作者: Wee-Chian Lim , Yongjun Wang , John K MacDonald , Stephen Hanauer
DOI: 10.1002/14651858.CD008870.PUB2
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摘要: Background Randomized trials investigating the efficacy of aminosalicylates for treatment mildly to moderately active Crohn's disease have yielded conflicting results. A systematic review was conducted critically examine current available data on sulfasalazine and mesalamine inducing remission or clinical response in these patients. Objectives To evaluate compared placebo, corticosteroids, other (alone combination with corticosteroids) disease. Search methods We searched PubMed, EMBASE, MEDLINE Cochrane Central Library from inception June 2015 identify relevant studies. There were no language restrictions. We also reference lists potentially papers articles, as well proceedings annual meetings (1991-2015) American Gastroenterological Association College Gastroenterology. Selection criteria Randomized controlled that evaluated included. Data collection analysis Data extraction assessment methodological quality independently performed by investigators any disagreement resolved discussion consensus. assessed using risk bias tool. The overall evidence supporting outcomes GRADE criteria. primary outcome measure a defined endpoint induction treatment. Secondary included mean activity index (CDAI) scores, adverse events, serious events withdrawal due events. For dichotomous we calculated pooled ratio (RR) corresponding 95% confidence interval (CI) random-effects model. continuous difference (MD) CI Sensitivity analyses based fixed-effect model duration therapy where appropriate. Main results Twenty studies (2367 patients) included. Two judged be at high lack blinding. Eight incomplete (high drop-out rates) potential selective reporting. 10 low bias. non-significant trend favour over placebo observed, benefit confined mainly patients colitis. Forty-five per cent (63/141) entered 17-18 weeks 29% (43/148) (RR 1.38, 1.00 1.89, 2 studies). analysis rated this moderate sparse (106 events). between event outcomes. Sulfasalazine significantly less effective than corticosteroids inferior 0.64, 0.47 0.86, 1 study, 110 patients). Forty-three (55/128) 17 18 60% (79/132) corticosteroid 0.68, 0.51 0.91; studies, 260 (134 experienced fewer 0.43, 0.22 0.82; 159 Olsalazine single trial 0.36, 0.18 0.71; 91 Low dose (1 g/day) not superior remission. Twenty-three (43/185) week 6 15% (18/117) = 1.46, 0.89 2.40; n 302). indicated (incomplete data) (61 proportion who had 1.33, 0.91 1.96; 3 342 withdrew 1.21, 0.75 1.95; High controlled-release (4 clinically non significant reduction CDAI (MD -19.8 points, -46.2 6.7; 615 patients), budesonide 0.56, 0.40 0.78; 182 patients, low). While delayed-release (3 4.5 2.02, 5.45; 38 very low), found when conventional 1.04, 0.79 1.36; 178 moderate) 0.89, 0.76 1.05; 307 moderate). However, limited (small numbers good comparing formulations. Adverse commonly reported headache, nausea, vomiting, abdominal pain diarrhea. Authors' conclusions Sulfasalazine is only modestly towards disease. are placebo. (3.2 4 more assessing results firm conclusions cannot made. Future large randomized needed provide definitive