皮质类固醇联合促血小板生成素受体激动剂治疗成人原发免疫性血小板减少症疗效和安全性的系统评价

Systematic evaluation of the efficacy and safety of corticosteroids combined with thrombopoietin receptor agonists in the treatment of adult primary immune thrombocytopenia

关键词:  成人原发免疫性血小板减少症  皮质类固醇  TPO-RA  疗效  安全性  Meta分析

Key words:  adult  primary immune  thrombocytopenia (ITP), corticosteroids, TPO-RA, efficacy, safety, meta-analysis

摘要:

目的 系统评价皮质类固醇联合促血小板生成素受体激动剂(Thrombopoietin receptor agonists, TPO-RA)类药物治疗成人原发免疫性血小板减少症(Immune Thrombocytopenia,ITP)的有效性及安全性。方法 检索中国知网、维普、万方、CBM、PubMed、EMbase、the Cochrane Library,检索时限为建库至2024 年 12月 23 日。收集皮质类固醇联合TPO-RA类药物治疗成人原发免疫性血小板减少症的随机对照试验(Randomized controlled trial, RCT)。筛选文献、提取数据并进行文献质量评价后,应用 RevMan 5.4及StataNow 18 MP软件进行 Meta 分析。结果 纳入9项RCT，共567例患者。Meta分析结果显示，相比于皮质类固醇或TPO-RA 类药物单药治疗，皮质类固醇联合TPO-RA类药物的临床总有效率显著提高[RR=1.30, 95%CI (1.20, 1.41), P< 0.00001]、升高血小板水平的效果增强[RR=1.59, 95%CI (1.32,1.92), P< 0.00001]；二者的不良反应发生率比较，差异无统计学意义[RR=0.73, 95%CI (0.48, 1.13), P=0.16]。结论 对比单采用皮质类固醇药物,或TPO-RA类药物治疗而言,皮质类固醇联合TPO-RA类药物可以提高治疗成人原发ITP的有效率,改善血小板水平,且未增加不良反应发生风险。

Abstract:

OBJECTIVE To systematically evaluate the efficacy and safety of corticosteroids combined with thrombopoietin receptor agonists (TPO-RAs) in treating adult primary immune thrombocytopenia (ITP). METHODS We searched databases up to December 23, 2024, for randomized controlled trials (RCTs) on this combination. Two reviewers independently screened studies, extracted data, and assessed quality. Meta-analysis was performed using RevMan 5.4 and StataNow 18 MP. RESULTS 9 RCTs involving a total of 567 patients were included. Meta-analysis showed that compared with corticosteroid or TPO-RAs monotherapy, corticosteroid combined with TPO-RAs had significantly higher overall clinical efficacy [RR=1.30, 95%CI (1.20, 1.41), P< 0.00001] and enhanced effect of elevating platelet levels [RR=1.59, 95%CI (1.32, 1.92), P< 0.00001]; the incidence of adverse events was not statistically significant when comparing the two groups [RR=0.73, 95%CI (0.48, 1.13), P=0.16]. CONCLUSION Versus treatment with corticosteroids alone, or TPO-RA, corticosteroids in combination with TPO-RA may improve the efficiency of treating adults with primary ITP and increase platelet levels more effectively. However, there was no statistical difference in the incidence of adverse effects. More high-quality RCTs are needed to further validate the efficacy and safety of corticosteroids combined with TPO-RAs in the treatment of adult primary ITP.