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1.
Clin Liver Dis (Hoboken) ; 18(3): 168-172, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34691406
2.
Am J Trop Med Hyg ; 2021 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-34583333

RESUMO

The route of hepatitis B transmission is believed to be horizontal in India, though pediatric studies showed mother as source in the majority of chronic HBV (CHB) cases. We aimed at establishing the fact that mother-child transmission is the main route of acquisition by documenting genotypically identical viruses in mother-child pairs. Blood samples of consecutive children (≤18 years) with CHB and high DNA (>10,000 IU/mL) and their positive mother were collected from January 2013 to December 2015. Polymerase chain reaction (PCR) products of HBV-DNA were amplified and sequenced by using BigDye Terminator Cycle Sequencing Kit v3.1 and aligned with previously described sequences in the region of interest for genotypes A to G by using BioEdit software. Phylogenetic tree was generated using p-distance algorithm in MEGA software version 6. Genotyping of 59 (33 children and 26 mothers) subjects include genotype A in 24 (40.7%) and genotype D in 35 (59.3%). Both mother-child pair genotyping was possible in 25. The median age of 25 children (20 males) was 9 (interquartile range, IQR: 4-11). The distribution of genotypes among mother-child pairs was similar. The concordance between children and their mothers was 24 of 25 (96%). Evolutionary analyses showed significant similarities between mother and child sequences for both genotype A and D, suggesting thereby the same virus. In conclusion, mother-baby transmission seems to be the major route of acquisition of HBV in children in India and near-complete homology in genetic sequences between mother-child pairs is definite proof for that. However, a larger epidemiological study is required to substantiate our findings.

4.
J Clin Exp Hepatol ; 11(3): 400-403, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33994721

RESUMO

Hepatitis E is one of the leading causes of acute viral hepatitis worldwide. Chronic infection with hepatitis E is less common and limited to immunosuppressed patients and is usually due to genotype 3 of the virus. Genotype 1, the most prevalent strain in the South Asian region, is seldom known to be associated with chronic hepatitis. Here we describe a case of chronic hepatitis E with genotype 1 in a post-liver transplant setting. In the index case, previously compensated cryptogenic cirrhosis was decompensated by an acute hepatitis E infection, which necessitated liver transplantation because of acute chronic liver failure. This later progressed to chronicity. This case may have significant implications in management, especially in the post-liver transplant setting.

5.
J Clin Exp Hepatol ; 11(3): 354-386, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33994718

RESUMO

Renal dysfunction is very common among patients with chronic liver disease, and concomitant liver disease can occur among patients with chronic kidney disease. The spectrum of clinical presentation and underlying etiology is wide when concomitant kidney and liver disease occur in the same patient. Management of these patients with dual onslaught is challenging and requires a team approach of hepatologists and nephrologists. No recent guidelines exist on algorithmic approach toward diagnosis and management of these challenging patients. The Indian National Association for Study of Liver (INASL) in association with Indian Society of Nephrology (ISN) endeavored to develop joint guidelines on diagnosis and management of patients who have simultaneous liver and kidney disease. For generating these guidelines, an INASL-ISN Taskforce was constituted, which had members from both the societies. The taskforce first identified contentious issues on various aspects of simultaneous liver and kidney diseases, which were allotted to individual members of the taskforce who reviewed them in detail. A round-table meeting of the Taskforce was held on 20-21 October 2018 at New Delhi to discuss, debate, and finalize the consensus statements. The evidence and recommendations in these guidelines have been graded according to the Grading of Recommendations Assessment Development and Evaluation (GRADE) system with minor modifications. The strength of recommendations (strong and weak) thus reflects the quality (grade) of underlying evidence (I, II, III). We present here the INASL-ISN Joint Position Statements on Management of Patients with Simultaneous Liver and Kidney Disease.

6.
Perspect Clin Res ; 12(2): 106-112, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34012908

RESUMO

Randomized controlled trials are the gold standard for determining the efficacy of a new intervention. Trials conducted for regulatory approval of an intervention compare the effect of the intervention with the standard of care or placebo to demonstrate efficacy. Randomization attempts to ensure that all known and unknown confounding factors are evenly distributed between the groups, and that the groups will be comparable at the end of the study, so that any inter-group differences in outcomes can be attributed to the intervention. However, in reality, intercurrent events may impact the assessment and subsequent interpretation of the outcome of interest. To address this, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2017, released an addendum to the E9 guideline (ICH E9 R1) putting forth the concept of Estimands and Sensitivity Analysis in Clinical Trials. This addendum addresses how these intercurrent events are to be handled using the Estimand concept, which is now expected to be detailed in a separate section of the study protocol. In this paper, we discuss what estimands are, and their likely impact on how regulatory trial protocols and their statistical analyses plans are written and implemented. We also look at the application of the concept of estimands to routine clinical practice.

7.
Perspect Clin Res ; 12(1): 53-57, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33816210

RESUMO

The previous two articles in this series gave an overview of the methodology of systematic reviews and meta-analysis. In this third and concluding article, we look at the different types of biases that can confound the results of a meta-analysis and briefly describe some special types of meta-analysis.

9.
Emerg Infect Dis ; 27(2): 666-669, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33496645

RESUMO

We conducted 3 population-based cross-sectional surveys, at 1-month intervals, to estimate the prevalence and time-trend of severe acute respiratory syndrome coronavirus 2 infection in Puducherry, India. Seropositivity rate increased from 4.9% to 34.5% over 2 months and was 20-fold higher than the number of diagnosed cases of infection.


Assuntos
Anticorpos Antivirais/sangue , Teste Sorológico para COVID-19/tendências , COVID-19/diagnóstico , COVID-19/epidemiologia , SARS-CoV-2/imunologia , Adulto , COVID-19/sangue , Análise por Conglomerados , Estudos Transversais , Feminino , Humanos , Índia/epidemiologia , Análise de Séries Temporais Interrompida , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Soroepidemiológicos , Fatores de Tempo
10.
Indian Heart J ; 72(6): 535-540, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33357641

RESUMO

OBJECTIVES: To determine efficacy and safety of sacubitril/valsartan compared with enalapril in Indian patients of PARADIGM-HF trial. METHODS: A randomized, double-blind, active-controlled, phase III sub-study (NCT01035255) was conducted between April 2010 and May 2014. Patients with chronic heart failure (HF), aged >18 years with left ventricular ejection fraction ≤40% were randomized (1:1) to receive either sacubitril/valsartan 200 mg twice-daily or enalapril 10 mg twice-daily. The primary endpoint was to compare efficacy of sacubitril/valsartan to enalapril in delaying time-to-first occurrence of the composite endpoint (cardiovascular [CV] death or HF hospitalization). RESULTS: The trial was stopped after a median follow-up of 27 months, because the boundary for benefit with sacubitril/valsartan had crossed. Among 637 Indian patients in PARADIGM-HF (sacubitril/valsartan, n = 322 and enalapril, n = 315), the primary outcome, CV death, and the first hospitalization for HF occurred in 21.81% and 24.76% (HR 0.89; 95% CI, 0.646-1.231), 17.45% and 20.63% (HR 0.87; 95% CI, 0.605-1.236), and 7.48% and 9.52% (HR 0.78; 95% CI, 0.461-1.350) patients in the sacubitril/valsartan and enalapril group, respectively. The all-cause mortality (19.0% vs. 21.9%) and adverse events (78.4% vs. 82.2%) were comparatively lower in the sacubitril/valsartan than enalapril group. No significant difference was seen between the benefits of treatment in Indian and the total PARADIGM-HF cohort (p value for interaction >0.05). CONCLUSION: Results support the use of sacubitril/valsartan in Indian patients with chronic HF with reduced ejection fraction with treatment benefits similar to global PARADIGM-HF cohort.


Assuntos
Aminobutiratos/uso terapêutico , Compostos de Bifenilo/uso terapêutico , Enalapril/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Volume Sistólico/fisiologia , Valsartana/uso terapêutico , Função Ventricular Esquerda/fisiologia , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/fisiopatologia , Humanos , Incidência , Índia/epidemiologia , Masculino , Pessoa de Meia-Idade , Taxa de Sobrevida/tendências , Resultado do Tratamento
11.
Artigo em Inglês | MEDLINE | ID: mdl-33097949

RESUMO

BACKGROUND: Sofosbuvir is not recommended in persons with estimated glomerular filtration rate (eGFR) <30 mL/min. We report the results of treatment with an off-label 8-week regimen of daclatasvir and half-dose sofosbuvir in patients with acute infection with hepatitis C virus ( HCV) and eGFR <30 mL/min. METHODS: Clinic records were searched to identify treatment-naïve, noncirrhotic adults with acute hepatitis C (HCV viremia and a ≥10-fold elevation of serum alanine aminotransferase activity) and eGFR <30 mL/min, who had been treated with a sofosbuvir-based regimen. Treatment response was assessed using serum HCV RNA testing at 4 weeks of treatment, end of the 8-week treatment and 12 weeks after stopping treatment. RESULTS: Of the 31 patients with acute hepatitis C, 27 [median age (range): 36 (18-74) years; 20 (74%) male] were started on treatment with 200 mg sofosbuvir and 60 mg daclatasvir daily for 8 weeks, irrespective of HCV genotype. All the 27 completed the planned 8-week treatment. One patient died 10 weeks after completing the treatment of an unrelated cause. All the 27 patients had undetectable HCV RNA after 4 weeks of and at the end of treatment. At 12 weeks after completion of treatment, only one tested HCV RNA positive and 25 were negative, with sustained virological response rate of 25/27 (92.6%) and 25/26 (96.2%) on intention-to-treat and per-protocol basis, respectively. CONCLUSION: Eight-week course of daclatasvir and half-dose sofosbuvir is effective for acute hepatitis C in patients with eGFR <30 mL/min and could be a useful alternative to costly, kidney-safe anti-HCV oral drugs in resource-constrained settings.

12.
Perspect Clin Res ; 11(2): 97-100, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32670836

RESUMO

In this series on research study designs, we have so far looked at different types of primary research designs which attempt to answer a specific question. In this segment, we discuss systematic review, which is a study design used to summarize the results of several primary research studies. Systematic reviews often also use meta-analysis, which is a statistical tool to mathematically collate the results of various research studies to obtain a pooled estimate of treatment effect; this will be discussed in the next article.

13.
Indian J Gastroenterol ; 39(2): 161-164, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32372189

RESUMO

INTRODUCTION: Transmission of hepatitis E virus (HEV) through transfusion has been reported from countries where genotype 3 virus is predominant. Data from countries with predominantly genotype 1 HEV, such as India, are limited. We studied the risk of HEV transmission following transfusion of blood or blood components in India. METHODS: Adult patients undergoing cardiac surgery who received transfusion of blood or blood products in the peri-operative period and who lacked history of any transfusion or surgery in the preceding 1 year were studied. A pre-transfusion blood specimen was collected for IgG anti-HEV antibody test. For the participants who were seronegative for anti-HEV, follow up specimens were collected at every 2-3-month intervals for up to 6 months after surgery and were tested for IgM and IgG anti-HEV antibodies. RESULTS: Of the 335 participants originally enrolled, 191 (57%) could be followed up. Of them, 103 (53.9%) were seropositive for HEV IgG at baseline and were excluded. Of the remaining 88 participants (age 42 ± 14.1 years; 55 [63%] male), none reported hepatitis-like illness during the follow up period of 81 ± 23 days. Also, none of these 88 participants was found to have seroconversion to anti-HEV IgM or IgG positivity in the follow up specimens. CONCLUSION: Transfusion-mediated transmission of HEV was not observed in our cohort and may be infrequent in the Indian population, where genotype 1 is the predominant HEV type.


Assuntos
Transfusão de Sangue , Hepatite E/etiologia , Hepatite E/transmissão , Resultados Negativos , Reação Transfusional/virologia , Adulto , Anticorpos Antivirais/sangue , Biomarcadores/sangue , Procedimentos Cirúrgicos Cardíacos , Estudos de Coortes , Feminino , Seguimentos , Hepatite E/diagnóstico , Hepatite E/epidemiologia , Vírus da Hepatite E/imunologia , Humanos , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Índia/epidemiologia , Masculino , Pessoa de Meia-Idade , Período Perioperatório , Risco
14.
J Clin Exp Hepatol ; 10(3): 266-270, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32362732

RESUMO

Coronavirus disease 2019 (COVID-19), which started in December 2019 in China, has resulted in a pandemic leading to significant morbidity and mortality across the globe. Although it mainly causes respiratory symptoms, respiratory failure and death due to multiorgan failure, there is evolving evidence to suggest gastrointestinal (GI) and liver involvement by this virus. Owing to this, health-care professionals taking care of GI and liver diseases are also at an increased risk of getting exposed. Hence, there is a need for protocols to be prepared to guide the handling of COVID-19 patients by the GI and liver specialists, as well as to manage the pre-existing GI and liver diseases during the ongoing pandemic. We present here the guidelines prepared jointly by the three Indian professional bodies in the field of GI diseases, namely the Society of Gastrointestinal Endoscopy of India, Indian Society of Gastroenterology, and Indian National Association for the Study of the Liver.

15.
Gastroenterol Clin North Am ; 49(2): 315-330, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32389365

RESUMO

Hepatitis E virus is a common cause of acute hepatitis and acute liver failure in resource-constrained parts of the world. The disease is particularly severe when the infection occurs during pregnancy. In developed countries, human infections occur primarily through zoonotic transmission from animal reservoirs; however, clinical disease is less frequent than in the developing world. The virus strains prevalent in these areas also cause chronic infection in immunocompromised persons, which, if untreated, can progress to cirrhosis; such infection responds well to oral ribavirin. A safe and highly effective recombinant vaccine is available in China, but is not available elsewhere.


Assuntos
Hepatite E , Animais , Antivirais/uso terapêutico , Feminino , Genótipo , Saúde Global , Hepatite E/epidemiologia , Hepatite E/prevenção & controle , Hepatite E/transmissão , Hepatite E/virologia , Vírus da Hepatite E/genética , Humanos , Hospedeiro Imunocomprometido , Masculino , Gravidez , Zoonoses
16.
Indian J Med Res ; 151(1): 93-103, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-32134020

RESUMO

Background & objectives: For bacterial community analysis, 16S rRNA sequences are subjected to taxonomic classification through comparison with one of the three commonly used databases [Greengenes, SILVA and Ribosomal Database Project (RDP)]. It was hypothesized that a unified database containing fully annotated, non-redundant sequences from all the three databases, might provide better taxonomic classification during analysis of 16S rRNA sequence data. Hence, a unified 16S rRNA database was constructed and its performance was assessed by using it with four different taxonomic assignment methods, and for data from various hypervariable regions (HVRs) of 16S rRNA gene. Methods: We constructed a unified 16S rRNA database (16S-UDb) by merging non-ambiguous, fully annotated, full-length 16S rRNA sequences from the three databases and compared its performance in taxonomy assignment with that of three original databases. This was done using four different taxonomy assignment methods [mothur Naïve Bayesian Classifier (mothur-nbc), RDP Naïve Bayesian Classifier (rdp-nbc), UCLUST, SortMeRNA] and data from 13 regions of 16S rRNA [seven hypervariable regions (HVR) (V2-V8) and six pairs of adjacent HVRs]. Results: Our unified 16S rRNA database contained 13,078 full-length, fully annotated 16S rRNA sequences. It could assign genus and species to larger proportions (90.05 and 46.82%, respectively, when used with mothur-nbc classifier and the V2+V3 region) of sequences in the test database than the three original 16S rRNA databases (70.88-87.20% and 10.23-24.28%, respectively, with the same classifier and region). Interpretation & conclusions: Our results indicate that for analysis of bacterial mixtures, sequencing of V2-V3 region of 16S rRNA followed by analysis of the data using the mothur-nbc classifier and our 16S-UDb database may be preferred.


Assuntos
Bactérias/genética , Classificação , Microbioma Gastrointestinal/genética , RNA Ribossômico 16S/genética , Bactérias/classificação , Humanos , Metagenômica/classificação , Filogenia , Análise de Sequência de DNA
17.
Sci Rep ; 10(1): 4089, 2020 03 05.
Artigo em Inglês | MEDLINE | ID: mdl-32139872

RESUMO

In Japan, 1.5-2 million people are chronically infected with hepatitis C virus (HCV) infection. New direct-acting antiviral agents (DAA) offer an unprecedented opportunity to cure HCV. While the price of HCV treatment decreased recently in most countries, it remains one of the highest in Japan. Our objective was to evaluate the cost-effectiveness of HCV treatment in patients of different age groups and to estimate the price at which DAAs become cost-saving in Japan. A previously developed microsimulation model was adapted to the Japanese population and updated with Japan-specific health utilities and costs. Our model showed that compared with no treatment, the incremental cost-effectiveness ratio (ICER) of DAAs at a price USD 41,046 per treatment was USD 9,080 per quality-adjusted life year (QALY) gained in 60-year-old patients. HCV treatment became cost-effective after 9 years of starting treatment. However, if the price of DAAs is reduced by 55-85% (USD 6,730 to 17,720), HCV treatment would be cost-saving within a 5 to 20-year time horizon, which should serve to increase the uptake of DAA-based HCV treatment. The payers of health care in Japan could examine ways to procure DAAs at a price where they would be cost-saving.


Assuntos
Antivirais/economia , Análise Custo-Benefício , Hepacivirus/efeitos dos fármacos , Hepatite C/economia , Anos de Vida Ajustados por Qualidade de Vida , Adulto , Idoso , Antivirais/uso terapêutico , Feminino , Seguimentos , Hepatite C/tratamento farmacológico , Hepatite C/epidemiologia , Hepatite C/virologia , Humanos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Prognóstico
18.
Perspect Clin Res ; 11(1): 47-50, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32154150

RESUMO

Several methodological and statistical aspects of clinical trials can affect the robustness of their results. We conclude the series of articles on "Interventional Studies" by discussing some of these features.

19.
Vox Sang ; 115(3): 120-132, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32030767

RESUMO

BACKGROUND: Hepatitis E virus (HEV) is usually transmitted by faecal-oral route. Recent reports have documented HEV viraemia in donated blood units and HEV transmission through blood transfusion. This systematic review summarizes the available data on prevalence of HEV viraemia in blood donors. METHODS: Electronic databases were searched on 17 December 2018 to identify full-text English papers reporting original data on prevalence of HEV RNA in donated blood units. Two authors independently extracted the relevant data, which were pooled using simple aggregation as well as a random-effects meta-analysis; heterogeneity was assessed using the I2 method. RESULTS: In all, 59 data sets from 28 countries were identified. The available data showed marked heterogeneity. Of a total of 2 127 832 units studied, 561 (263·6 [95% confidence intervals = 242·7-286·4] per million units) tested positive for HEV RNA. On random-effects meta-analysis, the pooled prevalence was 60·9 [6·7-155·4] per million units. In the viraemic units, HEV RNA titre varied by nearly one million-fold, and most had genotype 3 HEV. The prevalence was higher in blood units with anti-HEV antibodies or elevated alanine aminotransferase. Only nearly one-fourth of viraemic units had anti-HEV antibodies. CONCLUSIONS: The prevalence of HEV viraemia among healthy blood donors is low, though the available data had limited geographical representation and marked heterogeneity. There is a need for further data on HEV viraemia in blood donors from areas with non-3 HEV genotype preponderance.


Assuntos
Doadores de Sangue , Hepatite E/epidemiologia , África/epidemiologia , América/epidemiologia , Ásia/epidemiologia , Austrália/epidemiologia , Europa (Continente)/epidemiologia , Feminino , Anticorpos Anti-Hepatite/sangue , Hepatite E/sangue , Humanos , Masculino , Prevalência , Viremia/epidemiologia
20.
J Clin Exp Hepatol ; 10(1): 43-80, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32025166

RESUMO

Hepatocellular carcinoma (HCC) is one of the major causes of morbidity, mortality, and healthcare expenditure in patients with chronic liver disease in India. The Indian National Association for Study of the Liver (INASL) had published its first guidelines on diagnosis and management of HCC (The Puri Recommendations) in 2014, and these guidelines were very well received by the healthcare community involved in diagnosis and management of HCC in India and neighboring countries. However, since 2014, many new developments have taken place in the field of HCC diagnosis and management, hence INASL endeavored to update its 2014 consensus guidelines. A new Task Force on HCC was constituted that reviewed the previous guidelines as well as the recent developments in various aspects of HCC that needed to be incorporated in the new guidelines. A 2-day round table discussion was held on 5th and 6th May 2018 at Puri, Odisha, to discuss, debate, and finalize the revised consensus statements. Each statement of the guideline was graded according to the Grading of Recommendations Assessment Development and Evaluation system with minor modifications. We present here the 2019 Update of INASL Consensus on Prevention, Diagnosis, and Management of Hepatocellular Carcinoma in India: The Puri-2 Recommendations.

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