RESUMEN
BACKGROUND AND AIMS: The study sought to compare the efficacy of endoscopic injection sclerotherapy with cyanoacrylate glue (EIS-CYA) vs EIS-CYA plus a radiologic intervention (RI) (either transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration) for secondary prophylaxis in patients with liver cirrhosis who presented with acute variceal bleeding from cardiofundal varices. Primary outcome measure was gastric varix (GV) rebleed rates at 1 year. METHODS: Consecutive cirrhosis patients with acute variceal bleeding from cardiofundal varices were randomized into 2 arms (45 in each) after primary hemostasis by EIS-CYA. In the endoscopic intervention (EI) arm, EIS-CYA was repeated at regular intervals (1, 3, 6, and 12 months), while in the RI arm, patients underwent transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration followed by endoscopic surveillance. RESULTS: GV rebleed rates at 1 year were higher in the EI arm compared with the RI arm: 11 (24.4%; 95% confidence interval [CI], 12.9%-39.5%) vs 1 (2.2%; 95% CI, 0.1%-11.8%) (P = .004; absolute risk difference: 22.2%; 95% CI, 8.4%-36.6%). GV rebleed-related mortality in the EI arm (8 [17.8%; 95% CI, 8.0%-32.1%]) was significantly higher than in the RI arm (1 [2.2%; 0.1%-11.8%]) (P = .030; absolute risk difference: 15.6; 95% CI, 2.9%-29.2%); however, there was no difference in all-cause mortality between the 2 groups (12 [26.7%; 95% CI, 14.6%-41.9%] vs 7 [15.6%; 95% CI, 6.5%-29.5%]). The number needed to treat to prevent 1 GV-related rebleed at 1 year was 4.5. CONCLUSIONS: RI for secondary prophylaxis reduces rebleeding from GV and GV rebleeding-related mortality in patients with GV hemorrhage. (CTRI/2021/02/031396).
RESUMEN
AIM: This study illustrates parameters, procedures, and calculations for the statistical determination of sample size for different clinical study designs. MATERIALS AND METHODS: In any research process, the sample size is an important consideration for the implementation of the planned study. From time to time, literature on sample size has been documented in the medical literature. However, the situations covered under them lack comprehensiveness in terms of different study designs, demonstration of calculations, and overreliance on statistical software. RESULTS: The present study provides various facets of sample size determination, such as prerequisite parameters, mathematical formulation, and calculations for clinical study designs [descriptive studies, randomized controlled trials (RCT), correlational studies, comparison of multiple outcomes, survival analysis, sensitivity, and specificity], which will be quite useful. CONCLUSION: This communication will be a good education and learning source for medical professionals to pick and choose a specific scenario and estimate the sample size.
Asunto(s)
Proyectos de Investigación , Tamaño de la Muestra , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Clínicos como AsuntoRESUMEN
BACKGROUND: The relationship between body mass index (BMI) and outcomes in patients with nonalcoholic fatty liver disease (NAFLD) is not well defined. This study aimed to assess the presentations, outcomes, and development of liver-related events (LREs) and non-LREs in patients with NAFLD stratified by BMI. METHODS: Records of NAFLD patients from 2000-2022 were reviewed. Patients were categorized as lean (18.5-22.9 kg/m2), overweight (23-24.9 kg/m2), and obese (>25 kg/m2) based on BMI. Stage of steatosis, fibrosis, and NAFLD activity score were noted in the patients undergoing liver biopsy in each group. RESULTS: Out of 1051 NAFLD patients, 127 (12.1%) had normal BMI, 177 (16.8%) and 747 (71.1%) were overweight and obese, respectively. Median [interquartile range] BMI was 21.9 [20.6-22.5], 24.2 [23.7-24.6], and 28.3 [26.6-30.6] kg/m2 in each group, respectively. Prevalence of metabolic syndrome and dyslipidemia were significantly higher in the obese. Obese patients had significantly higher median [interquartile range] liver stiffness (6.4 [4.9-9.4] kPa) than overweight and lean subjects. A higher proportion of obese patients had significant and advanced liver fibrosis. At follow-up, there were no significant differences in the progression of liver disease, new LREs, coronary artery disease, or hypertension across the BMI groups. Overweight and obese patients were more likely to develop new-onset diabetes by follow-up. The mortality rates in the three groups were comparable (0.47, 0.68, and 0.49 per 100 person-years, respectively), with similar causes of death (liver-related vs non-liver-related). CONCLUSIONS: Patients with lean NAFLD have similar disease severity and rates of progression as the obese. BMI is not a reliable determinant of outcomes in NAFLD patients.
Asunto(s)
Enfermedad del Hígado Graso no Alcohólico , Humanos , Enfermedad del Hígado Graso no Alcohólico/complicaciones , Enfermedad del Hígado Graso no Alcohólico/patología , Sobrepeso , Índice de Masa Corporal , Obesidad/complicaciones , Obesidad/epidemiología , Cirrosis Hepática , Progresión de la EnfermedadRESUMEN
Background: The number of times a research work gets cited by another article is one of the article-level metrics for assessing the quality of a research publication. Citation analysis by bibliometric review has been performed in several disciplines. The current study was aimed to systematically review the literature available on pediatric inguinal hernia since 1960 in terms of the 25 most cited articles in this field and analyze the bibliometric variables author and organizational collaborative patterns. Methods: Thomson Reuters Web of Science citation indexing database and research platform were used to retrieve the most cited articles in pediatric inguinal hernia (PIH) using appropriate search strings. The characteristics (name of authors, the total number of authors, the title of publication, journal of publication, year of publication, etc.) of the 25 top-cited articles were recorded. Specific bibliographical parameters were derived and analyzed. Visualization maps were generated using VOSviewer software. Results: The analysis revealed that the Journal of Pediatric Surgery was leading the choice of journal for publication. While most of the publications originated from the United States of America, Schier was the most influential author. Five of the eight top-productive authors are also the most connected. Conclusion: Articles on laparoscopic repair in PIH have been heavily cited. Following the United States of America, Turkey stands out as the topmost productive country in PIH. The publications on PIH show that "collaboration" is the bridging force between productivity and influence on the academic community.
RESUMEN
Background: With the global assimilation of "publish and perish" culture into institutional academics, there has been an exponential rise in the publication numbers. There are ~2500 PUBMED entries related to "anorectal malformation (ARM)." The young clinician in his pursuit to translate experimental research to bedside often finds himself lost "in the midst of plenty." This bibliometric analysis has been conducted to codify the seminal work on ARM for future reference and pay tribute to the most impactful articles. Materials and Methods: Thomson Reuters Web of Science citation indexing database and research platform was used to retrieve the most cited articles in ARM using appropriate search strings. The characteristics (name of authors, the total number of authors, the title of publication, journal of publication, year of publication, etc.,) of the 50 top-cited articles were analyzed. Results: The analysis revealed that the Journal of Paediatric Surgery was leading the choice of journal for publication. While most of the publications originated from the United States of America, Alberto Pena was the most influential author. The most studied topic was on associated malformations, and the most common study design was cohort studies. Conclusion: The approach of citation analysis provided us an opportunity to retrieve the most influential articles on ARM. The trends in research in ARM have also been analyzed, spreading over five decades.
RESUMEN
BACKGROUND: Shannon's index is one of the measures of biodiversity, which is intended to quantify both richness and evenness of the species/individuals in the ecosystem or community. However, application of Shannon's index in the field of substance use among the street children has not been done till date. METHODS: This paper is concerned with methods of estimating Shannon's diversity index (SDI), which can be used to capture the variation in the population due to certain characteristics. Under the consideration that the probability of abundance, based on certain characteristics in the population, is a random phenomenon, we derive a Bayesian estimate in connection with Shannon's information measure and their properties (mean and variance), by using a probability matching prior, through simulation and compared it with those of the classical estimates of Shannon. The theoretical framework has been applied to the primary survey data of substance use among the street children in Delhi, collected during 2015. The measure of diversity was estimated across different age profiles and districts. RESULTS: The results unrevealing the diversity estimate for street children corresponding to each region of Delhi, under both the classical and Bayesian paradigms. Although the estimates were close to one another, a striking difference was noted in the age profile of children. CONCLUSIONS: The Bayesian methodology provided evidence for a greater likelihood of finding substance-using street children, belonging to the lower age group (7-10, maximum Bayesian entropy-3.73), followed by the middle (11-14) and upper age group (15-18). Moreover, the estimated variance under the Bayesian paradigm was lesser than that of the classical estimate. There is ample scope for further refinement in these estimates, by considering more covariates that may have a possible role in initiating substance use among street children in developing countries like India.
Asunto(s)
Jóvenes sin Hogar , Trastornos Relacionados con Sustancias , Teorema de Bayes , Niño , Ecosistema , Humanos , India/epidemiología , Trastornos Relacionados con Sustancias/epidemiologíaRESUMEN
Objective and method: Betel (areca) nut has recently received interest from researchers and policy makers for its role as a psychoactive substance. It was historically limited to Asia-pacific region, but with the advent of globalization, it has become an equally challenging public health problem across the globe. Previously published literature can give us valuable insights in terms of historical interest and understanding related to betel nut. With the expansion of biomedical research a huge number of articles have been published on the same. In terms of understanding the impact of an article, citations are considered a proxy estimate measure. Thus we decided to analyze the top 100 cited articles (till November 2018) related to betel nut. The search in Google scholar database was done with the help of freely available software, Publish or Perish. Results: Overall we found that most articles were published from the fields of dentistry and oncology, with relatively minimal contribution from the field of Addiction Psychiatry. Hence, most articles have addressed the issue of epidemiology and mechanism with lesser share of treatment related publications. Various important information related to these articles have been discussed including the institutions, countries, journals and impactful authors in the field. Subsequently, original research articles are further classified into descriptive/epidemiology, mechanism, management, scale/measurement, imaging and medical psychiatry. Importance: This citation analysis provides valuable information with regards to the emphasis of researchers in the field, and areas where more emphasis is required from contemporary world.
Asunto(s)
Areca , Investigación Biomédica , Investigación Biomédica/tendencias , HumanosRESUMEN
Urothelial cancer patients are prone to recurrence, and there is no marker to predict which cases become refractory to the immunotherapy given to these patients. Tumour behaviour is decided by the dynamics between the pro- and anti-tumorigenic cytokines. In this study, 27 cytokines were estimated in serum and urine of 72 urothelial cancer patients and 42 healthy volunteer controls. Serum cytokines IL-1RA, IL-4 and RANTES were in significantly higher concentration in serum of patients compared to controls, while IL-2 was significantly less in concentration. Patients were found to have significantly high concentrations of 12 urinary cytokines (IL-2, IL-4, IL-8, IL-10, GM-CSF, IFN-γ, IP-10, MIP-1a, PDGF, MIP-1b, RANTES and VEGF) in comparison to healthy controls. Serum VEGF and urinary IL-1ra, IL-4, IL-10, GM-CSF, IP-10, MIP-1a and MIP-1b concentrations were found significantly higher in concentration in high-grade tumours compared to low-grade tumours. There was no difference in either the serum or urinary cytokines between non-invasive and muscle-invasive cases. Serum IL-1ra, IL-6, IL-10, TNF-α and VEGF and urinary IL-1ra, IL-4, IL-8, IL-10, GM-CSF, IP-10, MIP-1a, PDGF, MIP-1b and VEGF were found to be significantly higher in recurrent patients compared to non-recurrent patients. Of these, high concentrations of urinary IL-1RA, IL-4, IL-10, IP-10, PDGF and VEGF and serum IL-1ra, IL-6, IL-10, VEGF and TNF-α were associated with poor recurrence-free survival. Poor recurrence-free survival was also seen with increasing number of cytokines showing high concentrations. The study shows that the estimation of a combination of these cytokines in minimally or non-invasive samples may act as a prognostic indicator.
Asunto(s)
Citocinas/metabolismo , Neoplasias de la Vejiga Urinaria/patología , Adulto , Anciano , Citocinas/sangre , Citocinas/orina , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Invasividad Neoplásica , Recurrencia Local de Neoplasia , Neoplasias de la Vejiga Urinaria/inmunología , Neoplasias de la Vejiga Urinaria/mortalidadRESUMEN
BACKGROUND: Globally, more than 350 million people of all ages suffer from depression. Elderly persons are more vulnerable to depression. We conducted this study to estimate the prevalence of depression, and to study the association of depression with sociodemographic and clinical variables among elderly persons in a rural community. METHODS: We conducted a community-based cross-sectional study among 395 randomly selected elderly persons aged 60 years and above in a rural area of Ballabgarh, Haryana, India. The participants were screened by using the Geriatric Depression Scale, and diagnosis was confirmed by the Mini International Neuropsychiatric Interview. Multivariate analysis was done for independent predictors of depression. RESULTS: The prevalence of depression was 11.4% (95% CI 8.6%-14.9%). Living in a nuclear family (adjusted odds ratio [AOR] 8.98, 95% CI 3.40-23.71), lack of physical activity (AOR 4.95, 95% CI 2.00-12.27), whole-time involvement in household work (AOR 4.47, 95% CI 1.18-16.93), presence of two or more chronic diseases (AOR 4.45, 95% CI 1.60-12.35), having no role in family decision-making (AOR 2.77, 95% CI 1.19-6.42), sleep problems in past one year (AOR 2.97, 95% CI 1.32-6.69) and bilateral hearing impairment (AOR 4.00, 95% CI 1.80-8.88) were factors associated with depression in elderly persons. CONCLUSIONS: Depression is common among elderly persons in rural areas. Individuals providing healthcare to elderly persons need to be trained to identify depression and take appropriate action; elderly persons with chronic diseases and hearing impairment deserve special attention.
Asunto(s)
Depresión/epidemiología , Población Rural/estadística & datos numéricos , Anciano , Enfermedad Crónica , Estudios Transversales , Ejercicio Físico , Femenino , Humanos , India/epidemiología , Masculino , Persona de Mediana Edad , Prevalencia , Factores SocioeconómicosRESUMEN
BACKGROUND: Patients with Post kala-azar dermal leishmaniasis (PKDL) are considered a reservoir of Leishmania donovani. It is imperative to identify and treat them early for control of visceral leishmaniasis (VL), a current priority in the Indian subcontinent. We explored trends in clinico-epidemiological features of PKDL cases over last two decades, for improving management of the disease. METHODS: Clinically suspected cases were diagnosed with rK39 strip test followed by parasitological confirmation by microscopy and/or PCR/qPCR in skin tissue/slit aspirates. Patients were treated with antimonials till 2008 and subsequently with miltefosine. RESULTS: The study indicated higher incidence of PKDL cases in areas of high endemicity for VL, with 20 % cases reporting no history of VL. Approximately 26 % cases of PKDL were initially misdiagnosed at primary health centers. Duration between onset of PKDL and diagnosis was above 12 months in 80 % cases. Diagnostic sensitivity was 32-36 % with microscopy and 96-100 % with PCR/qPCR. Compliance to treatment was over 85 % with miltefosine while 15 % with antimonials. Relapse rate with miltefosine was up to 13.2 %. CONCLUSIONS: PKDL patients tend to delay reporting and are often misdiagnosed. Confirmatory diagnosis using minimally invasive skin slit aspirate samples would help overcome such issues. There was a paradigm shift in compliance with miltefosine; however, increasing relapse rate indicated the need for newer therapies with oral formulations.
Asunto(s)
Anticuerpos Antiprotozoarios/sangre , Diagnóstico Tardío/estadística & datos numéricos , Errores Diagnósticos/estadística & datos numéricos , Leishmania donovani/aislamiento & purificación , Leishmaniasis Cutánea/diagnóstico , Leishmaniasis Visceral/diagnóstico , Adulto , Anciano , Femenino , Humanos , Incidencia , India/epidemiología , Leishmaniasis Cutánea/epidemiología , Leishmaniasis Cutánea/parasitología , Leishmaniasis Visceral/epidemiología , Masculino , Persona de Mediana Edad , Reacción en Cadena en Tiempo Real de la Polimerasa/métodos , Estudios Retrospectivos , Factores de Riesgo , Pruebas Serológicas/métodos , Adulto JovenRESUMEN
BACKGROUND & OBJECTIVES: Genetic polymorphisms in glutathione-S-transferase genes ( GSTM1 and GSTT1 ) have been studied intensively for their potential role in lung cancer susceptibility. However, most of the studies on association between the polymorphisms and lung cancer do not distinguish between genotypes with one or two copies of the genes. The present study investigates the gene dosage effects of GSTT1 and GSTM1 copy number and their environmental interactions to examine the association of lung cancer risk with trimodular genotypes of the GSTs in a high-risk population from north-east India. METHODS: A total of 154 lung cancer cases and 154 age and sex matched controls from the high risk region of north-east India were analyzed by multiplex real-time PCR to determine the trimodal genotypes (+/+, +/- and -/-) in both the genes ( GSTM1 and GSTT1 ). RESULTS: No significant association and gene dosage effect of GSTM1 gene copy number with lung cancer risk ( P trend =0.13) were found. However, absence of GSTT1 conferred 68 per cent (OR=0.32;95%CI=0.15-0.71;P=0.005) reduced risk compared to the two copy number of the gene. t0 here was evidence of gene dosage effect of GSTT1 gene ( P trend =0.006). Tobacco smoking was a major environmental risk factor to lung cancer (OR=3.03;95%CI=1.73-5.31;P<0.001). However, its interaction with null genotype of GSTT1 conferred significant reduced risk to lung cancer (OR=0.30;95%CI=0.10-0.91;P=0.03). Further in only tobacco smokers, null genotype was associated with increased reduced risk [0.03(0.001-0.78)0.03; P trend =0.006]. No effect modification of GSTM1 was observed with lung cancer risk by environmental risk factors. INTERPRETATION & CONCLUSIONS: The results suggest that absence of GSTT1 null genotype may be associated with a reduced risk of lung cancer and the effect remains unchanged after interaction with smoking.
Asunto(s)
Variaciones en el Número de Copia de ADN , Glutatión Transferasa/genética , Neoplasias Pulmonares/genética , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Casos y Controles , Femenino , Estudios de Asociación Genética , Predisposición Genética a la Enfermedad , Glutatión/metabolismo , Humanos , India , Neoplasias Pulmonares/patología , Masculino , Persona de Mediana Edad , Factores de Riesgo , Fumar/genéticaRESUMEN
INTRODUCTION: Opioid agonist treatment (OAT) is an effective treatment for opioid dependence syndrome in adults. However, studies on effectiveness of OAT in adolescents are limited; existing studies show varying retention rates. The present study aimed to assess OAT retention rates in adolescent patients with opioid dependence syndrome registered in a community drug treatment clinic in Delhi, India, and to analyse factors associated with retention at 1 year. METHODS: Retrospective cohort study. All adolescents (n = 130) aged 10-19 years, started on OAT from January 2020 to July 2022 were included. Baseline and follow-up data was extracted from online record system maintained at the clinic. OAT retention rates at different timepoints were assessed. Multivariable logistic regression was used to discern factors associated with one-year retention. RESULTS: The participants' mean age was 16.9 (SD 1.4) years. Mean age of starting opioids was 14.9 (SD 2.2) years; 29.5% (n = 38) injected opioids. The 6-, 12-, 18- and 24-month retention rate on OAT was 64.4%, 45.6%, 38.7% and 29% respectively. The retention rates with buprenorphine and methadone were comparable. Multivariate logistic regression showed retention for less than 12 months to be significantly associated with younger age of starting heroin, involvement in illegal activities, absenteeism from school and substance use in family. DISCUSSION AND CONCLUSIONS: The 12-month retention rates on OAT in adolescents is comparable to retention rates in adults. Various factors associated with early age of onset of opioid use are also associated with lower retention rates on OAT.
RESUMEN
Background: Street children are vulnerable to adverse health and risk behaviors and drug use. Substance use among street children has been well documented in several countries. This study reports sociodemographic and peer, family, and stress-related factors associated with substance use and non-use in a representative sample of street children of Delhi. Methods: This cross-sectional survey was conducted through six NGOs working with street children, using Respondent Driven Sampling, in nine districts of Delhi (n = 766, 7-18 years). The multivariable model was developed by applying binary logistic regression analysis. Results: The rate of substance use was 49%. Significant association was found between substance use in the past year and increasing age [Odds Ratio: OR (95% Confidence Interval)] [1.22(1.12,1.33)], male sex [4.34 (2.28,8.26)], lacking psychosocial support from family/relatives [3.27(1.84,5.80)], being engaged in earning from illegal sources, [3.04(1.75,5.29)], family use of substance [2.59(1.38,4.89)], presence of substance-using peers [29.86(14.38,62.01)], lack of non-drug-using peers [2.35(1.46,3.79)], and not possessing basic amenities [2.26(1.31,3.93)]. Conclusion: Multiple modifiable factors exist within the family and peer group, including risk and protective factors or a consequence of substance use. Some challenges in the form of difficulty in reaching out to them and poor treatment seeking by those using substances warrant intensification in both primary and secondary prevention initiatives.
RESUMEN
Aplastic anaemia (AA) is a rare hypocellular bone marrow disease with a large number of mutations in the telomerase reverse transcriptase gene (TERT), leading to bone marrow failure. We used our benchmarked whole exome sequencing (WES) pipeline to identify variants in adult Indian subjects with apparently acquired AA. For 36 affected individuals, we sequenced coding regions to a mean coverage of 100× and a sufficient depth was achieved. Downstream validation and filtering to call mutations in patients treated with Cyclosporin A (CsA) identified variants associated with AA. We report four mutations across the genes associated with the AA, TERT and CYP3A5, in addition to other genes, viz., IFNG, PIGA, NBS/NBN, and MPL. We demonstrate the application of WES to discover the variants associated with CsA responders and non-responders in an Indian cohort.
RESUMEN
Background Untreated co-occurring substance use and substance use disorders (SUDs) in patients with medical conditions may be associated with unfavourable medical outcomes. Understanding the prevalence of substance use and SUDs among patients admitted to hospital for medical illness may help in developing appropriate strategies to manage SUDs in this population and improve the outcomes of medical illness. We assessed the prevalence of substance use and SUDs among patients admitted for medical illnesses and the association between substance use and medical illness. Methods This cross-sectional study was done in an in-patient setting in a multidisciplinary teaching medical institution in India. Using systematic sampling, adult patients admitted in various departments for at least 24 hours were interviewed using standard instruments by psychiatrists trained in the study methodology. Results Two hundred and ninety patients participated. Their mean (SD) age was 42.2 (15.6) years. One hundred and nine participants (37.6%) reported lifetime use of any psychoactive substance, with tobacco being the most common substance used (91, 31.4%), followed by alcohol (69, 23.8%) and cannabis (12, 4.1%). Lifetime alcohol use was significantly associated with diseases of the circulatory system. Lifetime use of any substance or of alcohol, and current use of any substance or tobacco were significantly associated with injuries, poisoning and other consequences of external causes. Conclusions A large proportion of patients hospitalized for medical illness reported the use of psychoactive substances or had SUDs. The use of some of these substances was also associated with injuries as well as diseases of the circulatory system.
Asunto(s)
Trastornos Relacionados con Sustancias , Humanos , India/epidemiología , Estudios Transversales , Trastornos Relacionados con Sustancias/epidemiología , Adulto , Masculino , Femenino , Prevalencia , Persona de Mediana EdadRESUMEN
BACKGROUND: In cirrhosis patients with acute variceal bleeding (AVB), the optimal duration of vasoconstrictor therapy after endoscopic haemostasis is unclear. AIMS: We aimed to compare efficacy of 1-day versus 3-day terlipressin therapy in cirrhosis patients with AVB post-endoscopic intervention. The primary objective was to compare rebleeding at 5 days between the two arms. Secondary objectives included rebleeding and mortality rates at 6 weeks. METHODS: In this open-label, randomised controlled trial, cirrhosis patients with AVB were randomised to either 1-day or 3-day terlipressin therapy. RESULTS: A total of 150 cirrhosis patients with AVB were recruited to receive either 1 day (n = 75) or 3 days (n = 75) of terlipressin therapy. One patient from 1-day arm was excluded. Modified intention-to-treat analysis included 149 patients. Baseline characteristics were comparable between the two groups. Rebleeding at 5 days: 3 (4.1%; 95% confidence interval [CI]: 0.4-9.0) versus 4 (5.3%; 95% CI: 2.0-10.0), risk difference (RD) p = 0.726 and 5-day mortality rates: 1 (1.4%; 95% CI: 0-7.3) versus 1 (1.3%; 95% CI: 0.2-7.0), RD p = 0.960 were similar. Rebleeding at 42 days: 9 (12.2%; 95% CI: 7.0-20.0) versus 10 (13.3%; 95% CI: 7.0-20.0), RD p = 0.842 and mortality at 42 days: 5 (6.8%; 95% CI: 3.0-10.0) versus 4 (5.3%; 95% CI: 2.0-10.0), RD p = 0.704 were also similar. Patients in the 1-day terlipressin therapy arm experienced significantly fewer adverse effects compared with those receiving 3 days of terlipressin therapy: 28 (37.8%) versus 42 (56%), p = 0.026. CONCLUSIONS: Our results suggest that 1 day of terlipressin therapy is associated with similar 5-day and 42-day rebleeding rates, 42-day mortality and an overall superior safety profile compared with 3-day of terlipressin therapy. These findings require to be validated in double-blinded, larger, multiethnic and multicentre studies across the various stages of cirrhosis (CTRI/2019/10/021771).
Asunto(s)
Várices Esofágicas y Gástricas , Cirrosis Hepática , Terlipresina , Humanos , Várices Esofágicas y Gástricas/complicaciones , Várices Esofágicas y Gástricas/tratamiento farmacológico , Hemorragia Gastrointestinal/etiología , Hemorragia Gastrointestinal/inducido químicamente , Cirrosis Hepática/complicaciones , Cirrosis Hepática/tratamiento farmacológico , Proyectos Piloto , Terlipresina/administración & dosificación , Terlipresina/efectos adversos , Várices/complicaciones , Vasoconstrictores/administración & dosificación , Vasoconstrictores/efectos adversosRESUMEN
BACKGROUND: There is scant literature on hepatocellular carcinoma (HCC) in patients with Budd-Chiari syndrome (BCS). AIM: To assess the magnitude, clinical characteristics, feasibility, and outcomes of treatment in BCS-HCC. METHODS: A total of 904 BCS patients from New Delhi, India and 1140 from Mumbai, India were included. The prevalence and incidence of HCC were determined, and among patients with BCS-HCC, the viability and outcomes of interventional therapy were evaluated. RESULTS: In the New Delhi cohort of 35 BCS-HCC patients, 18 had HCC at index presentation (prevalence 1.99%), and 17 developed HCC over a follow-up of 4601 person-years, [incidence 0.36 (0.22-0.57) per 100 person-years]. BCS-HCC patients were older when compared to patients with BCS alone (P = 0.001) and had a higher proportion of inferior vena cava block, cirrhosis, and long-segment vascular obstruction. The median alpha-fetoprotein level was higher in patients with BCS-HCC at first presentation than those who developed HCC at follow-up (13029 ng/mL vs 500 ng/mL, P = 0.01). Of the 35 BCS-HCC, 26 (74.3%) underwent radiological interventions for BCS, and 22 (62.8%) patients underwent treatment for HCC [transarterial chemoembolization in 18 (81.8%), oral tyrosine kinase inhibitor in 3 (13.6%), and transarterial radioembolization in 1 (4.5%)]. The median survival among patients who underwent interventions for HCC compared with those who did not was 3.5 years vs 3.1 mo (P = 0.0001). In contrast to the New Delhi cohort, the Mumbai cohort of BCS-HCC patients were predominantly males, presented with a more advanced HCC [Barcelona Clinic Liver Cancer C and D], and 2 patients underwent liver transplantation. CONCLUSION: HCC is not uncommon in patients with BCS. Radiological interventions and liver transplantation are feasible in select primary BCS-HCC patients and may improve outcomes.
RESUMEN
Background and Aims: Assessment of the severity of substance use disorders (SUDs) in a culture-sensitive manner can help gauge the current condition of the substance user and assess change with time. The present study aimed to develop a scale for the assessment of the severity of SUDs in the Indian clinical context. Methods: Based upon the review of literature on previously available instruments and a consultative meeting of experts, a clinician-rated scale was developed that finally comprised 41 items. A briefer 5-item scale with current and lifetime versions was also developed. The scales were applied to patients with SUDs at six different clinical sites. Results: The instrument was applied to 720 patients (98.2% males, mean age: 34.6 years). The Cronbach's alpha of the full scale was 0.852. The inter-rater reliability Pearson correlation coefficient of the full-scale was r = 0.821 (P < 0.001), and the intra-class correlation coefficient single measure was 0.800 (95% confidence interval: 0.724-0.956). A four-factor solution was suggested to be the most tenable. The mean application duration of the full scale was 13.4 minutes, and that of the briefer version was 2 minutes. Conclusion: This validated scale could be a potentially useful assessment measure for the severity of SUDs in the Indian context. The utility lies in the simplicity of administration and scoring and the balance between brevity and thorough assessment.
RESUMEN
AIM: Ethyl glucuronide (EtG) in hair is a direct biomarker proven to be useful for the detection of chronic excessive alcohol use. This study investigated the association of self-reported alcohol consumption with traditional biomarkers: GGT, AST, ALT, CDT, and MCV in blood and a direct biomarker, hair EtG, in a total of 122 patients with alcohol dependence syndrome. The diagnostic accuracy of the biomarkers to differentiate heavy from non-heavy drinkers was also evaluated. METHOD: GGT, AST, and ALT in serum were measured by Automated Chemistry Analyzer, MCV in blood was measured by Haematology Analyzer, serum CDT was analyzed by ELISA, and EtG in hair was evaluated by gas chromatography-mass spectrometry. The association between the biomarkers and the amount of alcohol consumed (self-reported) was determined using Spearman's rank correlation. RESULTS: All participants showed EtG level above the cut-off (0.03 ng/mg). Hair EtG showed a statistically significant linear and positive correlation with the amounts (in grams) of alcohol consumed (r = 0.60; p < 0.001). No correlation was observed among the traditional biomarkers and the quantity of alcohol consumed. Also, EtG showed an excellent receiver operating characteristic (ROC) curve (98%) with good sensitivity (85%) and specificity (60%) to classify heavy drinkers among individuals with alcohol dependence syndrome. CONCLUSION: Hair EtG can be helpful to estimate retrospective alcohol consumption in long-term chronic alcohol consumption cases. Hair EtG also provides a reliable diagnostic test to detect heavy drinkers among individuals with alcohol dependence syndrome.
Asunto(s)
Alcoholismo , Glucuronatos , Cabello , Humanos , Consumo de Bebidas Alcohólicas , Alcoholismo/diagnóstico , Biomarcadores , Cabello/química , Estudios Retrospectivos , Detección de Abuso de Sustancias/métodos , Glucuronatos/análisisRESUMEN
Background: Comparative studies of the naturalistic course of patients of opioid dependence on naltrexone and buprenorphine are likely to be helpful for clinical decision-making. The article aimed to report on the three-months naturalistic outcomes of patients discharged on naltrexone or buprenorphine from the same center. Methods: Patients with opioid dependence who were discharged on either naltrexone (n = 86) or buprenorphine (n = 30) were followed up for three months for retention in treatment. The patients were also followed up telephonically, and the Maudsley Addiction Profile was applied. Results: The days of retention in treatment were significantly higher in the buprenorphine group (69.5 versus 48.7 days, P = 0.009). Heroin use, pharmaceutical opioid use, injection drug use, involvement in illegal activity, and percentage of contact days in conflict with friends in the last 30 days reduced over three months in both the groups, while the physical and psychological quality of life improved in both the groups. Additionally, in the naltrexone group, smoked tobacco use, cannabis use, and percentage of contact days in conflict with family within the last 30 days reduced at three months compared to baseline. Conclusion: With the possible limitations of choice of medication-assisted treatment for opioid dependence being determined by the patient, and prescribing related factors and sample size constraints, the study suggests that retention outcomes may vary between naltrexone and buprenorphine, though both medications may improve several patient-related parameters. However, a true head-to-head comparison of the outcomes of buprenorphine and naltrexone in a naturalistic setting may be difficult.