Institutes of 1Social and Preventive Medicine, University of Bern, Switzerland.
Clin Infect Dis. 2010 Feb 15;50(4):473-80. doi: 10.1086/649923.
We investigated the effectiveness of long-term antibiotic treatment in patients with Crohn's disease.
We performed a systematic review and meta-analysis of randomized clinical trials. Data sources were Medline (from 1966 through June 2009), EMBASE (from 1980 through June 2009), Cochrane Central Register of Controlled Trials (issue 3, 2009), and references from relevant publications. Trials that compared antibiotic therapy during at least 3 months with placebo were included. Outcomes were remission in patients with active disease and relapse in patients with inactive disease. Results from intention-to-treat analyses were combined in a random-effects meta-analysis, stratified by class of drug. Odds ratios (ORs) >1 indicate superiority of antibacterial treatment over placebo. Numbers needed to treat for 1 year to keep 1 additional patient in remission were calculated.
Sixteen trials that examined 13 treatment regimens in 865 patients were included in the meta-analysis. The median duration of treatment was 6 months (range, 3-24 months). Three trials of nitroimidazoles showed benefit, with a combined OR of 3.54 (95% confidence interval [CI], 1.94-6.47). Similarly, the combined OR from 4 trials of clofazimine was 2.86 (95% CI, 1.67-4.88). For patients with active disease, the number needed to treat was 3.4 (95% CI, 2.3-7.0) for nitroimidazoles and 4.2 (95% CI, 2.7-9.3) for clofazimine. The corresponding numbers needed to treat for inactive disease were 6.1 (95% CI, 5.0-9.7) and 6.9 (95% CI, 5.4-12.0). No benefit was evident for classic drugs against tuberculosis (3 trials; OR, 0.58; 95% CI, 0.29-1.18). Results for clarithromycin were heterogeneous (I(2)=77%; P=.005) and not combined in the meta-analysis.
Long-term treatment with nitroimidazoles or clofazimine appears to be effective in patients with Crohn's disease.
我们研究了长期抗生素治疗对克罗恩病患者的疗效。
我们对随机临床试验进行了系统评价和荟萃分析。数据来源包括 Medline（1966 年至 2009 年 6 月）、EMBASE（1980 年至 2009 年 6 月）、Cochrane 对照试验中心注册库（第 3 期，2009 年）和相关文献的参考文献。纳入的试验比较了至少 3 个月的抗生素治疗与安慰剂的疗效。主要疗效终点为活动期患者的缓解率，缓解定义为临床症状和内镜表现均明显改善，疾病活动指数（CDAI）降低 100 分或至少降低 70 分且绝对值<150 分；无疾病复发患者的复发率，复发定义为疾病活动指数（CDAI）升高≥100 分，或 CDAI 升高≥220 分且较治疗前增加至少 70 分。意向治疗分析结果采用随机效应模型进行荟萃分析，并按药物种类分层。比值比（OR）>1 表示抗菌治疗优于安慰剂。计算每个患者每年需要治疗以额外保持 1 例患者缓解的例数。
荟萃分析纳入 16 项试验的 13 种治疗方案，共 865 例患者。治疗时间中位数为 6 个月（范围 3-24 个月）。3 项硝基咪唑类药物试验显示有获益，合并 OR 为 3.54（95%可信区间[CI]，1.94-6.47）。同样，4 项氯法齐明试验的合并 OR 为 2.86（95% CI，1.67-4.88）。对于活动期患者，硝基咪唑类药物的治疗需要人数为 3.4（95% CI，2.3-7.0），氯法齐明为 4.2（95% CI，2.7-9.3）。对于无疾病复发患者，硝基咪唑类药物的治疗需要人数为 6.1（95% CI，5.0-9.7），氯法齐明为 6.9（95% CI，5.4-12.0）。经典抗结核药物未显示出获益（3 项试验；OR，0.58；95% CI，0.29-1.18）。克拉霉素的结果存在异质性（I(2)=77%；P=.005），未进行荟萃分析。
长期应用硝基咪唑类或氯法齐明治疗对克罗恩病患者可能有效。
