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过敏性紫癜性肾炎患儿他克莫司血药浓度参考范围及影响因素

分析
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李惠英 ，李发双，黎林波，张力麟（昆明医科大学附属儿童医院药学部，昆明 650228）

中图分类号 R985；R692.3+4 文献标志码 A 文章编号 1001-0408（2025）08-0975-06
DOI 10.6039/j.issn.1001-0408.2025.08.15

摘 要 目的 探讨他克莫司在过敏性紫癜性肾炎（HSPN）患儿中的血药浓度参考范围，并分析他克莫司血药浓度的影响因素，为
临床合理使用该药提供参考。方法 回顾性收集2018年1月至2024年1月就诊于昆明医科大学附属儿童医院使用他克莫司治疗
并定期进行血药浓度监测的HSPN患儿的临床资料，通过受试者工作特征曲线确定他克莫司血药浓度的有效临界值，对比他克莫
司不同浓度的临床疗效和不良反应发生率以确定他克莫司血药浓度参考范围。采用单因素和多元线性回归分析他克莫司血药浓
度的影响因素。结果 纳入97例患儿，共监测他克莫司血药浓度203次，测得血药浓度为4.26（2.47，6.34）ng/mL。受试者工作特征
曲线下面积为 0.723（95%CI 为 0.596～0.850，P＜0.01），对应的血药浓度有效临界值为 2.19 ng/mL。他克莫司血药浓度 3～＜5
ng/mL、5～＜10 ng/mL、≥10 ng/mL组患儿的临床疗效均显著高于＜3 ng/mL组（P＜0.05），5～＜10 ng/mL、≥10 ng/mL组患儿总
不良反应发生率均显著高于＜3 ng/mL、3～＜5 ng/mL组（P＜0.05）。体重指数和CYP3A5基因型对他克莫司血药浓度的影响具有
统计学意义（P＜0.05）。结论 临床应用他克莫司治疗HSPN患儿时，血药浓度参考范围为3～5 ng/mL；体重指数和CYP3A5 基因
型是他克莫司血药浓度的影响因素。
关键词 他克莫司；紫癜性肾炎；血药浓度；影响因素；儿童

Analysis of reference range and influencing factors of tacrolimus blood concentration in children with
Henoch-Schonlein purpura nephritis
LI Huiying，LI Fashuang，LI Linbo，ZHANG Lilin（Dept. of Pharmacy， Children’s Hospital Affiliated to
Kunming Medical University， Kunming 650228， China）

ABSTRACT OBJECTIVE To investigate the reference range of tacrolimus blood concentration in children with Henoch-
Schonlein purpura nephritis （HSPN） and analyze the factors affecting the blood concentration， in order to provide a reference for
rational use of the drug in clinic. METHODS Clinical data of children with HSPN who were treated with tacrolimus and regularly
monitored for blood concentration at the Children’s Hospital Affiliated to Kunming Medical University were retrospectively
collected from January 2018 to January 2024. The threshold of effective concentration of tacrolimus was determined by the receiver
operating characteristic curve of the subjects. The clinical efficacy of tacrolimus in different concentrations and the incidence of
adverse drug reaction （ADR） were compared to determine the reference range of tacrolimus blood concentration. The factors
influencing the blood concentration were analyzed by one-way and multiple linear regression. RESULTS A total of 97 pediatric
patients were included， and their tacrolimus blood concentrations were monitored 203 times， the blood concentration was 4.26
（2.47， 6.34） ng/mL. The area under the receiver operating characteristic curve of the subjects was 0.723 （95%CI：0.596-0.850， P＜
0.01）， which corresponded to an effective threshold of 2.19 ng/mL. The clinical efficacy in pediatric patients with tacrolimus blood
concentrations of 3-＜5 ng/mL， 5-＜10 ng/mL， and ≥10 ng/mL was significantly higher than that of children with
concentrations ＜3 ng/mL （P＜0.05）. Additionally， the overall incidence of ADR in children with concentrations of 5-＜10 ng/mL
and ≥10 ng/mL was significantly higher than that in children with concentrations ＜3 ng/mL and 3-＜5 ng/mL （P＜0.05）. The
impact of body mass index and CYP3A5 genotype on the blood concentration of tacrolimus was statistically significant （P＜0.05）.
CONCLUSIONS When using tacrolimus to treat HSPN in children clinically， the reference range for blood concentration is 3 to 5
ng/mL； body mass index and CYP3A5 genotype are factors that influence the blood concentration of tacrolimus.
KEYWORDS tacrolimus； Henoch-Schonlein purpura nephritis； blood concentration； influencing factors； children

Δ 基金项目 云南省科技厅科技计划项目（No.202301AY070001- 过敏性紫癜是一种全身性小血管炎，累及肾脏时被
280）；云南省卫生科技成果转化项目（No.YX-2023-02）；昆明市卫生健
称为过敏性紫癜性肾炎（Henoch-Schonlein purpura ne‐
康委员会卫生科研课题资助项目（No.2023-13-05-002）
phritis，HSPN）。HSPN是过敏性紫癜最严重的并发症之
＊第一作者 主任药师，硕士。研究方向：临床药学。E-mail：
2064790166@qq.com 一，也是一种儿童常见的继发性肾小球疾病 [1―2] 。对于

中国药房 2025年第36卷第8期 China Pharmacy 2025 Vol. 36 No. 8 · 975 ·