Faculty of Pharmacy, and Pharmaceutical Sciences Research Center, Tehran University of Medical, Sciences, Tehran, Iran.
Curr Pharm Des. 2010;16(33):3684-98. doi: 10.2174/138161210794079236.
This meta-analysis of randomized controlled trials was conducted to evaluate the efficacy and tolerability of two drug groups (immunoregulators and antibiotics) in the treatment of fistula in Crohn's disease (CD).
PubMed, Embase, Scopus, Google Scholar, and Web of Science were searched for clinical trial studies investigated the effects of immunoregulators and antibiotics in the treatment of fistulizing CD. Clinical response and adverse effects were the key outcomes of interest. Data were searched from the time period of 1966 through June 2010.
Eleven randomized placebo-controlled clinical trials that met our criteria (nine in different immunoregulators and two in antibiotics) were included in the analysis. Pooling of data showed that immunoregulators and antibiotics are significantly effective for at least a 50% reduction from baseline in the number of open actively draining fistulas with relative risk (RR) of 2.57 (95% CI of 1.55-4.25, P=0.0003) in four trials and 2.05 (95% CI of 1.03-4.08, P= 0.0414) in two trials respectively. The summary of RR for complete closure of fistulas in nine trials was 2.65 with a 95% CI of 1.66-4.22 and a significant RR (P < 0.0001). In regard to the tolerability, both immunoregulators and antibiotics showed insignificant adverse effects in comparison to placebo with an RR of 1.11 (95% CI of 0.96-1.27, P= 0.1513) and 0.6 (95% CI of 0.36-1, P= 0.0515), respectively and discontinuation because of these adverse effects in drug-treated groups was the same as placebo. Data about severe adverse effects were only available for immunoregulators that showed a significantly higher incidence when compared to placebo (RR= 2.24 with a 95% CI of 1.05-4.79; significant at P= 0.0374).
This meta-analysis demonstrates the efficacy of immunoregulators and antibiotics in fistulizing CD. Regarding the safety, mild to moderate adverse effects were the same in both antibiotic and immunoregulators groups in comparison to the placebo but incidence of severe adverse effects in immunoregulator groups was higher than that of antibiotics.
本荟萃分析纳入了随机对照试验，旨在评估免疫调节剂和抗生素这两类药物在治疗克罗恩病瘘管中的疗效和耐受性。
检索了 1966 年至 2010 年 6 月期间的文献，包括 PubMed、Embase、Scopus、Google Scholar 和 Web of Science，以寻找评估免疫调节剂和抗生素治疗瘘管型克罗恩病的临床疗效的临床试验。临床应答和不良反应是主要观察终点。
共有 11 项符合纳入标准的随机安慰剂对照临床试验（9 项评估不同免疫调节剂，2 项评估抗生素）被纳入荟萃分析。汇总数据显示，免疫调节剂和抗生素在减少活跃引流瘘管数量方面均显著有效（4 项研究中相对风险 [RR]为 2.57，95%置信区间 [CI]为 1.55-4.25，P=0.0003；2 项研究中 RR 为 2.05，95%CI 为 1.03-4.08，P=0.0414）。9 项研究中完全关闭瘘管的汇总 RR 为 2.65，95%CI 为 1.66-4.22，RR 有统计学意义（P<0.0001）。在耐受性方面，与安慰剂相比，免疫调节剂和抗生素的不良反应发生率均无统计学差异（RR 分别为 1.11，95%CI 为 0.96-1.27，P=0.1513 和 0.6，95%CI 为 0.36-1，P=0.0515），且药物治疗组因不良反应停药的比例与安慰剂组相同。仅有免疫调节剂的严重不良反应数据，与安慰剂相比，免疫调节剂的严重不良反应发生率更高（RR=2.24，95%CI 为 1.05-4.79；P=0.0374）。
本荟萃分析表明，免疫调节剂和抗生素对瘘管型克罗恩病有效。在安全性方面，与安慰剂相比，抗生素和免疫调节剂组的不良反应发生率相似，但免疫调节剂组的严重不良反应发生率更高。
