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INTRODUCTION: Intravenous corticosteroids are the mainstay of treatment of patients hospitalized with acute severe ulcerative colitis (ASUC). However, 30%-40% of the patients are refractory to corticosteroids. We investigated whether addition of tofacitinib to corticosteroids improved the treatment responsiveness in patients with ASUC. METHODS: This single-center, double-blind, placebo-controlled trial randomized adult patients with ASUC (defined by the Truelove Witts severity criteria) to receive either tofacitinib (10 mg thrice daily) or a matching placebo for 7 days while continuing intravenous corticosteroids (hydrocortisone 100 mg every 6 hours). The primary end point was response to treatment (decline in the Lichtiger index by >3 points and an absolute score <10 for 2 consecutive days without the need for rescue therapy) by day 7. The key secondary outcome was the cumulative probability of requiring initiation of infliximab or undergoing colectomy within 90 days following randomization. All analyses were performed in the intention-to-treat population. RESULTS: A total of 104 patients were randomly assigned to a treatment group (53 to tofacitinib and 51 to placebo). At day 7, response to treatment was achieved in 44/53 (83.01%) patients receiving tofacitinib vs 30/51 (58.82%) patients receiving placebo (odds ratio 3.42, 95% confidence interval 1.37-8.48, P = 0.007). The need for rescue therapy by day 7 was lower in the tofacitinib arm (odds ratio 0.27, 95% confidence interval 0.09-0.78, P = 0.01). The cumulative probability of need for rescue therapy at day 90 was 0.13 in patients who received tofacitinib vs 0.38 in patients receiving placebo (log-rank P = 0.003). Most of the treatment-related adverse effects were mild. One patient, receiving tofacitinib, developed dural venous sinus thrombosis. DISCUSSION: In patients with ASUC, combination of tofacitinib and corticosteroids improved treatment responsiveness and decreased the need for rescue therapy.
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Colitis, Ulcerative , Piperidines , Pyrimidines , Pyrroles , Humans , Piperidines/therapeutic use , Colitis, Ulcerative/drug therapy , Pyrimidines/therapeutic use , Male , Female , Double-Blind Method , Adult , Pyrroles/therapeutic use , Pyrroles/administration & dosage , Middle Aged , Acute Disease , Treatment Outcome , Severity of Illness Index , Drug Therapy, Combination , Protein Kinase Inhibitors/therapeutic use , Colectomy , Infliximab/therapeutic useABSTRACT
BACKGROUND: Ulcerative proctitis (UP), though associated with high symptom burden and poor quality of life, is excluded from most of the randomized controlled trials in UC, including the OCTAVE trials. We aimed to analyse the effectiveness of tofacitinib in UP, and compare it to that in left sided colitis (LSC) and pancolitis (PC). METHODS: This was a prospective cohort study. Patients with either steroid-dependent or refractory ulcerative colitis, who received tofacitinib, were divided into three groups based on the disease extent [UP, LSC and PC]. The primary outcome was comparison of proportion of patients in clinical remission in the three groups, at weeks 8, 16 and 48. Safety outcomes were reported using incidence rate per patient year of exposure. RESULTS: Clinical remission was achieved in 47%(15/32), 24%(23/94), and 43%(23/54) of patients at week 8, 56%(18/32), 37%(35/94), and 56%(30/54) of patients at week 16, and 59%(19/32), 38%(36/94), and 24%(13/54) of patients at week 48 in groups UP, LSC and PC, respectively. Corticosteroid-free clinical remission rates were significantly higher in patients in groups UP at week 48. Five (15%) patients with UP were primary non-responders to tofacitinib at week 16, while three (9%) patients had secondary loss of response at week 48. The probability of sustained clinical response was highest in patients with UP. Patients with UP had the lowest incidence of adverse effects. CONCLUSION: The effectiveness of tofacitinib in inducing and maintaining clinical remission is greater in patients with UP compared to LSC and PC.
Subject(s)
Colitis, Ulcerative , Piperidines , Proctitis , Pyrimidines , Humans , Colitis, Ulcerative/epidemiology , Quality of Life , Prospective StudiesABSTRACT
BACKGROUND: Patients with Inflammatory bowel disease (IBD) are susceptible to psychiatric co-morbidities. We aimed to ascertain the burden of anxiety, depression, and perceived stress in patients with IBD from north India. METHODS: Consenting adult patients with an established diagnosis of IBD were enrolled. The enrolled patients filled the Hospital Anxiety and Depression Scale (HADS) and Perceived Stress Scale (PSS) questionnaires. The patient and disease characteristics were analyzed to determine the correlations and predictors of psychiatric comorbidities. RESULTS: A total of 318 patients (255 UC, 63 CD; mean age 40.13 ± 12.06 years, 168 [52.8%] males; mean partial Mayo score 2.10 ± 2.35; and mean HBI 2.77 ± 2.13) were enrolled. The prevalence of anxiety, depression and moderate to high perceived stress was 14%, 12%, and 41%, respectively. Females had higher mean perceived stress, anxiety and depression scores compared to males. The partial Mayo score (PMS) correlated poorly with anxiety (ρ = 0.083, p = 0.187), depression (ρ = 0.123, p = 0.49) and perceived stress (ρ = 0.169; p = 0.007). The Harvey Bradshaw index (HBI) correlated fairly with anxiety (ρ = 0.336, p = 0.007) and poorly with depression (ρ = 0.287, p = 0.022) and perceived stress (ρ = 0.20; p = 0.117). Younger age (OR 0.93, 95% CI 0.90-0.97; p = 0.001) and hand-grip strength (OR 4.63, 95% CI 1.88-11.42; p = 0.001) predicted anxiety in patients with UC while rural area of residence (OR 4.75, 95% CI 1.03-21.98; p = 0.046) and HBI (OR 1.60, 95% CI 1.12-2.29; p = 0.009) were significant predictors of anxiety in patients with CD. CONCLUSION: Psychiatric comorbidities are common in patients with IBD, with higher prevalence in females. Young adults with UC and sarcopenia; and individuals with active CD living in rural areas are at an increased risk of anxiety.
Subject(s)
Colitis, Ulcerative , Crohn Disease , Inflammatory Bowel Diseases , Psychological Tests , Self Report , Male , Young Adult , Female , Humans , Adult , Middle Aged , Crohn Disease/diagnosis , Colitis, Ulcerative/diagnosis , Cohort Studies , Depression/diagnosis , Depression/epidemiology , Inflammatory Bowel Diseases/diagnosis , Anxiety/epidemiology , Anxiety/etiology , Stress, Psychological/diagnosis , Stress, Psychological/epidemiology , Severity of Illness IndexABSTRACT
BACKGROUND: Inflammatory bowel disease (IBD) is associated with an increased risk of malnutrition and sarcopenia. AIMS: To evaluate the nutritional status of patients with IBD and determine the threshold values of different parameters of nutritional assessment to identify malnutrition. METHODS: This was a single-centre cross-sectional analysis of adult patients with IBD [ulcerative colitis (UC) and Crohn's disease (CD)] who underwent anthropometry [body mass index (BMI), mid upper arm circumference (MUAC) and triceps-fold thickness (TSF)], body composition analysis and assessment for sarcopenia [hand-grip strength and skeletal muscle index (SMI) at L3 vertebral level)]. Age- and gender-matched healthy adults served as controls. Malnutrition was defined according to the European Society of Clinical Nutrition and Metabolism (ESPEN) criteria. RESULTS: A total of 406 patients [336 (82.76%) UC and 70 (17.24%) CD; mean age 40.56 ± 13.67 years; 215 (52.95%) males] with IBD and 100 healthy controls (mean age 38.69 ± 10.90 years; 56 (56%) males) were enrolled. The mean BMI, MUAC, TSF thickness, fat and lean mass, hand-grip strength, and SMI at L3 vertebral level were lower in patients with IBD compared to controls. The prevalence of malnutrition was similar in UC and CD [24.40% (n = 82) and 28.57% (n = 20), respectively (p = 0.46)]. Thresholds for fat mass in females (15.8 kg) and visceral fat index in males (0.26) were both sensitive and specific to detect malnutrition. The cutoff values of MUAC and TSF thickness to identify malnutrition were 23.25 cm and 25.25 cm, and 16.50 mm and 8.50 mm, in females and males, respectively. CONCLUSION: Malnutrition and sarcopenia were common in patients with IBD, with the prevalence being similar in patients with both UC and CD.
Subject(s)
Colitis, Ulcerative , Crohn Disease , Inflammatory Bowel Diseases , Malnutrition , Sarcopenia , Adult , Male , Female , Humans , Middle Aged , Crohn Disease/complications , Colitis, Ulcerative/complications , Cross-Sectional Studies , Prevalence , Malnutrition/diagnosis , Nutritional Status , Inflammatory Bowel Diseases/complicationsABSTRACT
INTRODUCTION: Intensive care unit (ICU) visitation has traditionally been restrictive, primarily due to septic considerations and staff apprehension towards unrestricted visitation policy. However, ICU admission is stressful for patients and their families and the presence of family relatives at ICU patients' bedside may help alleviate the same. The present study compares the viewpoints of healthcare workers (HCW) and patients' family members regarding these two types of visitation policies. MATERIALS AND METHODS: The initial assessment involved a qualitative investigation, based on an inductive grounded theory approach. Participant interviews were audiotaped, transcribed, manually coded, themes analyzed, and aggregate dimensions unfolded. Subsequently, a structured proforma filled by stakeholders and responses were coded as categorical variables (quantitative investigation). Their association with a continuous presence of family members was seen using univariate analysis (Chi-square test) and p <0.05 was considered significant. Satisfaction levels were rated on a Likert scale. RESULTS: Eighty-six stakeholders [group A: HCWs (15 doctors, 29 nurses), group B: patients (n = 18), and their relatives (n = 24)] were interviewed. While group A preferred restricted visitation policy (RVP), group B preferred unrestricted visitation policy (UVP). Quantitative data confirmed that HCWs (92.8% nurses and 85.7% doctors) were more satisfied with RVP and group B (92.3% relatives and 87.5% patients) with UVP. Group A (75.9% nurses and 93.3% doctors) therefore preferred RVP and group B (75% families and 66.6% patients) preferred UVP. CONCLUSION: The patients and their families were more satisfied with UVP contrary to HCWs who were skeptical towards UVP and preferred RVP. HOW TO CITE THIS ARTICLE: Mahajan RK, Gupta S, Singh G, Mahajan R, Gautam PL. Continuous Family Access to the Intensive Care Unit: A Mixed Method Exploratory Study. Indian J Crit Care Med 2021;25(5):540-550.
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BACKGROUND AND AIM: Fecal microbiota transplantation (FMT) targets gut microbiome dysbiosis and is an emerging therapy for ulcerative colitis (UC). Although initial results with FMT in patients with active UC are encouraging, data regarding its acceptability, tolerability, and safety are scant. METHODS: A retrospective analysis of patients with active UC (Mayo clinic score ≥ 4), who received multisession FMT (at weeks 0, 2, 6, 10, 14, 18, and 22) via colonoscopy between June 2016 and June 2018, was performed. Patient acceptability, tolerability, and immediate and long-term safety of the therapy were assessed. RESULTS: Of the 129 patients with active UC who were offered FMT, 101 patients consented, giving acceptability of 78.3%. Fecal slurry retention time improved with each session (3.27 ± 1.06 h for the first session vs 5.12 ± 0.5 h for the seventh session). Abdominal discomfort, flatulence, abdominal distension, borborygmi, and low-grade fever (30.8%, 15.9%, 9.8%, 7.9%, and 7.6%, respectively) were the most common post-procedural short-term adverse events. Long-term adverse events included new-onset urticaria (n = 2, 4.3%), arthritis/arthralgia (n = 3, 6.5%), depression (n = 1, 2.2%), partial sensorineural hearing loss (n = 1, 2.2%), and allergic bronchitis (n = 1, 2.2%). Thirteen (12.9%) patients dropped out because of adverse events. CONCLUSION: Fecal microbiota transplantation appears to be a safe and well-tolerated procedure, with good acceptability in patients with active UC.
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Colitis, Ulcerative/therapy , Fecal Microbiota Transplantation , Adult , Fecal Microbiota Transplantation/adverse effects , Female , Humans , Male , Retrospective Studies , Safety , Treatment Outcome , Young AdultABSTRACT
Coronavirus disease 2019 (COVID-19), caused due to a novel coronavirus SARS-CoV-2, has swept across the planet and has become a public health emergency of international concern. Like other coronaviruses, it predominantly involves the respiratory system. However, several atypical manifestations of the disease have been reported worldwide in a short span of time. Almost all organ systems (cardiovascular, gastrointestinal, renal, hepatic, endocrine, and nervous system) have been reported to be involved. This review concisely summarizes the systemic effects of COVID-19, thus emphasizing that the disease can present in various forms and the healthcare workers need to be extra vigilant, approaching all patients with a high index of suspicion.
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BACKGROUND: Leaving against medical advice (LAMA) is a worldwide healthcare problem, occurring due to various contributing factors, seen more commonly indeveloping countries like ours. AIM: To retrospectively study the prevalence of LAMA along with its affectingfactors. METHODS: We screened the hospital record of a tertiary care teaching hospital forone year, after obtaining approval from the institutional ethicalcommittee. Patient demography, disease characteristics and status at thetime of LAMA were noted and statistically analysed. RESULTS: During the study period, 4.95% patients took LAMA. The mean age was 47.2±21years (range newborn to 103 years) with 2:1 Male: Female ratio. Forty ninepercent of patients resided in rural areas and around 1/3rd were dependenton others for their living. The mean length of stay in hospital was 6.1±9.3days. Around 60% patients required mechanical ventilation and 51% patientshad been explained guarded prognosis. About 53% of patients taking LAMAwere admitted in medical wards, trauma being the most common diagnosis(17.2%). History of alcohol abuse and poisoning with suicidal intent wasseen in 11.47% and 3.9%, respectively. CONCLUSION: The number of patients taking LAMA from our country is quite high. This necessitates formulation and implementation of strategies to reduce the prevalence of LAMA discharges like further investigations to look into the causes contributing to patients taking LAMA, attending to substance abuseissues, recognizing psychological factors and strengthening the socialsystems, encouraging insurance cover, helping patients' treatment expensesthrough charity care and optimizing healthcare delivery and patient centredpolicies. KEY MESSAGES: LAMA is a global health issue precipitated by unemployment and alcohol abuse, commonly taken due to financial reasons. This necessitates a strong social system and national health insurance schemes to reduce the cost of treatment. HOW TO CITE THIS ARTICLE: Mahajan RK, Gautam PL, et al. Retrospective Evaluation of Patients Leaving against Medical Advice in a Tertiary Care Teaching Hospital. IndianJ Crit Care Med 2019;23(3):139-142.
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BACKGROUND AND AIM: The epidemiology and clinical profile of hepatitis C virus (HCV) varies worldwide, and data from developing countries are sparse. The aim of the present study was to assess the clinical profile of HCV infection in a developing country in South-East Asia (India). METHODS: This observational study assessed patient demographics, viral characteristics, risk factors for virus acquisition, and disease characteristics in HCV patients diagnosed between January 2004 and December 2015. RESULTS: Of 8035 patients who were diagnosed with HCV infection, a majority were men (68.3%), middle aged (52.2%), and from low (34%) to middle (46%) socioeconomic status and rural population (69.8%). Eighty-two percent had identifiable risk factors, the most common being history of dental treatment (52%) and therapeutic injections with reusable syringes/needles (45%). Household contacts of index patients had high prevalence of HCV (15.3%). Common genotypes were genotype 3 (70.4%) and genotype 1 (19.3%). Although a majority of patients were either asymptomatic (54.8%) or had non-specific symptoms (6.7%) at presentation, a significant proportion (9.3%) had advanced liver disease. Presentation with cirrhosis (38.8%) was associated with male gender, higher age at time of virus detection, rural residence, alcohol or opium intake, and coinfections with hepatitis B virus or human immunodeficiency virus. CONCLUSIONS: Hepatitis C virus infection in northern India is seen more commonly in men, the middle aged and people from rural background and low to middle socioeconomic status. The common possible risk factors are dental treatment and exposure to reused syringes and needles. Although the most common presentation is incidental detection, a large number of patients present with advanced liver disease.
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Hepatitis C/epidemiology , Hepatitis C/etiology , Adult , Age Factors , Aged , Aged, 80 and over , Dental Care/adverse effects , Female , Hepatitis C/transmission , Humans , India/epidemiology , Male , Middle Aged , Needle Sharing/adverse effects , Prevalence , Risk Factors , Rural Population , Sex Factors , Social Class , Young AdultABSTRACT
BACKGROUND AND AIM: Celiac disease is a multi-systemic disease, which can affect any organ system including liver. However, the prevalence of celiac disease and the sensitivity and specificity of anti-tissue transglutaminase (anti-tTG) in diagnosing celiac disease in patients with cirrhosis of liver is not well established. METHODS: We screened a cohort of patients with chronic liver disease for an associated diagnosis of celiac disease. Anti-tTG was carried out in all patients, and those with a high value were subjected to duodenal biopsy for histological confirmation. In patients where biopsy was contraindicated or refused, anti-endomysial antibody (anti-EMA) was tested. RESULTS: Of a total of 595 patients with chronic liver disease, high levels of anti-tTG were noted in 150 (25.2%) patients, and celiac disease was diagnosed in 14 patients (2.4%). Celiac autoimmunity (high levels of both anti-tTG and anti-EMA) was noted in seven patients (1.2%). CONCLUSIONS: Although a large number of cirrhotic patients have high levels of anti-tTG, duodenal histology and/or anti-EMA is normal in majority of these patients. This suggests high false positivity of anti-tTG in patients with cirrhosis and highlights the need of duodenal biopsy for histological confirmation of the diagnosis of celiac disease.
Subject(s)
GTP-Binding Proteins/immunology , Immunoglobulin A/blood , Liver Cirrhosis/diagnosis , Liver Cirrhosis/epidemiology , Transglutaminases/immunology , Adolescent , Adult , Aged , Aged, 80 and over , Biomarkers/blood , Celiac Disease/complications , Celiac Disease/diagnosis , Celiac Disease/epidemiology , Child , Cohort Studies , False Positive Reactions , Female , Humans , Liver Cirrhosis/etiology , Male , Middle Aged , Prevalence , Protein Glutamine gamma Glutamyltransferase 2 , Sensitivity and Specificity , Young AdultABSTRACT
BACKGROUND AND AIM: The introduction of sofosbuvir has revolutionized the treatment of chronic hepatitis C. This study was planned to observe whether the efficacy and tolerability of sofosbuvir-based regimens demonstrated in phase 3 clinical trial results translate into real-life clinical practice. METHODS: This prospective, non-randomized observational study conducted in Dayanand Medical College and Hospital, Punjab, included all consecutive treatment-naïve patients with chronic hepatitis C (genotypes 1-5) who were treated with sofosbuvir-based regimens. Response to therapy was assessed at week 4 (rapid virological response), week 12 or 24 (end of treatment response), and 12 weeks after cessation of therapy (sustained virological response [SVR]). RESULTS: Of 947 patients diagnosed with chronic hepatitis C virus and considered for treatment with direct-acting antivirals, 736 patients (77.1%) opted for treatment (age 45.1 ± 10.1 years, 64% men, genotype 3 [80%], genotype 1 [14.7%], and genotype 4 [4.9%]). Viral load was high (>600 000 IU/mL) in 361/736 (49%); 330 patients (44.8%) had cirrhosis (80 [14.3%] were decompensated). Patients with genotypes 1, 4, and 5 (n = 135) were treated with triple drug regime (pegylated interferon, ribavirin, and sofosbuvir) for 12 weeks. Patients with genotype 3 (n = 589) were treated either with dual therapy (sofosbuvir and ribavirin) for 24 weeks (n = 405) or triple therapy for 12 weeks (n = 184). SVR was achieved in 453/473 (95.8%). SVR rates did not differ among different genotypes but were higher in non-cirrhotics. CONCLUSION: Sofosbuvir-based treatment regimens achieve high SVR rates in real-life cohort of Indian patients with chronic hepatitis C infection (including those with cirrhosis).
Subject(s)
Antiviral Agents/administration & dosage , Hepatitis C, Chronic/drug therapy , Sofosbuvir/administration & dosage , Adult , Asian People , Cohort Studies , Drug Administration Schedule , Drug Therapy, Combination , Female , Genotype , Hepacivirus/genetics , Hepatitis C, Chronic/virology , Humans , India , Interferon alpha-2 , Interferon-alpha/administration & dosage , Male , Middle Aged , Polyethylene Glycols/administration & dosage , Prospective Studies , Recombinant Proteins/administration & dosage , Ribavirin/administration & dosage , Time Factors , Treatment OutcomeABSTRACT
Hyponatremia is a common disorder in elderly and can result in changes in cognition, seizures, coma or even respiratory arrest if not recognised and treated. Syndrome of inappropriate anti diuretic hormone secretion (SIADH) is the most common cause of hyponatremia in elderly hospitalised patients and in most cases the etiology cannot be determined on routine investigations. We present a 76 year old male with symptomatic hyponatremia who had chronic urinary retention due to a urethral stricture. His sodium levels improved with catheterisation and worsened again after the catheter was removed. This supports the hypothesis that urinary retention and bladder distension can stimulate ADH release from the posterior pituitary, producing a picture similar to SIADH.
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BACKGROUND: The global burden of inflammatory bowel disease (IBD) is reportedly increasing. Methodologies and datasets are routinely updated, allowing for more accurate estimates to guide healthcare policy. METHODS: The Global Burden of Diseases, Injuries and Risk Factors Study (GBD) dataset was accessed and the trends in IBD at the global and regional levels from 1990 to 2019 were estimated for incidence, prevalence, deaths, years of life lost (YLL), years lived with disability (YLD) and disability-adjusted life-years (DALYs) per 100,000 population. The three decadal trends of the disease measures were calculated. RESULTS: In 2019, there were 4.9 million (95% Uncertainty Interval [UI] 4.3-5.5) cases of IBD globally. The age-standardized prevalence and incidence rates decreased from 73.23 (95% UI 63.8-83.6) and 6.1 (95% UI 5.3-6.9) in 1990 to 59.2 (95% UI 52.7-66.4) and 4.9 (95% UI 4.4-5.6) in 2019, respectively. Like prior estimates, the highest age-standardized prevalence and incidence rates occurred in North America, but the lowest rates were reported in Oceania (209.5 [195.4-224.4] and 24.5 [22.6-26.7] and 3.87 [3.1-4.7] and 0.5 [0.5-0.7], respectively) and not the Caribbean, as previously reported. High socio-demographic index (SDI) locations had the highest age-standardized prevalence rate, though the rates declined in 2019 compared to 1990. The age-standardized prevalence and incidence rates increased in middle, low middle and low SDI quintiles over the three decades. The age-standardized rates for deaths, DALYs, YLD and YLL decreased globally from 1990 to 2019. Between 1990 and 2019 the total number of patients with IBD in India doubled from 0.13 million (95% UI 0.10-0.16) to 0.27 million (95% UI 0.21-0.33) with age-standardized incidence rate increasing from 2.23 (95% UI 1.85-2.73) to 2.34 (95% UI 1.95-2.86). CONCLUSION: This analysis of the GBD 2019 database demonstrates that the overall global burden of IBD is lower than previously estimated, but an increasing disease burden is observed in the middle and low-SDI locations.
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Global Burden of Disease , Inflammatory Bowel Diseases , Humans , Prevalence , Incidence , Risk Factors , Inflammatory Bowel Diseases/epidemiology , Global HealthABSTRACT
BACKGROUND: Oral corticosteroids are first-line agents to induce remission in moderately active ulcerative colitis [UC], but are associated with adverse effects. We compared the efficacy and safety of tofacitinib and prednisolone for induction of remission in moderately active UC. METHODS: This was a single-centre, prospective, open-label, randomized, active-controlled pilot study. Eligible patients [aged ≥18 years] had moderately active UC. Participants were randomly assigned to receive either prednisolone [40 mg daily, tapered by 5 mg every week] or tofacitinib [10 mg twice daily] for 8 weeks. The primary endpoint was composite remission [defined as total Mayo clinic score ≤2, with endoscopic sub-score of 0 and faecal calprotectin <100 µg/g] at 8 weeks. RESULTS: Seventy-eight patients were randomly assigned to either of the treatment groups. At week 8, the proportion of patients achieving composite remission in the tofacitinib [7/43, 16.28%] and prednisolone groups [3/35, 8.57%] were not significantly different (odds ratio [OR] 2.07, 95% confidence interval [CI] 0.49-8.70; pâ =â 0.31). The time to achieve symptomatic remission [normal stool frequency with absence of rectal bleeding] was similar (10 days, interquartile range [IQR 7-18.75] and 10 days [IQR 5-12.5] for tofacitinib and prednisolone, respectively; pâ =â 0.25) in the two groups. One patient each in the tofacitinib and prednisolone group discontinued treatment due to development of pulmonary tuberculosis and pustular acne, respectively. One patient receiving tofacitinib developed herpes zoster, but did not require cessation of therapy. No serious adverse events or major adverse cardiovascular events were observed. CONCLUSION: In patients with moderately active UC, there was no difference in the efficacy and safety of tofacitinib and oral prednisolone for induction of remission at 8 weeks. TRAIL REGISTRATION: Clinical Trials Registry of India [CTRI/2021/10/037641].
Subject(s)
Colitis, Ulcerative , Piperidines , Pyrimidines , Humans , Adolescent , Adult , Colitis, Ulcerative/drug therapy , Pilot Projects , Prospective Studies , Prednisolone/therapeutic use , Remission Induction , Treatment OutcomeABSTRACT
Introduction: The Papanicolaou Society of Cytopathology System for reporting Pancreaticobiliary Cytology (PSCPC) is a reliable method to classify pancreatic fine needle aspiration cytology (FNAC) smears. However, it is not without practical problems which can diminish the diagnostic accuracy of the cytological diagnosis. Aims and Objectives: To determine the diagnostic pitfalls while reporting cytomorphology of pancreatic lesions according to PSCPC on correlating FNAC findings with histopathology. Materials and Methods: Retrospective analysis of pancreatic FNAC smears received in the Department of Pathology of our tertiary care institute over a period of 2 years was done. The cytological diagnoses were classified according to the Papanicolaou Society of Cytopathology system of reporting pancreaticobiliary cytology and correlated with histopathology. The reasons of cyto-histological discordance were analyzed. Results: Out of 50 cases in which both FNAC and biopsy of pancreatic lesions were done, 34 cases were positive/malignant (Category VI), eight cases were suspicious for malignancy (Category V), three cases were neoplastic (Category IV), two cases were atypical (Category III), two cases were negative for malignancy (Category II), and one case was non-diagnostic (Category I). Out of 50 cases, histopathology was non-diagnostic due to inadequate material in six cases. The cytological diagnoses were compared with histopathology in the remaining 44 cases. Categories III, IV V, and VI were considered as positive for neoplastic pathology. The sensitivity of FNAC to predict neoplastic pathology was 97.5%, while the specificity was 25%. The positive predictive value was 92.9%. Two cases reported as atypical (Category III) turned out to be adenocarcinoma on histopathology. One case reported as neuroendocrine tumor and two cases reported as adenocarcinoma on cytology displayed features of chronic pancreatitis on histology. One case reported as neoplastic mucinous cyst (Category IV) turned out to be adenocarcinoma on histology (limited concordance). Conclusion: The cytopathologist needs to be wary of the potential pitfalls to improve the diagnostic accuracy of FNACs.
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As the therapeutic targets in ulcerative colitis (UC) shift from control of symptoms to mucosal healing and prevention of disease complications like disability, colectomy, and cancer, the definition of remission has evolved. The current definition of clinical remission is variable and is determined by the clinical context in which it is being used. This results in skepticism and uncertainty about the true meaning of the term "clinical remission." In this review, the authors reexamine the definition of clinical remission and propose a novel approach to define remission in UC.
The current definition of clinical remission in ulcerative colitis (UC) is variable and is determined by the clinical context in which it is being used. In this review, the authors reexamine the definition of clinical remission in UC and propose a novel approach to define remission based on the parameter being assessed.
Subject(s)
Colitis, Ulcerative , Humans , Colitis, Ulcerative/drug therapy , Mucous Membrane , Colectomy , Remission InductionABSTRACT
BACKGROUND/AIMS: Primary sclerosing cholangitis (PSC) represents the most common hepatobiliary extraintestinal manifestation of inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD). Limited data exist on PSC in patients with IBD from India. We aimed to assess the prevalence and disease spectrum of PSC in Indian patients with IBD. METHODS: Database of IBD patients at 5 tertiary care IBD centers in India were analyzed retrospectively. Data were extracted and the prevalence of PSC-IBD was calculated. RESULTS: Forty-eight patients out of 12,216 patients with IBD (9,231 UC, 2,939 CD, and 46 IBD unclassified) were identified to have PSC, resulting in a prevalence of 0.39%. The UC to CD ratio was 7:1. Male sex and pancolitis (UC) or colonic CD were more commonly associated with PSC-IBD. The diagnosis of IBD preceded the diagnosis of PSC in most of the patients. Majority of the patients were symptomatic for liver disease at diagnosis. Eight patients (16.66%) developed cirrhosis, 5 patients (10.41%), all UC, developed malignancies (3 colorectal cancer [6.25%] and 2 cholangiocarcinoma [4.16%]), and 3 patients died (2 decompensated liver disease [4.16%] and 1 cholangiocarcinoma [2.08%]) on follow-up. None of the patients mandated surgical therapy for IBD. CONCLUSIONS: Concomitant PSC in patients with IBD is uncommon in India and is associated with lower rates of development of malignancies.
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BACKGROUND/AIMS: The inflammatory bowel disease (IBD)-disk is a validated, visual, 10-item, self-administered questionnaire used to evaluate IBD-related disability. The present study aimed to evaluate IBD-disk in assessment of IBD daily life burden and its relation with disease activity. METHODS: A cross-sectional study was conducted between June 2021 and December 2021. Patients with IBD were asked to complete the IBD-disk and a visual analogue scale of IBD daily-life burden (scored from 0-10, score >5 indicative of high burden). The internal consistency of IBD-disk, correlation with IBD daily life burden and disease activity (assessed by partial Mayo score and Harvey Bradshaw Index in patients with ulcerative colitis [UC] and Crohn's disease [CD], respectively) and diagnostic performance of IBD-disk to detect high burden were analyzed. RESULTS: Out of the 546 patients (mean age 40.33±13.74 years, 282 [51.6%] males) who completed the IBD-disk, 464 (84.98%) had UC and the remaining (n=82, 15.02%) had CD. A total of 311 patients (291 UC and 20 CD; 56.95%) had active disease. The mean IBD-disk total score and IBD daily life burden were 18.39±15.23 and 2.45±2.02, respectively. The IBD-disk total score correlated strongly with the IBD daily life burden (ρ=0.94, P<0.001), moderately with partial Mayo score (ρ=0.50) and weakly with Harvey Bradshaw Index (ρ=0.34). The IBD-disk total score >30 predicted high IBD daily-life burden. CONCLUSIONS: The IBD-disk accurately predicts the daily life burden and parallels disease activity in patients with IBD and can be applied in clinical practice. (Intest Res, Published online).
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BACKGROUND/AIMS: Inflammatory bowel disease (IBD) is increasingly being recognized in elderly patients. Data on clinical spectrum of elderly-onset IBD patients is lacking from India. METHODS: A cross-sectional retrospective analysis of a prospectively maintained database of patients diagnosed with IBD was conducted at 2 centers in India. The clinical spectrum of elderly-onset IBD including demographic profile (age and sex), clinical presentation, disease characteristics (disease behavior and severity, extent of disease), and treatment were recorded and compared with adult-onset IBD. RESULTS: During the study period, 3,922 (3,172 ulcerative colitis [UC] and 750 Crohn's disease [CD]) patients with IBD were recorded in the database. A total of 186 patients (4.74%; 116 males [62.36%]) had elderly-onset IBD (69.35% UC and 30.64% CD). Diarrhea, blood in stools, nocturnal frequency and pain abdomen were the commonest presentations for UC, whereas pain abdomen, weight loss and diarrhea were the most frequent symptoms in CD. For both elderly onset UC and CD, majority of the patients had moderately severe disease. Left-sided colitis was the commonest disease location in UC. Isolated ileal disease and inflammatory behavior were the most common disease location and behavior, respectively in CD. 5-Aminosalicylates were the commonest prescribed drug for both elderly onset UC and CD. Thiopurines and biologics were used infrequently. Prevalence of colorectal cancer was higher in elderly onset IBD. CONCLUSIONS: Elderly onset IBD is not uncommon in India. Both the elderly onset UC and CD were milder, with no significant differences in disease characteristics (disease extent, location and behavior) when compared to adult-onset IBD. Colorectal cancer was more common in elderly onset IBD.