中国临床药理学杂志2026，Vol.42Issue(13)：1849-1853,5.DOI:10.13699/j.cnki.1001-6821.2026.13.009
霉酚酸药时曲线下面积与异基因造血干细胞移植患者腹泻相关性的临床研究
Clinical trial on the correlation between the area under the curve of mycophenolate mofetil and diarrhea in patients undergoing allogeneic hematopoietic stem cell transplantation
摘要
Abstract
Objective To investigate the correlation between mycophenolic acid(MPA)trough concentrations and the area under the concentration-time curve(MPA-AUC)with early post-transplant diarrhea in adult patients diagnosed with malignant hematologic diseases and undergoing allogeneic hematopoietic stem cell transplantation(allo-HSCT).Methods Adult patients diagnosed with hematologic diseases and treated with allo-HSCT were enrolled.Participants received oral mycophenolate mofetil(MMF)capsule at a daily dose of 0.75-1.50 g,and blood drug concentrations were monitored on day 8 of medication.MPA blood concentration data from 22 patients collected at multiple time points were used to establish a limited sampling model for calculating MPA-AUC0-12h through stepwise forward linear regression analysis.MPA blood concentration data from 27 patients were used for model validation.After model development,an additional 44 patients diagnosed with hematologic malignancies and undergoing allo-HSCT with myeloablative conditioning regimens were included.Based on the occurrence of diarrhea within 30 days post-transplant,patients were divided into diarrhea and non-diarrhea groups,and significant differences in MPA trough concentrations and MPA-AUC0-12h between the two groups were analyzed.Results The established limited sampling model was MPA-AUC0-12h=5.22 × C0+0.46 × C0.5+0.66 × C1.0+3.22 × C4.0+5.22(r2=0.87).Among the 44 patients,the incidence of diarrhea within 30 days post-transplant was 54.54％.MPA-AUC0-12 h values were(18.29±0.89)and(13.36±0.80)mg·h·L-1 in the diarrhea and non-diarrhea groups,respectively,with the diarrhea group significantly higher than the non-diarrhea group(P＜0.05).Receiver operating characteristic curve analysis suggested that MPA-AUC0-12h＞17.25 mg·h·L-1 may increase the risk of early post-transplant diarrhea.MPA trough concentrations were(0.38±0.08)and(0.24±0.03)mg·L-1 in the diarrhea and non-diarrhea groups,respectively,with no statistically significant difference(P＞0.05).Conclusion MPA-AUC0-12 h is closely associated with diarrhea occurring within 30 days post-allo-HSCT.关键词
霉酚酸/霉酚酸谷浓度及药时曲线下面积/腹泻/异基因造血干细胞移植Key words
mycophenolic acid/mycophenolic acid trough concentrations and the area under the concentration-time curve/diarrhea/allogeneic hematopoietic stem cell transplantation分类
医药卫生引用本文复制引用
林良沫,洪绵慧,王敏,吴琼诗,符祥俊..霉酚酸药时曲线下面积与异基因造血干细胞移植患者腹泻相关性的临床研究[J].中国临床药理学杂志,2026,42(13):1849-1853,5.基金项目
海南省自然科学基金青年项目基金资助项目(822QN452) （822QN452）
