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阿伐曲泊帕治疗血小板减少症患者的疗效和安全性:一项随机对照试验的系统评价和荟萃分析

Efficacy and Safety of Avatrombopag in Patients With Thrombocytopenia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

作者信息

Li Chunlu, Li Xiaoxuan, Huang Feihong, Yang Jing, Wu Anguo, Wang Long, Qin Dalian, Zou Wenjun, Wu Jianming

机构信息

Department of Chinese Materia Medica, School of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu, China.

Laboratory of Chinese Materia Medica, Department of Pharmacology, School of Pharmacy, Southwest Medical University, Luzhou, China.

出版信息

Front Pharmacol. 2019 Jul 26;10:829. doi: 10.3389/fphar.2019.00829. eCollection 2019.

DOI:10.3389/fphar.2019.00829
PMID:31402863
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6677019/
Abstract

Avatrombopag is a novel oral, nonpeptide thrombopoietin receptor agonist (TPO-RA). A few studies have shown that avatrombopag is effective against thrombocytopenia. However, no systematic review has been conducted on the efficacy and safety of avatrombopag. Therefore, the aim of this study was to comprehensively assess the efficacy and safety of avatrombopag patients with thrombocytopenia. Databases including Medline, PubMed, Embase, the Cochrane Library and ClinicalTrials.gov were searched for randomized controlled trials that compared avatrombopag with placebo in patients with thrombocytopenia. The deadline was March 2019. In total, 743 patients were analyzed in five clinical trials. Patients treated with avatrombopag achieved higher platelet response (OR: 17.71, 95% CI [11.01 to 28.48], < 0.00001) than with placebo. Avatrombopag produced an absolute increment in platelet count (WMD: 31.13%, 95% CI [22.27 to 39.99], < 0.00001) unlike the placebo. In addition, the incidence of serious adverse events (RR: 1.18, 95% CI [0.72 to 1.93], = 0.51) and deaths (RR: 0.93, 95% CI [0.19 to 4.45], = 0.93) in patients treated with avatrombopag was not significantly different from that in patients treated with placebo. The incidence of adverse events in patients treated with avatrombopag was slightly higher than that in patients treated with placebo (RR: 1.25, 95% CI [1.05 to 1.49], = 0. 01) after one trial with high heterogeneity was removed. This meta-analysis showed that avatrombopag was an effective treatment for thrombocytopenia, but there is sufficient evidence to indicate that adverse events may occur.

摘要

阿伐曲泊帕是一种新型口服非肽类血小板生成素受体激动剂(TPO-RA)。一些研究表明,阿伐曲泊帕对血小板减少症有效。然而,尚未对阿伐曲泊帕的疗效和安全性进行系统评价。因此,本研究的目的是全面评估阿伐曲泊帕治疗血小板减少症患者的疗效和安全性。检索了包括Medline、PubMed、Embase、Cochrane图书馆和ClinicalTrials.gov在内的数据库,以查找在血小板减少症患者中将阿伐曲泊帕与安慰剂进行比较的随机对照试验。截止日期为2019年3月。共有743例患者在五项临床试验中接受分析。与安慰剂相比,接受阿伐曲泊帕治疗的患者获得了更高的血小板反应(比值比:17.71,95%置信区间[11.01至28.48],P<0.00001)。与安慰剂不同,阿伐曲泊帕使血小板计数产生了绝对增量(加权均数差:31.13%,95%置信区间[22.27至39.99],P<0.00001)。此外,接受阿伐曲泊帕治疗的患者严重不良事件的发生率(风险比:1.18,95%置信区间[0.72至1.93],P=0.51)和死亡发生率(风险比:0.93,95%置信区间[0.19至4.45],P=0.93)与接受安慰剂治疗的患者相比无显著差异。在剔除一项异质性较高的试验后,接受阿伐曲泊帕治疗的患者不良事件发生率略高于接受安慰剂治疗的患者(风险比:1.25,95%置信区间[1.05至1.49],P=0.01)。这项荟萃分析表明,阿伐曲泊帕是治疗血小板减少症的有效药物,但有充分证据表明可能会发生不良事件。

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