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Thrombocytopenia (TCP), MELD Score, and Fibrosis Index (FI) Among Hospitalized Patients with Chronic Liver Disease (CLD) in Ma'abar City, Dhamar Governorate, Yemen: A Cross-Sectional Study. 也门达马省马阿巴尔市慢性肝病(CLD)住院患者的血小板减少症(TCP)、MELD评分和纤维化指数(FI):一项横断面研究
IF 2.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.2147/HMER.S392011
Mohammed Haidar Hazaa Al-Dholae, Mohammed Kassim Salah, Omar Yahya Al-Ashmali, Abdul Salam Mohamed Al Mokdad, Mohammed Ali Al-Madwami

Purpose: This study sought to assess the prevalence of thrombocytopenia (TCP), underlying aetiologies of chronic liver disease, and the grading and prognostic systems for chronic liver disease (CLD) using non-invasive biomarkers: the Fibrosis index and the Model for End-Stage Liver Disease-Na (MELD-Na) Score, respectively.

Patients and methods: This was a 15-month multi-centric cross-sectional study of 105 patients with chronic liver disease (CLD). The study was conducted using Sept 2019 to Nov 2020 admission records of CLD patients from Ma'abar City in Dhamar Governorate, Yemen.

Results: A total of 63 (60%) and 42 (40%) patients were identified as thrombocytopenic and non-thrombocytopenic, respectively. The means ± SD of the MELD score and FI were 19 ± 7.302 and 4.1 ± 1.06. TCP prevalence among leukopenic and non-leukopenic patients was 89.5% and 53.5%, respectively (P = 0.004). Likewise, the prevalence of traditional-ultrasonography-diagnosed cirrhotic patients needing liver transplantation (LT) was 82.3% versus 61.3% among corresponding non-cirrhotic patients (P = 0.000).

Conclusion: The prevalence of TCP among the participants of this study was similar to the global rate. However, the prevalence of decompensation was much higher among CLD patients than that found elsewhere, highlighting a need to improve methods for the early diagnosis of CLD in Yemen. This study also identified problems with the diagnostic work-up for non-infectious aetiologies of CLD. The findings suggest the need to improve clinician awareness about effective diagnostic strategies for these aetiologies.

目的:本研究旨在评估血小板减少症(TCP)的患病率,慢性肝病的潜在病因,以及慢性肝病(CLD)的分级和预后系统,分别使用非侵入性生物标志物:纤维化指数和终末期肝病模型na (MELD-Na)评分。患者和方法:这是一项为期15个月的多中心横断面研究,纳入105例慢性肝病(CLD)患者。该研究使用了也门达马省马阿巴尔市2019年9月至2020年11月的CLD患者入院记录。结果:共有63例(60%)和42例(40%)患者被确定为血小板减少性和非血小板减少性。MELD评分和FI的均值±SD分别为19±7.302和4.1±1.06。白细胞减少和非白细胞减少患者中TCP患病率分别为89.5%和53.5% (P = 0.004)。同样,传统超声诊断的肝硬化患者需要肝移植(LT)的患病率为82.3%,而相应的非肝硬化患者为61.3% (P = 0.000)。结论:本研究参与者中TCP患病率与全球患病率相似。然而,在CLD患者中,失代偿的患病率比在其他地方发现的要高得多,这突出表明需要改进也门CLD早期诊断方法。本研究还确定了CLD非感染性病因的诊断工作存在的问题。研究结果表明,需要提高临床医生对这些病因的有效诊断策略的认识。
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引用次数: 0
The Accuracy of Ultrasound Controlled Attenuation Parameter in Diagnosing Hepatic Fat Content. 超声控制衰减参数诊断肝脏脂肪含量的准确性。
IF 2.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.2147/HMER.S411619
Sebastiana Atzori, Yasmin Pasha, James B Maurice, Simon D Taylor-Robinson, Louise Campbell, Adrian K P Lim

Purpose: The Controlled Attenuation Parameter (CAP score) is based on ultrasonic properties of retropropagated radiofrequency signals acquired by FibroscanTM (Echosens, Paris, France). Since ultrasound propagation is influenced by the presence of fat, CAP score was developed to quantify steatosis. The aim of this study was to delineate the accuracy of CAP in diagnosing hepatic steatosis, compared to the gold standard of liver biopsy.

Patients and methods: A total of 150 patients underwent same-day liver biopsy and measurement of hepatic steatosis with Fibroscan. Only examinations with 10 satisfactory measurements, and an inter-quartile range of less than 30% of the median liver stiffness values were included for data analysis. Histological staging was then correlated with median values and Spearman correlation calculated. P values of <0.05 were considered statistically significant.

Results: For diagnosis of hepatic steatosis (HS), CAP could predict the steatosis S2 with AUROC 0.815 (95% CI 0.741-0.889), sensitivity (0.81) and specificity (0.73) when the optimal cut-off value was set at 288 dB/m. CAP detected histological grade S3 with AUROC 0.735 (95% CI 0.618-0.851), sensitivity (0.71) and specificity (0.74), with a cut-off value of 330 dB/m. The AUROC for steatosis grade S1 was 0.741 (95% CI 0.650-0.824), with a cut-off value of 263 dB/m with sensitivity 0.75 and specificity 0.70. Univariate analysis showed a correlation between CAP and diabetes (p 0.048).

Conclusion: The performance of CAP to diagnose steatosis severity decreases as steatosis progresses. CAP is associated with diabetes but not other clinical factors and parameters of the metabolic syndrome.

目的:控制衰减参数(CAP评分)是基于纤维scantm (Echosens,巴黎,法国)采集的反向传播射频信号的超声特性。由于超声传播受到脂肪存在的影响,CAP评分被用来量化脂肪变性。本研究的目的是描述CAP在诊断肝脂肪变性方面的准确性,与肝活检的金标准相比较。患者和方法:共有150例患者接受了当天肝活检和肝脂肪变性纤维扫描测量。只有10个满意的测量值,以及小于中位肝脏硬度值30%的四分位数范围的检查被纳入数据分析。然后将组织学分期与中位数相关,并计算Spearman相关。结果P值:对于肝脂肪变性(HS)的诊断,当最佳临界值为288 dB/m时,CAP预测S2脂肪变性的AUROC为0.815 (95% CI 0.741 ~ 0.889),敏感性为0.81,特异性为0.73。CAP检测组织学分级S3的AUROC为0.735 (95% CI为0.618-0.851),灵敏度为0.71,特异性为0.74,临界值为330 dB/m。S1级脂肪变性的AUROC为0.741 (95% CI 0.650-0.824),临界值为263 dB/m,敏感性0.75,特异性0.70。单因素分析显示CAP与糖尿病相关(p = 0.048)。结论:CAP对脂肪变性严重程度的诊断随脂肪变性的进展而降低。CAP与糖尿病有关,但与其他临床因素和代谢综合征参数无关。
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引用次数: 1
Mucinous Cystic Neoplasms of the Liver: Epidemiology, Diagnosis, and Management. 肝脏粘液囊性肿瘤:流行病学、诊断和治疗。
IF 2.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.2147/HMER.S284842
Jeffrey A Hutchens, Kevin J Lopez, Eugene P Ceppa

Mucinous cystic neoplasms (MCNs) are rare tumors of the liver, occasionally seen in the biliary tree. Epidemiologic data are limited by their indolence and recent changes to diagnostic criteria. They are considered premalignant lesions capable of invasive behavior. While their etiology remains unknown, their female predominance, age of onset, and hormonally responsive ovarian-type stroma suggest ectopic organogenesis during embryologic development. MCNs can typically be recognized on imaging; yet, invasiveness is often indeterminate, and percutaneous tissue biopsy has shown limited value. Therefore, complete excision is recommended for all lesions as focal malignant transformation and metastatic disease has been reported.

粘液囊性肿瘤(mcn)是一种罕见的肝脏肿瘤,偶尔见于胆道。流行病学数据因其不活跃和最近诊断标准的变化而受到限制。它们被认为是具有侵袭性行为的癌前病变。虽然其病因尚不清楚,但其女性优势,发病年龄和激素反应性卵巢型基质提示胚胎发育过程中的异位器官发生。mcn通常可以通过成像识别;然而,侵袭性往往是不确定的,经皮组织活检显示有限的价值。因此,当局灶性恶性转化和转移性疾病有报道时,建议对所有病变进行完全切除。
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引用次数: 1
Factors Associated with in-Hospital Mortality in Malagasy Patients with Acute Decompensation of Liver Cirrhosis: A Retrospective Cohort. 马达加斯加肝硬化急性失代偿患者住院死亡率相关因素:一项回顾性队列研究
IF 2.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.2147/HMER.S401628
Chantelli Iamblaudiot Razafindrazoto, Nitah Harivony Randriamifidy, Behoavy Mahafaly Ralaizanaka, Jean Tsitamita Andrianoelison, Haga Tsilavo Ravelomanantsoa, Mialitiana Rakotomaharo, Domoina Harivonjy Hasina Laingonirina, Sonny Maherison, Jolivet Auguste Rakotomalala, Anjaramalala Sitraka Rasolonjatovo, Andry Lalaina Rinà Rakotozafindrabe, Tovo Harimanana Rabenjanahary, Soloniaina Hélio Razafimahefa, Rado Manitrala Ramanampamonjy

Background: Cirrhosis is a pathology responsible for a significant hospital morbidity and mortality. The objective of this study was to determine the factors associated with hospital mortality in a sample of Malagasy cirrhotics.

Patients and methods: This was a retrospective cohort study from January 2018 to August 2020 conducted in the Hepato-Gastroenterology Unity, University Hospital Joseph Raseta Befelatanana, Antananarivo, Madagascar.

Results: One hundred and eight patients were included. The mean age was 51.13±13.50 years with a sex ratio of 2.37. The etiology of cirrhosis was dominated by alcohol (44.44%), hepatitis B virus (24.07%) and hepatitis C virus (13.89%). Twenty-eight patients (25.93%) had died. Factors associated with in-hospital mortality were hepatic encephalopathy (OR: 14.16; 95% CI: 5.08-39.4; p: 0.000), renal failure (OR: 8.55; 95% CI: 2.03-39.9; p: 0.0034), gastrointestinal bleeding (OR: 3.25; 95% CI: 1.32-7.92; p: 0.0099), hyponatraemia <130mmol/L (OR: 3.34; 95% CI: 1.04-10.6; p=0.046), Child-Pugh C classification (OR: 0.19; 95% CI: 0.12-0.21; p: 0.000), and MELD-Na score >32 (OR: 27.5; 95% CI: 4.32-174.8; p: 0.004).

Conclusion: The in-hospital mortality rate during acute decompensation of cirrhosis remains high in Madagascar. Hepatic encephalopathy, renal failure, GI bleeding and hyponatraemia are the main clinico-biological factors affecting in-hospital mortality. Early intervention on these modifiable factors is an important step to improve hospital outcomes. The natraemia, MELD score and MELD-Na score should be used in routine practice in Madagascar to identify patients with acute decompensation of cirrhosis at high risk of death.

背景:肝硬化是导致医院发病率和死亡率增高的一种病理。本研究的目的是确定与马达加斯加肝硬化患者住院死亡率相关的因素。患者和方法:这是一项回顾性队列研究,于2018年1月至2020年8月在马达加斯加塔那那利佛Joseph Raseta Befelatanana大学医院肝胃肠病学联合中心进行。结果:共纳入108例患者。平均年龄51.13±13.50岁,性别比2.37。肝硬化的病因以酒精(44.44%)、乙肝病毒(24.07%)和丙肝病毒(13.89%)为主。死亡28例(25.93%)。与住院死亡率相关的因素是肝性脑病(OR: 14.16;95% ci: 5.08-39.4;p: 0.000),肾功能衰竭(OR: 8.55;95% ci: 2.03-39.9;p: 0.0034),胃肠道出血(OR: 3.25;95% ci: 1.32-7.92;p: 0.0099),低钠血症32 (OR: 27.5;95% ci: 4.32-174.8;p: 0.004)。结论:马达加斯加肝硬化急性失代偿期的住院死亡率仍然很高。肝性脑病、肾功能衰竭、消化道出血和低钠血症是影响住院死亡率的主要临床生物学因素。早期干预这些可改变的因素是改善医院结果的重要一步。钠血症、MELD评分和MELD- na评分应用于马达加斯加的常规实践,以识别死亡风险高的肝硬化急性失代偿患者。
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引用次数: 0
Primary Biliary Cholangitis: Promising Emerging Innovative Therapies and Their Impact on GLOBE Scores. 原发性胆道胆管炎:新兴的创新疗法及其对GLOBE评分的影响。
IF 2.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.2147/HMER.S361077
Aalam Sohal, Kris V Kowdley

Primary biliary cholangitis (PBC), previously referred to as primary biliary cirrhosis, is an autoimmune disorder leading to the destruction of intra-hepatic bile ducts. If untreated, progressive bile duct damage and cholestasis can lead to ductopenia and result in cirrhosis. Ursodiol, the first drug approved for PBC, has changed the natural history of this disease and improved patient outcomes. Subsequently, several new prediction models incorporating a response to ursodiol were developed. These include the GLOBE score, which was shown to predict long-term outcomes in patients with PBC. In 2016, obeticholic acid (OCA) became the second drug to be approved by the FDA, predominantly based on improvement in alkaline phosphatase (ALP) levels. This trial has subsequently influenced the design of clinical trials. Several drugs are currently being evaluated as therapeutic options for PBC, with improvement in ALP being a main endpoint. In this review, we will discuss the impact of new therapies on GLOBE scores in patients with PBC.

原发性胆道炎(PBC),以前被称为原发性胆汁性肝硬化,是一种导致肝内胆管破坏的自身免疫性疾病。如果不及时治疗,进行性胆管损伤和胆汁淤积可导致胆管减少并导致肝硬化。乌索二醇是首个被批准用于PBC的药物,它改变了这种疾病的自然历史,改善了患者的预后。随后,开发了几种新的预测模型,其中包括对乌索二醇的反应。其中包括GLOBE评分,它被证明可以预测PBC患者的长期预后。2016年,奥贝胆酸(OCA)成为FDA批准的第二种药物,主要基于碱性磷酸酶(ALP)水平的改善。该试验随后影响了临床试验的设计。目前正在评估几种药物作为PBC的治疗选择,ALP的改善是主要终点。在这篇综述中,我们将讨论新疗法对PBC患者GLOBE评分的影响。
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引用次数: 0
Risk Factors for Hepatitis B Virus Infection in North Ethiopia: A Case-Control Study. 埃塞俄比亚北部乙型肝炎病毒感染的危险因素:一项病例对照研究
IF 2.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.2147/HMER.S407069
Desalegn Weldebrhan, Hailemariam Berhe, Yohannes Tesfay

Background: Hepatitis B virus infection (HBV) is an important clinical and public health problem that contributes to liver-related public health morbidity and mortality. Although childhood vaccination was introduced in 1980, hospital admissions, morbidity and mortality rates from HBV infection increased in Ethiopia. Risk factors for HBV infection and associated complications generally vary from case to case. No epidemiological studies have identified the risk factors for HBV infection in northern Ethiopia. Therefore, this study aimed to identify risk factors for HBV infection in specialist and teaching hospitals in Ayder.

Methods: From March 2019 to May 2019, an unmatched hospital-based case-control study has been carried out on a total of 213 patients [71 cases and 142 controls] in northern Ethiopia. Cases were selected sequentially and two consecutive controls were selected for each case by a simple random method. The data were collected using pretested questionnaires structured by the interviewer as part of a face-to-face interview. Data were entered in Epi Data version 3.1, exported and analyzed with SPSS version 22. Binary and multivariable logistic regression analyses were used. Statistical significance was given as P <0.05.

Results: Multivariate logistic regression analysis revealed that patients with familial exposure to hepatitis (AOR 3.7, 95% CI: 1.5-9.01), prior traditional medical procedure (AOR 1.2, 95% CI: 1.08-3.4), any history of dental procedures (AOR 3.8, 95% CI: 1.8-9.01) were associated risk factors to hepatitis B virus infection, and awareness of sexually transmitted hepatitis B virus infection (AOR 0.084, 95% CI: 0.01-0.6) is less likely to be infected with hepatitis B virus infection.

Conclusion: This study (findings) demonstrated that contact with a case of hepatitis in the family, history of dentist visits, prior traditional medical procedure, and lack of awareness of its transmission through sexual contact have been identified as independent risk factors for the development of hepatitis B virus infection.

背景:乙型肝炎病毒感染(HBV)是一个重要的临床和公共卫生问题,导致肝脏相关的公共卫生发病率和死亡率。尽管1980年开始接种儿童疫苗,但埃塞俄比亚乙型肝炎病毒感染的住院率、发病率和死亡率都有所上升。HBV感染和相关并发症的危险因素通常因病例而异。没有流行病学研究确定埃塞俄比亚北部乙型肝炎病毒感染的危险因素。因此,本研究旨在确定艾德省专科医院和教学医院HBV感染的危险因素。方法:2019年3月至2019年5月,在埃塞俄比亚北部对213例患者(71例和142例对照)进行了一项无与伦比的基于医院的病例对照研究。采用简单随机方法,按顺序选取病例,每例选取两个连续对照。数据是通过采访者预先测试的问卷收集的,作为面对面访谈的一部分。数据在Epi Data 3.1版本中输入,用SPSS 22版本导出和分析。采用二元和多变量logistic回归分析。结果:多因素logistic回归分析显示,家族性肝炎暴露(AOR 3.7, 95% CI: 1.5-9.01)、既往传统医疗程序(AOR 1.2, 95% CI: 1.08-3.4)、任何牙科手术史(AOR 3.8, 95% CI: 1.8-9.01)是乙型肝炎病毒感染的相关危险因素,性传播乙型肝炎病毒感染意识(AOR 0.084, 95% CI:0.01-0.6)感染乙型肝炎病毒的可能性较小。结论:本研究(结果)表明,与家族肝炎病例接触、牙医就诊史、先前的传统医疗程序以及缺乏通过性接触传播的意识已被确定为乙型肝炎病毒感染发展的独立危险因素。
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引用次数: 0
COVID-19-Associated Liver Injury. covid -19相关肝损伤。
IF 2.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.2147/HMER.S384108
Daniel T Gildea, Stephanie M Woo, Corinne E O'Connor, Amol S Rangnekar

This review analyzes data regarding liver injury associated with COVID-19 infection. We discuss reported effects on the liver from both COVID-19 and COVID-19 treatment as well as pathophysiology, review the potential role of drug-induced liver injury as an etiology of COVID-19-associated liver injury, and touch on other reports of significant outcomes including COVID-19 cholangiopathy and autoimmune hepatitis. Finally, we review the implications of COVID-19 infection in liver transplant recipients.

本综述分析了与COVID-19感染相关的肝损伤数据。我们讨论了已报道的COVID-19和COVID-19治疗对肝脏的影响以及病理生理学,回顾了药物性肝损伤作为COVID-19相关肝损伤病因的潜在作用,并讨论了其他重要结局的报道,包括COVID-19胆管病和自身免疫性肝炎。最后,我们回顾了COVID-19感染对肝移植受者的影响。
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引用次数: 1
COVID-Associated Cast-Forming Cholangiopathy: A Commentary on Disease Mechanism, Treatment, and Prognosis. 新型冠状病毒相关铸型胆管病:发病机制、治疗及预后综述
IF 2.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.2147/HMER.S384176
Yara Sarkis, Nasir Saleem, Raj Vuppalanchi, Mark Gromski

The complete impact of COVID-19 infection continues to develop since the onset of the COVID-19 pandemic. COVID-19 cholangiopathy has been recently described in a subset of patients who recovered from severe COVID-19 infection. The most common phenotype of patients suffering from COVID-19 cholangiopathy had severe infection requiring a stay in the intensive care unit, mechanical ventilation and vasopressor medications. Patients with COVID-cholangiopathy present with severe and prolonged cholestatic liver injury. In cases where biliary cast formation is identified, we defined the entity as "COVID-19 cast-forming cholangiopathy". This subset of COVID-19 cholangiopathy is not well understood and there are no standardized diagnosis or management to this date. The reported clinical outcomes are variable, from resolution of symptoms and liver test abnormalities to liver transplant and death. In this commentary, we discuss the proposed pathophysiology, diagnosis, management, and prognosis of this disease.

自2019冠状病毒病大流行开始以来,COVID-19感染的全面影响继续发展。最近在一些从严重COVID-19感染中康复的患者中发现了COVID-19胆管病。COVID-19胆管病患者最常见的表型是严重感染,需要留在重症监护室、机械通气和血管加压药物治疗。新冠肺炎胆管病患者存在严重和长期的胆汁淤积性肝损伤。如果发现胆道铸型形成,我们将其定义为“COVID-19铸型胆管病”。COVID-19胆管病的这一亚群尚未得到很好的了解,迄今尚无标准化的诊断或管理。报告的临床结果是可变的,从症状缓解和肝检查异常到肝移植和死亡。在这篇评论中,我们讨论了该病的病理生理、诊断、治疗和预后。
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引用次数: 0
Polycystic Liver Disease: Pathophysiology, Diagnosis and Treatment. 多囊性肝病:病理生理、诊断与治疗。
IF 2.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-09-29 eCollection Date: 2022-01-01 DOI: 10.2147/HMER.S377530
Luiz Fernando Norcia, Erika Mayumi Watanabe, Pedro Tadao Hamamoto Filho, Claudia Nishida Hasimoto, Leonardo Pelafsky, Walmar Kerche de Oliveira, Ligia Yukie Sassaki

Polycystic liver disease (PLD) is a clinical condition characterized by the presence of more than 10 cysts in the liver. It is a rare disease Of genetic etiology that presents as an isolated disease or associated with polycystic kidney disease. Ductal plate malformation, ciliary dysfunction, and changes in cell signaling are the main factors involved in its pathogenesis. Most patients with PLD are asymptomatic, but in 2-5% of cases the disease has disabling symptoms and a significant reduction in quality of life. The diagnosis is based on family history of hepatic and/or renal polycystic disease, clinical manifestations, patient age, and polycystic liver phenotype shown on imaging examinations. PLD treatment has evolved considerably in the last decades. Somatostatin analogues hold promise in controlling disease progression, but liver transplantation remains a unique curative treatment modality.

多囊性肝病(PLD)是一种以肝脏中存在10个以上囊肿为特征的临床疾病。它是一种罕见的遗传性疾病,表现为孤立性疾病或与多囊肾病相关。导管板畸形、纤毛功能障碍和细胞信号的改变是其发病的主要因素。大多数PLD患者无症状,但在2-5%的病例中,该病有致残症状,生活质量显著下降。诊断基于肝和/或肾多囊病的家族史、临床表现、患者年龄和影像学检查显示的多囊肝表型。在过去的几十年里,PLD的治疗已经有了很大的发展。生长抑素类似物在控制疾病进展方面有希望,但肝移植仍然是一种独特的治疗方式。
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引用次数: 3
Post-Marketing Surveillance Study of the Safety and Efficacy of Nalfurafine (Capsules 2.5 μg, Oral Dispersing Tablets 2.5 μg) in 1186 Patients with Chronic Liver Disease and Intractable Pruritus 呋喃西林(胶囊2.5μg,口服分散片2.5μg)治疗1186例慢性肝病和顽固性瘙痒患者的上市后安全性和有效性监测研究
IF 2.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-05-01 DOI: 10.2147/HMER.S352775
H. Yoshitani, Junko Ito, H. Kozono
Background Nalfurafine (Remitch®, Toray Industries, Inc.) is a selective κ-receptor agonist approved in Japan for the improvement of pruritus in patients with chronic liver diseases (only when existing treatments bring insufficient efficacy) in May 2015. Methods A post-marketing Specific Drug Use Survey was conducted in Japan (March 1, 2016 to June 30, 2020) of the safety and efficacy of nalfurafine for the improvement of pruritus in patients with chronic liver disease. Results Among 1186 cases analyzed for safety, the incidence of adverse drug reactions was 9.4% (112/1186 cases), lower than 61.4% reported in pre-marketing surveillance (297/484 cases). No specific safety issues were found and no cases of concern for drug dependence identified. Efficacy (itch improvement) was demonstrated in 73.16% (815/1114 cases; 12-week analysis set) and in 85.67% (520/607; general assessment of itch improvement at 1-year analysis set). A significant difference was found in 4 items of itch improvement at 12 weeks and 8 items of itch improvement at 1 year. No noteworthy issues were identified. Mean Visual Analog Scale (VAS) values after 12 weeks and 1 year after the first dose were significantly lower than the baseline (p < 0.0001 for both treatment durations). Mean severity scores (Kawashima’s classification scheme) were significantly lower than the pretreatment score at 12 weeks and 1 year after the first dose (both p < 0.0001). No concerns were identified in the efficacy and safety of nalfurafine in patients with specific background, ie, the elderly (aged ≥ 65 years), those with renal impairment, and those on long-term treatment (≥ 365 days) compared with patients without corresponding background. Conclusion No new safety issues of concern or cases of insufficient efficacy were identified in this Specific Drug Use Survey of the safety and efficacy of nalfurafine for the improvement of pruritus in patients with chronic liver diseases.
背景那曲芬(Remitch®,Toray Industries,股份有限公司)是一种选择性κ-受体激动剂,于2015年5月在日本获得批准,用于改善慢性肝病患者的瘙痒(仅当现有治疗效果不足时)。方法在日本(2016年3月1日至2020年6月30日)进行了一项上市后特定药物使用调查,了解纳呋胺改善慢性肝病患者瘙痒的安全性和有效性。结果在1186例安全性分析病例中,药物不良反应发生率为9.4%(112/1186例),低于上市前监测报告的61.4%(297/484例)。没有发现具体的安全问题,也没有发现任何令人担忧的药物依赖病例。疗效(瘙痒改善)在73.16%(815/1114例;12周分析集)和85.67%(520/607例;在1年分析集对瘙痒改善进行总体评估)中得到证实。12周时瘙痒改善4项,1年时瘙痒改善8项,差异有统计学意义。没有发现任何值得注意的问题。第一次给药后12周和1年的平均视觉模拟量表(VAS)值显著低于基线(两种治疗持续时间均<0.0001)。第一次给药后12周和1年,平均严重程度评分(Kawashima分类方案)显著低于预处理评分(均<0.0001)。在有特定背景的患者中,即老年人(年龄≥65岁)、肾功能损害患者、,以及那些长期治疗(≥365天)的患者与没有相应背景的患者相比。结论在本次针对呋喃西林治疗慢性肝病患者瘙痒的安全性和有效性的专项用药调查中,没有发现新的安全性问题或疗效不足的情况。
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Hepatic Medicine : Evidence and Research
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