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N-acetyl-L-cysteine combined with mesalamine in the treatment of ulcerative colitis: Randomized,placebo-controlled pilot study

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World Journal of Gastroenterology 2008年第18期14卷 2851-2857页

作者： Luis G Guijarro Jose Mate Javier P Gisbert Jose Luis Perez-Calle Ignacio Marín-Jimenez Encarna Arriaza tomás olleros Mario Delgado Maria s Castillejo David Prieto-Merino Venancio Gonzalez Lara Amado salvador Pea Department of Biochemistry and Molecular Biology CIBERehd Alcalá University Alcalá de Henares Madrid Spain Gastroenterology Unit CIBERehd La Princesa University Hospital Autonomous University Madrid Spain Gastroenterology Unit Gregorio Maraón University Hospital Complutense University Madrid Spain Group Farmasierra sL. Ctra N-Ⅱ Km 26.200 San Sebastián de los Reyes Madrid Spain Laboratory of Immunogenetics Department of Pathology VU University Medical Center Amsterdam The Netherlands

AIM: To evaluate the effectiveness and safety of oral N-acetyl-L-cysteine (NAC) co-administration with mesalamine in ulcerative colitis (UC) patients. METHODs: Thirty seven patients with mild to moderate UC were randomized to receive a four-wk course of oral mesalamine (2.4 g/d) plus N-acetyl-L-cysteine (0.8 g/d) (group A) or mesalamine plus placebo (group B). Patients were monitored using the Modified Truelove-Witts severity Index (MTWsI). The primary endpoint was clinical remission (MTWsI ≤ 2) at 4 wk. secondary endpoints were clinical response (defined as a reduction from baseline in the MTWsI of ≥ 2 points) and drug safety. The serum TNF-α, interleukin-6, interleukin-8 and MCP-1 were evaluated at baseline and at 4 wk of treatment. REsULTs: Analysis per-protocol criteria showed clinical remission rates of 63% and 50% after 4 wk treatment with mesalamine plus N-acetyl-L-cysteine (group A) and mesalamine plus placebo (group B) respectively (OR = 1.71; 95% CI: 0.46 to 6.36; P = 0.19; NNT = 7.7). Analysis of variance (ANOVA) of data indicated a significant reduction of MTWsI in group A (P = 0.046) with respect to basal condition without significant changes in the group B (P = 0.735) during treatment. Clinical responses were 66% (group A) vs 44% (group B) after 4 wk of treatment (OR = 2.5; 95% CI: 0.64 to 9.65; P = 0.11; NNT = 4.5). Clinical improvement in group A correlated with a decrease of IL-8 and MCP-1. Rates of adverse events did not differ significantly between both groups. CONCLUsION: In group A (oral NAC combined with mesalamine) contrarily to group B (mesalamine alone), the clinical improvement correlates with a decrease of chemokines such as MCP-1 and IL-8. NAC addition not produced any side effects.

关键词： Ulcerative colitis Interleukin Mesalamine N-acetyl-L-cysteine

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