首页|他克莫司治疗儿童肾病综合征的最佳血药浓度范围探究

他克莫司治疗儿童肾病综合征的最佳血药浓度范围探究

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目的 探究他克莫司(TAC)治疗儿童肾病综合征(NS)的最佳血药浓度范围。方法 回顾性选取2021年1月至2023年12月河北省儿童医院肾脏免疫科收治的NS患儿为研究对象。根据治疗是否有效分为有效组和无效组,采用受试者工作特征(ROC)曲线确定治疗有效的TAC阈值。根据NS患儿TAC浓度分为低浓度组(<3 ng/mL)、中浓度组(3~5 ng/mL)和目标浓度组(5~10 ng/mL),分析TAC浓度与临床疗效和不良反应的关系。结果 研究共纳入患儿160例。NS患儿完全缓解(CR)、部分缓解(PR)和无效(NR)例数分别为91例、37例和32例,治疗有效128例(80%)。ROC曲线分析结果显示,TAC平均谷浓度预测疗效的ROC曲线下面积(95%CI)、敏感性、特异性和阈值分别为 0。779(0。704,0。853)、62。5%、84。45%和 3。33 ng/mL。临床疗效方面,与目标浓度组比较,低浓度组CR和PR较低,而NR较高(P<0。05);而中浓度组CR较低,PR较高(P<0。05),NR差异无统计学意义(P>0。05)。NS不同激素反应型方面,与目标浓度组或中浓度组比较,低浓度组CR较低(P<0。05);而中浓度组与目标浓度组CR和PR差异无统计学意义(P>0。05)。NS不同病理类型方面,与目标浓度组或中浓度组比较,低浓度组CR较低(P<0。05);而中浓度组与目标浓度组CR和PR差异无统计学意义(P>0。05)。不良反应方面,目标浓度组肢体震颤和血糖异常发生率显著高于其余两组(P<0。05)。此外,3组严重感染和高血压差异无统计学意义(P>0。05)。结论 TAC治疗儿童NS时,推荐TAC浓度范围为3~5 ng/mL。
The optimal blood concentration range of tacrolimus for the treatment of nephrotic syndrome in children
Objective To investigate the optimal blood concentration range of tacrolimus(TAC)for the treatment of nephrotic syndrome(NS)in children.Methods Children with NS admitted to the Department of Nephrology and Immunology of Hebei Children's Hospital from January 2021 to December 2023 were retrospectively selected as study subjects.They were divided into the effective group and the ineffective group according to whether the treatment was effective or not,and the TAC threshold for effective treatment was determined by using the receiver operator characteristic(ROC)curve.The children with NS were divided into a low concentration group(<3 ng/mL),a medium concentration group(3-5 ng/mL)and a target concentration group(5-10 ng/mL)according to the TAC concentration,and the relationships between the TAC concentration and the clinical efficacy and adverse reactions was analyzed.Results A total of 160 children were enrolled in the study.The numbers of complete remission(CR),partial remission(PR),and null remission(NR)cases of NS children were 91,37,and 32,respectively,and the treatment was effective in 128 cases(80%).The ROC curve analysis results showed that the area under the ROC curve(95%CI),sensitivity,specificity,and threshold of the mean trough concentration of TAC for predicting the efficacy of the treatment were 0.779(0.704,0.853),62.5%,84.45%,and 3.33 ng/mL,respectively.In terms of clinical efficacy,CR and PR were lower and NR was higher in the low concentration group compared with the target concentration group(P<0.05);whereas,CR was lower and PR was higher in the medium concentration group(P<0.05),and the difference in NR was not statistically significant(P>0.05).In terms of different hormone-responsive phenotypes of NS,the CR of the low concentration group was lower(P<0.05),while there was no significant difference in CR and PR between the medium concentration group and the target concentration group(P>0.05).As for the different pathological types of NS,CR was lower in the low concentration group when compared with the target concentration group or medium concentration group(P<0.05);while the differences in CR and PR between the medium concentration group and the target concentration group were not statistically significant(P>0.05).Regarding adverse reactions,the incidence of limb tremor and abnormal blood glucose was significantly higher in the target concentration group than in the other two groups(P<0.05).In addition,the differences in serious infections and hypertension among the three groups were not statistically significant(P>0.05).Conclusion When TAC is used to treat NS in children,the recommended TAC concentration range is 3-5 ng/mL.

TacrolimusNephrotic syndromeBlood concentrationChildrenReceiver operator characteristic curveAdverse effects

尹美娜、孟艳、刘玲

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河北省儿童医院肾脏免疫科(石家庄 050031)

河北省儿童医院药学部(石家庄 050031)

他克莫司 肾病综合征 血药浓度 儿童 受试者工作特征曲线 不良反应

2024

中国药师
国家药品监督管理局高级研修学院,武汉医药(集团)股份有限公司

中国药师

CSTPCD
影响因子:0.944
ISSN:1008-049X
年,卷(期):2024.28(9)