一种新型的低密度脂蛋白/纤维蛋白原吸附法治疗血管重建选择差的慢性肢体威胁性缺血患者：一项多中心、单臂临床试验。
A novel low-density lipoprotein/fibrinogen apheresis method for chronic limb-threatening ischemia in patients with poor options for revascularization: A multicenter, single-arm clinical trial.
机构信息
Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Japan.
Department of Plastic Surgery, Oita Oka Hospital, Oita, Japan.
出版信息
Ther Apher Dial. 2023 Apr;27(2):361-369. doi: 10.1111/1744-9987.13915. Epub 2022 Aug 16.
INTRODUCTION
Low-density lipoprotein (LDL) apheresis is a treatment option for patients with unhealed chronic limb-threatening ischemia (CLTI) after revascularization. The newly developed AS-25 is a direct hemoperfusion-type apheresis device that differs from conventional LDL apheresis therapy and is designed to specifically adsorb both LDL-C and fibrinogen. We evaluate the efficacy and safety of AS-25.
METHODS
This study included 61 patients whose ulcers failed to heal after revascularization or were ineligible for revascularization. Of these, 50 were undergoing hemodialysis. The primary endpoint was the healing rate of a target lesion of interest (ulcer), using historical data as control.
RESULTS
The ulcer healing rate of 45.9% was significantly higher than the historical data. No significant safety concerns were observed.
CONCLUSIONS
AS-25 was effective in healing ulcers and preventing major amputation even in CLTI refractory patients on hemodialysis, thus showing potential clinical applicability and high significance.
CLINICAL TRIAL REGISTRATION
UMIN study ID UMIN000020336.
简介
低密度脂蛋白（LDL）吸附治疗是血管重建后未愈合的慢性肢体威胁性缺血（CLTI）患者的一种治疗选择。新开发的 AS-25 是一种直接血液灌流型吸附设备，与传统的 LDL 吸附疗法不同，旨在专门吸附 LDL-C 和纤维蛋白原。我们评估了 AS-25 的疗效和安全性。
方法
本研究纳入了 61 例血管重建后溃疡未愈合或不适合血管重建的患者，其中 50 例正在接受血液透析。主要终点是目标病变（溃疡）的愈合率，以历史数据作为对照。
结果
45.9%的溃疡愈合率显著高于历史数据。未观察到明显的安全性问题。
结论
AS-25 对于治疗透析患者难治性 CLTI 引起的溃疡和预防大截肢是有效的，因此具有潜在的临床适用性和重要意义。
临床试验注册
UMIN 研究 ID UMIN000020336。
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