Comparison of cryoprotectants in hematopoietic cell infusion?related adverse events
Comparison of cryoprotectants in hematopoietic cell infusion?related adverse events
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冷冻保护剂在造血细胞输注中相关不良事件的比较
DOI：
10.1111/trf.16877
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发表时间：
2022
期刊：
影响因子：
2.9
通讯作者：
Takahashi Tsut
中科院分区：
文献类型：
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作者：
Ikeda Kazuhiko;Minakawa Keiji;Yamahara Kenichi;Yamada‐Fujiwara Minami;Okuyama Yoshiki;Fujiwara Shin‐ichiro;Yamazaki Rie;Kanamori Heiwa;Iseki Tohru;Nagamura‐Inoue Tokiko;Kameda Kazuaki;Nagai Kazuhiro;Fujii Nobuharu;Ashida Takashi;Hirose Asao;Takahashi Tsut
背景人类细胞制品的标准冷冻保护剂是二甲基亚砜（DMSO），它与包括外周血干细胞（PBSC）移植（PBSCT）在内的造血干细胞移植中的造血细胞输注相关不良事件（HCI-AE）有关。DMSO通常与羟乙基淀粉（HES）一起使用，这降低了DMSO浓度，同时保持了解冻后的细胞恢复。冷冻保护剂介质CP-1（Kyokuto Pharmaceutical Industrial）在日本广泛使用。产品与CP-1混合后，DMSO和HES浓度分别为5%和6%。研究设计和方法为了比较CP-1与其他冷冻保护剂，我们在HCI-AE的前瞻性监测研究中对PBSCT受者进行了亚组分析。结果CP-1组（CP-1组）和非CP-1组（非CP-1组）分别将CP-1和非CP-1冷冻保护剂（主要为10%DMSO）冷冻保存的PBSC产品输注到418和58只受体中。与非CP-1组相比，CP-1组中≥ 2级HCI-AE的发生率较高，但总体或≥ 3级HCI-AE的发生率无显著差异。同样，在倾向评分匹配后，CP-1组中≥ 2级HCI-AE的发生率更高，但两组间≥ 3级HCI-AE的发生率无显著差异。无论CP-1的剂量在90 rats.ConclusionsInfusion的含CP-1的PBSC产品的HCI-AE方面是可行的，没有显着的毒性检测。
BackgroundThe standard cryoprotectant for human cellular products is dimethyl sulfoxide (DMSO), which is associated with hematopoietic cell infusion‐related adverse events (HCI‐AEs) in hematopoietic stem cell transplantation including peripheral blood stem cell (PBSC) transplantation (PBSCT). DMSO is often used with hydroxyethyl starch (HES), which reduces DMSO concentration while maintaining the postthaw cell recovery. The cryoprotectant medium CP‐1 (Kyokuto Pharmaceutical Industrial) is widely used in Japan. After mixture of a product with CP‐1, DMSO and HES concentrations are 5% and 6%, respectively. However, the safety profile of CP‐1 in association with HCI‐AEs has not been investigated.Study Design and MethodsTo compare CP‐1 with other cryoprotectants, we conducted a subgroup analysis of PBSCT recipients in a prospective surveillance study for HCI‐AEs. Moreover, we validated the toxicity of CP‐1 in 90 rats following various dose administration.ResultsThe PBSC products cryopreserved with CP‐1 (CP‐1 group) and those with other cryoprotectants, mainly 10% DMSO (non‐CP‐1 group), were infused into 418 and 58 recipients, respectively. The rate of ≥grade 2 HCI‐AEs was higher in the CP‐1 group, but that of overall or ≥grade 3 HCI‐AEs was not significantly different, compared to the non‐CP‐1 group. Similarly, after propensity score matching, ≥grade 2 HCI‐AEs were more frequent in the CP‐1 group, but the ≥grade 3 HCI‐AE rate did not differ significantly between the groups. No significant toxicity was detected regardless of the CP‐1 dose in the 90 rats.ConclusionsInfusion of a CP‐1‐containing PBSC product is feasible with the respect of HCI‐AEs.