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目的 分析我国公共脐血库提供的脐血用于移植治疗恶性血液病的疗效和安全性,并探讨我国公共脐血库脐血的质量控制体系.方法 回顾性分析2008年5月至2016年12月因恶性血液病接受单份非血缘脐血移植(sUCBT)治疗的409例受者的临床资料,对各脐血库脐血在冷冻前、复苏后的总有核细胞数(TNC)、CD34+细胞数、细胞回收率与移植效果进行对比分析.结果 409份脐血分别来自我国7家(8个)公共脐血库.409份脐血TNC在冷冻前、小管复苏后及大袋复苏后的均数分别为18.5×108/L、16.34×108/L和15.86×108/L,小管复苏后及大袋复苏后的TNC数量较冷冻前均显著减少(P=0.000).小管复苏后和大袋复苏后的TNC平均回收率分别为88.5％和85.9％,各脐血库间回收率的比较,差异均有显著统计学意义(P=0.000).冷冻前与小管复苏后的CD34+细胞数均数分别为11.18×106/L和8.68×106/L(P=0.000),小管复苏后CD34+细胞的平均回收率为80.75％,各脐血库间的CD34+细胞数回收率的差异均有显著统计学意义(P=0.000).409例受者移植后42 d粒系累积植入率为95.4％,植入时间中位数为17 d(11～38 d),移植后120 d血小板累积植入率为84.6％,植入时间中位数为36 d(14～93 d),移植后60 d红系累积植入率为92％,植入时间中位数为22 d(9～60 d),各脐血库脐血在移植后粒系、血小板和红系累积植入率比较,差异均有统计学意义(P=0.004,P=0.01,P=0.0002).移植后100 d受者Ⅱ～Ⅳ度和Ⅲ～Ⅳ度急性移植物抗宿主病(aGVHD)发生率分别为28.63％和15.7％,各脐血库脐血在移植后aGVHD发生率的差异均无统计学意义(P=0.809,P=0.68);409例受者移植后3年白血病复发率为15.89％,总体存活率(OS)为66.7％,无白血病复发存活率(DFS)为59％,无GVHD及白血病复发存活率(GRFS)为54.3％,各脐血库脐血移植后白血病复发率、OS、DFS及GRFS的差异均无统计学意义(P=0.898,P=0.566,P=0.703,P=0.449).结论 我国公共脐血库提供的脐血用于移植治疗恶性血液病的安全性较高,移植效果良好,但需要建立我国公共脐血库标准化、规范化的脐血质量控制体系.

Objective To study the curative efficacy and safety of single-unit umbilical cord blood transplantation (sUCBT) for malignant hematologic diseases,which is provided by China's public cord blood bank.Methods We retrospectively analyzed 409 cases of malignant hematologic diseases who accepted myeloablative single-unit unrelated donor UCBT without ATG at our center between May 2008 and December 2016.A comparative analysis was made on the total nuclear cells (TNC) of the umbilical cord blood before freezing and after thawing,the cells of CD34+,the recovery rate of cells and the clinical effect of UCBT.Result 409 units of umbilical cord blood used in UCBT respectively came from eight China's public cord blood banks.The average TNC of 409 units of umbilical cord blood before freezing and after the tubular recovery were respectively 18.5 × 108 and 16.34 × 108 (p =0.000).The average recovery rate of the tubular recovery was 88.5％,and there was significant difference among cord blood banks (P =0.000).The average TNC of umbilical cord blood before freezing and transfusion were respectively 18.5 × 108 and 15.86 × 108 (p =0.000).The average recovery rate of umbilical cord blood transfusion was 85.9％,with the difference being significant among cord blood banks (P =0.000).The average number of CD34+ cells before freezing and after the tubular recovery was 11.18 × 106and 8.68 × 106 (p =0.000).The average recovery rate of CD34+ cells after the tubular recovery was 80.75 ％,with the difference being significant among the cord blood banks (P =0.000).At 42nd day after UCBT,the cumulative incidence of neutrophil engraftment was 95.4％,and the median time of the engraftment was 17 days (11-38 days).The cumulative incidence of platelet engraftment at 120th day was 84.6％,and the median time of the engraftment was 36 days (14-93 days).The cumulative incidence of erythrocyte engraftment at 60th day was 92％,and the median time of engraftment was 22 days (9d-60 days).After the umbilical cord blood provided by each bank was used in UCBT,it got the difference in cumulative incidence of engraftment.The P values for cumulative incidence of neutrophil,platelet and erythrocyte engraftment were respectively 0.004,0.01 and 0.000 2,with the differences being statistically significant.At 100th day after UCBT,the cumulative incidence of Ⅱ-Ⅳ and Ⅲ-Ⅳ degrees of acute graft-versus-host disease (aGVHD) was respectively 28.63％ and 15.7％.After umbilical cord blood provided by each bank was used in UCBT,it got the difference in cumulative incidence of aGVHD.There was no significant difference between Ⅱ-Ⅳ and Ⅲ-Ⅳ degrees (P =0.809 and 0.68 respectively).At 3rd year after UCBT,the cumulative incidence of relapse was 15.89％.After umbilical cord blood provided by each bank was used in UCBT,there was no significant difference in the cumulative incidence of relapse (P =0.898).At 3rd year after UCBT,the overall survival (OS) rate and disease free survival (DFS) rate were respectively 66.7％ and 59％.After umbilical cord blood provided by each bank was used in UCBT,it got the difference in OS and DFS.There was no significant difference in OS and DFS (P =0.566 and 0.703 respectively).At 3rd year after sUCBT,the rate of graft-versus-host diseases/relapse-free survival (GRFS) was 54.3％.After umbilical cord blood provided by each bank was used in UCBT,there was no significant difference in the rate of GRFS (P =0.449).Conclusion The umbilical cord blood provided by China's public cord blood bank was used in UCBT.It has a high safety and good efficacy in treating malignant hematologic diseases.But it needs to set up the standardized and normalized quality-control system of umbilical cord blood for China's public cord blood bank.