Arai Yasuyuki, Matsui Hiroyuki, Jo Tomoyasu, Kondo Tadakazu, Takaori-Kondo Akifumi
Department of Hematology and Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Laboratory of Host Defenses, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States.
TH Open. 2017 Jul 14;1(2):e73-e81. doi: 10.1055/s-0037-1604168. eCollection 2017 Jul.
Corticosteroids have been established as first-line therapy in acute primary immune thrombocytopenia (ITP), and the clinical guidelines recommend either dexamethasone (Dex) or prednisolone (PSL). The types and dosages of corticosteroids, however, have not yet been determined, because previous randomized control trials (RCTs) comparing Dex and PSL showed controversial results in terms of efficacy. To understand and interpret all available evidence, we conducted a systematic review and meta-analysis of RCTs. The main outcome measure was the incidence of sustained response (SR; platelet count >30 × 10 /L for 6 months without concomitant treatments after the completion of the final therapies). Eight RCTs (totaling 704 patients) were included in this study. The incidence of SR showed no significant difference, while it was significantly higher in the Dex arm when used with posttherapy (more than one course of Dex or tapering corticosteroids added; risk ratio [RR], 1.82; 95% confidence interval [CI], 1.38-2.41; < 0.01). A single course of Dex showed no significant difference. The overall response (platelet >30 × 10 /L) at day 28 was significantly improved in the Dex arm (RR, 1.11; 95% CI, 1.01-1.22; = 0.03) and Dex with posttherapy suppressed long-term relapse (RR of nonevent, 1.32; 95% CI, 1.10-1.59; < 0.01). There were significantly fewer adverse events in the Dex arm (RR, 0.45; 95% CI, 0.37-0.55; < 0.01). Use of Dex with posttherapy instead of PSL may be more beneficial as the initial therapy. Studies comparing Dex with other new strategies are essential to determine the most suitable therapeutic regimens for acute ITP.
皮质类固醇已被确立为急性原发性免疫性血小板减少症（ITP）的一线治疗方法，临床指南推荐使用地塞米松（Dex）或泼尼松龙（PSL）。然而，皮质类固醇的类型和剂量尚未确定，因为之前比较Dex和PSL的随机对照试验（RCT）在疗效方面显示出有争议的结果。为了理解和解释所有可用证据，我们对RCT进行了系统评价和荟萃分析。主要结局指标是持续缓解（SR；最终治疗完成后6个月内血小板计数>30×10⁹/L且无伴随治疗）的发生率。本研究纳入了8项RCT（共704例患者）。SR的发生率无显著差异，而在治疗后使用Dex时，Dex组的发生率显著更高（多疗程使用Dex或加用逐渐减量的皮质类固醇；风险比[RR]，1.82；95%置信区间[CI]，1.38 - 2.41；P < 0.01）。单疗程Dex无显著差异。Dex组在第28天时的总体缓解率（血小板>30×10⁹/L）显著提高（RR，1.11；95%CI，1.01 - 1.22；P = 0.03），且治疗后使用Dex可抑制长期复发（无事件RR，1.32；95%CI，1.10 - 1.59；P < 0.01）。Dex组的不良事件明显更少（RR，0.45；95%CI，0.37 - 0.55；P < 0.01）。治疗后使用Dex而非PSL作为初始治疗可能更有益。比较Dex与其他新策略的研究对于确定急性ITP最合适的治疗方案至关重要。
