Toor Amir, Simmons Gary, Sabo Roy, Aziz May, Martin Erika, Bernard Robyn, Sriparna Manjari, McIntire Cody, Kreiger Elizabeth, Brophy Donald, Natarajan Ramesh, Fowler Alpha, Roberts Catherine
Virginia Commonwealth University Massey Cancer Center.
VCU.
Res Sq. 2023 Nov 10:rs.3.rs-3538792. doi: 10.21203/rs.3.rs-3538792/v1.
Intravenous (IV) vitamin C improves organ function and reduces inflammation in sepsis, an inflammatory state like the post-hematopoietic stem cell transplant (HCT) milieu. The safety and efficacy of parenteral vitamin C after allogeneic HCT were evaluated in a phase I/II trial. Clinical outcomes were compared with a propensity score - matched historical control.
Patients with advanced hematologic malignancies received IV vitamin C, 50mg/kg/d, divided into 3 doses given on days 1-14 after HCT, followed by 500 mg bid oral from day 15 until 6 months post-SCT.
55 patients received IV vitamin C. All patients were deficient in vitamin C at day 0. Vitamin C recipients had lower non-relapse mortality (NRM) (p = 0.07) and improved survival compared to historical controls (p=0.06), with no attributable grade 3 and 4 toxicities. Vitamin C recipients had similar relapse rate and acute graft versus host disease (GVHD) (p=0.35), but lower severe chronic GVHD (p=0.35). Patients with myeloid malignancies had improved survival (p=0.02) and NRM (p=0.009), as well as chronic GVHD, with similar relapse rates compared to controls.
In patients undergoing allogeneic HCT the administration of IV vitamin C is safe and reduces non-relapse mortality and chronic GVHD improving overall survival.
静脉注射维生素C可改善器官功能并减轻脓毒症（一种类似于造血干细胞移植（HCT）后环境的炎症状态）中的炎症。在一项I/II期试验中评估了异基因造血干细胞移植后肠外维生素C的安全性和有效性。将临床结果与倾向评分匹配的历史对照进行比较。
患有晚期血液系统恶性肿瘤的患者接受静脉注射维生素C，剂量为50mg/kg/天，在造血干细胞移植后的第1 - 14天分为3剂给药，然后从第15天开始至造血干细胞移植后6个月每天口服500mg，每日两次。
55例患者接受了静脉注射维生素C。所有患者在第0天均缺乏维生素C。与历史对照相比，接受维生素C的患者非复发死亡率（NRM）较低（p = 0.07）且生存率有所提高（p = 0.06），且无3级和4级毒性反应。接受维生素C的患者复发率和急性移植物抗宿主病（GVHD）相似（p = 0.35），但严重慢性GVHD较低（p = 0.35）。与对照组相比，患有髓系恶性肿瘤的患者生存率（p = 0.02）和NRM（p = 0.009）有所改善，慢性GVHD情况相似，复发率也相似。
在接受异基因造血干细胞移植的患者中，静脉注射维生素C是安全的，可降低非复发死亡率和慢性GVHD，提高总体生存率。
