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1.
J Crohns Colitis ; 2023 Nov 01.
Article in English | MEDLINE | ID: mdl-37930823

ABSTRACT

INTRODUCTION: Intra-abdominal abscesses complicating Crohn's disease (CD) are a challenging situation. Their management, during the hospitalization and after resolution, is still unclear. METHODS: Adult patients with CD complicated with intraabdominal abscess who required hospitalization were included from the prospectively maintained ENEIDA registry from GETECCU. Initial strategy effectiveness and safety to resolve abscess was assessed. Survival analysis was performed to evaluate recurrence risk. Predictive factors associated with resolution were evaluated by multivariate regression and predictive factors associated with recurrence were assessed by Cox regression. RESULTS: 520 patients from 37 Spanish hospitals were included; 322 (63%) were initially treated with antibiotics alone, 128 (26%) with percutaneous drainage, and 54 (17%) with surgical drainage. The size of the abscess was critical to the effectiveness of each treatment. In abscesses < 30mm, the antibiotic was as effective as percutaneous or surgical drainage. However, in larger abscesses, percutaneous or surgical drainage was superior. In abscesses > 50mm, surgery was superior to percutaneous drainage, although it was associated with a higher complication rate. After abscess resolution, luminal resection was associated with a lower 1-year abscess recurrence risk (HR 0.43, 95% CI 0.24-0.76). However, those patients who initiated anti-TNF therapy had a similar recurrence risk whether luminal resection had been performed. CONCLUSIONS: Small abscesses (<30mm) can be managed with antibiotics alone, while larger ones require drainage. Percutaneous drainage will be effective and safer than surgery in many cases. After discharge, anti-TNF therapy reduces abscess recurrence risk in a similar way to bowel resection.

2.
J Clin Med ; 11(10)2022 May 15.
Article in English | MEDLINE | ID: mdl-35628914

ABSTRACT

Background: Iron deficiency (ID) without anaemia is a common comorbidity associated with inflammatory bowel disease (IBD) that has a negative impact on health-related quality of life (HRQoL). Methods: This multicentre, prospective, observational study examined the response to, safety of and impact on HRQoL of a single 500 mg dose of intravenous ferric carboxymaltose (FCM) in patients with IBD and ID without anaemia. The diagnostic criteria for ID were low serum ferritin (<30 µg/L in the absence of inflammatory activity or <100 µg/L with inflammation) and transferrin saturation index (TSAT) < 16%. The effect on iron levels and HRQoL, according to the health status questionnaires SF-12v2 and EQ-5D, was evaluated 1 month after FCM infusion in an outpatient setting. Results: Of the 105 patients who received FCM, 98 patients completed the study. After 1 month, a single dose of FCM significantly increased serum ferritin, serum iron and TSAT. Importantly, patients reported fewer ID symptoms and problems on all EQ-5D dimensions. They also had higher EQ-5D visual analogue scale and SF-12v2 scores after treatment. FCM had similar clinical effects on men and women and on patients with Crohn's disease (n = 66) and ulcerative colitis (n = 32). Conclusion: A single dose of FCM rapidly restored iron parameters and significantly improved patients' symptoms and HRQoL at 1 month after treatment.

3.
World J Clin Cases ; 9(36): 11285-11299, 2021 Dec 26.
Article in English | MEDLINE | ID: mdl-35071559

ABSTRACT

BACKGROUND: In recent years, biological therapies have revolutionized the management of inflammatory bowel disease (IBD); however, they are expensive. The development of biosimilar products has allowed us to reduce healthcare costs and improve patients' access to these treatments. Although various studies support the similarity between infliximab and its biosimilar CT-P13 in terms of efficacy and safety, there are unmet needs regarding research on these agents in the context of IBD. AIM: To analyze clinical response rates to CT-P13 and adverse events in IBD patients treated in real-life practice. METHODS: An observational, prospective, multicenter study of IBD patients treated with CT-P13 in clinical practice who were naïve to biological treatments or failed to respond to other anti-tumor necrosis factor drugs or had switched from infliximab originator was carried out. No diagnostic or follow-up interventions were conducted on patients outside usual clinical practice. The primary endpoints were clinical response rates and number of adverse events. The primary efficacy variable was the proportion of patients who were in clinical remission and/or had a clinical response at 3, 6, 9, and 12 mo. RESULTS: A total of 220 IBD patients treated with CT-P13 (Remsima®) were included in the study: 87 (40%) with ulcerative colitis and 133 (60%) with Crohn's disease. Mean age of the patients was 41.47 (SD 15.74) years, and 58% were female. Nineteen (9%) patients started treatment with CT-P13 after switching from infliximab. Of the remaining 201 patients, 142 (65%) were naïve to biologic agents. At baseline, 68.6% (n = 138/201) of patients presented with active disease. After 12 mo of treatment, 14.8% (n = 12/81) presented with active disease, and 64.2% (n = 52/81) were in clinical remission without corticosteroids. After 3 mo, 75.5% (n = 115/152) had a clinical response or achieved clinical remission, which was sustained for 12 mo (85.2%; n = 69/81). There was a decrease in specific IBD indices at 3, 6, 9, and 12 mo (P < 0.001). A total of 34 adverse events were reported by 27 (12.3%) patients, 9 (26.5%) of which were serious. CONCLUSION: CT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD in real-life practice and may be a valid and attractive alternative for the treatment of IBD.

4.
Gastroenterol. hepatol. (Ed. impr.) ; 43(3): 155-168, mar. 2020. ilus, graf, tab
Article in Spanish | IBECS | ID: ibc-190792

ABSTRACT

Las recomendaciones son consejos dados por considerarse beneficiosos y no dejan de ser sugerencias, abiertas por tanto a diferentes interpretaciones. En ese sentido, el objetivo final de la revisión ha sido, con las evidencias disponibles, intentar homogeneizar al máximo la aproximación al diagnóstico y tratamiento medicoquirúrgico de una de las manifestaciones más complejas de la enfermedad de Crohn como son las fístulas perianales simples y complejas


Recommendations are advice that is given and considered to be beneficial; however, they are still suggestions and are therefore open to different interpretations. In this sense, the final objective of the review has been to try to homogenize, with the evidence available, the approach to the diagnosis and medical/surgical treatment of one of the most complex manifestations of Crohn's disease, such as simple and complex perianal fistulas


Subject(s)
Humans , Rectal Fistula/therapy , Crohn Disease/epidemiology , Colitis, Ulcerative/therapy , Crohn Disease/surgery , Crohn Disease , Consensus , Severity of Illness Index
5.
Gastroenterol Hepatol ; 43(3): 155-168, 2020 Mar.
Article in English, Spanish | MEDLINE | ID: mdl-31870681

ABSTRACT

Recommendations are advice that is given and considered to be beneficial; however, they are still suggestions and are therefore open to different interpretations. In this sense, the final objective of the review has been to try to homogenize, with the evidence available, the approach to the diagnosis and medical/surgical treatment of one of the most complex manifestations of Crohn's disease, such as simple and complex perianal fistulas.


Subject(s)
Crohn Disease/complications , Rectal Fistula/therapy , Adrenal Cortex Hormones/therapeutic use , Anti-Bacterial Agents/therapeutic use , Antibodies, Monoclonal/therapeutic use , Antirheumatic Agents/therapeutic use , Endoscopy/methods , Female , Fissure in Ano/etiology , Fissure in Ano/therapy , Humans , Hyperbaric Oxygenation , Immunosuppressive Agents/therapeutic use , Magnetic Resonance Imaging/methods , Mesenchymal Stem Cell Transplantation , Proctitis/drug therapy , Proctitis/etiology , Proctitis/surgery , Rectal Fistula/classification , Rectal Fistula/diagnosis , Rectal Fistula/etiology , Rectovaginal Fistula/etiology , Rectovaginal Fistula/surgery , Rectovaginal Fistula/therapy , Salicylates/therapeutic use , Surgical Flaps , Tomography, X-Ray Computed/methods , Ultrasonography/methods
6.
Rev. esp. enferm. dig ; 111(6): 431-436, jun. 2019. tab, graf
Article in English | IBECS | ID: ibc-190077

ABSTRACT

Background: therapeutic monitoring of anti-TNF drugs and anti-drug antibody levels are useful for clinical decision-making, via the rationalization and optimization of the use of anti-TNF treatments. The objective of the present study was to validate the model of Ternant et al., in a cohort of patients with inflammatory bowel diseases (IBD). This model was originally established for patients with rheumatoid arthritis and was used in this study to optimize the adalimumab (ADA) dose and predict ADA trough levels (ATL). Methods: this study used concentration data points from 30 IBD patients who received ADA treatment between 2014 and 2015. A goodness-of-fit of the model was determined by evaluating the relationship between the observed ATL values and population model-predicted values (PRED) or individual model-predicted values (IPRED). Results: a total of 51 ADA concentration points were analyzed. The bias of the model was 2.39 (95% CI, 1.63-3.15) for PRED and 0.63 (95% CI, 0.23-1.03) for IPRED. The precision was 3.57 (95% CI, 2.90-4.13) and 1.53 (95% CI, 1.22-1.80), respectively. Conclusions: therapeutic drug monitoring involving ATL may allow the optimization of the treatment of IBD patients. The validation results of the phamacokinectic (PK) model for ADA in IBD patients are inadequate. However, additional studies will strengthen the bias and precision of the model


No disponible


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Drug Monitoring/methods , Adalimumab/pharmacokinetics , Inflammatory Bowel Diseases/drug therapy , Biological Availability , Infliximab/pharmacokinetics , Treatment Outcome , Crohn Disease/drug therapy , Colitis, Ulcerative/drug therapy
7.
Rev Esp Enferm Dig ; 111(6): 431-436, 2019 Jun.
Article in English | MEDLINE | ID: mdl-31021170

ABSTRACT

BACKGROUND: therapeutic monitoring of anti-TNF drugs and anti-drug antibody levels are useful for clinical decision-making, via the rationalization and optimization of the use of anti-TNF treatments. The objective of the present study was to validate the model of Ternant et al., in a cohort of patients with inflammatory bowel diseases (IBD). This model was originally established for patients with rheumatoid arthritis and was used in this study to optimize the adalimumab (ADA) dose and predict ADA trough levels (ATL). METHODS: this study used concentration data points from 30 IBD patients who received ADA treatment between 2014 and 2015. A goodness-of-fit of the model was determined by evaluating the relationship between the observed ATL values and population model-predicted values (PRED) or individual model-predicted values (IPRED). RESULTS: a total of 51 ADA concentration points were analyzed. The bias of the model was 2.39 (95% CI, 1.63-3.15) for PRED and 0.63 (95% CI, 0.23-1.03) for IPRED. The precision was 3.57 (95% CI, 2.90-4.13) and 1.53 (95% CI, 1.22-1.80), respectively. CONCLUSIONS: therapeutic drug monitoring involving ATL may allow the optimization of the treatment of IBD patients. The validation results of the phamacokinectic (PK) model for ADA in IBD patients are inadequate. However, additional studies will strengthen the bias and precision of the model.


Subject(s)
Adalimumab/pharmacokinetics , Adalimumab/therapeutic use , Anti-Inflammatory Agents/pharmacokinetics , Anti-Inflammatory Agents/therapeutic use , Inflammatory Bowel Diseases/drug therapy , Models, Chemical , Adult , Cohort Studies , Female , Humans , Male , Middle Aged
8.
Gastroenterol. hepatol. (Ed. impr.) ; 41(9): 535-543, nov. 2018. tab, graf
Article in Spanish | IBECS | ID: ibc-178114

ABSTRACT

Vedolizumab (VDZ), un anticuerpo monoclonal humanizado que se une específicamente a -alpha4beta7-integrina, aprobado para el tratamiento de la enfermedad de Crohn (EC) y la colitis ulcerosa (CU), ha demostrado su eficacia en ensayos clínicos controlados. OBJETIVO: Describir una población tratada con VDZ y evaluar su efectividad y seguridad a largo plazo en práctica clínica. MÉTODOS: Estudio observacional y multicéntrico en pacientes con enfermedad inflamatoria intestinal tratados con VDZ durante al menos un año. Se evaluaron los índices de actividad, niveles de calprotectina fecal y proteína C reactiva, hospitalizaciones, cirugías y eventos adversos. RESULTADOS: Se analizaron un total de 73 pacientes (43 CU y 30 EC). El 74 y 23% de CU y el 90 y 37% de EC habían llevado previamente más de un anti-TNF y más de un inmunosupresor respectivamente. VDZ se suspendió en 17 pacientes (23%), 10 CU y 7 EC, debido a la falta o pérdida de respuesta antes del primer año o a eventos adversos. Veintisiete (63%) CU y 16 (53%) pacientes con EC requirieron intensificación de la dosis. A los 6 meses, el 70 y 42% de CU y el 80 y 43% de EC lograron respuesta clínica y remisión respectivamente. Al año, el 58 y 35% de CU y el 47 y 43% de EC mantuvieron la respuesta clínica y la remisión, respectivamente. La proteína C reactiva disminuyó significativamente tanto en la EC como en la CU. Sin embargo, la disminución de la calprotectina fecal se logró durante el seguimiento solo en CU pero no en EC. Ocho pacientes con EC que habían sido tratados previamente con ustekinumab evitaron la cirugía al año. En 8 CU (18,6%) se realizó colectomía y 4 EC (13,3%) necesitaron cirugía. Seis pacientes (8%) (5 UC y una enfermedad de Crohn) tuvieron eventos adversos. El uso concomitante de corticoides o inmunomoduladores no aumentó la efectividad. A mayor número de anti-TNF previos, menos remisión en la CU y respuesta en la EC. CONCLUSIONES: Tras un año de VDZ se induce respuesta y remisión clínica en una no desdeñable proporción de pacientes refractarios a diferentes biológicos o inmunosupresores. VDZ puede considerarse una alternativa en intolerantes a inmunosupresores con pocos eventos adversos


Vedolizumab (VDZ), a human monoclonal antibody that binds specifically to alpha4beta7-integrin, and is approved for the treatment of Crohn's disease (CD) and ulcerative colitis (UC), has demonstrated its efficacy in controlled clinical trials. OBJECTIVE: To describe a population treated with VDZ and to evaluate its long-term efficacy and safety in clinical practice. METHODS: An observational and multicentre study was carried out on patients with inflammatory bowel disease treated with VDZ for at least one year. An evaluation was performed on the activity indices, faecal calprotectin and C-reactive protein levels, hospital admissions, surgeries, and adverse events. RESULTS: A total of 73 patients were analysed (43 UC and 30 CD). More than one anti-TNF and more than one immunosuppressive was previously used by 74 and 23%, respectively, of UC patients, and 90 and 37%, respectively of CD patients. VDZ was stopped in 17 (23%) patients, 10 UC and 7 CD, due to a lack or loss of response before the first year, or due to adverse events. An intensification of the dose was required in 26 (63%) UC, and 16 (53%) CD patients. At 6 months, 70 and 42% of UC patients, and 80 and 43% of CD patients achieved a clinical response and remission, respectively. At one year, 58 and 35% of UC patients and 47 and 43% of CD patients, maintained the clinical response and remission, respectively. The C-reactive protein decreased significantly in both CD and UC patients. However, the decrease in faecal calprotectin was only achieved during follow-up in UC, but not in CD patients. Eight patients with CD that had been treated previously with ustekinumab avoided surgery at one year. A colectomy was performed on 8 (18.6%) UC patients, and 4 (13.3%) CD patients needed surgery. Six patients (8%) (5 UC and 1 CD) had adverse events. The concomitant use of corticosteroids or immunomodulators did not increase the efficacy. Those with a higher number of previous anti-TNF treatments showed less remissions in UC and responses in CD. CONCLUSIONS: After one year of VDZ, a clinical response and remission was induced in a considerable percentage of patients refractory to different biological or immunosuppressive therapies. VDZ can be considered as an alternative in those intolerant to immunosuppressives, with few adverse events


Subject(s)
Humans , Female , Adult , Middle Aged , Antibodies, Monoclonal, Humanized/therapeutic use , Crohn Disease/drug therapy , Colitis, Ulcerative/drug therapy , Biological Factors/therapeutic use , Observational Study , Antibodies, Monoclonal, Humanized , Antibodies, Monoclonal, Humanized/adverse effects , Immunosuppressive Agents/adverse effects , Integrins/therapeutic use , C-Reactive Protein , Biomarkers/analysis , Feces/chemistry , Dose-Response Relationship, Drug
9.
Scand J Gastroenterol ; 53(9): 1079-1084, 2018 Sep.
Article in English | MEDLINE | ID: mdl-30189153

ABSTRACT

INTRODUCTION: The fastest growing segment of our population is that of people above 70 years of age. Elderly patients with IBD exhibit several specific problems. Our objective was to evaluate the clinical course, the side effects of the treatments and the need for surgery of elderly patients, regardless of the age of onset. MATERIALS AND METHODS: This was a cross-sectional study wherein retrospective data were collected from multiple centers from seven hospitals within the Valencia metropolitan area. Data were collected on patients older than 70 y with inflammatory bowel disease. RESULTS: We identified a total of 331 patients older than 70 years of age (5.3% of patients monitored at our centers). The mean age at the time of the study was 77.34 y (±5.39). Mesalamine were the most frequently used medications. Corticosteroids were used in 66% of the patients. However, the use of corticosteroids and biologics was less probable in older patients (OR 0.96, p = .06). The longer the disease progressed, the more immunosuppressive medications were used (OR 1.3, p = .052). Neoplasms appeared in 41 patients (13%). Of the 36 patients with tumors that appeared after the onset of the disease, 20 patients had not been treated with immunomodulators or biologics. CONCLUSIONS: Mesalamine was the most frequently used medication. There is no increased risk of tumors regarding the medications used. The use of immunosuppressive medications is more prevalent with longer disease progression times, although with a high rate of adverse events.


Subject(s)
Disease Progression , Immunologic Factors/therapeutic use , Inflammatory Bowel Diseases/epidemiology , Inflammatory Bowel Diseases/therapy , Neoplasms/epidemiology , Adrenal Cortex Hormones/therapeutic use , Aged , Aged, 80 and over , Comorbidity , Cross-Sectional Studies , Female , Humans , Logistic Models , Male , Mesalamine/therapeutic use , Retrospective Studies , Spain/epidemiology , Surgical Procedures, Operative
10.
Gastroenterol Hepatol ; 41(9): 535-543, 2018 Nov.
Article in English, Spanish | MEDLINE | ID: mdl-30031573

ABSTRACT

Vedolizumab (VDZ), a human monoclonal antibody that binds specifically to α4ß7-integrin, and is approved for the treatment of Crohn's disease (CD) and ulcerative colitis (UC), has demonstrated its efficacy in controlled clinical trials. OBJECTIVE: To describe a population treated with VDZ and to evaluate its long-term efficacy and safety in clinical practice. METHODS: An observational and multicentre study was carried out on patients with inflammatory bowel disease treated with VDZ for at least one year. An evaluation was performed on the activity indices, faecal calprotectin and C-reactive protein levels, hospital admissions, surgeries, and adverse events. RESULTS: A total of 73 patients were analysed (43 UC and 30 CD). More than one anti-TNF and more than one immunosuppressive was previously used by 74 and 23%, respectively, of UC patients, and 90 and 37%, respectively of CD patients. VDZ was stopped in 17 (23%) patients, 10 UC and 7 CD, due to a lack or loss of response before the first year, or due to adverse events. An intensification of the dose was required in 26 (63%) UC, and 16 (53%) CD patients. At 6 months, 70 and 42% of UC patients, and 80 and 43% of CD patients achieved a clinical response and remission, respectively. At one year, 58 and 35% of UC patients and 47 and 43% of CD patients, maintained the clinical response and remission, respectively. The C-reactive protein decreased significantly in both CD and UC patients. However, the decrease in faecal calprotectin was only achieved during follow-up in UC, but not in CD patients. Eight patients with CD that had been treated previously with ustekinumab avoided surgery at one year. A colectomy was performed on 8 (18.6%) UC patients, and 4 (13.3%) CD patients needed surgery. Six patients (8%) (5 UC and 1 CD) had adverse events. The concomitant use of corticosteroids or immunomodulators did not increase the efficacy. Those with a higher number of previous anti-TNF treatments showed less remissions in UC and responses in CD. CONCLUSIONS: After one year of VDZ, a clinical response and remission was induced in a considerable percentage of patients refractory to different biological or immunosuppressive therapies. VDZ can be considered as an alternative in those intolerant to immunosuppressives, with few adverse events.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Gastrointestinal Agents/therapeutic use , Inflammatory Bowel Diseases/drug therapy , Adrenal Cortex Hormones/therapeutic use , Adult , Antibodies, Monoclonal, Humanized/adverse effects , Biological Factors/therapeutic use , C-Reactive Protein/analysis , Colectomy , Combined Modality Therapy , Drug Resistance , Feces/chemistry , Female , Gastrointestinal Agents/adverse effects , Hospitalization , Humans , Immunologic Factors/therapeutic use , Inflammatory Bowel Diseases/surgery , Leukocyte L1 Antigen Complex/analysis , Male , Middle Aged , Treatment Outcome , Ustekinumab/therapeutic use
11.
World J Gastroenterol ; 22(47): 10432-10439, 2016 Dec 21.
Article in English | MEDLINE | ID: mdl-28058024

ABSTRACT

AIM: To evaluate the real-world effectiveness of golimumab in ulcerative colitis (UC) and to identify predictors of response. METHODS: We conducted an observational, prospective and multi-center study in UC patients treated with golimumab, from September 2014 to September 2015. Clinical activity was assessed at week 0 and 14 with the physician's global clinical assessment (PGA) and the partial Mayo score. Colonoscopies and blood tests were performed, following daily-practice clinical criteria, and the results were recorded in an SPSS database. RESULTS: Thirty-three consecutive patients with moderately to severely active UC were included. Among them, 54.5% were female and 42 years was the average age. Thirty percent had left-sided UC (E2) and 70% had extensive UC (E3). All patients had an endoscopic Mayo score of 2 or 3 at baseline. Twenty-seven point three percent were anti-tumor necrosis factor (TNF) treatment naïve, whereas 72.7% had previously received infliximab and/or adalimumab. Sixty-nine point seven percent showed clinical response and were steroid-free at week 14 (a decrease from baseline in the partial Mayo score of at least 3 points). Based on PGA, the clinical remission and clinical response rates were 24% and 55% respectively. Withdrawal of corticosteroids was observed in 70.8% of steroid-dependent patients at the end of the study. Three out of 10 clinical non-responders needed a colectomy. Mean fecal calprotectin value at baseline was 300 µg/g, and 170.5 µg/g at week 14. Being anti-TNF treatment naïve was a protection factor, which was related to better chances of reaching clinical remission. Twenty-seven point three percent of the patients required treatment intensification at 14 wk of follow-up. Only three adverse effects (AEs) were observed during the study; all were mild and golimumab was not interrupted. CONCLUSION: This real-life practice study endorses golimumab's promising results, demonstrating its short-term effectiveness and confirming it as a safe drug during the induction phase.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , Antibodies, Monoclonal/therapeutic use , Colitis, Ulcerative/drug therapy , Gastrointestinal Agents/therapeutic use , Adrenal Cortex Hormones/therapeutic use , Adult , Anti-Inflammatory Agents/adverse effects , Antibodies, Monoclonal/adverse effects , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/immunology , Colonoscopy , Drug Therapy, Combination , Female , Gastrointestinal Agents/adverse effects , Humans , Male , Middle Aged , Prospective Studies , Remission Induction , Severity of Illness Index , Spain , Time Factors , Treatment Outcome , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Tumor Necrosis Factor-alpha/immunology
14.
Surg Endosc ; 25(6): 1876-82, 2011 Jun.
Article in English | MEDLINE | ID: mdl-21136105

ABSTRACT

BACKGROUND: Current studies have addressed ways to improve the success of selective biliary cannulation in endoscopic retrograde cholangiopancreatography (ERCP). The objective of this study was to assess the efficacy of deep bile duct access using a short-wire system with sphincterotome and guidewire controlled only by the endoscopist. METHODS: This was a prospective study of 70 patients with biliary diseases subjected to ERCP. Biliary cannulation was performed by the endoscopist without direct cooperation of the assistant in two centers with different experience in ERCP. The RX Biliary System™ was used in all patients. Efficacy (success rate and time to cannulation) of deep bile duct access and procedure-related complications were determined. RESULTS: Overall guidewire cannulation was successful in 65 of 70 patients (92.9%). Nonintentional pancreatic duct cannulation with the guidewire was performed in 22 patients (31.4%). Additional techniques were needed in 18 patients (25.7%): guidewire into the pancreatic duct in 11 patients (15.7%); contrast-medium was used in 13 patients (18.6%); and precut was performed in 3 patients (4.3%). Attempts at papilla cannulation numbered<10 in 48 patients (68.6%), and time to biliary cannulation was <10 min in 42 patients (60%). Minor complications occurred in five patients (7.1%). There were no significant differences between patients in both centers. CONCLUSIONS: The short-wire system allows the endoscopist to have access to the bile duct with a high success rate--early and safely--without the direct participation of the assistant.


Subject(s)
Biliary Tract Diseases/diagnosis , Biliary Tract Diseases/surgery , Catheterization/methods , Cholangiopancreatography, Endoscopic Retrograde/methods , Sphincterotomy, Endoscopic/instrumentation , Aged , Aged, 80 and over , Equipment Design , Female , Humans , Male , Middle Aged , Prospective Studies
15.
Dig Dis Sci ; 56(3): 773-6, 2011 Mar.
Article in English | MEDLINE | ID: mdl-20676770

ABSTRACT

BACKGROUND: Heartburn is frequently reported by patients with achalasia before treatment. However, the esophageal sensitivity to acid as a possible mediator of this symptom has not been previously evaluated. AIM: To evaluate the prevalence of gastroesophageal reflux symptoms and the esophageal sensitivity to acid perfusion in patients with untreated achalasia. METHODS: Forty patients with achalasia were prospectively evaluated. Forty-three patients with gastroesophageal reflux disease comprised the control group (ten of them with Barrett's esophagus). Symptoms were evaluated by a structured clinical questionnaire. Objective assessment was performed by ambulatory 24-h esophageal pH monitoring and endoscopy. Esophageal sensitivity to acid was evaluated by esophageal perfusion of ClH 0.1 N. RESULTS: Fifteen (37%) of the 40 patients with achalasia presented heartburn, but only four of them had esophagitis and/or abnormal esophageal pH recording. Eight patients had abnormal pH recording. Three patients had esophagitis. The esophagus was sensitive to acid in seven (17%) patients with achalasia, three of them with heartburn and one with abnormal pH recording. In the control group, 40 of 43 (93%) presented heartburn. Acid perfusion was positive in 32 (74%). Sensitivity to acid was lower in patients with achalasia than in those with gastroesophageal reflux disease with or without Barrett's esophagus. CONCLUSIONS: The prevalence of heartburn in patients with achalasia is high, although its association with objective indicators of gastroesophageal reflux disease is weak. Patients with achalasia have lower esophageal sensitivity to acid than patients with GERD, suggesting that heartburn is does not arise from this condition.


Subject(s)
Esophageal Achalasia/epidemiology , Heartburn/epidemiology , Acids , Adolescent , Adult , Aged , Barrett Esophagus/diagnosis , Barrett Esophagus/epidemiology , Endoscopy , Esophageal Achalasia/diagnosis , Esophageal pH Monitoring , Esophagitis/diagnosis , Esophagitis/epidemiology , Female , Gastroesophageal Reflux/diagnosis , Gastroesophageal Reflux/epidemiology , Heartburn/diagnosis , Humans , Male , Middle Aged , Prevalence , Prospective Studies , Young Adult
16.
Ann Pharmacother ; 42(7): 1130-3, 2008 Jul.
Article in English | MEDLINE | ID: mdl-18492783

ABSTRACT

OBJECTIVE: To report a case of severe myalgia associated with adalimumab in a patient with Crohn's disease. CASE SUMMARY: A 44-year-old woman was diagnosed as having ileocecal Crohn's disease with perianal fistula lesions. She was treated with 3 infusions of infliximab 5 mg/kg, which stabilized her condition. However, when reactivation of Crohn's disease occurred, infliximab was discontinued. Eight weeks after infliximab was suspended, treatment with adalimumab was started, with an initial dose of 160 mg followed by 80 mg in week 2; 48 hours after the first dose, the woman complained of generalized severe pain in her upper and lower extremities. Results of all laboratory tests were within normal limits. A diagnosis of severe drug-related myalgia was made. We suspected that adalimumab was the causative agent since it was the only drug that had been added before the musculoskeletal symptoms appeared. Adalimumab was stopped and treatment with ibuprofen and tramadol was started. Fifteen days after stopping adalimumab, the patient reported complete resolution of her muscle pain. DISCUSSION: Myalgia following administration of adalimumab is uncommon. This adverse reaction rarely is severe enough to result in cessation of the drug. In our patient, the most likely cause of the severe myalgias was considered to be adalimumab. The onset and resolution of the signs and symptoms followed a reasonable temporal sequence following drug initiation and discontinuation. In accordance with the data obtained and based on the Naranjo algorithm, the adverse reaction could be considered probable. CONCLUSIONS: This case documents the importance of recognizing the possibility of musculoskeletal adverse reactions even with medications like adalimumab, which have a good safety profile. These findings should further alert clinicians to the potential for myalgias associated with adalimumab administration.


Subject(s)
Anti-Inflammatory Agents/adverse effects , Antibodies, Monoclonal/adverse effects , Crohn Disease/drug therapy , Muscular Diseases/chemically induced , Pain/chemically induced , Adalimumab , Adult , Anti-Inflammatory Agents/therapeutic use , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized , Female , Humans
17.
Dig Dis Sci ; 49(11-12): 1771-6, 2004.
Article in English | MEDLINE | ID: mdl-15628701

ABSTRACT

The nonstenotic, nonfistulizing (or inflammatory) pattern of Crohn's disease appears to be unstable in time and may evolve toward either the stenotic or the fistulizing pattern. We aimed to assess the course of the inflammatory disease and its relation to certain clinical characteristics. After a mean follow-up of 93 months, we evaluated 73 patients with an inflammatory pattern. The behavior trend and its relation to disease location, initial treatment, and need for corticosteroids, immunosuppressors, and surgical resection were analyzed. In 64% of the patients the inflammatory pattern did not change, while in 14 and 22% it evolved toward a stenotic and a fistulizing pattern, respectively. This change was mainly determined by the appearance of perianal disease (75%). The mean time to behavior evolution was 67 months. Most patients required corticosteroids (92%). Need for immunosuppressors (48%) and surgical resection (30%) was significantly greater (P < 0.05) among patients with a change in pattern than in those with persistent inflammatory disease. The inflammatory pattern of CD remains stable in about half of patients. The course of this pattern is not indolent, however, since the needs for immunosuppression and surgical resection during follow-up are considerable.


Subject(s)
Crohn Disease/classification , Adolescent , Adult , Aged , Constriction, Pathologic/pathology , Crohn Disease/drug therapy , Crohn Disease/pathology , Crohn Disease/surgery , Disease Progression , Female , Follow-Up Studies , Glucocorticoids/therapeutic use , Humans , Immunosuppressive Agents/therapeutic use , Male , Middle Aged , Time Factors
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