抗肿瘤坏死因子α制剂治疗溃疡性结肠炎的疗效和安全性的 Meta 分析

摘要

目的：采用 Meta 分析方法评价抗肿瘤坏死因子α(TNF-α)制剂治疗中重度溃疡性结肠炎(UC)的疗效和安全性。方法全面检索 Cochrane 图书馆、PubMed、Embase、ISI、OVID 和中国生物医学文献数据库、中国知网、万方数据库、维普数据库中有关抗 TNF-α制剂治疗 UC 的临床随机对照试验(RCT),按照纳入与排除标准选择文献、提取资料并进行方法学质量评价后,采用 Revman 5.1软件进行 Meta 分析。结果共纳入11项 RCT,共3334例患者。Meta分析结果显示,抗 TNF-α制剂在治疗 UC 的短期应答(OR =2.51,95% CI 1.73,3.64)与短期缓解(OR =2.74,95%CI 1.80,4.16),长期应答(OR=2.98,95% CI 1.98,4.47)与长期缓解(OR =2.64,95% CI 1.89,3.67),黏膜愈合率(OR=1.89,95% CI 1.39,2.59)各个方面均优于对照组,并可以降低结肠手术切除率(OR =0.61,95% CI 0.41,0.89),改善生活质量[IBDQ 评分的均数差(MD)为14.74,95% CI 11.43,18.06],在所有报道不良反应(OR =1.14,95% CI 0.97,1.34)与严重不良反应(OR=0.78,95% CI 0.56,1.09)发生方面与对照组差异无统计学意义。结论抗肿瘤坏死因子α制剂治疗中重度 UC 不仅可以诱导缓解及长期维持,而且可以促进黏膜愈合、降低结肠手术切除率、提高生活质量,长期使用也较为安全。上述结论仍需要更多高质量 RCT 证实。%ABSTRACT:Objective To evaluate the clinical therapeutic effect and safety of tumor necrosis factor alpha (TNF-α)blockers in treating moderately to severely active ulcerative colitis (UC)by meta-analysis.Methods Such databases as the Cochrane Central Register of Controlled Trials,PubMed,OVID,Embase,ISI,CBM,CNKI, VIP,and WanFang Data were searched from establishment to June 2013.All randomized clinical trials (RCTs)on tumor necrosis factor alpha blockers in treating UC were collected,and then selected on the basis of the inclusion and exclusion criteria.We assessed the methodological quality,extracted the data from the included articles and performed the meta-analysis with Revman 5.1.Results A total of 13 RCTs involving 3334 patients were analyzed.TNF-αblockers group was superior to the control group in the short-term clinical response (OR =2.5 1, 95% CI 1.73,3.64),short-term clinical remission (OR =2.74,95% CI 1.80,4.1 6),long-term clinical response (OR =2.98,95% CI 1.98,4.47),1ong-term clinical remission (OR =2.64,95% CI 1.89,3.67),and mucosal healing (OR =1.89,95% CI 1.39,2.59)compared with control group.TNF-αblockers could also reduce the rate of colectomy (OR =0.61,95% CI 0.41,0.89)and improve inflammatory bowel disease questionnaire scores (MD=14.74,95% CI 1 1.43,18.06 ).There was no significant difference between the two groups in all reported adverse effects (OR =1.14,95% CI 0.97,1.34)and serious adverse effects (OR=0.78,95% CI 0.56,1.09).Conclusion Compared with conventional therapy or placebo,TNF-αblocking agents can improve the therapeutics effect on UC in clinical response,clinical remission and mucosal healing,and also can reduce the rate of colectomy. In patients with moderately to severely active UC treated with TNF-α blocking agents,it is easier to achieve the improvement of life quality.TNF-αblocking agents treatment is safe for UC.This conclusion should be verified with more large-scale and high-quality RCTs.