Therapeutic Plasma Exchange for Acute and Acute-on-Chronic Liver Failure: A Randomized Pilot Study Comparing Standard- and High-Volume Protocols in a Resource-Limited Setting.
Amany Sholkamy, Ahmed Fayed, Sanaa A Khalil, Amr Osama Elsayed, Ahmad Mohamed Shenawy, Karim M Soliman, Rasha Ahmed Darwish
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引用次数: 0
Abstract
Background: Acute liver failure (ALF) and acute-on-chronic liver failure (ACLF) carry substantial short-term mortality. While liver transplantation is the definitive therapy, access is often delayed in settings reliant on living-donor transplantation, such as Egypt. Therapeutic plasma exchange (TPE) has emerged as a potential bridging strategy, but evidence from resource-limited health systems remains scarce.
Methods: We conducted a prospective randomized pilot study including 46 adults with ALF or ACLF at a tertiary center in Egypt. Participants were assigned to standard medical therapy (SMT; n = 15), standard-volume plasma exchange (SVPE; n = 16), or high-volume plasma exchange (HVPE; n = 15). SVPE involved exchange of 1.5-2.0 plasma volumes per session, whereas HVPE delivered 8-12 L/day for 3 consecutive days. All patients received guideline-based SMT. Changes in alanine aminotransferase (ALT), total bilirubin, international normalized ratio (INR), and MELD-Na score were evaluated alongside procedure-related complications and 90-day mortality.
Results: Both TPE strategies produced greater improvements in ALT, total bilirubin, INR, and MELD-Na compared with SMT alone. HVPE achieved the largest reduction in MELD-Na but was associated with higher rates of catheter-related infection and neurological complications. SVPE demonstrated a more favorable safety-effectiveness profile. Ninety-day mortality was highest with SMT and lower in both TPE groups.
Conclusions: In a resource-limited tertiary setting, protocolized TPE is feasible and may improve short-term outcomes in ALF and ACLF. SVPE may represent a safer and more scalable bridging strategy when immediate access to liver transplantation is limited.
背景:急性肝衰竭(ALF)和急性伴慢性肝衰竭(ACLF)具有大量的短期死亡率。虽然肝移植是最终的治疗方法,但在依赖活体供体移植的环境中,如埃及,获得肝移植往往会延迟。治疗性血浆交换(TPE)已成为一种潜在的过渡性策略,但来自资源有限的卫生系统的证据仍然很少。方法:我们在埃及的一家三级医疗中心进行了一项前瞻性随机试点研究,包括46名患有ALF或ACLF的成年人。参与者被分配到标准药物治疗(SMT, n = 15),标准容量血浆置换(SVPE, n = 16),或高容量血浆置换(HVPE, n = 15)。SVPE每次交换1.5-2.0血浆量,而HVPE连续3天每天交换8-12 L。所有患者均接受基于指南的SMT治疗。评估丙氨酸转氨酶(ALT)、总胆红素、国际标准化比值(INR)和MELD-Na评分的变化以及手术相关并发症和90天死亡率。结果:与单独SMT相比,两种TPE策略在ALT、总胆红素、INR和MELD-Na方面都有更大的改善。HVPE最大程度地降低了MELD-Na,但与较高的导管相关感染和神经系统并发症发生率相关。SVPE表现出更有利的安全性和有效性。SMT组90天死亡率最高,TPE组均较低。结论:在资源有限的三级环境中,协议化TPE是可行的,可以改善ALF和ACLF的短期预后。当立即获得肝移植的机会有限时,SVPE可能是一种更安全、更可扩展的桥接策略。