BACKGROUND: Infliximab and adalimumab are considered effective drugs in the management of Crohn’s disease. However, due to significant immunossupression, they can cause important adverse events, mostly infections. OBJECTIVE: The aim of this study was to quantify and describe adverse events derived from adalimumab and infliximab use in Crohn’s disease patients, and to compare the safety profile between these two agents. METHODS: This was an observational, single-center, longitudinal, retrospective study with Crohn’s disease patients under infliximab or adalimumab therapy. Variables analyzed: demographic characteristics (including the Montreal classification), type of agent used, concomitant immunomodulators, presence and types of adverse events observed. Patients were allocated in two groups (infliximab and adalimumab) and had their adverse events accessed and subsequently compared. RESULTS: A total of 130 patients were included (68 in infliximab and 62 in adalimumab groups, respectively). The groups were fully homogeneous in all baseline characteristics, with a median follow-up of 47.21±36.52 months in the infliximab group and 47.79±35.09 in the adalimumab group (P=0.512). Adverse events were found in 43/68 (63.2%) and 40/62 (64.5%) in each group, respectively (P=0.879). There were no differences between the groups regarding infections (P=0.094) or treatment interruption (P=0.091). There were higher rates of infusion reactions in the infliximab group (P=0.016). Cephalea and injection site reactions were more prevalent in adalimumab patients. CONCLUSION: Adverse events were found in approximately two thirds of Crohn’s disease patients under anti-TNF therapy, and there were no significant differences between infliximab or adalimumab.
Purpose: A prospective study was conducted to assess the efficacy of dextranomer based implants as a new bulking agent for endoscopic treatment of pediatric structural incontinence.Materials and Methods: A total of 33 children and adolescents 5 to 18 years old with severe incontinence due to sphincteric incompetence (exstrophy-epispadias in 13, neuropathic bladder in 16, bilateral ectopic ureters in 4) were enrolled in the study. All but 1 patient wore diapers. Preoperative evaluation consisted of medical history, pad test, urine culture, urinary tract ultrasound and videourodynamics. This evaluation was repeated 6 months and 1 year after treatment and then on a yearly basis. Of the patients 14 had 2 and 1 had 3 treatment sessions to achieve a definitive result. At each evaluation the patient was considered cured-dryness interval of 4 hours confirmed by pad test, significantly improved-minimal incontinence requiring no more than 1 pad a day with less than 10 gm. leakage during pad test; and no further treatment required, and treatment failure-no significant improvement. Videourodynamics were mainly useful to study the evolution of the bladder capacity, activity and compliance. Followup after the last injection ranged from 6 to 36 months (mean 18).Results: The mean injected volume was 3.9 ml. (range 1.6 to 12) and the procedure lasted a mean of 30 minutes (10 to 60). In the postoperative period 2 patients had temporary dysuria and 10 had a nonfebrile urinary tract infection. At 1 month 24 of the 33 patients (73%) were dry or improved. Two patients were subsequently excluded from study for noncompliance with followup. At 6 months 17 of 31 patients (55%), at 1 year 13 of 28 (46%), at 2 years 10 of 23 (43%) and at 3 years 10 of 20 (50%) were dry or improved. Similar success occurred in cases of neuropathic bladder (57%) and exstrophy-epispadias complex (46%). Success rate of re-treated patients was 35%. Of 13 patients with a normal initial bladder capacity 3 had a bladder decompensation requiring augmentation after 6 months. Also an increase of at least 50% in capacity was observed in 12 of 18 patients with an initial small bladder. No side effect related to the substance was observed.Conclusions: Endoscopic treatment of pediatric structural urinary incontinence with dextranomer implant, a nontoxic, nonimmunogenic, nonmigrant synthétic substance, was effective after 3 years in half of our patients. It may also be beneficial for patients with small bladder functional capacity. As the success rate decreased during the first year of followup, the result observed at 1 year seems to remain stable subsequently.KEY WORDS: urinary incontinence; bladder exstrophy; epispadias, endoscopy, dextrans Sphincteric incompetence in children and adolescents related to neuropathic bladder sphincter dysfunction and the exstrophy-epispadias complex is a major therapeutic challenge for the pediatric urologist. The 2 conditions for successful treatment are achievement of good outlet resistance and a compliant nonoveractive bladder ...
The Malone procedure generally meets the expectations of patients but it is considered by a majority as painful and lengthy. The umbilicus is the preferred stoma site but may prove to be disturbing in young patients. Abandonment of the procedure and postoperative depression experienced by some patients, despite a good functional result, deserve better prevention.
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