Effectiveness and Safety of the Switch from Remicade® to CT-P13 in Patients with Inflammatory Bowel Disease.

BACKGROUND AND AIMS: To evaluate the clinical outcomes in patients with IBD after switching from Remicade® to CT-P13 in comparison with patients who maintain Remicade®. METHODS: Patients under Remicade® who were in clinical remission with standard dosage at study entry were included. The 'switch cohort' [SC] comprised patients who made the switch from Remicade® to CT-P13, and the 'non-switch' cohort [NC] patients remained under Remicade®. RESULTS: A total of 476 patients were included: 199 [42%] in the SC and 277 [58%] in the NC. The median follow-up was 18 months in the SC and 23 months in the NC [p < 0.01]. Twenty-four out of 277 patients relapsed in the NC; the incidence of relapse was 5% per patient-year. The cumulative incidence of relapse was 2% at 6 months and 10% at 24 months in this group. Thirty-eight out of 199 patients relapsed in the SC; the incidence rate of relapse was 14% per patient-year. The cumulative incidence of relapse was 5% at 6 months and 28% at 24 months. In the multivariate analysis, the switch to CT-P13 was associated with a higher risk of relapse (HR = 3.5, 95% confidence interval [CI] = 2-6). Thirteen percent of patients had adverse events in the NC, compared with 6% in the SC [p < 0.05]. CONCLUSIONS: Switching from Remicade® to CT-P13 might be associated with a higher risk of clinical relapse, although this fact was not supported in our study by an increase in objective markers of inflammation. The nocebo effect might have influenced this result. Switching from Remicade® to CT-P13 was safe.

[Macrocystic serous cystadenoma of the pancreas, about a case]. / Cystadénome séreux macrokystique du pancréas, à propos d'un cas.

Serous cystadenomas of pancreas are unusual cystic tumour. The microcystic forms is more common and its radiological diagnosis is easy. However, the macrocystic unilocular form of serous cystadenoma can be mistaken with other malignant macrocystic lesions of the pancreas. We report the case of a 17 year-old girl, admitted to the National Hospital of Niamey (Niger), with abdominal pain and an unilocular macrocystic serous cystadenoma of pancreas, diagnosed after histological examination of the surgical specimen. The diagnostic tests, including ultrasound, CT scan, MRI, endoscopic ultrasonography are inconclusive. Challenge of its management is related to the preoperative diagnosis.

Les cystadénomes séreux (CS) du pancréas sont des tumeurs kystiques rares. La forme microkystique du CS est la plus fréquente et de diagnostic radiologique facile. Par contre la forme macrokystique du CS peut être confondue avec les autres lésions macrokystiques du pancréas à potentiel malin. Nous rapportons l'observation d'une jeune patiente de 17 ans admise à l'Hôpital national de Niamey (Niger) dans un tableau de douleurs abdominales, ayant un cystadénome séreux macrokystique uniloculaire du pancréas, diagnostiqué après l'examen histologique de la pièce opératoire. Les examens paracliniques réalisés, notamment l'échographie, le scanner, l'IRM, l'échoendoscopie ne sont pas concluants. La difficulté de la prise en charge réside dans le diagnostic préopératoire.

[The treatment of lower limb varices by stripping and cross sectioning of the saphenous vein at the National Hospital of Niamey: 31 operated limbs]. / Le traitement des varices des membres inferieurs par stripping et crossectomie de la grande et petite veine saphene a l'Hopital National de Niamey: a propos de 31 membres opérés.

OBJECTIVE: The authors reported the results of surgical procedure of lower limbs varicose (LLV) by stripping and crossectomy of saphenous vein at the National hospital of Niamey. METHODS: It is a prospective study during 5 years and half from January 2001 to June 2006. It concerned the all the patients with LLV who underwent a stripping-crossectomy of the great saphenous vein (GVS) and short saphenous vein (SSV) and elastic stocking. The anaes's clinical classification is used. RESULTS: The series included 27 patients (31 limbs): 20 males and 7 females (Ratio: 2.8). The average age was 32.4 years (ranged: 21 to 58 years). The mean duration of symptoms was 4.2 years (ranged: 3 to 12 years). According the ANAES's classification we found 63% of patients in stage B, and 37% in stage C. We performed 35 stripping crossectomy (28 for GSV and 7 for SSV) with avulsions accessory veins in 6 cases (14%), incompetent perforator ligature in 2 cases (4.6%) and complementary sclerotherapy in 19 cases (61.3%). The postoperative complications including haematomas (9.7%), wound infections (6.5%) and paraesthesia of saphenous nerve (6.5%) were subsequently resolved with treatment. The mean duration of hospitalization was 11 days (ranged: 4 to 18 days). After a mean follow-up period of 3 years (ranged: 6 months to 6 years) the recurrent varices rate was 6.5% (2 cases) due to leg perforators in 1 case/2 and 4 cases (9.7%) of residual ankle oedema. CONCLUSION: The LLV concerned young people. The results were good and recurrent rate is low after stripping and crossectomy for varicose stage B and C according ANAES's classification. The surgical procedure needed minute clinical and paraclinical assessment.

Amoxicillin-clavulanic acid versus cefotaxime in the therapy of bacterial infections in cirrhotic patients.

BACKGROUND/AIM: Cefotaxime is considered the first-choice antibiotic for empirical treatment in cirrhotic patients developing bacterial infections. It has been suggested that amoxicillin-clavulanic acid could be an alternative to cefotaxime, particularly in patients developing bacterial infections while on prophylactic norfloxacin. The aim of the present study was to compare amoxicillin-clavulanic acid with cefotaxime in the treatment of bacterial infections in cirrhosis. METHODS: Ninety-six hospitalized cirrhotic patients with suspicion of bacterial infection were prospectively included and randomized into two groups: one group (n=48) received amoxicillin-clavulanic acid, first intravenously 1 g-0.2 g every 8 h, and then orally 500 mg-125 mg every 8 h, and the other group (n=48) received intravenous cefotaxime 1 g every 6 h. Patients were stratified for previous prophylaxis with norfloxacin and ascitic fluid infection. RESULTS: Sixteen patients were excluded from the analysis because bacterial infection was not demonstrated or because of secondary peritonitis. Therefore, 38 patients from the amoxicillin-clavulanic acid group and 42 from the cefotaxime group were finally analyzed. There were 24 ascitic fluid infections in each group. Infection resolution (86.8% vs 88%, 95% CI: -0.15 to 0.13, p NS), spontaneous bacterial peritonitis resolution (87.5% vs 83.3%, 95% CI: -0.15 to 0.24, p NS), duration of treatment, incidence of complications, time of hospitalization and hospital mortality were similar in both groups. Considering patients on prophylactic norfloxacin, infection resolution was also similar (100% vs 83.3%, 95% CI: -0.04 to 0.37, p NS). No adverse events were observed in either of the two groups. The cost of antibiotics was statistically lower in the amoxicillin-clavulanic acid group (p<0.001). CONCLUSIONS: Amoxicillin-clavulanic acid is as effective as cefotaxime in the treatment of bacterial infections in cirrhotic patients, but is less expensive and can be administered orally. These results suggest that amoxicillin-clavulanic acid is an effective alternative to cefotaxime for the empirical treatment of bacterial infections in cirrhosis.

Parenteral antibiotic prophylaxis of bacterial infections does not improve cost-efficacy of oral norfloxacin in cirrhotic patients with gastrointestinal bleeding.

OBJECTIVE: Selective intestinal decontamination with norfloxacin is useful in the prevention of bacterial infections in cirrhotic patients with gastrointestinal bleeding. However, bleeding cirrhotic patients with ascites, encephalopathy, or shock are at high risk to develop bacterial infections in spite of prophylactic norfloxacin. The aim of this study was to assess whether the addition of intravenous ceftriaxone could improve the efficacy of prophylaxis with norfloxacin in these patients. METHODS: Fifty-six cirrhotic patients with gastrointestinal hemorrhage and ascites, encephalopathy, or shock were randomized into two groups: Group 1 (n = 28) received oral norfloxacin 400 mg/12 h for 7 days, and group 2 (n = 28) received norfloxacin plus intravenous ceftriaxone 2 g daily during the first 3 days of admission. RESULTS: Ten patients were excluded because of community-acquired infection, surgery, or death within the first 24 h. The incidence of bacterial infections during hospitalization was 18.1% in group 1 and 12.5% in group 2 (p = NS). The incidence of severe infections (spontaneous bacterial peritonitis, bacteremia, or pneumonia) was also similar in both groups: 9% in group 1 versus 8.3% in group 2 (p = NS). There were no statistical differences between the two groups with respect to duration of hospitalization or mortality. The cost of antibiotic therapy (including prophylaxis and treatment of infections) was significantly higher in group 2. CONCLUSION: These results suggest that the addition of intravenous ceftriaxone during the first 3 days of hospitalization does not improve the cost-efficacy of oral norfloxacin in the prevention of bacterial infections in cirrhotic patients with gastrointestinal bleeding and high risk of infection.