Li X Y, Liu S H, Liu C, Zu H M, Guo X Q, Xiang H L, Huang Y, Yan Z L, Li Y J, Sun J, Song R X, Yan J Q, Ye Q, Liu F, Huang L, Meng F P, Zhang X N, Yang S S, Hu S J, Ruan J G, Li Y L, Wang N N, Cui H P, Wang Y M, Lei C, Wang Q H, Tian H L, Qu Z S, Yuan M, Shi R C, Yang X T, Jin D, Su D, Liu Y J, Chen Y, Xia Y X, Li Y Z, Yang Q H, Li H, Zhao X L, Tian Z M, Yu H J, Zhang X J, Wu C X, Wu Z J, Li S S, Shen Q, Liu X M, Hu J P, Wu M Q, Dang T, Wang J, Meng X M, Wang H Y, Jiang Z Y, Liu Y Y, Liu Y, Qu S X, Tao H, Yan D M, Liu J, Fu W, Yu J, Wang F S, Qi X L, Fu J L
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.
Zhonghua Gan Zang Bing Za Zhi. 2023 Sep 20;31(9):961-968. doi: 10.3760/cma.j.cn501113-20220602-00298.
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. 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 -test, Mann-Whitney test, and (2) test. A kappa test was used to compare the consistency between groups. 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, < 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 groups of patients with Child-Pugh grades A, B, and C were 52.68%, 58.82%, and 73.53%, respectively, according to the Stroop test standard. However, among the results of each diagnostic standard, the prevalence of MHE showed an increasing trend with an increasing Child-Pugh grade. Further comparison demonstrated that the scores obtained by the number connection test A and the number symbol test were consistent according to the normal value standards of the two studies in China and South Korea ( = -0.982, -1.702; = 0.326, 0.089), while the other three sub-tests had significant differences ( < 0.001). The prevalence rate of MHE in the cirrhotic population is high, but the prevalence of MHE obtained by using different diagnostic criteria or methods varies greatly. Therefore, in line with the current changes in demographics and disease spectrum, it is necessary to enroll a larger sample size of a healthy population as a control. Moreover, the establishment of more reliable diagnostic scoring criteria will serve as a basis for obtaining accurate MHE incidence and formulating diagnosis and treatment strategies in cirrhotic populations.
通过使用心理测量肝性脑病评分(PHES)和Stroop智能手机应用程序(Encephal App)测试,比较肝硬化患者中轻度微肝性脑病(MHE)患病率的差异。这项前瞻性、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,并在国际临床试验注册中心(NCT05140837)注册。全国19家医院共纳入354例肝硬化患者。对所有患者进行了PHES(包括数字连接测试A和B、数字符号测试、轨迹绘制测试和连续管理测试)和Stroop测试。PHES采用中国和韩国两项研究制定的标准诊断标准进行区分。Stroop测试根据研发团队的标准进行评估。分析不同诊断标准或方法对肝硬化患者MHE发病率的影响。组间数据采用t检验、Mann-Whitney检验和χ²检验进行区分。采用kappa检验比较组间一致性。PHES检测后,根据中国研究标准和韩国研究正常值标准,354例肝硬化患者中MHE的患病率分别为78.53%和15.25%。然而,根据Stroop测试,MHE的患病率为56.78%,三组之间的两两比较差异具有统计学意义(kappa = -0.064,P < 0.001)。分层分析显示,根据中国研究人员的正常值标准,Child-Pugh A、B和C级三组患者的MHE患病率分别为74.14%、83.33%和88.24%,而根据韩国研究人员的正常值标准,Child-Pugh A、B和C级三组患者的MHE患病率分别为8.29%、23.53%和38.24%。此外,根据Stroop测试标准,Child-Pugh A、B和C级三组患者的MHE患病率分别为52.68%、58.82%和73.53%。然而,在每种诊断标准的结果中,MHE的患病率随着Child-Pugh分级的增加呈上升趋势。进一步比较表明,根据中国和韩国两项研究的正常值标准,数字连接测试A和数字符号测试获得的分数一致(r = -0.982,-1.702;P = 0.326,0.089),而其他三个子测试存在显著差异(P < 0.001)。肝硬化人群中MHE的患病率较高,但使用不同诊断标准或方法获得的MHE患病率差异很大。因此,为适应目前人口统计学和疾病谱的变化,有必要纳入更大样本量的健康人群作为对照。此外,建立更可靠的诊断评分标准将为获得准确的MHE发病率以及制定肝硬化人群的诊断和治疗策略提供依据。