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选择性白细胞去除术治疗溃疡性结肠炎的疗效和安全性:荟萃分析。

The efficacy and safety of selective leukocytapheresis in the treatment of ulcerative colitis: a meta-analysis.

机构信息

Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Disease, Shanghai Jiao Tong University School of Medicine, Shanghai, 200001, China.

出版信息

Int J Colorectal Dis. 2011 Aug;26(8):999-1007. doi: 10.1007/s00384-011-1193-9. Epub 2011 Apr 8.

Abstract

PURPOSE

The use of selective leukocytapheresis for the treatment of ulcerative colitis (UC) has been evaluated in several open and controlled trials, with varying outcomes. A meta-analysis was performed to better assess the efficacy and safety of selective leukocytapheresis as supplemental therapy compared with conventional pharmacotherapy in patients with UC.

METHODS

All randomized trials comparing selective leukocytapheresis supplementation with conventional pharmacotherapy were included from electronic databases and reference lists. A meta-analysis that pooled the outcome effects of leukocytapheresis and pharmacotherapy was performed. A fixed effect model or random effect model was selected depending on the heterogeneity test of the trials.

RESULTS

Nine randomized controlled trials met the inclusion criteria contributing a total of 686 participants. Compared with conventional pharmacotherapy, leukocytapheresis supplementation presented a significant benefit in promoting a response rate (OR, 2.88, 95% CI: 1.60-5.18) and remission rate (OR, 2.04; 95% CI, 1.36-3.07) together with significant higher steroid-sparing effects (OR, 10.49; 95% CI, 3.44-31.93) in patients with active moderate-to-severe UC by intention-to-treat analysis. Leukocytapheresis was more effective in maintaining clinical remission for asymptomatic UC patients than conventional therapy (OR, 8.14; 95% CI, 2.22-29.90). The incidence of mild-moderate adverse effects was much less frequent in the leukocytapheresis groups than conventional pharmacotherapy groups (OR, 0.16; 95% CI, 0.04-0.60). Few severe adverse events were observed.

CONCLUSIONS

Current data indicate that leukocytapheresis supplementation may be more efficacious on improving response and remission rates and tapering corticosteroid dosage with excellent tolerability and safety than conventional pharmacotherapy in patients with UC. In addition, more high-quality randomized controlled trials are required to confirm the higher efficacy of leukocytapheresis in patients with UC.

摘要

目的

已有多项开放和对照试验评估了选择性白细胞去除术治疗溃疡性结肠炎(UC)的效果,结果不一。本研究通过荟萃分析,更好地评估了与常规药物治疗相比,选择性白细胞去除术作为补充疗法治疗 UC 患者的疗效和安全性。

方法

从电子数据库和参考文献列表中纳入所有比较选择性白细胞去除术联合常规药物治疗的随机试验。对白细胞去除术和药物治疗的疗效进行荟萃分析。根据试验的异质性检验,选择固定效应模型或随机效应模型。

结果

9 项随机对照试验符合纳入标准,共纳入 686 例患者。与常规药物治疗相比,白细胞去除术联合治疗在促进缓解率(OR,2.88,95%CI:1.60-5.18)和缓解率(OR,2.04;95%CI,1.36-3.07)方面具有显著优势,且具有更高的类固醇保留效果(OR,10.49;95%CI,3.44-31.93)。根据意向治疗分析,白细胞去除术对活动期中重度 UC 患者的疗效优于常规治疗。白细胞去除术在维持无症状 UC 患者的临床缓解方面比常规治疗更有效(OR,8.14;95%CI,2.22-29.90)。白细胞去除术组的轻度-中度不良反应发生率明显低于常规药物治疗组(OR,0.16;95%CI,0.04-0.60)。很少观察到严重不良事件。

结论

现有数据表明,与常规药物治疗相比,白细胞去除术联合治疗可能更有效改善 UC 患者的缓解率和缓解率,减少皮质类固醇剂量,且具有良好的耐受性和安全性。此外,需要更多高质量的随机对照试验来证实白细胞去除术在 UC 患者中的更高疗效。

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