Oral 5-aminosalicylic acid for maintenance of medically-induced remission in Crohn's Disease.

摘要: Background The prevention of relapse is a major issue in the management Crohn's disease. Corticosteroids, mainstay treatment acute exacerbations, are not effective for maintenance remission and its chronic use limited by numerous adverse events. Randomised controlled trials assessing efficacy oral 5-aminosalicylic acid (5-ASA) agents medically-induced disease have produced conflicting results. Objectives To conduct systematic review to evaluate safety 5-ASA disease. Search methods We searched MEDLINE, EMBASE, CENTRAL IBD Group Specialized Register from inception 8 June 2016. We also reference lists conference proceedings. Selection criteria We included randomised that compared either placebo or sulphasalazine patients with quiescent The had duration at least six months. Data collection analysis Two authors independently extracted data performed risk bias assessment. Any disagreements were resolved discussion consensus. primary outcome measure was occurrence as defined studies. Secondary outcomes time relapse, events, withdrawal due events serious calculated pooled ratio (RR) corresponding 95% confidence interval (95% CI) using fixed-effect model. All analysed on an intention-to-treat basis drop-outs considered be relapses. Sensitivity analyses available case analysis where ignored random-effects evaluated overall quality evidence supporting GRADE criteria. Main results Twelve studies (2146 participants) included. did identify any placebo. Seven judged low bias. other unclear various items insufficient details allow judgement. There no statistically significant difference rates 12 months. Fifty-three per cent (526/998) (dose 1.6 g 4 g/day) relapsed months 54% (544/1016) (RR 0.98, CI 0.91 1.07; 11 studies; 2014 patients; moderate-quality evidence). based model impact results. One study found 24 Fifty-four (31/57) 2 58% (36/62) 0.94, 0.68 1.29, 119 low-quality paediatric Sixty-two (29/47) 50 mg/kg/day) 64% (35/55) 0.97, 0.72 1.31; 102 proportion who experienced event, Thirty-four (307/900) one event 33% (301/914) 1.05, 0.95 1.17; 10 1814 patients). Fourteen (127/917) withdrew 13% (119/916) 1.11, 0.88 1.38; 9 1833 (3/293) 0.7% (2/283) 1.43, 0.24 2.83; 3 576 Common reported diarrhoea, nausea vomiting, abdominal pain, headache skin rash. Authors' conclusions We this suggest preparations superior Additional may justified.