摘要
Abstract
Objective:To investigate the efficacy of ferric derisomaltose in the treatment of Chinese patients with iron deficiency anemia(IDA).Methods:Data of IDA patients who treated with ferric derisomaltose were collected in 79 hospitals across the country from June 2021 to September 2022.SAS 9.4 software was used for statistical analysis.The T-test(normal distribution)and Wilcoxon signed-rank test(non-normal distribution)were used to compare the pre-and post-treatment differences in blood indices.The factors that influencing the clinical efficacy[defined as the change in hemoglobin(Hb)levels at 4 weeks post-treatment relative to baseline]were analyzed using mixed linear model.Results:A total of 2 083 IDA patients were enrolled in this study.Among them,63,2 009,and 11 patients re-ceived 500,1 000 mg,and 1 500 mg of ferric derisomaltose at a single intravenous infusions,respectively.The mean dose was(987.5±93.4)mg.The blood indexes such as hemoglobin(Hb:92.26 g·L-1vs 74.28 g·L-1),mean corpuscular volume(77.72 fL vs 70.89 fL),mean corpuscular hemoglobin(28.51 pg vs 24.14 pg),mean corpuscular hemoglobin concentration(298.64 g·L-1 vs 275.26 g·L-1),Fe(20.40 μmol·L-1 vs 5.00 μmol·L-1),serum ferritin(78.00 ng·mL-1 vs 4.50 ng·mL-1)and transferrin saturation(21.40％vs 5.80％)were significantly improved at 2 weeks post-treatment(P＜0.001).Further improvements in these blood indexes were observed at 4 weeks post-treatment.Among them,33.8％(705/2 083)IDA patients achieved normal hemoglobin levels and 91.7％(1 911/2 083)improved the anemia(Hb increase ≥20 g·L-1)at 4 weeks post-treatment.Multivariate analysis showed that age,body weight,patient source,etiology of anemia,ferric derisomaltose dosage,blood transfusion,and baseline Hb levels were factors influencing clinical efficacy of patients receiving ferric derisomaltose therapy(P＜0.05).Conclusion:Ferric derisomaltose is effective in Chinese patients with IDA,with significant improvements in anemia observed after a single infusion.关键词
异麦芽糖酐铁/缺铁性贫血/静脉铁剂/回顾性分析/有效性Key words
Ferric derisomaltose/Iron deficiency anemia/Intravenous iron/Retrospective analysis/Efficacy分类
药学
