{"title":"Risk Factors for Hepatitis B Virus Infection in North Ethiopia: A Case-Control Study.","authors":"Desalegn Weldebrhan, Hailemariam Berhe, Yohannes Tesfay","doi":"10.2147/HMER.S407069","DOIUrl":"https://doi.org/10.2147/HMER.S407069","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":12917,"journal":{"name":"Hepatic Medicine : Evidence and Research","volume":"15 ","pages":"79-91"},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/07/72/hmer-15-79.PMC10363344.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9872795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Daniel T Gildea, Stephanie M Woo, Corinne E O'Connor, Amol S Rangnekar
{"title":"COVID-19-Associated Liver Injury.","authors":"Daniel T Gildea, Stephanie M Woo, Corinne E O'Connor, Amol S Rangnekar","doi":"10.2147/HMER.S384108","DOIUrl":"https://doi.org/10.2147/HMER.S384108","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":12917,"journal":{"name":"Hepatic Medicine : Evidence and Research","volume":"15 ","pages":"1-9"},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/15/3c/hmer-15-1.PMC9960793.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10802534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yara Sarkis, Nasir Saleem, Raj Vuppalanchi, Mark Gromski
{"title":"COVID-Associated Cast-Forming Cholangiopathy: A Commentary on Disease Mechanism, Treatment, and Prognosis.","authors":"Yara Sarkis, Nasir Saleem, Raj Vuppalanchi, Mark Gromski","doi":"10.2147/HMER.S384176","DOIUrl":"https://doi.org/10.2147/HMER.S384176","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":12917,"journal":{"name":"Hepatic Medicine : Evidence and Research","volume":"15 ","pages":"27-32"},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/0a/93/hmer-15-27.PMC10066716.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9247375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Connie Chen, Mary Ayers, Judy H Squires, James E Squires
{"title":"Perspectives on Sarcopenia as a Predictor for Outcomes in Pediatric Patients with Chronic Liver Disease.","authors":"Connie Chen, Mary Ayers, Judy H Squires, James E Squires","doi":"10.2147/HMER.S348888","DOIUrl":"https://doi.org/10.2147/HMER.S348888","url":null,"abstract":"<p><p>Sarcopenia, a pathologic deficiency of muscle mass and function, has emerged as an important secondary feature of many chronic disease states. For adults with end stage liver disease, there are multiple mechanisms which contribute to sarcopenia and its presence has proven to be an important predictor of morbidity and mortality. In children, there are only a limited number of reports which investigate the role of sarcopenia in liver disease. These studies, which are discussed and summarized in this review, report small, single-center analyses with dissimilar study cohorts and varying clinical definitions. Still, children meeting the study entry criteria have sarcopenia with a reported prevalence of 24-70%. When assessed, sarcopenia appears to be associated with more severe disease but is independent of the Pediatric End-Stage Liver Disease (PELD) score and does not correlate with age, gender, or traditional anthropometric measures such as weight, height, weight-for-height, or body mass index (BMI). While individual studies may identify sarcopenia as a statistically significant risk factor for certain post-transplant outcomes such as longer ICU stay, longer duration of intubation, repeat operation, development of serious infection, longer hospital stay, death, or long-term growth failure, such associations are not consistently replicated across studies. Finally, although various methods of muscle mass quantification are utilized, the most reported is the total psoas muscle surface area (tPMSA) on computed tomography. This method, along with others such as skeletal muscle area and skeletal muscle index, have had normative values recently defined and these collective efforts should enable researchers a common basis of comparison when delineating sarcopenia, and its impact, across various study populations in future investigations - including in children with liver disease.</p>","PeriodicalId":12917,"journal":{"name":"Hepatic Medicine : Evidence and Research","volume":" ","pages":"173-183"},"PeriodicalIF":2.1,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2a/c7/hmer-14-173.PMC9618237.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40661450","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Elias Rugaatwa Ndibarema, Ronald Olum, David Ayebare, Jerome Kabakyenga
{"title":"Prevalence and Factors Associated with Hepatitis B Infection Among Outpatient Adults in South-Western Uganda.","authors":"Elias Rugaatwa Ndibarema, Ronald Olum, David Ayebare, Jerome Kabakyenga","doi":"10.2147/HMER.S381809","DOIUrl":"https://doi.org/10.2147/HMER.S381809","url":null,"abstract":"<p><strong>Background: </strong>About 2 billion people in the world are exposed to hepatitis B virus. Africa contributes 25% of the global Hepatitis B burden and prevalence in Uganda is 4.3%. Routine testing to establish the burden, improve prevention and control through early diagnosis and management are rare in hospital settings. We aimed at establishing the prevalence and factors associated with hepatitis B infection among adults attending outpatient clinic at Mbarara Regional Referral Hospital (MRRH) in Uganda.</p><p><strong>Methods: </strong>A hospital-based cross-sectional study was conducted among outpatients attending MRRH. Consecutive sampling method was used to recruit participants. Interviewer-administered questionnaires were used to collect data. Blood samples were collected to test HBsAg. Summary statistics were used to describe the socio-demographic characteristics of study participants and the proportion of Serostatus for hepatitis B infection. Bivariate followed by multivariate logistic regression analysis was conducted to assess the factors associated with hepatitis B infections. All independent variables with <i>p</i>-values <0.2 were entered into a multivariate model to adjust for confounding. A p value <0.05 was considered statistically significant.</p><p><strong>Results: </strong>A total of 400 participants were recruited. 64.5% were females (n=258) and aged 18-29 years (48.5%, n=193). Overall, 22(5.5%) participants were found to be seropositive for hepatitis B infection. Residing in Kiruhura district (AOR = 11.9, 95% CI: 2.40-59.25, <i>p</i><0.003) was significantly associated with hepatitis B infection while being female (AOR = 0.3, 95% CI: 0.11-0.88, <i>p</i><0.018) was protective.</p><p><strong>Conclusion: </strong>Prevalence of hepatitis B infection among adult patients attending outpatient clinic at MRRH was 5.5% with male gender and residing in Kiruhura district as factors associated with high prevalence of hepatitis B infection. Ministry of Health should scale up hepatitis B routine testing and treatment at MRRH and its catchment area, with special control programs such as screening, vaccination, and sensitization involving men.</p>","PeriodicalId":12917,"journal":{"name":"Hepatic Medicine : Evidence and Research","volume":" ","pages":"163-172"},"PeriodicalIF":2.1,"publicationDate":"2022-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/66/6a/hmer-14-163.PMC9592731.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40653303","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Luiz Fernando Norcia, Erika Mayumi Watanabe, Pedro Tadao Hamamoto Filho, Claudia Nishida Hasimoto, Leonardo Pelafsky, Walmar Kerche de Oliveira, Ligia Yukie Sassaki
{"title":"Polycystic Liver Disease: Pathophysiology, Diagnosis and Treatment.","authors":"Luiz Fernando Norcia, Erika Mayumi Watanabe, Pedro Tadao Hamamoto Filho, Claudia Nishida Hasimoto, Leonardo Pelafsky, Walmar Kerche de Oliveira, Ligia Yukie Sassaki","doi":"10.2147/HMER.S377530","DOIUrl":"https://doi.org/10.2147/HMER.S377530","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":12917,"journal":{"name":"Hepatic Medicine : Evidence and Research","volume":"14 ","pages":"135-161"},"PeriodicalIF":2.1,"publicationDate":"2022-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/bc/12/hmer-14-135.PMC9528914.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33490332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abayneh Tunta Boye, Peter Etim Ekanem, Tesfamichael Berhe Hailu, Ifa Dereje Hordofa, Mulu Shiferaw Asfaw
{"title":"Histopathological Evaluation of Ethanolic Leaf Extract of <i>Lippia adoensis</i> on Liver, Kidney, and Biochemical Parameters in Swiss Albino Mice.","authors":"Abayneh Tunta Boye, Peter Etim Ekanem, Tesfamichael Berhe Hailu, Ifa Dereje Hordofa, Mulu Shiferaw Asfaw","doi":"10.2147/HMER.S370927","DOIUrl":"https://doi.org/10.2147/HMER.S370927","url":null,"abstract":"<p><strong>Background: </strong>Eighty percent of Ethiopians use traditional medicine, one of which is the leaf of <i>Lippea adoensis</i>.</p><p><strong>Objective: </strong>To investigate subacute toxicity of aqueous extracts of <i>L. adoensis</i> leaves on the liver and kidney and biochemical parameters in Swiss albino mice.</p><p><strong>Methods: </strong>LD<sub>50</sub> was assessed with nine experimental groups and one control group of adult female Swiss albino mice (five in each group). In the subacute study, 40 mice of both sexes were randomly divided into four groups of ten mice (both sexes) per group. Group I served as controls and received distilled water and feed only. Groups II-IV were used as treatment groups. They received calculated doses of aqueous leaf extracts orally at doses of 500 mg/kg, 1000 mg/kg, and 2000 mg/kg body weight, respectively.</p><p><strong>Results: </strong>Since 80% of deaths occurred at the 10,000 mg/kg body-weight dose in this experiment, LD<sub>50</sub> was considered to be <10,000 mg/kg. In the subacute test, general signs of toxicity like hypoactivity, piloerection, lethargy, and a single episode of convulsion were observed at the 2000 mg/kg dose. Beginning from the third week of administration, both male and female mice receiving 500 mg/kg and 2000 mg/kg and all treatment groups in the fourth week showed significant (<i>P</i><0.05) weight loss compared to controls. Biochemical parameters were found to increase in all groups treated with ethanolic leaf extracts. Several histopathological changes like congestion, hemorrhage, severe necrosis, and infiltration of inflammatory cells in both liver and kidney in the <i>L. adoensis</i>-treated rats were observed at all doses.</p><p><strong>Conclusion: </strong>In the present study, the ethanolic leaf extracts of <i>L. adoensis</i> produced dose-dependent weight loss and histopathological and biochemical changes in Swiss albino mice.</p>","PeriodicalId":12917,"journal":{"name":"Hepatic Medicine : Evidence and Research","volume":" ","pages":"123-133"},"PeriodicalIF":2.1,"publicationDate":"2022-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2c/14/hmer-14-123.PMC9512065.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40381502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Long Cong Nguyen, Thuy Thi-Bich Lo, Huong Dieu La, Ha Thi-Ngoc Doan, Ngoan Tran Le
{"title":"Clinical, Laboratory and Bacterial Profile of Spontaneous Bacterial Peritonitis in Vietnamese Patients with Liver Cirrhosis.","authors":"Long Cong Nguyen, Thuy Thi-Bich Lo, Huong Dieu La, Ha Thi-Ngoc Doan, Ngoan Tran Le","doi":"10.2147/HMER.S369966","DOIUrl":"https://doi.org/10.2147/HMER.S369966","url":null,"abstract":"<p><strong>Aim: </strong>To determine several clinical and laboratory features as well as the bacterial profile of spontaneous bacterial peritonitis (SBP) in 58 Vietnamese patients admitted to a single center due to liver cirrhosis.</p><p><strong>Methods: </strong>We retrospectively analyzed bacteriological, clinical and laboratory characteristics of patients with SBP admitted to the Gastroenterology and Hepatology Center from July 2019 to July 2020.</p><p><strong>Results: </strong>Out of a total 58 SBP patients, 41 (70.9%) had culture-negative neutrocytic ascites. The majority of patients experienced abdominal pain (93,1%) and large ascites (65,5%). Gram-negative bacteria formed the main pathogens (14/17). <i>Escherichia coli</i> (9/17) was the predominant cause followed by <i>Burkholderia cepacia</i> (2/17). Antibiotic sensitivity rate of <i>E. coli</i> for third generation cephalosporin was low but high for aminoglycoside and carbapenem antibiotics. The resistance of <i>E. coli</i> was significant against fluoroquinolones (100%). All 3 cases of gram-positive bacteria were sensitive to vancomycin.</p><p><strong>Conclusion: </strong>Our study reported the bacteriological and clinical characteristics of patients with SBP and compared these findings between two groups: positive ascitic fluid culture and negative fluid culture. Ascitic fluid culture can guide for the right antibiotic choice since resistance to commonly prescribed antibiotics is common in SBP patients.</p>","PeriodicalId":12917,"journal":{"name":"Hepatic Medicine : Evidence and Research","volume":" ","pages":"101-109"},"PeriodicalIF":2.1,"publicationDate":"2022-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3c/4f/hmer-14-101.PMC9348134.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40688119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Current Perspectives on Nucleos(t)ide Analogue Therapy for the Long-Term Treatment of Hepatitis B Virus.","authors":"Teresa Broquetas, José A Carrión","doi":"10.2147/HMER.S291976","DOIUrl":"https://doi.org/10.2147/HMER.S291976","url":null,"abstract":"<p><p>The hepatitis B virus (HBV) infection remains a global public health problem. This review presents updated recommendations for the optimal current treatment of choice with nucleos(t)ide analogues (NA). Current clinical practice guidelines on the management of chronic hepatitis B (CHB) by the Asian Pacific Association for the Study of the Liver, the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases have been considered. Patients with chronic HBV infection are at increased risk of liver disease progression to cirrhosis and hepatocellular carcinoma (HCC) development. The main goal of therapy is to improve survival preventing disease progression and HCC. The induction of long-term suppression of HBV replication represents the main endpoint of current treatment strategies, while hepatitis B surface antigen (HBsAg) loss is the optimal endpoint. The typical indication for treatment requires elevated HBV desoxyribonucleic acid (DNA), elevated alanine aminotransferase and/or at least moderate histological lesions, while all cirrhotic patients with detectable HBV DNA should be treated. The long-term administration of a potent NA with high barrier to resistance, ie, entecavir, tenofovir disoproxil fumarate or tenofovir alafenamide, represents the treatment of choice. However, HBsAg seroclearance is anecdotal with NA. Treated patients should be monitored for therapy response, adherence, risk of disease progression, and risk of HCC development. This review aims to assess the evolving trends on the potent NA and the new perspectives on finite therapy.</p>","PeriodicalId":12917,"journal":{"name":"Hepatic Medicine : Evidence and Research","volume":" ","pages":"87-100"},"PeriodicalIF":2.1,"publicationDate":"2022-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/1c/1d/hmer-14-87.PMC9346298.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40688118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"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","authors":"H. Yoshitani, Junko Ito, H. Kozono","doi":"10.2147/HMER.S352775","DOIUrl":"https://doi.org/10.2147/HMER.S352775","url":null,"abstract":"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.","PeriodicalId":12917,"journal":{"name":"Hepatic Medicine : Evidence and Research","volume":"14 1","pages":"37 - 66"},"PeriodicalIF":2.1,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42328252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}