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

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, and χ (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 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 (Z = -0.982, -1.702; P = 0.326, 0.089), while the other three sub-tests had significant differences (P < 0.001). Conclusion: 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.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，从而建立更可靠的诊断评分标准，为获得准确的肝硬化人群MHE发病情况和制定诊疗策略提供依据。.