■尽管有限制,血小板输注已被用于降低血小板减少症患者的出血风险.Lusutrombopag是一种口腔,血小板生成素受体激动剂被批准用于治疗计划侵入性手术患者中与慢性肝病相关的血小板减少症.该事后分析根据2个相似的III期多中心的综合方案人群评估了血小板计数变化的幅度。随机化,双盲,安慰剂对照试验。
■患有慢性肝病诱导的血小板减少症和血小板计数<50(×109/L)的成年人在随机分组后9-14天计划的侵入性手术前7天接受lusutrombopag3mg或安慰剂。如果在计划的侵入性手术前不超过2天血小板计数保持<50,则根据方案需要输注血小板。事后分析包括:血小板计数≥50,≥1.5倍增加的患者比例,和血小板计数加倍;血小板计数的最大和最大变化;和血小板计数时程。
■血小板计数≥50,血小板计数增加≥1.5倍,血小板计数至少达到了88.3%的两倍,86.9%,lusutrombopag组52.6%的患者(n=137)与58.6%,32.3%,和6.0%的患者在安慰剂组(n=133),分别。在lusutrombopag组中,基线血小板计数<30,≥30~<40和≥40的中位最大血小板计数分别为46,76和87.基线血小板计数的血小板计数的中位数最大变化分别为+24、+42和+40。接受lusutrombopag而不输注血小板的患者3周的中位血小板计数≥50。
■用lusutrombopag治疗的患者在相当长的时间内经历了血小板计数的临床相关反应。
■因慢性肝病引起的血小板计数低的患者可能不会接受计划的侵入性手术或手术,因为出血风险增加。Lusutrombopag先前已证明在提高血小板计数方面具有功效,并在计划的手术前被批准用于治疗血小板计数低的慢性肝病患者。医生需要更清楚地了解使用lusutrombopag时对血小板计数变化的期望;这种综合分析提供数据来帮助指导其临床应用。
OBJECTIVE: Despite limitations, platelet transfusion has been used to minimise bleeding risk in patients with thrombocytopaenia. Lusutrombopag is an oral, thrombopoietin receptor agonist approved for treatment of thrombocytopaenia associated with chronic liver disease in patients undergoing planned invasive procedures. This post-hoc analysis assessed the magnitude of platelet count change based on the integrated per-protocol population from 2 similar phase III multicentre, randomised, double-blind, placebo-controlled trials.
METHODS: Adults with chronic liver disease-induced thrombocytopaenia and platelet count <50 (× 109/L) received lusutrombopag 3 mg or placebo ≤7 days before invasive procedure scheduled 9-14 days after randomisation. Platelet transfusion was required per protocol if the platelet count remained <50 no more than 2 days before the planned invasive procedure. Post-hoc analysis included: proportion of patients with platelet count ≥50, ≥1.5-fold increase, and a doubling of platelet count; maximum and maximum change in platelet count; and platelet count time course.
RESULTS: Platelet count ≥50, a platelet count increase ≥1.5-fold, and at least a doubling in platelet count were achieved in 88.3%, 86.9%, and 52.6% of patients in the lusutrombopag group (n = 137) vs. 58.6%, 32.3%, and 6.0% of patients in the placebo group (n = 133), respectively. In the lusutrombopag group, median maximum platelet count across baseline platelet counts of <30, ≥30 to <40, and ≥40 was 46, 76, and 87, respectively. Median maximum change in platelet count by baseline platelet count was +24, +42, and +40, respectively. Patients who received lusutrombopag without platelet transfusion achieved a median platelet count ≥50 for 3 weeks.
CONCLUSIONS: Patients treated with lusutrombopag experienced a clinically relevant response in platelet count for a substantial duration of time.
BACKGROUND: Patients with low platelet counts caused by chronic liver disease may not receive planned invasive procedures or surgeries because of an increased risk of bleeding. Lusutrombopag has previously demonstrated efficacy in raising platelet counts and is approved to treat chronic liver disease patients with low platelet counts in advance of a planned surgery. Physicians need to understand more clearly what to expect in terms of platelet count change when using lusutrombopag; this integrated analysis provides data to help guide its clinical application.