摘要
目的 运用循证药学的方法评价阿伐曲泊帕用于治疗免疫性血小板减少症(ITP)的临床证据,为超说明书用药提供循证依据。方法 系统检索PubMed、Embase、Cochrane Library、中国知网、维普网和万方数据库,并采用AMSTAR-2对文献进行质量评价;同时检索国外药品说明书及Micromedex循证数据库,提取相应信息。结果 共纳入5篇Meta分析,以及FDA、EMA药品说明书、循证数据库Micromedex、4项专家共识。阿伐曲泊帕与安慰剂相比能显著改善血小板反应、血小板早期反应、血小板持续反应,并减少治疗ITP的联合用药;血小板反应同样优于艾曲泊帕、罗普司亭、海曲泊帕、利妥昔单抗单药或联合重组人血小板生成素(rhTPO);血小板早期反应也优于利妥昔单抗;阿伐曲泊帕出血事件发生率均显著低于安慰剂、艾曲泊帕和罗普司亭。安全性方面,阿伐曲泊帕不良事件发生率与安慰剂、艾曲泊帕和罗普司亭相比也没有显著性差异;阿伐曲泊帕严重不良反应事件与艾曲泊帕、罗普司亭、芦曲泊帕、利妥昔单抗之间均无显著性差异。5项Meta分析的质量评价为极低或低。结论 阿伐曲泊帕用于治疗既往治疗反应不佳的成人慢性ITP患者具有较好的疗效,但目前的证据有限,且质量较低,需要更多高质量的RCT研究,提供更好的循证支持。
OBJECTIVE Evaluate the evidence of avatrombopag in the treatment of primary immune thrombocytopenia to provide evidence-based basis for the off-label drug use of avatrombopag.METHODS Systematic reviews/Meta-analyses of avatrombopag on primary immune thrombocytopenia were searched using the following database:PubMed,Embase,Cochrane Library,CNKI,VIP and Wanfang database,The A Measurement Tool to Assess Systematic Reviews 2(AMSTAR 2) scale was used to evaluate the methodological quality of the included studies.And foreign drug instruction website and Micromedex evidence-based database were also searched and data were extracted.RESULTS A total of five Meta-analyses,the FDA and EMA package insert,data from Micromedex,four 4 expert consensuses were included.Compared with placebo,avatrombopag statistically significant improvements in platelet response,early platelet responses,durable platelet response,reduction in use of concomitant ITP medication.Avatrombopag is preferred over eltrombopag,romiplostim,hetrombopag,rituximab alone or in combination with recombinant human thrombopoietin(rhTPO) for platelet response.Early platelet response is also superior to rituximab.And the incidence of bleeding events in avatrombopag was significantly lower than that of placebo,eltrombopag and romiplostim.In terms of safety,there was no significant difference in the incidence of adverse events between avatrombopag and placebo,eltrombopag and romiplostim.Avatrombopag produced more satisfactory outcomes than placebo,eltrombopag,and romiplostim in terms of incidence of bleeding episodes.Severe AEs profiles were similar across all 5 arms.One study was of low quality and five were of very-low quality in methodological quality.CONCLUSION Avatrombopag was effective in the treatment of Immune thrombocytopenia,Chronic;with insufficient response to previous treatment.The evidence-based basis of avatrombopag is insufficient and low-quality.More high-quality researches are still needed for further investigation.
作者
彭惠芳
洪玮莉
陈曼娜
余靓平
PENG Hui-fang;HONG Wei-li;CHEN Man-na;YU Liang-ping(Zhongshan Hospital Affiliated to Xiamen University,Xiamen 361004,China)
出处
《海峡药学》
2024年第11期76-80,共5页
Strait Pharmaceutical Journal
