目的:鞘氨醇1-磷酸受体调节剂(S1PRMs)是溃疡性结肠炎(UC)的有效治疗方法。这篇综述总结了有关S1PRM治疗的疗效和安全性的所有可用随机试验数据。
方法:系统搜索多个出版物数据库,寻找成人中度至重度UC患者接受S1PRM治疗的随机对照试验(RCTs),进行随机效应荟萃分析。使用Cochrane偏差风险2工具评估偏差风险,使用建议分级对证据的总体质量进行评级,评估,发展,和评估(等级)方法。
结果:我们确定了7个RCTs(1737例患者)涉及使用S1PRM治疗中度至重度UC。在感应过程中,与安慰剂相比,S1PRM治疗对临床缓解有效[RR:2.65(95%CI:2.00,3.53)],临床反应[RR:1.68(95%CI:1.48,1.91)],内镜改善[RR:2.17(95%CI:1.76,2.68)],内镜正常化[RR:2.56(95%CI:1.58,3.83)],粘膜愈合[RR:2.88(95%CI:1.94,4.26)],和组织学缓解[RR:2.42(95%CI:1.60,3.66)]。在整个维护周期中都看到了类似的结果,尽管可供汇集的数据较少;特别是,持续[RR:3.57(95%CI:1.23,10.35)]和无类固醇[RR:2.92(95%CI:1.35,6.33)]缓解通过S1PRM显著增加.S1PRM和安慰剂之间的不良事件[RR:1.02(95%CI:0.90,1.15)]和感染[RR:1.15(95%CI:0.82,1.60)]没有显着差异。
结论:收集RCT数据证实,S1PRM治疗对中度至重度UC患者既有效又安全。
OBJECTIVE: Sphingosine 1-phosphate receptor modulators (S1PRMs) are an effective treatment for ulcerative colitis (UC). This review summarizes all available randomized trial data on the efficacy and safety of S1PRM therapy.
METHODS: Multiple publication databases were systematically searched for randomized control trials (RCTs) of adults with moderate to severe UC treated with S1PRMs. Random effects meta-analysis was performed. The risk of bias was assessed using the Cochrane Risk-of-Bias 2 tool, and the overall quality of evidence was rated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.
RESULTS: We identified 7 RCTs (1737 patients) involving the use of S1PRMs for moderate to severe UC. During induction, S1PRM therapy was efficacious when compared with placebo for clinical remission [RR: 2.65 (95% CI: 2.00, 3.53)], clinical response [RR: 1.68 (95% CI: 1.48, 1.91)], endoscopic improvement [RR: 2.17 (95% CI: 1.76, 2.68)], endoscopic normalization [RR: 2.56 (95% CI: 1.58, 3.83)], mucosal healing [RR: 2.88 (95% CI: 1.94, 4.26)], and histologic remission [RR: 2.42 (95% CI: 1.60, 3.66)]. Similar results were seen throughout the maintenance peroid, although fewer data were available to pool; notably, both sustained [RR: 3.57 (95% CI: 1.23, 10.35)] and steroid-free [RR: 2.92 (95% CI: 1.35, 6.33)] remission were significantly increased by S1PRM. There were no significant differences in adverse events [RR: 1.02 (95% CI: 0.90, 1.15)] and infections [RR: 1.15 (95% CI: 0.82, 1.60)] between S1PRM and placebo.
CONCLUSIONS: Pooling of RCT data confirms that S1PRM therapy is both effective and safe for patients with moderate to severe UC.