Long-Term Albumin administration: a survival benefit in cirrhotic refractory ascites beyond TIPS eligibility

IF 4 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Digestive and Liver Disease Pub Date : 2024-09-01 DOI:10.1016/j.dld.2024.08.029
V. Calvaruso, A. Lombardo, L. Capodicasa, D. Alaimo, F. Simone, F. Mercurio, A. Zimbardo, N. Alessi, C. Celsa, G. Pennisi, G. Cabibbo, S. Petta, C. Cammà, V. Di Marco
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Abstract

Background and Aims

Evidence suggests that long-term albumin administration (LTA) prolongs overall survival in patients with cirrhosis and refractory ascites. However, LTA is not yet standard care, and the effects of its combination with TIPS (Transjugular Intrahepatic Portosystemic Shunt) placement remains unclear.

Methods

This observational study compared two groups of patients with cirrhosis and ascites who required at least one large volume paracentesis (LVP). The first group, observed from January 2019 to December 2021, received standard medical treatment (SMT: diuretics and albumin administration after LVP). The second group, observed from January 2022 to February 2024, received SMT plus LTA at a dosage of 40 mg/week. The primary endpoint was mortality and the cause-specific Cox model was used to estimate covariate effects. The Fine and Gray competing risks regression model was used account for death, and LT as competing risk.

Results

A total of 153 patients were analyzed: 63 in the SMT+LTA group and 90 in the SMT group. No differences in liver disease etiology, age, gender, Child-Pugh score, presence of Hepatocellular Carcinoma(HCC), Hepatic Encephalopathy(HE), and eligibility for TIPS and OLT are observed between the two groups.

During the follow-up(median 9 months; range 2-67), 11 patients in the LTA group(17.4%) and 9 in the SMT group(10%) underwent TIPS(p=ns), 7(11.1%) and 8(9%) patients were transplanted in LTA and SMT group respectively(p=ns), and 16 patients in the LTA group(25.4%) versus 71 in the SMT group(79%) died(p<0.001).

Multivariate analysis showed that LTA(HR:0.16; p<0.001), creatinine(HR:1.40; p=0.025), bilirubin (HR:1.16; p=0.014), viral etiology (HR:0.24; p=0.013), and TIPS placement (HR:0.10; p<0.001) were independently associated with mortality. The same results were observed when substituting TIPS placement with TIPS eligibility (Figure 1).

Conclusions

For patients with refractory ascites, LTA in addition to SMT significantly prolongs overall survival and may serve as a disease-modifying treatment, particularly for those contraindicated for TIPS.

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长期服用白蛋白:肝硬化难治性腹水患者的生存获益超出了 TIPS 的资格范围
背景和目的有证据表明,长期服用白蛋白(LTA)可延长肝硬化和难治性腹水患者的总生存期。方法这项观察性研究比较了两组至少需要一次大容量腹腔穿刺术(LVP)的肝硬化腹水患者。第一组的观察时间为 2019 年 1 月至 2021 年 12 月,接受标准医疗治疗(SMT:LVP 后使用利尿剂和白蛋白)。第二组的观察时间为 2022 年 1 月至 2024 年 2 月,接受 SMT 加 LTA 治疗,剂量为 40 毫克/周。主要终点是死亡率,采用特定病因 Cox 模型估计协变量效应。结果 共分析了 153 名患者:SMT+LTA 组 63 人,SMT 组 90 人。两组患者在肝病病因、年龄、性别、Child-Pugh 评分、是否存在肝细胞癌(HCC)、肝性脑病(HE)以及是否符合 TIPS 和 OLT 的条件等方面均无差异。在随访期间(中位 9 个月;范围 2-67),LTA 组有 11 名患者(17.4%)和 SMT 组有 9 名患者(10%)接受了 TIPS(P=ns),7 名患者(11.1%)和 8 名患者(9%)接受了 OLT(P=ns)。LTA组和SMT组分别有7例(11.1%)和8例(9%)患者进行了移植(p=ns),LTA组有16例(25.4%)患者死亡,而SMT组有71例(79%)患者死亡(p<0.001)。多变量分析显示,LTA(HR:0. 16;p<0.001)、肌酐(HR:1.40;p=0.025)、胆红素(HR:1.16;p=0.014)、病毒病因(HR:0.24;p=0.013)和TIPS置入(HR:0.10;p<0.001)与死亡率独立相关。结论对于难治性腹水患者,除 SMT 外,LTA 还能显著延长总生存期,可作为一种疾病调节治疗方法,尤其适用于那些有 TIPS 治疗禁忌症的患者。
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来源期刊
Digestive and Liver Disease
Digestive and Liver Disease 医学-胃肠肝病学
CiteScore
6.10
自引率
2.20%
发文量
632
审稿时长
19 days
期刊介绍: Digestive and Liver Disease is an international journal of Gastroenterology and Hepatology. It is the official journal of Italian Association for the Study of the Liver (AISF); Italian Association for the Study of the Pancreas (AISP); Italian Association for Digestive Endoscopy (SIED); Italian Association for Hospital Gastroenterologists and Digestive Endoscopists (AIGO); Italian Society of Gastroenterology (SIGE); Italian Society of Pediatric Gastroenterology and Hepatology (SIGENP) and Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD). Digestive and Liver Disease publishes papers on basic and clinical research in the field of gastroenterology and hepatology. Contributions consist of: Original Papers Correspondence to the Editor Editorials, Reviews and Special Articles Progress Reports Image of the Month Congress Proceedings Symposia and Mini-symposia.
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