Recombinant human serum albumin (rHA) is a promising alternative to human serum albumin (HSA) for managing ascites in cirrhotic patients. This phase Ib study aims to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) profiles of rHA in this population. This randomized, open-label, phase Ib trial was conducted between December 2019 and September 2020 at 3 medical centers in China. Patients with cirrhotic ascites were randomly assigned to receive rHA or HSA at 10 g/day, 20 g/day, or 30 g/day. Each group had 12 participants (nine receiving rHA and three receiving HSA as positive control). Treatment lasted up to 14 days or until serum albumin levels reached 35 g/L, followed by a 28-day follow-up. Adverse events monitored assessed safety and tolerability, while PK/PD was evaluated by tracking serum albumin levels and plasma colloid osmotic pressure (PCOP) before and after each dose (ClinicalTrials.gov No. NCT04701697). Thirty-six Chinese participants were enrolled, with 32 completing the study. The incidence of adverse events was similar between the rHA and HSA groups (44.4

BACKGROUND AND AIMS:Studies have shown that blocking the programmed cell death-1/programmed cell death ligand 1 pathway may lead to a potential cure for HBV infections. ASC22 (envafolimab) is a humanized, single-domain programmed cell death ligand 1 antibody administered subcutaneously. This study aimed to evaluate the efficacy and safety of ASC22 in virally suppressed patients with chronic hepatitis B on nucleos(t)ide analogs. APPROACH AND RESULTS:This randomized, single-blind, phase IIb trial enrolled patients with chronic hepatitis B in 2 cohorts for a 24-week treatment with ASC22 or placebo (PBO) once every 2 weeks and 24-week follow-up. In total, 60, 59, and 30 patients were treated with 1.0, 2.5 mg/kg ASC22, and PBO, respectively. The mean changes in HBsAg from baseline at weeks 24 and 48 were -0.309 ( p < 0.001) and -0.272 ( p < 0.023) log 10 IU/mL in the 1.0 mg/kg ASC22 group, -0.231 ( p = 0.007) and -0.205 ( p = 0.12) log 10 IU/mL in the 2.5 mg/kg ASC22 group, and -0.003 and -0.063 log 10 IU/mL in the PBO group, respectively (intent-to-treat population). Three out of 10 patients with baseline HBsAg levels ≤100 IU/mL in the 1.0 mg/kg group obtained on-treatment HBsAg loss. Most adverse events were mild (97.9%). There were no study drug-related serious adverse events in the 1.0 mg/kg ASC22 group. CONCLUSIONS:Subcutaneous administration of 1.0 mg/kg ASC22 once every 2 weeks for 24 weeks was shown to be safe and well-tolerated in virally suppressed patients with chronic hepatitis B on nucleos(t)ide analogs and can induce HBsAg decline, especially in patients with HBsAg ≤100 IU/mL.

原发性胆汁性胆管炎(PBC)可合并多种肝外自身免疫性疾病,包括甲状腺炎、溃疡性结肠炎、干燥综合征、类风湿性关节炎、系统性红斑狼疮、免疫性血小板减少症(Idiopathic thrombocytopenic purpura, ITP)等.在此报道 1 例PBC合并结缔组织病及 ITP的病例,结合文献讨论,提高临床医生对该病的认识.

腹水是由门静脉高压引起的肝硬化失代偿期的明确标志.虽然经颈静脉肝内门体分流术(TIPS )用于治疗复发性和难治性腹水,但没有证据表明降低门静脉肝压力梯度(PPG)的具体目标.

ALT) levels throughout the study; 2 participants in each regimen had grade 1 ALT elevations.No treatment-related serious AEs were reported. Conclusion:These preliminary data support that a longer duration of treatment with VIR-2218 results in deeper and more sustained reductions in HBsAg.In both regimens of VIR-2218, no differences in safety or tolerability were observed.

Acute-on-chronic liver failure (ACLF) is a syndrome characterized by multiple organ failure and high short-term mortality rate, and it has always been a research hotspot in the field of severe liver diseases. Therefore, early and accurate risk stratification and timely intervention are of great significance to improve prognosis. This article summarizes the serum biomarkers identified in recent years for evaluating the prognosis of patients with ACLF, and it is pointed out that new serum biomarkers have an important guiding significance in the prognostic evaluation of ACLF patients.

门静脉血栓(PVT)是肝硬化的常见并发症之一,由于肝硬化存在凝血功能障碍和出血风险,临床上对于肝硬化合并PVT的治疗存在诸多争议.PVT常用治疗方法包括抗凝、介入和溶栓,重点阐述了肝硬化合并PVT的治疗现状,以期为临床制订规范合理的治疗策略提供帮助.

ObjectiveTo investigate the value of albumin-bilirubin (ALBI) score in evaluating the prognosis of patients with liver cirrhosis and esophagogastric variceal bleeding, and to compare it with Child-Turcotte-Pugh (CTP) score and Model for End-stage Liver Disease combined with serum sodium concentration (MELD-Na) score. MethodsA retrospective analysis was performed for the clinical data of 155 patients who were diagnosed with liver cirrhosis and esophagogastric variceal bleeding in The First Hospital of Jilin University from August 2018 to April 2019, and according to disease outcome after 1 year of follow-up, these patients were divided into survival group with 98 patients and death group with 57 patients. The influencing factors for prognosis were analyzed, and the value of ALBI score in predicting prognosis was assessed. The t-test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test was used for comparison of categorical data between two groups. A Spearman correlation analysis was performed to investigate the correlation between two variables. A multivariate logistic regression analysis was used to investigate independent influencing factors for death within 1 year. The receiver operating characteristic (ROC) curve was plotted, and the area under the ROC curve (AUC) was calculated; the optimal cut-off value was determined based on Youden index. The Z test was used for comparison of AUC between these three scoring systems. ResultsThere were significant differences between the survival group and the death group in initial blood loss (U=1994.5, P=0.002), presence or absence of hepatic encephalopathy (χ2=14.154, P＜0.001), severity of ascites (χ2=10.537, P=0.005), total bilirubin (U=16940, P＜0.001), albumin (t=-6.633, P＜0.001), aspartate aminotransferase (U=2223.5, P=0.035), Na (U=1859.5, P=0001), international normalized ratio (U=1259.5, P＜0.001), prothrombin time (U=1331.5, P＜0.001), white blood cell count (U=2008.5, P=0.004), red blood cell count (t=-2.633, P=0009), red blood cell volume distribution width (U=1719.5, P＜0001), hemoglobin (U=2150.0, P=0.017), ALBI grade (χ2=48.732, P＜0.001), and CTP class (χ2=34.646, P＜0.001). The death group had a significantly higher ALBI score on admission than the survival group (-1.11±0.59 vs -1.79±0.44, t=7.618, P＜0.001), as well as significantly higher MELD-Na score (18.0［14.5-24.0］ vs 12.0［10.0-16.0］, U=1176.0, P＜0.001） and CTP score （9.0［8.0-11.0］ vs 7.0［6.0-8.0］, U=1078.0, P＜0.001）. The Spearman correlation analysis showed that ALBI score was positively correlated with CTP score and MELD-Na score (r=0.753 and 0.668, both P＜0.001). The multivariate logistic regression analysis showed that ALBI score (odds ratio ［OR］=8.349, 95% confidence interval ［CI］: 2.658-26.232), CTP score (OR=1.586, 95%CI: 1.157-2.175), and MELD-Na score (OR=1.188, 95%CI: 1.062-1.328) were independent risk factors for predicting death within 1 year. The optimal cut-off value was -1.485 for ALBI score, 8.5 for CTP score, and 17.5 for MELD-Na score in predicting the 1-year prognosis of patients, with an AUC of 0.818, 0.807, and 0.789, respectively. There was no significant difference between the three scoring systems in predicting the 1-year mortality rate (P＞0.05). ConclusionThe performance of ALBI score is comparable to that of CTP and MELD-Na scores in predicting the risk of death within 1 year in patients with liver cirrhosis and esophagogastric variceal bleeding, and ALBI score has a good evaluation ability.

[据Journal of Hepatology 2020年9月报道]题:慢性高氨血症可诱导外周炎症,导致小鼠认知障碍:抗TNFα治疗可逆转(作者Balzano T等) 慢性高氨血症可诱导神经炎症,引起认知障碍.但是高氨血症如何引起神经炎症尚不清楚.研究旨在评估:慢性高氨血症是否会诱发周围炎症,再进一步导致神经炎症、神经传导改变和空间学习受损;以及当高氨血症消除或用抗TNFα治疗周围炎症后,神经炎症和损伤是否是可逆的.

多发性骨髓瘤表现不典型,误诊率极高,骨髓穿刺是确诊的重要手段.多发性骨髓瘤表现多样,反复感染发热、骨痛、贫血等均应考虑多发性骨髓瘤的可能.本文报道1例丙型肝炎后肝硬化合并多发性骨髓瘤患者的诊治经过,并进行文献复习,以提高临床医师对该病的认识.

ObjectiveTo investigate the clinical efficacy and safety of sofosbuvir combined with ribavirin in the treatment of treatment-nave patients with genotype 2 chronic hepatitis C virus (HCV) infection. MethodsTreatment-nave patients with genotype 2 HCV infection were screened in sixteen research centers of China. All patients received sofosbuvir (400 mg/tablet, 1 tablet/d) combined with ribavirin (1000 mg/d for patients with a body weight of ＜75 kg and 1200 mg/d for those with a body weight of ≥75 kg) for 12 weeks and were followed up for 12 weeks after drug withdrawal. The primary outcome measure was sustained virologic response at week 12 of follow-up, and the secondary outcome measures included the proportion of patients with HCV RNA below the lower limit of quantitation at weeks 2, 4, 8, and 12 of treatment and after 4 weeks of drug withdrawal, virological rebound rate at weeks 4, 8, and 12 of treatment, and recurrence rate at weeks 4 and 12 of follow-up. Adverse events were observed during treatment to evaluate drug safety. ResultsA total of 136 subjects were enrolled, among whom 121 had no liver cirrhosis and 15 had compensated liver cirrhosis. The sustained virologic response (SVR) rate was 92.6% (95% confidence interval: 88.3%-97.0%) after 12 weeks of drug withdrawal. At week 8 of treatment, 1 patient experienced virological rebound; after 4 weeks of drug withdrawal, 8 patients experienced virological rebound; after 12 weeks of drug withdrawal, 10 patients experienced virological rebound. Among the 136 subjects, 128 (94.1%) reported 549 cases of treatment-emergent adverse events, among which 243 cases were associated with sofosbuvir and/or ribavirin and were reported in 99 subjects (72.8%). No adverse events leading to the adjustment or discontinuation of sofosbuvir were observed. A total of 7 serious adverse events were reported in 6 patients (4.4%), among which only one (a low echo area in the liver with unknown nature) was considered possibly associated with sofosbuvir and/or ribavirin. No adverse events leading to study discontinuation or death were observed. ConclusionSofosbuvir combined with ribavirin can achieve a high SVR rate in treatment-nave patients with genotype 2 chronic HCV infection, with mild adverse reactions and acceptable safety profile.

Rationale: Myelodysplastic syndrome (MDS) can be complicated with Crohn disease (CD). Irritable bowel disease (IBD) associated with MDS has already been reported in the past; however, hematopoietic stem cell transplantation (HSCT) is rarely performed. Herein, we report a case of CD with MDS for HSCT. Patient concerns: A 41-year-old man was hospitalized due to abdominal pain and intermittent fever for 40 days. Two years later, he was readmitted due to abdominal pain and diarrhea with fever for 10 days. Diagnosis: Symptoms, laboratory examinations, and imaging findings of the patient were indicative of CD complicated with MDS. Interventions: An allogeneic HSCT was performed. Outcomes: He died of severe lung infection 125 days post-transplantation. Lessons: The number of cases of CD combined with MDS remains insufficient, and no consensus opinions are available to date. Hence, HSCT is a very potential treatment method. Additional experiences are needed to determine its effectiveness.

ObjectiveLactulose is effective in the treatment and prevention of overt hepatic encephalopathy (OHE), but there are limited data on its use on microbiota in relations to minimal hepatic encephalopathy (MHE) recovery. The present study aimed to assess the efficacy of lactulose in recovery of MHE in aspects of cognitive function, quality of life, and impact on intestinal microbiota.MethodsThis multicenter, open‐label randomized controlled trial was conducted in 11 teaching hospitals in China. Participants were randomly allocated on a 2:1 basis to receive lactulose (Gp‐L) or no therapy as control (Gp‐NL) for 60 days. The primary endpoint was the MHE reversal rate. Gut microbiota were compared between MHE patients and healthy volunteers, as well as lactulose‐responders and non‐responders.ResultsA total of 98 cirrhotic patients were included in the study, with 31 patients in the Gp‐NL group and 67 patients in the Gp‐L group. At day 60, the MHE reversal rate in Gp‐L (64.18%) was significantly higher than that in Gp‐NL (22.58%) (P = .0002) with a relative risk of 0.46 (95% confidence interval 0.32‐0.67). Number needed to treat was 2.4. Further, there was significantly more improvement in physical functioning in Gp‐L (4.62 ± 6.16) than in Gp‐NL (1.50 ± 5.34) (P = .0212). Proteobacteria was significantly higher in MHE patients compared with healthy volunteers (12.27% vs 4.65%, P < .05). Significant differences were found between lactulose responders and non‐responders in Actinobacteria, Bacteroidetes, Firmicutes, and Proteobacteria.ConclusionsTreatment with lactulose significantly improves MHE recovery rate, and gut microbiota change in MHE patients can modulate the effectiveness of this therapy. Chinese Clinical Trial Register (ChiCTR) (ID: ChiCTR‐TRC‐12002342).

患者 ,女性 ,14岁 ,因"发现转氨酶增高7个月"入院.患者7个月前因体检时发现转氨酶升高就诊于外院 ,行保肝治疗(具体用药不详)无明显好转 ,期间复查肝功反复异常.病程中患者无发热 ,无咳嗽、咳痰 ,无恶心、呕吐 ;饮食、睡眠尚可 ,小便正常 ,偶有腹泻 ,近期体重未见明显改变.既往平素体健 ,但身高及体质量长期明显低于同龄儿童 ,有饮用生水的习惯.查体:营养不良、发育障碍 ,身高144 cm ,体重33 kg ,体质指数(BM I)15 .9.皮肤、巩膜无黄染 ,未见肝掌、蜘蛛痣、K-F环.

十二指肠乳头旁憩室压迫胰胆管致急性胆管炎、梗阻性黄疸、急性胰腺炎,而不伴胆总管结石、胆胰肿瘤的一组症候群称为乳头旁憩室综合征,是由Lemmel于1934 年首次报道,又称为 Lemmel 综合征[1-3]. 其中由十二指肠憩室所致的复发性急性胰腺炎较少见,易误诊或漏诊[4]. 现将吉林大学第一医院收治的一例Lemmel综合征并复发性急性胰腺炎资料进行分析,并结合该病例进行相关文献复习.

1 病例资料 患者男性,52岁,货车司机,因"间断乏力、腹胀10年,加重伴发热、尿黄、腰痛5天"于2018年9月27日入住吉林大学第一医院治疗.患者10年前无明显诱因出现乏力、腹胀,就诊于当地医院完善相关检查后明确诊断为"酒精性肝硬化",未治疗,未戒酒.5年前因呕血于当地医院行食管胃底静脉曲张套扎治疗后好转出院,出院后仍未戒酒.