Department of Pharmacy, Guizhou Provincial People's Hospital, Guiyang, China.
Chinese Evidence-based Medicine Center, Sichuan University, Chengdu, China.
PLoS One. 2018 Jun 1;13(6):e0198504. doi: 10.1371/journal.pone.0198504. eCollection 2018.
In absence of direct comparison randomized controlled trials (RCTs), indirect comparison was conducted to evaluate the efficacy and safety of thrombopoietin-receptor agonists (TPO-RAs) in treatment of adult immune thrombocytopenia (ITP).
We searched PubMed, Embase and Cochrane Library, Clinical Trials.gov, China National Knowledge Infrastructure, and Chinese Biomedical Literature Database from their earliest records to May 2017. RCTs comparing the TPO-RAs with placebo in adult ITP were included. Primary outcomes were the overall response rate. Secondary outcomes included safety, durable response, overall or clinically significant bleeding, and the proportion of patients receiving rescue medication.
Nine randomized placebo-controlled trials (786 participants) were included in this systematic review. Overall response [Risk Ratio(RR) = 0.59, 95%Confidence Interval(CI): 0.24-1.45], the incidence of adverse events (RR = 0.98, 95%CI: 0.79-1.21), durable response (RR = 0.47, 95%CI: 0.08-2.81), the incidence of overall bleeding (RR = 1.15, 95%CI: 0.52-2.57) and clinically significant bleeding (RR = 1.09, 95%CI: 0.37-3.24), and the proportion of patients receiving rescue treatment (RR = 0.95, 95%CI: 0.47-1.90) were similar between eltrombopag and romiplostim.
Eltrombopag and romiplostim might be equivalent in efficacy and safety for adult ITP, however, physicians should still take into account drug cost and comorbidities of the specific patient while making decisions on the treatment of ITP with TPO-RAs.
PROSPERO International Prospective Register of Systematic Review (PROSPERO 2017: CRD42017068661).
在缺乏直接比较的随机对照试验(RCT)的情况下,进行间接比较以评估血小板生成素受体激动剂(TPO-RA)在成人免疫性血小板减少症(ITP)治疗中的疗效和安全性。
我们检索了 PubMed、Embase 和 Cochrane Library、ClinicalTrials.gov、中国国家知识基础设施(CNKI)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 与安慰剂治疗成人 ITP 的 RCT。主要结局为总体反应率。次要结局包括安全性、持久反应、总体或临床显著出血以及接受解救药物治疗的患者比例。
本系统评价纳入了 9 项随机安慰剂对照试验(786 名参与者)。总体反应[风险比(RR)=0.59,95%置信区间(CI):0.24-1.45]、不良反应发生率(RR=0.98,95%CI:0.79-1.21)、持久反应(RR=0.47,95%CI:0.08-2.81)、总体出血发生率(RR=1.15,95%CI:0.52-2.57)和临床显著出血发生率(RR=1.09,95%CI:0.37-3.24)以及接受解救治疗的患者比例(RR=0.95,95%CI:0.47-1.90)在艾曲波帕和罗米司亭之间相似。
艾曲波帕和罗米司亭在治疗成人 ITP 的疗效和安全性方面可能相当,然而,医生在决定使用 TPO-RA 治疗 ITP 时,仍应考虑药物成本和患者的合并症。
PROSPERO 国际前瞻性系统评价注册(PROSPERO 2017:CRD42017068661)。