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依替巴肽与罗米司亭治疗持续性或慢性免疫性血小板减少症儿童:系统评价结合间接比较荟萃分析。

Eltrombopag versus romiplostim in treatment of children with persistent or chronic immune thrombocytopenia: a systematic review incorporating an indirect-comparison meta-analysis.

机构信息

Chinese Evidence-based Medicine Center, Sichuan University, Chengdu, China.

Department of Pharmacy, Guizhou Provincial People's Hospital, Guiyang, China.

出版信息

Sci Rep. 2018 Jan 12;8(1):576. doi: 10.1038/s41598-017-19099-8.

Abstract

In absence of direct comparison, we conducted an indirect-comparison meta-analysis to evaluate the efficacy and safety of thrombopoietin-receptor agonists(TPO-RAs) in treatment of pediatric persistent or chronic immune thrombocytopenia(ITP). PubMed, Embase, Cochrane Library, Clinical Trials.gov, China National Knowledge Infrastructure, and Chinese Biomedical Literature Database were searched from their earliest records to May 2017. Randomized controlled trials comparing the TPO-RAs with placebo in pediatric ITP were included. Outcomes included overall response rate(primary), durable response, overall or clinically significant bleeding, the proportion of patients receiving rescue medication, and safety. Five randomized placebo-controlled studies(N = 261) were analyzed. The overall response[Risk Ratio(RR) 0.57, 95% confidence interval(CI) 0.21-1.56], the incidence of adverse events (RR 0.96, 95%CI 0.66-1.39), durable response(RR 2.48, 95%CI 0.31-19.97), and the proportion of patients receiving rescue treatment(RR 0.73, 95%CI 0.20-2.73) were similar between eltrombopag and romiplostim group. Nevertheless, eltrombopag might have lower risk of overall bleeding(RR 0.43, 95%CI 0.23-0.80) and clinically significant bleeding(RR 0.33, 95%CI 0.12-0.89) than romiplostim. This meta-analysis suggests that eltrombopag might be similar to romiplostim in efficacy and safety, but seems to reduce the risk of bleeding compared to romiplostim. Furthermore, cost of the treatment, comorbidity of patients and drug compliance should also be considered in clinical decision making.

摘要

在缺乏直接比较的情况下,我们进行了一项间接比较荟萃分析,以评估血小板生成素受体激动剂(TPO-RA)在治疗儿科持续性或慢性免疫性血小板减少症(ITP)中的疗效和安全性。我们检索了 PubMed、Embase、Cochrane 图书馆、ClinicalTrials.gov、中国国家知识基础设施和中国生物医学文献数据库,检索时间截至 2017 年 5 月。纳入了比较 TPO-RA 与安慰剂治疗儿科 ITP 的随机对照试验。主要结局指标为总体反应率(一级结局)、持久反应、总体或临床显著出血、接受解救药物治疗的患者比例以及安全性。分析了 5 项随机安慰剂对照研究(N=261)。总体反应率[风险比(RR)0.57,95%置信区间(CI)0.21-1.56]、不良反应发生率(RR 0.96,95%CI 0.66-1.39)、持久反应率(RR 2.48,95%CI 0.31-19.97)和接受解救治疗的患者比例(RR 0.73,95%CI 0.20-2.73)在艾曲波帕组和罗米司亭组之间相似。然而,与罗米司亭相比,艾曲波帕可能具有较低的总体出血风险(RR 0.43,95%CI 0.23-0.80)和临床显著出血风险(RR 0.33,95%CI 0.12-0.89)。这项荟萃分析表明,艾曲波帕在疗效和安全性方面可能与罗米司亭相似,但与罗米司亭相比,似乎降低了出血风险。此外,在临床决策中还应考虑治疗费用、患者合并症和药物依从性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eee8/5766584/e85766a994f4/41598_2017_19099_Fig1_HTML.jpg

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