Abe Masaya, Fujii Keiko, Fujii Nobuharu, Mitsuhashi Toshiharu, Fukumi Takuya, Sumii Yuichi, Kimura Maiko, Urata Tomohiro, Kondo Takumi, Otsuka Fumio, Maeda Yoshinobu
Department of Hematology, Oncology and Respiratory Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan; Division of Transfusion, Okayama University Hospital, Okayama, Japan.
Division of Clinical Laboratory, Okayama University Hospital, Okayama, Japan; Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan.
Hematol Transfus Cell Ther. 2024 Dec;46 Suppl 6(Suppl 6):S234-S240. doi: 10.1016/j.htct.2024.06.010. Epub 2024 Sep 20.
Citrate-related hypocalcemia is the most common adverse event linked with peripheral blood progenitor cell apheresis. A previous retrospective study highlighted the prophylactic effectiveness of oral calcium drinks before apheresis, supplemented with intravenous calcium gluconate. Consequently, this study is a randomized controlled trial comparing oral calcium with placebo drinks STUDY DESIGN AND METHODS: Healthy donors were randomized to receive either oral calcium (Cohort A) or placebo (Cohort B) drinks. If symptoms emerged, all donors were given calcium drinks to counteract hypocalcemia. The primary endpoint centered on the incidence of Grade 1 or higher citrate-related symptoms. Analyses were performed using the crude model and doubly robust estimation.
Forty-two healthy donors participated from January 2021 to July 2022. Case distribution (Cohort A: Cohort B) stood at 3:7 (Grade 1), 2:2 (Grade 2), and 1:0 (Grade 3); no Grade 4 cases were identified. There was no statistical significance in the incidence of Grade 1 or higher and Grade 3 citrate-related symptoms.
The cumulative incidence of citrate-related side effects was less pronounced than in the previous research. This could stem from absence of blinding, and the decision to administer calcium drinks to the untreated group upon symptom detection. Although preemptive oral calcium intake before peripheral blood progenitor cell apheresis is not wholly effective, providing calcium-rich beverages to symptomatic donors may stave off symptom intensification.
枸橼酸盐相关的低钙血症是外周血祖细胞单采最常见的不良事件。先前的一项回顾性研究强调了单采前口服补钙饮料并补充静脉注射葡萄糖酸钙的预防效果。因此，本研究是一项比较口服钙剂与安慰剂饮料的随机对照试验。
健康供者被随机分为两组，分别接受口服钙剂（A组）或安慰剂饮料（B组）。如果出现症状，所有供者都给予钙剂饮料以对抗低钙血症。主要终点集中在1级或更高等级的枸橼酸盐相关症状的发生率。分析采用粗模型和双重稳健估计。
2021年1月至2022年7月，42名健康供者参与研究。病例分布（A组：B组）为3:7（1级）、2:2（2级）和1:0（3级）；未发现4级病例。1级或更高等级以及3级枸橼酸盐相关症状的发生率无统计学意义。
枸橼酸盐相关副作用的累积发生率比先前的研究中要低。这可能源于未设盲，以及在症状出现时对未治疗组给予钙剂饮料的决定。尽管在外周血祖细胞单采前预防性口服钙剂并非完全有效，但为有症状的供者提供富含钙的饮料可能会避免症状加重。
