人脐带间充质干细胞治疗失代偿性乙型肝炎肝硬化的安全性与疗效

Safety and efficacy of human umbilical cord derived-mesenchymal stem cell transplantation for treatingpatients with HBV-related decompensated cirrhosis

目的回顾性研究人脐带间充质干细胞（UC—MSC）治疗乙型肝炎相关性肝硬化失代偿期（HBV—D-LC）患者的疗效和安全．陛。方法入组HBV—D—LC患者60例，给予综合治疗联合静脉输注UC—MSC，UC—MSC细胞剂量为（0．5～1．0）×10^6个／kg，每月1次，共输注3次；按照1：2原则匹配120例HBV-D—LC患者作为对照组，给予综合治疗，匹配因素包括年龄、性别、诊断和随访时间。收集并记录观察组输注UC—MSC前后及对照组随访期间的血清生物化学指标、血常规、腹部B型超声、CT和（或）MRI检查、Child-Pugh评分及不良反应等数据。计量资料比较采用两独立样本t检验；计数资料比较采用x^2检验。结果与对照组相比，观察组在回输UC—MSC后12周以及24周胆碱酯酶和白细胞水平显著升高垆〈0．05）；12周、24周和96周球蛋白水平明显升高（P〈0．05）；12周、24周和48周的碱性磷酸酶水平有明显升高（P〈0．05）；Child—Pugh评分在12周开始降低（尸〈0．05）。但两组问丙氨酸转氨酶、天冬氨酸转氨酶、总胆红素、白蛋白、总胆固醇、甘油三酯、肾脏功能指标和凝血酶原活动度等指标变化差异无统计学意义妒〉0．05）。结论人UC—MSC治疗可有效改善HBV—D—LC患者的胆碱酯酶和白细胞水平，降低Child-Pugh评分，且安全性良好，具有一定的临床应用前景。

Objective To retrospectively investigate the efficacy of human umbilical cord-derived mesenchymal stem cells （UC-MSC） as clinical treatment for HBV-related decompensated liver cirrhosis （HBV- DLC）oD. Methods Sixty patients with HBV-DLC were given standard medical treatment combined with a 3-month regimen of UC-MSC at a dose of 0.5-1.0×10^6 cells/kg/month. Another group of patients with HBV-DLC （n=120; control group） that was matched （2：1） to the case group by age, sex, diagnosis, and follow-up period was given the standard medical treatment only. We reviewed all patients＇ data of biochemical tests, imaging examinations, Child-Pugh scores, and adverse reactions. Comparisons of continuous data between the two groups were made by independent-sample t-test, and comparisons of categorical data were made by chi-square test. Results Compared with the control group, the group that received the combination UC-MSC treatment showed a significant rise in cholinesterase, globulin and alkaline phosphatase, and reduced Child-Pugh scores during the follow-up period.However, there was no significant difference between the groups of patients for levels of alanine transaminase, total bilimbin, albumin, total cholesterol, or prothrombin activity. Conclusions Addition of the UC-MSC treatment to the standard therapy could help to improve liver function in patients with HBV-DLC.