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Drugs for Non-alcoholic Steatohepatitis (NASH): Quest for the Holy Grail

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Journal of Clinical and Translational Hepatology 2021年第1期9卷 40-50页

作者： Mithun Sharma Madhumita Premkumar Anand V Kulkarni Pramod Kumar D Nageshwar Reddy nagaraja padaki rao Department of Hepatology Asian Institute of GastroenterologyHyderabadIndia Department of Hepatology PGIMERChandigarhIndia Department of Gastroenterology Asian Institute of GastroenterologyHyderabadIndia

Nonalcoholic fatty liver disease (NAFLD) is a global epidemic that is likely to become the most common cause of chronic liver disease in the next decade, worldwide. Though numerous drugs have been evaluated in clinical trials, most of them have returned inconclusive results and shown poorly-tolerated adverse effects. None of the drugs have been approved by the Food and Drug Administration for treating biopsy-proven non-alcoholic steatohepatitis (NASH). Vitamin E and pioglitazone have been extensively used in treatment of biopsy-proven nondiabetic NASH patients. Although some amelioration of inflammation has been seen, these drugs did not improve the fibrosis component of NASH. Therefore, dietary modification and weight reduction have remained the cornerstone of treatment of NASH;moreover, they have shown to improve histological activity as well as fibrosis. The search for an ideal drug or ‘Holy Grail’ within this landscape of possible agents continues, as weight reduction is achieved only in less than 10% of patients. In this current review, we summarize the drugs for NASH which are under investigation, and we provide a critical analysis of their up-to-date results and outcomes.

关键词： Fatty liver NAFLD NASH Obeticholic acid Saroglitazar

Favipiravir-induced Liver Injury in Patients with Coronavirus Disease 2019

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Journal of Clinical and Translational Hepatology 2021年第2期9卷 276-278页

作者： Pramod Kumar Anand Kulkarni Mithun Sharma padaki nagaraja rao Duvvuru Nageshwar Reddy Department of Hepatology and Liver Transplantation Asian Institute of Gastroenterology HospitalsHyderabadIndia Department of Gastroenterology Asian Institute of Gastroenterology HospitalsHyderabadIndia

Favipiravir,an antiviral,was given restricted emergency use approval to treat coronavirus disease 2019(COVID-19)in many *** the clinical efficacy of favipiravir in COVID-19 remains uncertain,the approval was based on findings from in vitro studies and a clinical trial.1 Limited data from studies of the Ebola virus and influenza disease showed a favorable safety profile.2 Herein,we provide the first report of drug-induced liver injury(DILI)due to favipiravir in patients treated for COVID-19.

关键词： clinical approval Liver

Pooled genetic analysis in ultrasound measured non-alcoholic fatty liver disease in Indian subjects:A pilot study

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World Journal of Hepatology 2014年第6期6卷 435-442页

作者： Vishnubhotla Venkata Ravi Kanth Mitnala Sasikala padaki nagaraja rao Urmila Steffie Avanthi Kalashikam Rajender rao Duvvuru Nageshwar Reddy Asian Healthcare Foundation Hyderabad 500082India Asian Institute of Gastroenterology Hyderabad 500082India Division of Endocrinology and Metabolism National Institute of NutritionTarnakaHyderabad 500082India

AIM: To investigate genetic susceptibility in Indian subjects with non-alcoholic fatty liver disease(NAFLD) by performing a pooled genetic ***: Study subjects(n = 306) were recruited and categorized into NAFLD and control groups based on ultrasound findings of fatty infiltration. Of the 306 individuals, 156 individuals had fatty infiltration and thus comprised the NAFLD group. One hundred and fifty(n = 150) individuals were normal, without fatty infiltration of the liver, comprising the control group. Blood samples, demographic and anthropometric data from the individuals were collected after obtaining informed consent. Anthropometric data, blood glucose, lipids and liver function tests were estimated using standard methods. Genome wide association stud-ies done to date on NAFLD were identified, 19 single nucleotide polymorphisms(SNPs) were selected from these studies that were reported to be significantly associated with NAFLD and genotyping was performed on the Sequenom platform. Student's t test for continuous variables and χ2 test was applied to variant carriers from both groups. Required corrections were applied as multiple testing was *** The mean age of the control group was 39.78 ± 10.83 and the NAFLD group was 36.63 ± 8.20 years. The waist circumference of males and females in the control and NAFLD groups were 80.13 ± 10.35; 81.77 ± 13.65 and 94.09 ± 10.53; 92.53 ± 8.27 respectively. The mean triglyceride and alanine transaminase(ALT) levels in the control and NAFLD groups were 135.18 ± 7.77; 25.39 ± 14.73 and 184.40 ± 84.31; 110.20 ± 67.05 respectively. When χ2 test was applied to the number of individuals carrying the variant risk alleles between the control and NAFLD group, a significant association was seen between rs738409 of the patatin-like phospholipase domain containing 3(PNPLA3) gene(P = 0.001), rs2073080 of the PARVB gene(P = 0.02), rs2143571 of SAMM50 gene(P = 0.05) and rs6487679 of the pregnancy zone protein(PZP) gene(P = 0.0

关键词： Non-alcoholic fatty liver disease Genome wide association studies Genetic association Hepatic steatosis Genotyping Single nucleotide polymorphisms Susceptibility

Genetics of non-alcoholic fatty liver disease: From susceptibility and nutrient interactions to management

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World Journal of Hepatology 2016年第20期8卷 827-837页

作者： Vishnubhotla Venkata Ravi Kanth Mitnala Sasikala Mithun Sharma padaki nagaraja rao Duvvuru Nageshwar Reddy Asian Healthcare Foundation a Research Wing of Asian Institute of Gastroenterology Asian Institute of Gastroenterology

Genetics plays an important role in determining the susceptibility of an individual to develop a disease. Complex, multi factorial diseases of modern day(diabetes, cardiovascular disease, hypertension and obesity) are a result of disparity between the type of food consumed and genes, suggesting that food which does not match the host genes is probably one of the major reasons for developing life style diseases. Non-alcoholic fatty liver is becoming a global epidemic leading to substantial morbidity. While various genotyping approaches such as whole exome sequencing using next generation sequencers and genome wide association studies have identified susceptibility loci for non-alcoholic fatty liver disease(NAFLD) including variants in patatin-like phospholipase domain containing 3 and transmembrane 6 superfamily member 2 genes apart from others; nutrient based studies emphasized on a combination of vitamin D, E and omega-3 fatty acids to manage fatty liver disease. However majority of the studies were conducted independent of each other and very few studies explored the interactions between the genetic susceptibility and nutrient interactions. Identifying such interactions will aid in optimizing the nutrition tailor made to an individual's genetic makeup, thereby aiding in delaying the onset of the disease and its progression. The present topic focuses on studies that identified the genetic susceptibility for NAFLD, nutritional recommendations, and their interactions for better management of NAFLD.

关键词： Transmembrane 6 superfamily member 2 gene Patatin-like phospholipase domain containing 3 gene Genotyping Nutrient interactions Non-alcoholic fatty liver disease Genetic susceptibility

Synthesis of some new 3-[5-(2-oxo-2H-3-chromenyl)-1,3-oxazol-2-yl]-1,3-thiazolan-4-ones as antimicrobials

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Chinese Chemical Letters 2010年第9期21卷 1045-1048页

作者： Cherkupally Sanjeeva Reddy L.Sanjeeva rao M.Vani Devi G.Rajesh Kumar A.nagaraj Department of Chemistry Kakatiya University Department of Pharmaceutical Chemistry Telangana University

A series of some new 2-imino-5-[（Z）-1-（4-methylphenyl）methylidene]-3-[5-（2-oxo-2H-3-chromenyl）-1,3-oxazol-2-yl]-1,3- thiazolan-4-ones 5a-j has been synthesized and assayed for their antibacterial activity against Gram-positive bacteria *** subtilis（ATCC 6633）,Staphylococcus aureus（ATCC 6538p） and Micrococcus luteus（IFC 12708）,and Gram-negative bacteria viz. Proteus vulgaris（ATCC 3851）.Salmonella typhimurium（ATCC 14028） and Escherichia coli（ATCC 25922）.Among the screened compounds,5d,5e,5f,5g,and 5j exhibited potent inhibitory activity compared to standard drug,and emerged as potential molecules for further development.

关键词： 1,3-Thiazolan-4-ones 2-Oxo-2H-chromenyl 1,3-Oxazolyl Antibacterial activity

Regional differences in genetic susceptibility to nonalcoholic liver disease in two distinct Indian ethnicities

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World Journal of Hepatology 2017年第26期9卷 1101-1107页

作者： Govardhan Bale Avanthi Urmila Steffie Vishnubhotla Venkata Ravi Kanth padaki nagaraja rao Mithun Sharma Mitnala Sasikala Duvvur Nageshwar Reddy Asian Healthcare Foundation Asian Institute of Gastroenterology

AIM To validate the association of variants in PNPLA3(rs2281135) and TM6SF2(rs58542926) genes with ultrasound detected non-alcoholic fatty liver disease(NAFLD).METHODS A total of 503 individuals with and without fatty infiltration were recruited. Fatty infiltration was confirmed based on ultrasound findings. Anthropometric data and blood samples were collected from the study group. DNA was isolated from peripheral blood, quality and quantity was assessed by gel electrophoresis and spectrophotometer respectively. Genotyping of the variants in PNPLA3 and TM6SF2 genes was carried out by employing taqman probes(C_15875080_10 for PNPLA3 and C_8946351_10 for TM6SF2 SNP) on real time PCR(Stepone-Lifetechnologies). Genotype data was tested for deviations from Hardy-Weinbergequilibrium. χ~2 test was used to analyze the statistical significance of the difference in genotype distribution of the studied variants in patients and controls and the strength of association was expressed as odds ratio(95%CI). A two-tailed P value of ≤ 0.05 was considered statistically significant. RESULTS The study group comprised of 503 individuals of which 256 had fatty infiltration and 247 without fatty infiltration and thus formed the patient and control groups respectively. As the patient group could be divided in to two distinct ethnicities(ancestral South Indians-ASI and North-East Indians-NEI), further recruitment of control cohort and association analyses was carried out based on ethnicities. Of the 256 with fatty infiltration 93 were ASI and 163 were NEI and of the 247 controls 138 were ASI and 109 were NEI. As expected, there were significant differences in the anthropometric and other clinical data between the control and the patient groups. However significant differences within the ethnicities were also noted. While rs2281135 in PNPLA3 gene was significantly associated(P = 0.03) with higher risk(odds 1.9, 95%CI: 1.5-3.14, P = 0.03) of NAFLD in NEI ethnicity, rs58542926 in TM6SF2 gene wa

关键词： Transmembrane 6 superfamily 2 Patatinlike phospholipase domain-containing protein 3 Fatty infiltration Genetic susceptibility Ethnicity Nonalcoholic fatty liver disease Cirrhosis Single nucleotide polymorphism

Autologous mobilized peripheral blood CD34^+ cell infusion in non-viral decompensated liver cirrhosis

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World Journal of Gastroenterology 2015年第23期21卷 7264-7271页

作者： Mithun Sharma padaki nagaraja rao Mitnala Sasikala Mamata Reddy Kuncharam Chimpa Reddy Vardaraj Gokak BPSS Raju Jagdeesh R Singh Piyal Nag D Nageshwar Reddy Department of Gastroenterology and Hepatology Asian Institute of Gastroenterology Asian Healthcare Foundation Asian Healthcare Foundation Department of Interventional Radiology Asian Institute of Gastroenterology

AIM: To study the effect of mobilized peripheral blood autologous CD34 positive(CD34+) cell infusion in patients with non-viral decompensated ***: Cirrhotic patients of non-viral etiology were divided into 2 groups based on their willingness to be listed for deceased donor liver transplant(DDLT)(control, n = 23) or to receive autologous CD34+ cell infusion through the hepatic artery(study group, n= 22). Patients in the study group were admitted to hospital and received granulocyte colony stimulating factor injections 520 μg/d for 3 consecutive days to mobilize CD34+ cells from the bone marrow. On day 4,leukapheresis was done and CD34+ cells were isolated using CliniMAC magnetic cell sorter. The isolated CD34+ cells were infused into the hepatic artery under radiological guidance. The patients were discharged within 48 h. The control group received standard of care treatment for liver cirrhosis and were worked up for DDLT as per protocol of the institute. Both groups were followed up every week for 4 wk and then every month for 3 ***: In the control and the study group, the cause of cirrhosis was cryptogenic in 18(78.2%) and16(72.72%) and alcohol related in 5(21.7%) and6(27.27%), respectively. The mean day 3 cell count(cells/μL) was 27.00 ± 20.43 with a viability of 81.84± 11.99%. and purity of 80%-90%. Primary end point analysis revealed that at 4 wk, the mean serum albumin in the study group increased significantly(2.83± 0.36 vs 2.43 ± 0.42, P = 0.001) when compared with controls. This improvement in albumin was,however, not sustained at 3 mo. However, at the end of3 mo there was a statistically significant improvement in serum creatinine in the study group(0.96 ± 0.33 vs 1.42 ± 0.70, P = 0.01) which translated into a significant improvement in the Model for End-Stage Liver Disease score(15.75 ± 5.13 vs 19.94 ± 6.68,P = 0.04). On statistical analysis of secondary end points, the transplant free survival at the end of 1 mo and 3 mo did not show

关键词： CD34 cell infusion Stem cell Cirrhosis Model for end-stage liver disease Liver transplantation

Nonselective beta‐blockers reduce mortality in patients with acute‐on‐chronic liver failure

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Portal Hypertension & Cirrhosis 2022年第1期1卷 15-22页

作者： Anand V.Kulkarni Madhumita Premkumar Karan Kumar Juned A.Khan Baqar A.Gora Sowmya Tirumalle Sameer Shaik Mithun Sharma Rajesh Gupta Nageshwar D.Reddy padaki N.rao Department of Hepatology AIG HospitalsHyderabadIndia Department of Hepatology PGIMERChandigarhIndia Department of Hepatology Mahatma Gandhi HospitalsJaipurIndia Department of Hepatology Hopewell HospitalLucknowIndia

Aim:Nonselective beta‐blockers(NSBBs)can reduce the incidence of complications in patients with cirrhosis and prolong *** safety and efficacy of NSBBs in real‐world settings in patients with acute‐on‐chronic liver failure(ACLF)identified by the Asian Pacific Association for the Study of Liver criteria are *** study aimed to assess the safety and efficacy of NSBBs in patients with Asian Pacific Association for the Study of Liver(APASL)‐defined ACLF Methods:In this retrospective,multicenter study,patients with ACLF with complete 30 days follow‐up from January 2019 to December 2021 were *** primary objective was to compare 30‐day mortality among standard of care(SOC)and NSBB(+SOC)*** secondary objectives were to compare the incidence of infection,variceal bleed,and recompensation among both the ***:A total of 346 patients were *** 26%(n=89)of them received NSBBs,while 74%(n=257)received only *** Kaplan-Meier analysis,the incidence of mortality was 21%(95%confidence interval[CI]:16.20-26.50)in SOC group compared to only 8%(95%CI:3.22-15.53)in NSBB group at Day 30(p=0.005).Similarly,mortality in SOC group was 63%(95%CI:56.81-69.00)compared to 46%(95%CI:35.44-57.00)in NSBB group at 1 year(p=0.001).NSBB therapy could not reduce the incidence of infections or variceal ***‐seven percent of patients in the SOC group and 73%of patients in the NSBB group(p<0.001)*** was prescribed in 77.5%and propranolol in 22.5%of ***:NSBBs reduce mortality without any effect on infection or variceal bleed in patients with ***,only one in four ACLF patients are suitable for NSBB therapy.

关键词： ACLF infection portal hypertension variceal bleed

Identification of circulating CD90^+ CD73^+ cells in cirrhosis of liver

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World Journal of Stem Cells 2011年第7期3卷 63-69页

作者： Mitnala Sasikala Pugazhelthi Surya Gaddipati Radhika Pondugala Pavan Kumar Mekala Subba rao Rathindra Mohan Mukherjee padaki nagaraja rao D Nageshwar Reddy Institute of Basic Sciences and TranslationalResearch Asian Health Care Foundation Asian Institute of Gastroenterology

AIM:To identify circulating CD90 + CD73 + CD45 cells and evaluate their in vitro proliferating ***:Patients with cirrhosis(n=43),and healthy volunteers(n=40)were recruited to the *** cells were isolated and cultured from the peripheral blood of controls and cirrhosis ***-like cells that appeared in cultures were analyzed for morphological features,enumerated by flow cytometry and confirmed by immunocytochemistry(ICC).Colony forming efficiency(CFE)of these cells was assessed and expressed as a ***:In comparison to healthy volunteers,cells obtained from cirrhotic patients showed a significantincrease(P<0.001)in the percentage of CD90+CD73+ CD45 cells in *** cells also showed 10 fold increases in *** cytometry and ICC confirmed that the proliferating cells expressed CD90 + CD73 + in the cultures from cirrhosis ***:These results indicate the presence of circulating CD90 + CD73 + CD45 cells in patients with liver cirrhosis that have the potential to proliferate at a higher rate.

关键词： CD90+ CD73+ CD45 cells Liver cirrhosis Proliferation Colony forming efficiency