人脐带间充质干细胞治疗肝硬化腹水患者的安全性

Prospective controlled trial of safety of human umbilical cord derived-mesenchymal stem cell transplantation in patients with decompensated liver cirrhosis

目的评价人脐带间充质干细胞（UC—MSCs）治疗肝硬化腹水患者1年的安全陛。方法采用前瞻性对照、单盲分组法，将本中心收治的54例肝硬化腹水患者进行分组，其中38例为治疗组，接受UC-MSCs外周静脉回输治疗；16例为对照组，给予等渗盐水回输，两组均同时行综合内科治疗。观察两组患者Uc州Scs回输术后在临床症状、不良反应、并发症及肾功能、白细胞计数及凝血功能等的变化情况。组间数据比较采用非参数两独立样本Matin-Whitney U检验；回输前后数据比较采用非参数两配对样本Wilcoxon检验；并发症发生率比较采用描述统计的列联表分析。结果UC—MSCs回输治疗后，大多数患者的乏力、纳差、腹胀、失眠等症状均不同程度改善；除个别患者体温有自限性升高外，无其他不良反应；治疗组与对照组的原发性肝癌发生率差异无统计学意义（1／38对比1／16，P〉0．05）；UC—MSCs回输对患者的血糖、胆固醇、尿素氮、甲胎蛋白、白细胞计数、凝血酶原活动度均无明显影响。结论人UC—MSCs治疗肝硬化腹水患者安全陛好，能改善患者的临床症状，具有良好的临床应用前景。

Objective To evaluate the safety of human umbilical cord derived-mesenchymal stem cell （UC-MSC） transplantation therapy in patients with decompensated liver cirrhosis. Methods UC-MSCs were transplanted intravenously into patients with decompensated liver cirrhosis. Serum levels of glucose （GLU）, total cholesterol （TC）, blood urea nitrogen （BUN）, alpha fetoprotein （AFP）, white blood cells （WBC）, and prothrombin activity （PA） were detected at different time points after UC-MSCs transplantation. Results Most UC-MSC transplanted patients experienced an improvement in quality of life, to varying degrees. With the exception of low-grade fever in a few patients, side effects and oncogenic events were rare （treatment group： 1/38 vs. control group： 1/16; P〉0.05）. The UC-MSCs transplantation showed no effect on GLU, TC, BUN, AFP, WBC, or PA. Conclusion UC-MSCs transplantation in patients with decompensated liver cirrhosis is safe and may improve the patient＇s quality of life.