市第三人民医院肝病科,太原030000 [7]天津市第三中心医院消化肝病科天津市重症疾病体外生命支持重点实验室天津市人工细胞工程技术研究中心天津市肝胆疾病研究所,天津300000 [8]中南大学湘雅医院感染病科病毒性肝炎湖南省重点实验室,长沙410000 [9]宁夏医科大学总医院消化内科,银川750000 [10]宁夏回族自治区人民医院消化内科,银川750000 [11]宁夏医科大学总医院心脑血管病医院,银川750000 [12]中国医科大学附属第一医院消化内科,沈阳110000 [13]湖南省常德市第一人民医院肝病科,常德415000 [14]湘西自治州人民医院感染科,吉首416000 [15]吴忠市人民医院消化内科,吴忠751100 [16]湖南中医药高等专科学校第一附属医院肝病科,株洲412000 [17]怀化市第一人民医院感染科,怀化418000 [18]重庆市公共卫生医疗救治中心肝病科,重庆400000 [19]益阳市第四人民医院肝病诊疗中心,益阳413000 [20]银川市第二人民医院消化内科,银川750000 [21]银川市第一人民医院消化内科,银川750000 [22]包头医学院第二附属医院消化内科,包头014000 [23]丹东市中心医院消化内科,丹东118000 [24]沈阳七三九医院肝病科,沈阳110000 [25]解放军总医院第五医学中心感染性疾病科,北京100039

出　　处：《中华肝脏病杂志》2023年第9期961-968,共8页Chinese Journal of Hepatology

基　　金：国家自然科学基金创新群体项目(81721002);北京市科委首都临床诊疗技术研究与转化应用项目(Z201100005520046);天津市重点医学专科建设项目(TJYXZDXK-034A);天津市卫生科技项目(TJWJ2022XK029);包头医学院科学研究基金项目(BYJJ-QWB202217);宁夏科技惠民项目(2021CMG03017)。

摘　　要：目的采用肝性脑病心理学评分(PHES)方法及Stroop智能手机应用(Encephal App)测试,比较不同方法测试时肝硬化患者轻微型肝性脑病(MHE)患病率的差异。方法该项前瞻性、多中心、真实世界研究由国家感染性疾病临床医学研究中心和门静脉高压联盟发起并在国际临床试验ClinicalTrials.gov注册(NCT05140837)。在全国19家医院入组354例肝硬化患者,均完成PHES评分(包括数字连接试验A和B、数字符号试验、轨迹描绘试验、系列打点试验)及Stroop测试。PHES分别采用中国和韩国两项研究建立的正常值诊断标准进行评分,Stroop测试依据研发者团队标准进行评定。分析采用不同诊断标准或方法对肝硬化人群MHE患病率的影响。组间数据比较分别采用t检验或Mann-Whitney U检验、χ^(2)检验;组间一致性比较采用kappa检验。结果在354例肝硬化患者中,PHES依据中国和韩国研究正常值标准进行评分后,MHE的患病率分别为78.53%和15.25%;依据Stroop测试,MHE患病率为56.78%,三者间两两比较的差异均有统计学意义(kappa=-0.064,P<0.001)。分层分析显示,依据中国标准,Child-Pugh A、B、C级3组患者的MHE患病率分别为74.14%、83.33%、88.24%;依据韩国标准,Child-Pugh A、B、C级3组患者的MHE患病率分别为8.29%、23.53%、38.24%;依据Stroop测试标准,Child-Pugh A、B、C级3组患者的MHE患病率分别为52.68%、58.82%、73.53%。各诊断标准结果中,MHE患病率均呈现随Child-Pugh分级升高而增加的趋势。进一步比较发现数字连接试验A与数字符号试验在依据中国、韩国标准所得到的分数有较好的一致性(Z值分别为-0.982,-1.702;P值分别为0.326,0.089),而其他3项子测试则差异性较大(P<0.001)。结论MHE在肝硬化人群中的发病率较高,但使用不同的诊断标准或方法得到的MHE患病率差异较大;需要根据目前人口学和疾病谱的变化,入组更大样本量的健康人群作为对照,从而建立更�Objective To compare the differences in the prevalence of mild micro-hepatic encephalopathy(MHE)among patients with cirrhosis by using the psychometric hepatic encephalopathy score(PHES)and the Stroop smartphone application(Encephal App)test.Methods This prospective,multi-center,real-world study was initiated by the National Clinical Medical Research Center for Infectious Diseases and the Portal Hypertension Alliance and registered with International ClinicalTrials.gov(NCT05140837).354 cases of cirrhosis were enrolled in 19 hospitals across the country.PHES(including digital connection tests A and B,digital symbol tests,trajectory drawing tests,and serial management tests)and the Stroop test were conducted in all of them.PHES was differentiated using standard diagnostic criteria established by the two studies in China and South Korea.The Stroop test was evaluated based on the criteria of the research and development team.The impact of different diagnostic standards or methods on the incidence of MHE in patients with cirrhosis was analyzed.Data between groups were differentiated using the t-test,Mann-Whitney U test,andχ^(2) test.A kappa test was used to compare the consistency between groups.Results After PHES,the prevalence of MHE among 354 cases of cirrhosis was 78.53%and 15.25%,respectively,based on Chinese research standards and Korean research normal value standards.However,the prevalence of MHE was 56.78%based on the Stroop test,and the differences in pairwise comparisons among the three groups were statistically significant(kappa=-0.064,P<0.001).Stratified analysis revealed that the MHE prevalence in three groups of patients with Child-Pugh classes A,B,and C was 74.14%,83.33%,and 88.24%,respectively,according to the normal value standards of Chinese researchers,while the MHE prevalence rates in three groups of patients with Child-Pugh classes A,B,and C were 8.29%,23.53%,and 38.24%,respectively,according to the normal value standards of Korean researchers.Furthermore,the prevalence rates of MHE in the three

关 键 词：肝硬化 轻微型肝性脑病 肝性脑病心理学评分 Stroop测试 

分 类 号：R575.2[医药卫生—消化系统]