抗肿瘤坏死因子单抗对溃疡性结肠炎治疗的系统评价

Anti-tumor necrosis factor monoclonal antibody for ulcerative colitis:A systematic review

目的系统评价抗肿瘤坏死因子单抗(anti-TNF)治疗溃疡性结肠炎的疗效和安全性。方法计算机检索中国生物医学文献光盘数据库、Cochrane图书馆临床对照试验资料库、MEDLINE、EMbase和SCIE等数据库,收集抗肿瘤坏死因子单抗与安慰剂治疗溃疡性结肠炎的随机对照试验,采用Cochrane协作网推荐的RevMan4.2软件对数据进行统计分析。结果共纳入8个RCT,包括598例患者。结果①临床缓解率:微生态制剂加氨基水杨酸类制剂联合治疗优于氨基水杨酸类制剂,OR为2.48[95%CI,(1.54,4.00)];②临床有效率:两组未见差异,OR为2.64[95%CI,(0.64,5.88)];③总缓解率:微生态制剂加氨基水杨酸类制剂联合治疗优于氨基水杨酸类制剂,OR为7.38[95%CI,(1.65,33.06)];④临床复发率:微微生态制剂加氨基水杨酸类制剂联合治疗优于氨基水杨酸类制剂,OR为0.22[95%CI,(0.05,0.87)]。结论现有的证据显示,在诱导缓解溃疡性结肠炎临床症状和预防复发方面,微生态制剂加氨基水杨酸类制剂联合治疗优于单用氨基水杨酸类制剂。

Objective To systematically evaluate the efficacy and safety of anti-tumor necrosis factor monoclonal antibody（anti-TNF McAb） for ulcerative colitis（UC）.Methods We searched the database of Chinese Biology Medicine,the Controlled Trials Register of Cochrane Library,MEDLINE,EMbase and SCIE for randomized controlled trials（RCTs） with anti-TNF McAb plus placebo for UC.Meta-analyses were conducted to the collected data with RevMan 4.2 software recommended by the Cochrane Collaboration.Results Eight RCTs involving 598 patients were included in the study.The results were as follows.① Clinical remission rate：The combination of probiotic agents and aminosalicylates was superior to aminosalicylates alone for inducing remission of acute UC with OR being 2.48[95% CI,（1.54,4.00）].② Clinical response rate：Two groups showed no difference with OR being 2.64 [95% CI,（0.64,5.88）].③ Overall response rate：The combination of probiotic agents and aminosalicylates was superior to aminosalicylates alone with OR being 7.38 [95% CI,（1.65,33.06）].④ Clinical relapse rate：Probiotic agents plus aminosalicylates were better than aminosalicylates alone with OR being 0.22 [95% CI,（0.05,0.87）].Conclusion The combination of probiotic agents and aminosalicylates is superior to aminosalicylates alone in inducing remission and preventing relapse of UC.