Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB).

BACKGROUND: Anti-TNF therapy represented a landmark in medical treatment of ulcerative colitis (UC). There is lack of data on the efficacy and safety of these agents in Brazilian patients. The present study aimed to analyze rates of clinical and endoscopic remission comparatively, between adalimumab (ADA) and infliximab (IFX), in Brazilian patients with UC, and evaluate factors associated with clinical and endoscopic remission after 1 year of treatment. METHODS: A national retrospective multicenter study (24 centers) was performed including patients with UC treated with anti-TNF therapy. Outcomes as clinical response and remission, endoscopic remission and secondary loss of response were measured in different time points of the follow-up. Baseline predictive factors of clinical and endoscopic remission at week 52 were evaluated using logistic regression model. Indirect comparisons among groups (ADA and IFX) were performed using Student's t, Pearson χ2 or Fisher's exact test when appropriated, and Kaplan Meier analysis. RESULTS: Overall, 393 patients were included (ADA, n = 111; IFX, n = 282). The mean age was 41.86 ± 13.60 years, 61.58% were female, most patients had extensive colitis (62.40%) and 19.39% had previous exposure to a biological agent. Overall, clinical remission rate was 66.78%, 71.62% and 82.82% at weeks 8, 26 and 52, respectively. Remission rates were higher in the IFX group at weeks 26 (75.12% vs. 62.65%, p < 0.0001) and 52 (65.24% vs. 51.35%, p < 0.0001) when compared to ADA. According to Kaplan-Meier survival curve loss of response was less frequent in the Infliximab compared to Adalimumab group (p = 0.001). Overall, endoscopic remission was observed in 50% of patients at week 26 and in 65.98% at week 52, with no difference between the groups (p = 0.114). Colectomy was performed in 23 patients (5.99%). Age, non-prior exposure to biological therapy, use of IFX and endoscopic remission at week 26 were associated with clinical remission after 52 weeks. Variables associated with endoscopic remission were non-prior exposure to biological therapy, and clinical and endoscopic remission at week 26. CONCLUSIONS: IFX was associated with higher rates of clinical remission after 1 year in comparison to ADA. Non-prior exposure to biological therapy and early response to anti-TNF treatment were associated with higher rates of clinical and endoscopic remission.

Propranolol associated with endoscopic band ligation reduces recurrence of esophageal varices for primary prophylaxis of variceal bleeding: a randomized-controlled trial.

OBJECTIVE: The aim of this study was to compare the recurrence of esophageal varices (EVs) after endoscopic band ligation (EBL) associated with propranolol (PP) versus EBL alone. PATIENTS AND METHODS: Sixty-six cirrhotic outpatients (EBL group, n=32 and EBL+PP group, n=34) with high-risk EVs without previous bleeding were studied. MAIN OUTCOME MEASUREMENTS: The primary outcome was recurrence of EV. The secondary outcomes were EV eradication, bleeding before EV eradication, mortality, and adverse events. RESULTS: Demographic characteristics and the initial endoscopic findings were similar. EV eradication was achieved in all patients. Three patients presented gastrointestinal bleeding before variceal eradication, two in the EBL group and one in the EBL+PP group (P=0.13). Six patients died (liver failure), two in the EBL group and four in the EBL+PP group (P=0.27). Twelve (38%) patients in the EBL group and three (9%) patients in the EBL+PP group had variceal recurrence. The risk of recurrence of EVs after eradication was significantly higher among patients in the EBL group (P=0.003). CONCLUSION: EBL alone and EBL+PP were effective in the primary prophylaxis of bleeding from EVs in cirrhotic patients (EV eradication, bleeding before EV eradication, mortality, and adverse events were similar in both groups). However, variceal recurrence was lower in the EBL+PP group than band ligation alone.

Prospective study of bacteremia rate after elective band ligation and sclerotherapy with cyanoacrylate for esophageal varices in patients with advanced liver disease.

CONTEXT: Band ligation (BL) is the most appropriate endoscopic treatment for acute bleeding or prophylaxis of esophageal variceal bleeding. Sclerotherapy with N-butyl-2-cyanoacrylate (CY) can be an alternative for patients with advanced liver disease. Bacteremia is an infrequent complication after BL while the bacteremia rate following treatment with CY for esophageal varices remains unknown. OBJECTIVES: To evaluate and compare the incidence of transient bacteremia between cirrhotic patients submitted to diagnostic endoscopy, CY and BL for treatment of esophageal varices. METHODS: A prospective study comprising the period from 2004 to 2007 was conducted at Hospital of Universidade Federal de São Paulo, UNIFESP, SP, Brazil. Cirrhotic patients with advanced liver disease (Child-Pugh B or C) were enrolled. The patients were divided into two groups according treatment: BL Group (patients undergoing band ligation, n = 20) and CY Group (patients receiving cyanoacrylate injection for esophageal variceal, n = 18). Cirrhotic patients with no esophageal varices or without indication for endoscopic treatment were recruited as control (diagnostic group n = 20). Bacteremia was evaluated by blood culture at baseline and 30 minutes after the procedure. RESULTS: After 137 scheduled endoscopic procedures, none of the 58 patients had fever or any sign suggestive of infection. All baseline cultures were negative. No positive cultures were observed after CY or in the control group - diagnostic endoscopy. Three (4.6 %) positive cultures were found out of the 65 sessions of band ligation (P = 0.187). Two of these samples were positive for coagulase-negative staphylococcus, which could be regarded as a contaminant. The isolated microorganism in the other case was Klebsiella oxytoca. The patient in this case presented no evidence of immunodeficiency except liver disease. CONCLUSIONS: There was no significant difference in bacteremia rate between these three groups. BL or CY injection for non-bleeding esophageal varices may be considered as low-risk procedures regarding bacteremia even when performed on patients with advanced liver disease.

Prospective study of bacteremia rate after elective band ligation and sclerotherapy with cyanoacrylate for esophageal varices in patients with advanced liver disease / Estudo de bacteriemia relacionada à ligadura elástica versus injeção de cianocrilato para varizes esofágicas em pacientes com doença hepática avançada

CONTEXT: Band ligation (BL) is the most appropriate endoscopic treatment for acute bleeding or prophylaxis of esophageal variceal bleeding. Sclerotherapy with N-butyl-2-cyanoacrylate (CY) can be an alternative for patients with advanced liver disease. Bacteremia is an infrequent complication after BL while the bacteremia rate following treatment with CY for esophageal varices remains unknown. OBJECTIVES: To evaluate and compare the incidence of transient bacteremia between cirrhotic patients submitted to diagnostic endoscopy, CY and BL for treatment of esophageal varices. METHODS: A prospective study comprising the period from 2004 to 2007 was conducted at Hospital of Universidade Federal de São Paulo, UNIFESP, SP, Brazil. Cirrhotic patients with advanced liver disease (Child-Pugh B or C) were enrolled. The patients were divided into two groups according treatment: BL Group (patients undergoing band ligation, n = 20) and CY Group (patients receiving cyanoacrylate injection for esophageal variceal, n = 18). Cirrhotic patients with no esophageal varices or without indication for endoscopic treatment were recruited as control (diagnostic group n = 20). Bacteremia was evaluated by blood culture at baseline and 30 minutes after the procedure. RESULTS: After 137 scheduled endoscopic procedures, none of the 58 patients had fever or any sign suggestive of infection. All baseline cultures were negative. No positive cultures were observed after CY or in the control group - diagnostic endoscopy. Three (4.6 percent) positive cultures were found out of the 65 sessions of band ligation (P = 0.187). Two of these samples were positive for coagulase-negative staphylococcus, which could be regarded as a contaminant. The isolated microorganism in the other case was Klebsiella oxytoca. The patient in this case presented no evidence of immunodeficiency except liver disease. CONCLUSIONS: There was no significant difference in bacteremia rate between these three groups. BL or CY injection for non-bleeding esophageal varices may be considered as low-risk procedures regarding bacteremia even when performed on patients with advanced liver disease.

CONTEXTO: A ligadura elástica é considerada o melhor tratamento endoscópico para o sangramento agudo por varizes esofágicas ou para profilaxia do sangramento varicoso, sendo a escleroterapia com N-2-butil-cianoacrilato uma alternativa para os pacientes com doença hepática avançada e distúrbio de coagulação. Bacteriemia é uma complicação rara associada à ligadura elástica, por outro lado, a incidência de bacteriemia relacionada com o uso de N-2-butil-cianoacrilato permanece desconhecida. OBJETIVOS: Avaliar e comparar a incidência de bacteriemia transitória entre os pacientes cirróticos submetidos a endoscopia digestiva alta diagnóstica, escleroterapia com N-2-butil-cianoacrilato ou ligadura elástica para tratamento das varizes esofágicas. MÉTODOS: Estudo prospectivo realizado entre 2004 e 2007 foi conduzido no Hospital da Universidade Federal de São Paulo, UNIFESP, Brasil. Cirróticos com doença hepática avançada (Child B ou C) foram incluídos. Os pacientes foram divididos em dois grupos de acordo com o tratamento: grupo ligadura elástica (pacientes submetidos a ligadura elástica, n = 20) e grupo N-2-butil-cianoacrilato (pacientes submetidos a injeção de N-2-butil-cianoacrilato, n = 18). Cirróticos sem varizes esofágicas ou com varizes esofágicas sem indicação de tratamento endoscópico foram recrutados como controles (grupo endoscopia diagnóstica, n = 20). Bacteriemia foi avaliada por hemocultura basal e 30 minutos após o procedimento. RESULTADOS: Dos 137 procedimentos endoscópicos realizados, nenhum dos 58 pacientes apresentou febre ou qualquer sinal sugestivo de infecção. Todas as hemoculturas de base foram negativas. Nenhuma cultura positiva foi observada após o uso de N-2-butil-cianoacrilato ou no grupo controle. Três (4,6 por cento) culturas positivas foram encontradas após as 65 sessões de ligadura elástica (P = 0,187). Duas dessas foram positivas para Staphylococcus coagulase-negativo, provavelmente relacionadas à contaminação. O microorganismo isolado no terceiro caso foi Klebsiella oxytoca. Nesse caso, o paciente apresentava a própria doença hepática como única situação relacionada à imunodeficiência. CONCLUSÕES: Não houve diferença significante na incidência de bacteriemia entre os três grupos de pacientes. Ligadura elástica ou injeção de N-2-butil-cianoacrilato para profilaxia do sangramento varicoso podem ser considerados procedimentos de baixo risco quanto ao surgimento de bacteriemia, mesmo em pacientes com doença hepática avançada.

Sedation during upper GI endoscopy in cirrhotic outpatients: a randomized, controlled trial comparing propofol and fentanyl with midazolam and fentanyl.

BACKGROUND: Patients with liver cirrhosis frequently undergo diagnostic or therapeutic upper GI endoscopy (UGIE), and the liver disease might impair the metabolism of drugs usually administered for sedation. OBJECTIVE AND SETTING: To compare sedation with a combination of propofol plus fentanyl and midazolam plus fentanyl in cirrhotic outpatients undergoing UGIE. DESIGN: A prospective, randomized, controlled trial was conducted between February 2008 and February 2009. MAIN OUTCOMES MEASUREMENTS: Efficacy (proportion of complete procedures using the initial proposed sedation scheme), safety (occurrence of sedation-related complications), and recovery time were measured. RESULTS: Two hundred ten cirrhotic patients referred for UGIE were randomized to 2 groups: midazolam group (0.05 mg/kg plus fentanyl 50 µg intravenously) or propofol group (0.25 mg/kg plus fentanyl 50 µg intravenously). There were no differences between groups regarding age, sex, weight, etiology of cirrhosis, and Child-Pugh or American Society of Anesthesiologists classification. Sedation with propofol was more efficacious (100% vs 88.2%; P < .001) and had a shorter recovery time than sedation with midazolam (16.23 ± 6.84 minutes and 27.40 ± 17.19 minutes, respectively; P < .001). Complication rates were similar in both groups (14% vs 7.3%; P = .172). LIMITATIONS: Single-blind study; sample size. CONCLUSION: Both sedation schemes were safe in this setting. Sedation with propofol plus fentanyl was more efficacious with a shorter recovery time compared with midazolam plus fentanyl. Therefore, the former scheme is an alternative when sedating cirrhotic patients undergoing UGIE.

Treatment of inflammatory bowel disease and pregnancy: a review of the literature.

CONTEXT: The inflammatory bowel disease is diagnosed frequently among woman of childbearing capacity. The management must be carefully because there are potential risks for the mother and fetus. RESULTS AND CONCLUSIONS: We review literature about the management of inflammatory bowel disease in pregnancy. Some studies are needed to ensure the best approach to inflammatory bowel disease in pregnant women.

Inflammatory bowel disease and pregnancy: report of two cases treated with infliximab and a review of the literature.

Inflammatory bowel disease is relatively frequent in women of childbearing age. Disease management requires greater attention during this clinical condition because of potential risk of maternal-fetal complications. Infliximab has been shown to be safe during pregnancy and lactation, but reports in the literature are scarce. We report two cases of refractory Crohn's disease treated with infliximab with good results, in women. Both patients became pregnant during maintenance regimen and treatment was continued. The literature regarding pregnant patients with inflammatory bowel disease was reviewed.

Treatment of inflammatory bowel disease and pregnancy: a review of the literature / Tratamento da doença inflamatória intestinal durante a gravidez: revisão da literatura

CONTEXT: The inflammatory bowel disease is diagnosed frequently among woman of childbearing capacity. The management must be carefully because there are potential risks for the mother and fetus. RESULTS AND CONCLUSIONS: We review literature about the management of inflammatory bowel disease in pregnancy. Some studies are needed to ensure the best approach to inflammatory bowel disease in pregnant women.

CONTEXTO: A doença inflamatória intestinal acomete mulheres em idade fértil com relativa frequência. A conduta exige maior atenção durante esta condição clínica em virtude dos riscos potenciais de complicações materno-fetais. RESULTADOS E CONCLUSÕES: Esta é uma revisão sobre as manifestações clínicas das doenças inflamatórias intestinais durante a gravidez e seu tratamento durante este período. Ainda são necessários estudos sobre o tema para melhor abordagem das doenças inflamatórias intestinais em gestantes.

Doença inflamatória intestinal e gravidez: relatos de dois casos de uso de infliximab e revisão da literatura / Inflammatory bowel disease and pregnancy use of infliximab: a report of two cases and literature review

A doença inflamatória intestinal acomete mulheres em idade fértil com relativa frequência. A conduta exige maior atenção durante esta condição clínica em virtude dos riscos potenciais de complicações materno-fetais. O uso de infliximab tem se mostrado seguro durante a gravidez e lactação, todavia ainda são poucos os relatos existentes na literatura. Relatamos dois casos de gestação durante o uso de infliximab e realizamos revisão dos dados existentes na literatura acerca da conduta em pacientes com doença inflamatória intestinal nessa condição.

The inflammatory bowel disease is diagnosed frequently among woman of childbearing capacity. The management must be carefully because there are potential risks for the mother and fetus. Infliximab seems to be safe in pregnancy and nursing, however there are few studies about this issue. We report two cases and review literature about the management of inflammatory bowel disease in pregnancy.