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首页> 外文期刊>Inflammatory bowel diseases >Sargramostim (GM-CSF) for induction of remission in crohn's disease: A cochrane inflammatory bowel disease and functional bowel disorders systematic review of randomized trials
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Sargramostim (GM-CSF) for induction of remission in crohn's disease: A cochrane inflammatory bowel disease and functional bowel disorders systematic review of randomized trials

机译：Sargramostim（GM-CSF）诱导克罗恩病缓解：一种Cochrane炎症性肠病和功能性肠病随机试验的系统综述

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Background: We planned to systematically review the efficacy of sargramostim (granulocyte colony stimulating factor [GM-CSF]) for remission induction in patients with Crohn's disease (CD). Methods: A literature search to April 2011 was performed to identify all randomized trials studying sargramostim in patients with CD. The Cochrane risk of bias tool was used to evaluate study quality and the GRADE criteria were utilized to assess the overall quality of the evidence. Results: Three randomized studies (total 537 patients) were identified. The risk of bias was low for the three included studies. There was no statistically significant difference in the proportion of patients who achieved clinical remission (GM-CSF 25.3%; placebo 17.5%; relative risk [RR] 1.67; 95% confidence interval [CI] 0.80-3.50; P = 0.17), or 100-point clinical response (GM-CSF 38.3%; placebo 24.8%; RR 1.71 95% CI 0.98-2.97; P = 0.06). There was no statistically significant difference in the proportion of patients (GM-CSF 95.8%; placebo 89.3%) who experienced adverse events (RR 1.07; 95% CI 0.99-1.16; P = 0.08), or serious adverse events (GM-CSF 12.0% vs. placebo 4.8%; RR 2.21; 95% CI 0.84-5.81; P = 0.11). Conclusions: Sargramostim does not appear to be more effective than placebo for induction of clinical remission or improvement in active CD. However, the GRADE analysis indicates that the overall quality of the evidence for the primary and secondary outcomes was low due to sparse data and heterogeneity, indicating that further research likely would have a significant impact on the effect estimates.
机译：背景：我们计划系统地审查sargramostim（粒细胞集落刺激因子[GM-CSF]）对克罗恩病（CD）患者缓解症状的疗效。方法：进行文献检索至2011年4月，以鉴定所有研究沙格列汀治疗CD患者的随机试验。使用Cochrane偏倚风险工具评估研究质量，并使用GRADE标准评估证据的整体质量。结果：确定了三项随机研究（共537例患者）。对于包括在内的三项研究，偏倚风险低。达到临床缓解的患者比例没有统计学上的显着差异（GM-CSF 25.3％;安慰剂17.5％;相对风险[RR] 1.67; 95％置信区间[CI] 0.80-3.50; P = 0.17），或100分临床反应（GM-CSF 38.3％;安慰剂24.8％; RR 1.71 95％CI 0.98-2.97; P = 0.06）。发生不良事件（RR 1.07; 95％CI 0.99-1.16; P = 0.08）或严重不良事件（GM-CSF）的患者比例（GM-CSF 95.8％;安慰剂89.3％）没有统计学意义的差异12.0％对比安慰剂4.8％; RR 2.21; 95％CI 0.84-5.81; P = 0.11）。结论：Sargramostim在诱导临床缓解或改善活动性CD方面似乎不比安慰剂更有效。但是，GRADE分析表明，由于数据稀疏和异质性，主要和次要结果的证据总体质量较低，这表明进一步的研究可能会对效果估计产生重大影响。

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