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抗真菌药物泊沙康唑治疗药物监测与临床结局的真实世界相关性:一项单中心回顾性队列研究。

Real-world correlation between therapeutic drug monitoring and clinical outcomes of the antifungal drug posaconazole: a single-center retrospective cohort study.

作者信息

Yi Qiaoyan, Dong Lin, Wang Peng, Shi Yinping, Yang Yilei, Dong Zhonghua, Li Siwen, Li Yan, Huang Xin, Liu Jinjuan, Shi Haiyan, Wang Hongmei

机构信息

Department of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital, Shandong Engineering and Technology Research Center for Pediatric Drug Development, Jinan, Shandong, China.

Department of Hematology, The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital, Jinan, Shandong, China.

出版信息

Front Pharmacol. 2025 Sep 10;16:1592767. doi: 10.3389/fphar.2025.1592767. eCollection 2025.

Abstract

OBJECTIVE

Posaconazole is a first-line drug for preventing invasive fungal disease (IFD) in patients undergoing haematopoietic stem cell transplantation (HSCT). Few retrospective studies have examined the impact of therapeutic drug monitoring (TDM) on preventing IFD with posaconazole. This study was designed to evaluate the efficacy, safety, and cost-effectiveness of posaconazole in preventing IFD based on real-world data.

METHODS

This single-centre, retrospective cohort study analyzed the use of posaconazole for fungal prophylaxis in HSCT patients at the First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital). Patients were classified into TDM and non-TDM groups based on their TDM status. Clinical data were analyzed using propensity score matching (PSM) to further elucidate the role of TDM in posaconazole prophylaxis.

RESULTS

After PSM, the prophylactic success rate was significantly higher in the TDM group (100%) than in the non-TDM group (52.9%) (P = 0.003). There was no statistically significant difference in gastrointestinal, hepatic and renal adverse effects between the two groups (P > 0.05). Both the total cost of treatment and the cost of medication were lower in the TDM group compared to the non-TDM group.

CONCLUSION

Real-world data demonstrate that TDM enhances the effectiveness of posaconazole in preventing IFD in HSCT patients and moderately reduces treatment costs.

摘要

目的

泊沙康唑是预防造血干细胞移植(HSCT)患者侵袭性真菌病(IFD)的一线药物。很少有回顾性研究探讨治疗药物监测(TDM)对泊沙康唑预防IFD的影响。本研究旨在基于真实世界数据评估泊沙康唑预防IFD的疗效、安全性和成本效益。

方法

这项单中心回顾性队列研究分析了山东第一医科大学第一附属医院(山东省千佛山医院)HSCT患者使用泊沙康唑进行真菌预防的情况。根据患者的TDM状态将其分为TDM组和非TDM组。使用倾向评分匹配(PSM)分析临床数据,以进一步阐明TDM在泊沙康唑预防中的作用。

结果

PSM后,TDM组的预防成功率(100%)显著高于非TDM组(52.9%)(P = 0.003)。两组在胃肠道、肝脏和肾脏不良反应方面无统计学显著差异(P > 0.05)。与非TDM组相比,TDM组的总治疗费用和药物费用均较低。

结论

真实世界数据表明,TDM可提高泊沙康唑在预防HSCT患者IFD方面的有效性,并适度降低治疗成本。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8153/12457156/dc04a186aea3/fphar-16-1592767-g001.jpg

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