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血液病合并侵袭性真菌感染患儿泊沙康唑谷浓度与疗效的相关性及影响因素分析
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| 篇名： | 血液病合并侵袭性真菌感染患儿泊沙康唑谷浓度与疗效的相关性及影响因素分析 |
| TITLE： | Study on the correlation between posaconazole trough concentration and efficacy and its influencing factors in pediatric patients with hematological diseases complicated with invasive fungal infections |
| 摘要： | 目的 探究血液病合并侵袭性真菌感染患儿泊沙康唑谷浓度（Cmin）与临床疗效的关系，并分析可能影响泊沙康唑Cmin的因素。方法纳入河北医科大学第二医院2019年1月至2024年8月使用泊沙康唑治疗血液病合并侵袭性真菌感染的患儿，收集研究对象的基础信息、真菌感染相关检查、泊沙康唑用药情况、治疗前实验室检查指标，根据泊沙康唑治疗目的不同，采用分层评估标准评价治疗有效性。采用高效液相色谱法检测泊沙康唑Cmin，将进行治疗药物监测的患儿按临床是否有效分组，比较组间泊沙康唑Cmin差异；采用受试者工作特征（ROC）曲线确定泊沙康唑Cmin与疗效的相关性；根据患儿泊沙康唑Cmin是否达到ROC预测的最佳临界值进行分组，分析可能影响泊沙康唑Cmin的因素。结果最终纳入130例接受泊沙康唑治疗的血液病合并侵袭性真菌感染患儿，其中80例临床有效，有效率为61.54%。39例患儿（53份血样）进行了治疗药物监测，其中27例临床有效；有效组患儿泊沙康唑Cmin为2.17（1.31，3.51）μg/mL，无效组患儿为1.19（0.59，2.10）μg/mL，组间差异有统计学意义（P＝0.005）。泊沙康唑Cmin预测临床疗效的ROC曲线最佳临界值为1.58μg/mL。单因素分析结果显示，不同泊沙康唑剂型对Cmin的影响差异有统计学意义（P＝0.020）。结论泊沙康唑用于治疗血液病合并侵袭性真菌感染患儿有效性良好。当Cmin≥1.58μg/mL时，泊沙康唑Cmin与临床疗效呈正相关，泊沙康唑剂型是影响Cmin的因素。 |
| ABSTRACT： | OBJECTIVE To investigate the relationship between posaconazole trough concentration （ C min ） and clinical efficacy， and to analyze the factors potentially influencing posaconazole C min in pediatric patients with hematological diseases complicated with invasive fungal infections.METHODS Pediatric patients with hematological diseases complicated with invasive fungal infections who received posaconazole therapy at The Second Hospital of Hebei Medical University from January 2019 to August 2024 were enrolled. Baseline information， fungal infection-related examinations， posaconazole medication details， and pre-treatment laboratory indicators were collected. According to the different therapeutic purposes of posaconazole， stratified evaluation criteria were used to assess therapeutic effectiveness. Posaconazole C min was determined by high performance liquid chromatography. Patients who underwent therapeutic drug monitoring （TDM） were divided into groups according to whether clinical efficacy was achieved， and the difference in posaconazole C min between groups was compared. Receiver operating characteristic （ROC） curve was used to determine the correlation between posaconazole C min and efficacy. Patients were further grouped according to whether posaconazole C min reached the optimal cut-off value predicted by ROC cure， and the factors potentially influencing posaconazole C min were analyzed.RESULTS A total of 130 pediatric patients with hematological diseases complicated with invasive fungal infections who received posaconazole treatment were enrolled， of whom 80 achieved clinical efficacy， with an effective rate of 61.54%. Thirty-nine patients （53 blood samples） underwent TDM， of whom 27 achieved clinical efficacy. The posaconazole C min in the effective group was 2.17 （1.31， 3.51） μg/mL， while that in the ineffective group was 1.19 （0.59， 2.10） μg/mL， with a statistically significant difference between groups （ P ＝0.005）. The optimal cut-off value of posaconazole C min for predicting clinical efficacy by ROC curve was 1.58 μg/mL. Univariate analysis showed that dosage form of posaconazole was a factor influencing C min .CONCLUSIONS Posaconazole demonstrated favorable efficacy in the treatment of pediatric patients with hematological diseases complicated with invasive fungal infections. When C min ≥1.58 μg/mL， posaconazole C min was positively correlated with clinical efficacy； posaconazole dosage form was a factor influencing C min . |
| 期刊： | 2026年第37卷第18期 |
| 作者： | 李文利；张甜甜；张亚坤；张志清 |
| AUTHORS： | LI Wenli，ZHANG Tiantian，ZHANG Yakun，ZHANG Zhiqing |
| 关键字： | 侵袭性真菌感染;泊沙康唑;血液病;治疗药物监测;谷浓度;影响因素 |
| KEYWORDS： | Invasive fungal infection;Posaconazole;hematological diseases;Therapeutic drug monitoring;Trough concentration;Influencing factors |
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