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1.
Medicina (Kaunas) ; 60(7)2024 Jun 28.
Article in English | MEDLINE | ID: mdl-39064497

ABSTRACT

Inflammatory bowel disease (IBD) poses significant challenges in its management, encompassing a spectrum of conditions from Crohn's disease to ulcerative colitis. Dietary interventions have emerged as integral components of the multidisciplinary approach to IBD management, with implications ranging from disease prevention to treatment of active manifestations and addressing complications such as malnutrition. While dietary interventions show promise in improving outcomes for some patients with IBD, there is no consensus in the existing literature regarding remission maintenance in those patients. Furthermore, many patients explore dietary modifications often guided by anecdotal evidence or personal experiences and this could lead to malnutrition and decreased quality of life. This comprehensive review synthesizes existing literature to elucidate the complex interplay between diet and IBD, offering insights into the efficacy and safety of various dietary modalities in maintaining disease remission. It also highlights the importance of patient education in navigating dietary choices and potential risks associated with food avoidance, including the heightened risk of micronutrient deficiencies. Furthermore, it emphasizes the pivotal role of a multidisciplinary care team comprising clinicians and dietitians in providing personalized dietary guidance tailored to individual patient needs and goals. By synthesizing the latest evidence and providing insights into both the potential benefits and risks of dietary interventions, this review could be used as a resource for healthcare professionals and patients alike in navigating the complex landscape of dietary management in IBD.


Subject(s)
Inflammatory Bowel Diseases , Humans , Inflammatory Bowel Diseases/diet therapy , Adult , Quality of Life , Remission Induction/methods , Malnutrition/prevention & control , Diet
3.
Medicina (Kaunas) ; 60(6)2024 Jun 13.
Article in English | MEDLINE | ID: mdl-38929596

ABSTRACT

Despite the decreased rates in inflammatory bowel disease (IBD) colectomies due to high advances in therapeutic options, a significant number of patients still require proctocolectomy with ileal pouch-anal anastomosis (IPPA) for ulcerative colitis (UC). Pouchitis is the most common complication in these patients, where up to 60% develop one episode of pouchitis in the first two years after UC surgery with IPAA with severe negative impact on their quality of life. Acute cases usually respond well to antibiotics, but 15% of patients will still develop a refractory disease that requires the initiation of advanced immunosuppressive therapies. For chronic idiopathic pouchitis, current recommendations suggest using the same therapeutic options as for IBD in terms of biologics and small molecules. However, the available data are limited regarding the effectiveness of different biologics or small molecules for the management of this condition, and all evidences arise from case series and small studies. Vedolizumab is the only biologic agent that has received approval for the treatment of adult patients with moderately to severely active chronic refractory pouchitis. Despite the fact that IBD treatment is rapidly evolving with the development of novel molecules, the presence of pouchitis represents an exclusion criterion in these trials. Recommendations for the approach of these conditions range from low to very low certainty of evidence, resulting from small randomized controlled trials and case series studies. The current review focuses on the therapeutic management of idiopathic pouchitis.


Subject(s)
Inflammatory Bowel Diseases , Pouchitis , Proctocolectomy, Restorative , Humans , Pouchitis/drug therapy , Pouchitis/etiology , Pouchitis/diagnosis , Inflammatory Bowel Diseases/surgery , Inflammatory Bowel Diseases/complications , Chronic Disease , Proctocolectomy, Restorative/adverse effects , Proctocolectomy, Restorative/methods , Acute Disease , Antibodies, Monoclonal, Humanized/therapeutic use , Colitis, Ulcerative/surgery , Colitis, Ulcerative/complications , Colitis, Ulcerative/drug therapy , Anti-Bacterial Agents/therapeutic use
4.
Medicina (Kaunas) ; 59(3)2023 Mar 09.
Article in English | MEDLINE | ID: mdl-36984533

ABSTRACT

Background and Objectives: Inflammatory bowel diseases (IBD) are chronic conditions with an unpredictable course and a remitting-relapsing evolution. Fatigue is a frequent complaint in patients with IBD, affecting approximately half of the newly diagnosed patients with IBD. The aim of this study was to analyze fatigue in patients with IBD in remission. Materials and Methods: One hundred nineteen consecutive outpatients diagnosed with IBD for over 3 months that were in corticosteroid-free clinical and biochemical remission at the time of assessment were included in this cross-sectional study. Out of them, 72 (60.5%) were male; the median age was 39 years (IQR 30-47). Seventy-seven patients (64.7%) were diagnosed with Crohn's disease and forty-two (35.3%) with ulcerative colitis, with a median disease duration of 6 years (IQR 2-10). Fatigue, health-related quality of life (HR-QoL), anxiety and depression were evaluated using the following self-administered questionnaires: FACIT Fatigue, IBDQ 32 and HADS. Results: The mean FACIT-Fatigue score was 41.6 (SD ± 8.62), and 38.7% of patients were revealed as experiencing fatigue when a cut-off value of 40 points was used. The mean IBDQ 32 score was 189.4 (SD ± 24.1). Symptoms of anxiety and depression were detected in 37% and 21% of the patients, respectively. In the multivariate analysis, fatigue was significantly associated with lower HR-QoL (OR 2.21, 95% CI: 1.42-3.44, p < 0.001), symptoms of anxiety (OR 5.04, 95% CI: 1.20-21.22, p = 0.008), female sex (OR 3.32, 95% CI: 1.02-10.76, p = 0.04) and longer disease duration (OR 1.13, 95% CI: 1.01-1.27, p = 0.04). Conclusions: Fatigue is highly prevalent even in patients with inactive IBD and is correlated with lower HR-QoL and anxiety, as well as with clinical factors such as longer disease duration and female sex.


Subject(s)
Inflammatory Bowel Diseases , Quality of Life , Humans , Male , Female , Adult , Cross-Sectional Studies , Anxiety/epidemiology , Anxiety/etiology , Anxiety/diagnosis , Fatigue/epidemiology , Fatigue/etiology , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/diagnosis , Surveys and Questionnaires
5.
Medicina (Kaunas) ; 59(2)2023 Feb 09.
Article in English | MEDLINE | ID: mdl-36837530

ABSTRACT

Background and Objectives: Inflammatory bowel diseases are a main focus in current research, with diet being an emerging therapeutic line due to its links in both onset and progression. A Western-style diet high in processed foods, food additives, red meat, and animal fat has been linked to a higher risk of developing IBD. The aim of this study was to establish an association between an anti-inflammatory exclusion diet and maintenance of remission in IBD. Also, we assessed the efficacy and safety of this diet compared to a non-dietary group and the possible therapeutic effect of this diet in the maintenance of IBD remission. Materials and Methods: A total of 160 patients with IBD were screened for inclusion, but 21 did not met the inclusion criteria. Thus, 139 patients were assigned to either an exclusion diet or a regular diet according to their choice. Results: Clinical remission after six months was maintained in the exclusion diet arm (100%). In the control arm, four patients had clinically active disease (one patient with UC and three with CD), and 90 patients maintained the clinical remission state (95.7%) (p-value = 0.157). Regarding biochemical markers, ESR at baseline was higher in the exclusion diet arm: 29 (5-62) versus in the control arm 16 (4-48) (p-value = 0.019), but six months after, the groups were similar (p-value = 0.440). Conclusions: Patients who followed an exclusion diet maintained clinical remission more frequently. However, the threshold for statistical significance was not achieved. There was also a trend of improvement in inflammation tests in the intervention group.


Subject(s)
Colitis, Ulcerative , Crohn Disease , Inflammatory Bowel Diseases , Animals , Crohn Disease/therapy , Colitis, Ulcerative/therapy , Disaccharides , Inflammatory Bowel Diseases/therapy , Meat
6.
Medicina (Kaunas) ; 58(4)2022 Mar 27.
Article in English | MEDLINE | ID: mdl-35454325

ABSTRACT

Background and Objectives: Inflammatory bowel diseases (IBD) are chronic conditions with an unpredictable evolution that can have a negative impact on patients' quality of life (QoL). Even though patients in remission have a better QoL compared to patients with active disease, they still have a lower QoL compared to healthy people. The aim of this study is to identify the factors that are associated with a lower QoL in patients with IBD in clinical remission, in a tertiary IBD center in Romania. Materials and Methods: Ninety-seven adult patients with a current diagnosis of IBD for over 3 months who were in clinical remission were enrolled in this study. Pregnant women, patients with ostomy, perianal disease, extraintestinal manifestations or other significant comorbidities were excluded. Out of the 97 patients, 63.9% were men. The median age was 39 years (IQR 29−47), and the median disease duration was 5 years (IQR 2−10). Disease activity was assessed using the SCCAI score for ulcerative colitis and HBI score for Crohn's disease. Remission was defined for SCCAI score ≤ 1 and HBI score ≤ 4. The health-related quality of life (HR-QoL) was assessed using the IBDQ32 score. FACIT-Fatigue was used to evaluate the level of fatigue. Patients with symptoms of anxiety or depression were identified with the HADS score. Symptoms of anxiety were considered when HADS-A >7 points and symptoms of depression when HADS-D >7 points. Results: Sixty-five patients (67%) were diagnosed with CD and the remaining 32 (33%) with UC. Ninety-three patients (95.9%) were on biological therapy. The mean IBDQ score (total score) was 190.54 points (SD +/− 8.2). The mean FACIT Fatigue score was 42.5 (SD +/− 8.2), with 6.2% of patients suffering from severe fatigue (FACIT Fatigue < 30 points). A total of 33% of patients had symptoms of anxiety and 16.5% of depression. Exposure to more than one biologic therapy (p = 0.02), fatigue (p < 0.001) and symptoms of anxiety (p < 0.001) were associated with a lower HR-QoL in the multivariate analysis. Female patients, patients with Crohn's disease, patients with anemia and patients with symptoms of depression also had a lower HR-QoL, but this did not reach statistical significance in our study. Conclusions: Exposure to a higher number of biological agents (patients that switched multiple biologics), the presence of fatigue and symptoms of anxiety impair the HR-QoL of patients with IBD in clinical remission. Further studies should assess in a prospective manner whether early identification of these factors with prompt clinical interventions could lead to a better HR-QoL in these patients.


Subject(s)
Crohn Disease , Inflammatory Bowel Diseases , Adult , Chronic Disease , Crohn Disease/complications , Crohn Disease/drug therapy , Fatigue/diagnosis , Female , Humans , Inflammatory Bowel Diseases/complications , Male , Pregnancy , Prospective Studies , Quality of Life
7.
J Gastrointestin Liver Dis ; 33(2): 184-193, 2024 Jun 29.
Article in English | MEDLINE | ID: mdl-38944867

ABSTRACT

BACKGROUND AND AIMS: Recent research has shown that Western-style diets have been associated with an increased risk of inflammatory bowel diseases (IBD). Our aim was to examine the link between an anti-inflammatory diet and the maintenance of IBD remission, as well as to assess the potential therapeutic advantages of this dietary approach in preserving IBD remission. METHODS: The inclusion and exclusion criteria were applied to a total of 189 individuals with IBD, with 21 individuals not meeting the criteria. Therefore, 168 eligible patients were enrolled in the study and allocated to either an anti-inflammatory diet or a regular diet, based on their personal preference. RESULTS: A cohort of 168 IBD adult patients was recruited for the study: 88 patients with ulcerative colitis and 80 with Crohn's disease. The intervention group received an anti-inflammatory diet consisting of the removal of red and processed meat, fried foods, high-lactose foods, fast food, white bread, sugar, and vegetable oils rich in omega-6 for a period of 1 year. The clinical response was maintained in 80 patients (95.2%) in the intervention group and in 72 patients (85.7%) in the control group (p-value=0.036). Although not statistically significant, fecal calprotectin was higher in the control group than in the intervention group at follow-up. CONCLUSIONS: Patients who adhered to an anti-inflammatory diet exhibited a higher rate of maintenance of clinical remission. Furthermore, improvement in inflammation tests was observed in the intervention group, reinforcing the proposition that IBD is a lifestyle-related disease.


Subject(s)
Biomarkers , Colitis, Ulcerative , Crohn Disease , Feces , Recurrence , Humans , Female , Male , Adult , Prospective Studies , Crohn Disease/diet therapy , Colitis, Ulcerative/diet therapy , Colitis, Ulcerative/diagnosis , Biomarkers/blood , Middle Aged , Feces/chemistry , Remission Induction , Leukocyte L1 Antigen Complex/analysis , Treatment Outcome , Young Adult , Time Factors , Inflammation Mediators/metabolism , Inflammation Mediators/blood , Diet, Healthy
8.
Maedica (Bucur) ; 19(1): 9-16, 2024 03.
Article in English | MEDLINE | ID: mdl-38736928

ABSTRACT

Introduction:Metabolic dysfunction-associated steatotic liver disease (MASLD) is an entity with a growing incidence but only a few pharmacological options. In Romania, the prevalence of MASLD has been increasing, while that of viral hepatitis has been decreasing. The purpose of this study is to compare two supplements for the treatment of MASLD. Methods:Between January 2020 and May 2022, 90 patients with MASLD were randomized to receive either silymarin 150 mg b.i.d (45 subjects) or essential phospholipids (EPLs) 825 mg b.i.d. (45 subjects) for six months. All study participants received recommendations for lifestyle and diet modifications. Assessment of the severity of steatosis and liver fibrosis was performed using FibroScan® with controlled attenuated parameter (CAP) at the beginning and end of treatment. Results:A total of 68 patients completed the trial. The two groups were statistically comparable in terms of clinical, biological and FibroScanR parameters. Aspartate transferase (AST) decreased from a median of 40 to 28 IU/L in the EPL arm (compared to 25→¨25.5 IU/L in the silymarin arm) (p-value=0.11) and alanine transaminase (ALT) decreased from 46 to 37.5 IU/L (compared to 31→30 IU/L) (p-value = 0.38). Plasma cholesterol levels also decreased significantly in the EPL group (218→189.5 mg/dL) compared to the silymarin arm (217→209 mg/dL) (p = 0.01). At the end of treatment, liver stiffness decreased by 0.7 KPa (6.9→6.2 KPa) in the EPL group but increased by 2.3 KPa (7.2→9.5 KPa) in the silymarin group (p = 0.1). The reduction in hepatic steatosis was comparable between the two groups: it decreased by 5% of the initial value. Conclusion:In our study, a six-month treatment with EPLs was superior to silymarin in MASLD patients because it succeeded in improving both laboratory parameters and liver fibrosis, as estimated by FibroScan®.

9.
J Crohns Colitis ; 18(8): 1202-1214, 2024 Aug 14.
Article in English | MEDLINE | ID: mdl-38243807

ABSTRACT

BACKGROUND AND AIMS: No consensus exists on optimal strategy to prevent postoperative recurrence [POR] after ileocaecal resection [ICR] for Crohn's disease [CD]. We compared early medical prophylaxis versus expectant management with treatment driven by findings at elective endoscopy 6-12 months after ICR. METHODS: A retrospective, multicentric, observational study was performed. CD patients undergoing first ICR were assigned to Cohort 1 if a biologic or immunomodulator was [re]started prophylactically after ICR, or to Cohort 2 if no postoperative prophylaxis was given and treatment was started as reaction to elective endoscopic findings. Primary endpoint was rate of endoscopic POR [Rutgeerts >i1]. Secondary endpoints were severe endoscopic POR [Rutgeerts i3/i4], clinical POR, surgical POR, and treatment burden during follow-up. RESULTS: Of 346 included patients, 47.4% received prophylactic postoperative treatment [proactive/Cohort 1] and 52.6% did not [reactive/Cohort 2]. Endoscopic POR [Rutgeerts >i1] rate was significantly higher in Cohort 2 [41.5% vs 53.8%, OR 1.81, p = 0.039] at endoscopy 6-12 months after surgery. No significant difference in severe endoscopic POR was found [OR 1.29, p = 0.517]. Cohort 2 had significantly higher clinical POR rates [17.7% vs 35.7%, OR 3.05, p = 0.002] and numerically higher surgical recurrence rates [6.7% vs 13.2%, OR 2.59, p = 0.051]. Cox proportional hazards regression analysis showed no significant difference in time to surgical POR of proactive versus expectant/reactive approach [HR 2.50, p = 0.057]. Quasi-Poisson regression revealed a significantly lower treatment burden for immunomodulator use in Cohort 2 [mean ratio 0.53, p = 0.002], but no difference in burden of biologics or combination treatment. CONCLUSIONS: The PORCSE study showed lower rates of endoscopic POR with early postoperative medical treatment compared with expectant management after first ileocaecal resection for Crohn's disease.


Subject(s)
Crohn Disease , Secondary Prevention , Humans , Crohn Disease/surgery , Crohn Disease/prevention & control , Female , Retrospective Studies , Male , Adult , Secondary Prevention/methods , Secondary Prevention/statistics & numerical data , Ileum/surgery , Recurrence , Middle Aged , Immunologic Factors/therapeutic use , Biological Products/therapeutic use , Europe , Cecum/surgery , Colonoscopy/statistics & numerical data , Colonoscopy/methods
10.
Medicine (Baltimore) ; 102(19): e33713, 2023 May 12.
Article in English | MEDLINE | ID: mdl-37171347

ABSTRACT

Inflammatory bowel diseases (IBD) are chronic conditions characterized by a remitting-relapsing course. Patients with IBD have an impaired quality of life and are more often affected by anxiety and depression. This study aimed to evaluate the prevalence and severity of anxiety and depression in patients with inactive IBD, and to identify factors associated with them. A total of 132 consecutive patients diagnosed with IBD for over 3 months that were in corticosteroid-free remission at the time of assessment were enrolled in this observational, cross-sectional study. Anxiety, depression, fatigue, and health-related quality of life (HR-QoL) were evaluated using the following self-administered questionnaires: HADS, Functional Assessment of Chronic Illness Therapy-Fatigue, and IBDQ 32. Symptoms of anxiety and depression were considered for HADS-A > 7 points and HADS-D > 7 points, respectively. Out of the 132 patients included, 76 (57.6%) were men. The median patient age was 38 years (interquartile range 30-47). Eighty-three patients (62.9%) were diagnosed with Crohn disease, and 49 (37.1%) with ulcerative colitis. Most of the patients were treated with biologics (85.6%). Anxiety was identified in 34.1% of patients, and two thirds of them (68.9%) had mild symptoms. A lower proportion of patients were presenting symptoms of depression (18.2%), the vast majority (91.7%) having mild forms. In the multivariate analysis, anxiety was significantly associated with fatigue [odds ratio (OR) 4.39, 95% confidence interval (CI): 1.22-15.79, P = .02] and lower HR-QoL (OR 2.46, 95% CI: 1.70-3.91, P < .001), while depression was associated with exposure to multiple biologics (OR 3.33, 95% CI: 1.01-10.97, P = .04) and fatigue (OR 9.70, 95% CI: 1.67-56.27, P = .01). In conclusion, anxiety and depression are highly prevalent in patients with IBD even during the periods of remission. Both anxiety and depression are associated with fatigue. In addition, lower HR-QoL is associated with anxiety and exposure to multiple biologics with depression.


Subject(s)
Biological Products , Inflammatory Bowel Diseases , Male , Humans , Adult , Female , Quality of Life , Depression/diagnosis , Cross-Sectional Studies , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/epidemiology , Inflammatory Bowel Diseases/diagnosis , Anxiety/diagnosis , Surveys and Questionnaires , Fatigue/epidemiology , Fatigue/etiology
11.
Maedica (Bucur) ; 18(2): 174-181, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37588829

ABSTRACT

Objectives:Inflammatory bowel diseases (IBD) have been associated with multiple environmental factors, including diet. A dietary pattern characterized by low fiber content, high fat content and high carbohydrate content has been linked to the development of IBD. The objective of the current investigation is to examine the potential link between dietary patterns and the occurrence of IBD and to investigate whether there are any differences in relation to the type of IBD and specific food groups. Material and methods:We conducted an observational retrospective comparative study using three cohorts: 89 Crohn's disease (CD) patients, 40 ulcerative colitis (UC) patients and 64 healthy subjects. All participants underwent structured interviews and were required to complete a questionnaire regarding their dietary habits either prior to the onset of IBD or within the last year for control subjects. Results:A higher proportion of CD patients reported a higher rate of salt intake (71.9% vs. 53.1%, p-value = 0.043), sweetened beverages (38.2% vs. 17.2%, p-value=0.022), processed meat (66.3% vs. 40.6%, p-value=0.007), fatty meat (50.6% vs. 28.1%, p-value=0.021), fried foods (47.2% vs. 9.4%, p-value<0.001) and mayonnaise (21.3% vs. 6.2%, p-value=0.032) and a lower intake of nuts and seeds (20.2% vs. 43.8%, p-value=0.004) and yogurt (23.6% vs. 43.8%, p-value=0.030) compared to healthy subjects. Compared to controls, in the UC group there was a higher consumption of salt (85% vs. 53.1%, p-value=0.003), sweetened beverages (47.5% vs. 17.2%, p-value=0.005), fatty meat (55% vs. 28.1%, p-value=0.025) and fried foods (55% vs. 9.4%, p-value<0.001) and a lower intake of nuts and seeds (10% vs. 43.8%, p-value=0.001). Conclusion:Diet patterns before the onset of the disease are similar in patients with Crohn's disease and patients with ulcerative colitis: increased consumption of sweetened beverages, processed and fatty meat, fried food, salt, store-bought ice cream, and mayonnaise, and decreased intake of seeds, nuts, and yogurt.

12.
J Gastrointestin Liver Dis ; 31(2): 191-197, 2022 06 12.
Article in English | MEDLINE | ID: mdl-35694992

ABSTRACT

BACKGROUND AND AIMS: Celiac disease is characterized by an inappropriate T-cell-mediated response to gluten in small bowel in genetically predisposed individuals, carriers of the DQ2 and/or DQ8 haplotypes of the human leukocyte antigen. The aim of our study was to asses HLA typing in adult patients with celiac disease, in their first degree relatives and in a healthy control group. METHODS: We conducted a prospective observational study on three cohorts: 117 patients diagnosed with celiac disease, 41 first-degree relatives of celiac patients and 57 asymptomatic healthy volunteers. Low resolution HLA typing for DQ alleles was performed in all study subjects with DNA extracted from peripheral blood, using SSP HLA-DQB1 kit (Innotrain Diagnostik GmbH, Germany).  Next Generation Sequencing (NGS) was used only in 18 patients for typing confirmation of DQB1 and DQA1 loci and whole gene sequencing. RESULTS: Prevalence of HLA-DQ2 was significantly higher in the CD group compared to the healthy subjects group (95.6% vs 29.8%, p <0.001), with no statistically significant differences in HLA-DQ8 and combined HLA-DQ2/DQ8 prevalences.Several HLA DQA1 and DQB1 alleles (HLA-DQA1* 05:01, HLA-DQB1*02:01, HLA-DQB1*02:02) and haplotypes (DQA1*02:01-DQB1*02:02,DQA1*05:01-DQB1*02:01) were strongly associated with celiac disease in our group: OR 4.28, 4.28, 4.67 and 5.43 and 4.28 respectively. Predominantly, patients presented with typical symptoms and iron deficiency anemia. 95.5% of them had histological Marsh type modifications ≥3a. A relatively poor response to gluten-free diet was observed and 9.4% developed complications (refractory celiac disease, enteropathy-associated T cell lymphoma, intestinal adenocarcinoma), with a death rate of 6.8%. 23% associated other autoimmune diseases.Screening adherence for 1st degree relatives was very low: only 16%. Familial screening diagnosed 4 cases of asymptomatic celiac disease. 32 relatives (78%) had HLA-DQ2 haplotype, 5 carried HLA-DQ8, 4 didn't carry any risk haplotype. CONCLUSIONS: This study demonstrated a higher prevalence of the HLA-DQ2 genotype in patients with celiac disease compared to the healthy population but not of HLA-DQ8 or combined HLA-DQ2/DQ8. Alleles HLA-DQA1* 05:01, HLA-DQB1*02:01, HLA-DQB1*02:02 and haplotypes (DQA1*02:01-DQB1*02:02,DQA1*05:01-DQB1*02:01) were strongly associated with celiac disease in our cohort.


Subject(s)
Celiac Disease , Adult , Alleles , Celiac Disease/diagnosis , Celiac Disease/epidemiology , Celiac Disease/genetics , Genetic Predisposition to Disease , Genotype , Haplotypes , Humans , Romania/epidemiology
13.
J Gastrointestin Liver Dis ; 31(4): 437-443, 2022 12 17.
Article in English | MEDLINE | ID: mdl-36535062

ABSTRACT

BACKGROUND AND AIMS: The sofosbuvir (SOF) / velpatasvir (VEL) / voxilaprevir (VOX) combination has been evaluated in more than 800 patients enrolled in phase II and phase III studies, where it demonstrated excellent safety and efficacy, achieving overall sustained viral response (SVR) rates of more than 95%. We aimed to assess the efficacy and safety of SOF/VEL/VOX in a real-world study, including patients previously treated for genotype 1b hepatitis C virus (HCV) infection that did not obtain a sustained viral response with previous direct-acting antivirals (DAAs) therapy. METHODS: In Romania, through a nationwide government-funded program in 2019-2020, 213 patients with chronic hepatitis C non-responders to previous DAAs therapy, received treatment with SOF/VEL/ VOX 400/100/100 mg/day for 12 weeks. We performed a retrospective longitudinal study that included 143 individuals who were treated in Bucharest, Iași, Craiova and Constanța clinics, all with genotype 1b HCV infection. Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12). Serious adverse events (SAE) were registered. RESULTS: Our cohort comprised 53% males with a median age of 60 years (27÷77); 47% were pre-treated with ombitasvir/paritaprevir/ritonavir+dasabuvir ± ribavirin, 40% with ledipasvir/SOF, 13% with elbasvir/ grazoprevir. 42% of patients associated co-morbidities, 45% had compensated liver cirrhosis, 2% had treated hepatocellular carcinoma (HCC) and 1% had hepatitis B virus co-infection. SVR by intention to treat was reported in 139/143 (97.2%) and per protocol in 141/143 (98.6%). No predictive factors for SVR were identified. Rate of liver decompensation in patients with cirrhosis was 6% and was statistically associated in multivariate analysis with Child-Pugh score (p<0.01) and with severe steatosis (p=0.004). Occurrence of new HCC was reported in 3.6% of all patients with cirrhosis and was associated with poor liver function [higher Child-Pugh score (p=0.001) and low albumin levels (p=0.02)]. Serious adverse events related to therapy were reported in 1/143(0.7%). CONCLUSIONS: SOF/VEL/VOX was highly efficient in our population of patients with a 97.2% SVR. Liver decompensation occurred in 6% of cirrhotic patients at SVR, related to hepatic dysfunction.


Subject(s)
Carcinoma, Hepatocellular , Hepatitis C, Chronic , Hepatitis C , Liver Neoplasms , Male , Humans , Middle Aged , Female , Sofosbuvir/therapeutic use , Antiviral Agents/therapeutic use , Romania , Hepatitis C, Chronic/drug therapy , Hepacivirus/genetics , Retrospective Studies , Carcinoma, Hepatocellular/drug therapy , Longitudinal Studies , Treatment Outcome , Liver Neoplasms/drug therapy , Hepatitis C/drug therapy , Genotype , Drug Therapy, Combination , Sustained Virologic Response
14.
J Gastrointestin Liver Dis ; 30(2): 291-306, 2021 06 18.
Article in English | MEDLINE | ID: mdl-33951120

ABSTRACT

BACKGROUND AND AIMS: The nonpharmacological therapy in irritable bowel syndrome (IBS) is expanding rapidly. Practitioners and medical educators need to be aware of progress and changes in knowledge of this topic. The Romanian Society of Neurogastroenterology aimed to create guidelines based on best evidence on the use of nonpharmacological therapy in IBS. METHODS: A group of experts was constituted. This was divided in eleven subgroups dedicated to eleven categories of nonpharmacological therapy. The subgroups searched the literature and formulated statements and recommendations. These were submitted to vote in order to obtain consensus. RESULTS: The outcome of this activity is represented by the guidelines of the Romanian Society of Neurogastroenterology, presented in this paper. The recommendations are seen as complementary to the pharmacological therapy and are not intended to recommend avoiding pharmacological drugs. CONCLUSIONS: These guidelines were elaborated by a Delphi process and represent a useful tool for physicians managing patients with IBS.


Subject(s)
Guidelines as Topic , Irritable Bowel Syndrome , Consensus , Humans , Irritable Bowel Syndrome/diagnosis , Irritable Bowel Syndrome/drug therapy , Romania
15.
J Gastrointestin Liver Dis ; 29(4): 549-553, 2020 Dec 12.
Article in English | MEDLINE | ID: mdl-33331349

ABSTRACT

BACKGROUND AND AIMS: Inflammatory bowel diseases (IBD) patients management has been challenging during the ongoing coronavirus disease 2019 (COVID-19) pandemic, due to lockdowns, limitation of access to medical facilities and new recommendations regarding patient management. The implications of the COVID-19 pandemic on IBD patients' management were assessed in our Tertiary Gastroenterology Center in Bucharest, Romania. METHODS: Medical records of IBD patients admitted between 15th of March and 15th of August 2020 were retrospectively reviewed and compared to a control cohort of consecutive IBD patients admitted to our unit during the corresponding period of 2019. RESULTS: There was a highly significant shift towards one-day hospitalization during the referral period in 2020 for IBD cases (91% in 2020 vs 82.2% in 2019, p=0.0001). There was no statistically significant difference between the distribution of patient's gender, IBD phenotype or newly diagnosed IBD cases. A significantly lower proportion of admitted patients received 5-aminosalicylic acid (29% vs 41.2%, p=0.0001), whereas a substantially higher number of patients were prescribed biological therapy in 2020 in comparison to the corresponding 2019-time frame (79.5% vs 57.9%, p<0.0001). The distribution of the biological agent used was significantly different in 2019 in comparison to the 2020 period mainly due to the increase in vedolizumab prescription in 2020 (p<0.0001). During the study period in 2020, seven IBD patients (1.7%) were diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-Cov2) infection, all of them with mild symptoms without impact on the IBD course. CONCLUSIONS: The COVID-19 pandemic led to reorganizing medical care, limiting the hospital admissions in favor of severe IBD cases, favoring telemedicine for mild disease and optimization of treatment for moderate to severe IBD with an increased use of biologicals aimed to maximize the risk/benefit ratio. Incidence of SARS-Cov2 infection during the first wave of COVID-19 infection in our study group was 1.7% and did not adversely impact the IBD disease course.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , Biological Products/therapeutic use , COVID-19/epidemiology , Delivery of Health Care, Integrated/trends , Hospitalization/trends , Inflammatory Bowel Diseases/drug therapy , Telemedicine/trends , Anti-Inflammatory Agents/adverse effects , Biological Products/adverse effects , COVID-19/diagnosis , Humans , Incidence , Inflammatory Bowel Diseases/diagnosis , Inflammatory Bowel Diseases/epidemiology , Patient Safety , Retrospective Studies , Romania/epidemiology , Tertiary Care Centers , Time Factors , Treatment Outcome
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