本文由小咖机器人翻译整理

期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-023-02794-7

摘要内容如下：

接受血液透析的肾衰竭患者发生血栓栓塞事件的风险升高。凝血因子（F）Xi是凝血的内在途径，它正在成为新的抗凝剂的一个有吸引力的靶点，可能比现有的药物更安全。Osocimab-一种抑制性FXIA抗体-是这类患者的一种潜在治疗选择。我们进行了一项第2B期、双盲、安慰剂对照试验，其中704名接受血液透析的肾衰竭患者（男性448名，女性256名）随机接受较低或较高剂量的osocimab或安慰剂。总共有686名参与者（436名男性，250名女性）接受了≤18个月的治疗（计划最短治疗期为6个月）。共同主要转归为临床相关出血（严重出血和临床相关非严重出血的复合转归）和中度、重度或严重不良事件发生率的复合转归。分别有16/232（6.9%）和11/224（4.9%）名接受低剂量和高剂量osocimab治疗的受试者以及18/230（7.8%）名接受安慰剂治疗的受试者发生临床相关出血。对于复合不良事件终点，低剂量osocimab组、高剂量osocimab组和安慰剂组的发生率分别为51%、47%和43%。这些结果表明，osocimab与出血的低风险相关，并且在该人群中具有良好的耐受性。需要在大型试验中确认的发现。ClinicalTrials.gov标识符，NCT04523220。

英文原文如下：

Abstracts

Individuals with kidney failure undergoing hemodialysis are at elevated risk for thromboembolic events. Factor (F) XI, which is in the intrinsic pathway of coagulation, is emerging as an attractive target for new anticoagulants that may be safer than existing agents. Osocimab-an inhibitory FXIa antibody-is a potential treatment option for such patients. We conducted a phase 2b, double-blind, placebo-controlled trial, in which 704 participants (448 male, 256 female) with kidney failure undergoing hemodialysis were randomized to receive lower- or higher-dose osocimab or placebo. In total, 686 participants (436 male, 250 female) received treatment for ≤18 months (planned minimal treatment period of 6 months). The co-primary outcomes were clinically relevant bleeding (a composite of major and clinically relevant nonmajor bleeding) and a composite of the incidence of moderate, severe or serious adverse events. Clinically relevant bleeding occurred in 16/232 (6.9%) and 11/224 (4.9%) participants who received lower- and higher-dose osocimab, respectively, and in 18/230 participants (7.8%) who received a placebo. For the composite adverse event endpoint, incidences were 51%, 47% and 43% in the lower-dose osocimab, higher-dose osocimab and placebo groups, respectively. These results suggest that osocimab is associated with a low risk of bleeding and is generally well tolerated in this population; findings that require confirmation in larger trials. ClinicalTrials.gov identifier, NCT04523220 .

-----------分割线---------

点击链接：https://www.mediecogroup.com/community/user/vip/categories/ ，成为医咖会员，获取12项专属权益。

现在购买可享受最大优惠（买一年送三个月，买两年送一年），2024年2月10日起将不再享有该优惠。