自体外周血干细胞移植治疗乙型肝炎肝硬化失代偿期的长期疗效和安全性临床研究。

A Clinic Study on Long-term Efficacy and Safety of Autologous Peripheral Blood Stem Cell Transplantation in Patients with Decompensated Hepatitis B Cirrhosis.

出版信息

Altern Ther Health Med. 2024 Jan;30(1):160-166.

DOI:

Abstract

OBJECTIVE

To investigate the long-term safety and efficacy of autologous peripheral blood stem cell transplantation (APBSCT) in treating decompensated hepatitis B cirrhosis.

METHODS

In this study, a retrospective analysis was conducted on a cohort of 84 patients diagnosed with decompensated hepatitis B cirrhosis between January 2011 and December 2012. The patients were categorized into two groups based on their treatment approach: the transplantation group, consisting of 34 cases who received APBSCT in addition to medical treatment, and the comprehensive medical treatment (CMT) group, comprising 50 cases who solely received CMT. EPI Data software was used for data input and verification. Survival curves were drawn by Kaplan-Meier method and analyzed by log-rank test. Paired t test and independent sample t test were used for intra-group and inter-group mean comparison of measurement data, respectively. The Mann-Whitney U test is used for non-normally distributed data.

RESULTS

After the ten-year follow-up period, it was found that overall survival (OS) in the transplantation group was markedly higher than that in the CMT (56% vs. 16%, P < .001). Albumin (ALB), prothrombin time (PT), and indocyanine green retention at 15 min (ICG R15) were significantly improved in sequence at 4 to 12 weeks of early treatment in APBSCT group; subsequently, the Acoustic radiation force impulse (ARFI) index and spleen length significantly decreased at 48 weeks. Compared with the CMT group, ALB and PT levels in the APBSCT group continued to recover and eventually stabilize at normal or low-risk levels at subsequent follow-ups up to 8 years. The ten-year prevalence of hepatocellular carcinoma (HCC) in the APBSCT group was markedly lower than that in the CMT group (26% vs. 62%; P = .025). Moreover, APBSCT significantly reduced ascites (χ2 = 6.997, P = .041) and was not associated with any significant adverse events during APBSCT. Based on clinical evidence, APBSCT is a safe and effective treatment for decompensated hepatitis B cirrhosis, resulting in a favorable long-term prognosis with no significant adverse events.

CONCLUSIONS

APBSCT is a relatively safe and effective treatment for decompensated hepatitis B cirrhosis.

摘要

目的

探讨自体外周血干细胞移植（APBSCT）治疗乙型肝炎肝硬化失代偿期的长期安全性和疗效。

方法

本研究对 2011 年 1 月至 2012 年 12 月期间诊断为乙型肝炎肝硬化失代偿期的 84 例患者进行回顾性分析。根据治疗方法将患者分为两组：移植组（n=34）接受 APBSCT 联合内科治疗，综合内科治疗（CMT）组（n=50）仅接受 CMT。使用 EPI Data 软件进行数据录入和验证。采用 Kaplan-Meier 法绘制生存曲线，对数秩检验进行分析。配对 t 检验和独立样本 t 检验分别用于组内和组间计量资料的均值比较。Mann-Whitney U 检验用于非正态分布数据。

结果

经过 10 年的随访，发现移植组的总生存率（OS）明显高于 CMT 组（56%比 16%，P<.001）。APBSCT 组在早期治疗的 4 至 12 周时，白蛋白（ALB）、凝血酶原时间（PT）和 15 分钟吲哚氰绿潴留率（ICG R15）明显改善；随后，48 周时声辐射力脉冲（ARFI）指数和脾脏长度明显下降。与 CMT 组相比，APBSCT 组的 ALB 和 PT 水平持续恢复，在随后的 8 年随访中最终稳定在正常或低危水平。APBSCT 组 10 年肝癌（HCC）患病率明显低于 CMT 组（26%比 62%；P=.025）。此外，APBSCT 显著减少腹水（χ2=6.997，P=.041），且在 APBSCT 过程中无明显不良反应。基于临床证据，APBSCT 是治疗乙型肝炎肝硬化失代偿期的一种安全有效的方法，可改善预后，且无明显不良反应。