Article(id=1236678331580600710, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236678328279683421, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1663257600000, acceptedDateStr=2022-09-16, onlineDate=1772776690621, onlineDateStr=2026-03-06, pubDate=1686758400000, pubDateStr=2023-06-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772776690621, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772776690621, creator=13701087609, updateTime=1772776690621, updator=13701087609, issue=Issue{id=1236678328279683421, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='11', pageStart='1073', pageEnd='1176', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772776689834, creator=13701087609, updateTime=1772776816684, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236678860406837840, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236678328279683421, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236678860406837841, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236678328279683421, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1121, endPage=1127, ext={EN=ArticleExt(id=1236678331811287439, articleId=1236678331580600710, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Monitoring and evaluation of tacrolimus concentration in serum of patients with systemic lupus erythematosus, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To systematically explore the correlation between serum tacrolimus trough concentration (C0) and the efficacy in patients with systemic lupus erythematosus (SLE), and to obtain the effective concentration threshold of tacrolimus in such patients, so as to provide reference for the safety and efficacy of clinical medication.
Methods: The clinical and laboratory data of SLE patients treated with tacrolimus in our hospital from January 2016 to December 2021 were collected retrospectively, including demographic information (sex, age, height, and weight), course of disease, results of laboratory test, medication, monitoring data on blood concentration and clinical response, and efficacy and safety were evaluated. The correlation between C0 and efficacy was analyzed, and the threshold of effective concentration of tacrolimus was determined by receiver operating characteristic curve (ROC).
Results: A total of 72 patients who met the criteria were included in this study, and 176 monitoring data of C0 (0.1~10.3 ng·mL-1) were collected. There was a weak correlation between daily dose of tacrolimus and C0 (r=0.326). With the prolonging of time of tacrolimus treatment, there was no significant change in C0, and there was significant difference in complement C3 among different blood concentration groups (P<0.05). There was no significant difference in other biochemical indexes. In the effective concentration study, 124 monitoring results of blood concentration in 59 patients with long-term of tacrolimus treatment (tacrolimus >3 months) were analyzed. They were divided into effective group (76 cases) and ineffective group (48 cases) according to clinical manifestations and biochemical indexes. Binary logistics regression analysis showed that C0 had a significant effect on the curative effect of the patients (P<0.001). The area under ROC curve (AUC) is 0.763 (P<0.001, 95%CI: 0.674~0.851).
Conclusion: This study showed that the drug dose affected the blood concentration of tacrolimus in patients with SLE, and there was a correlation between the plasma concentration of tacrolimus and the curative effect. The threshold of its effective concentration was determined by ROC curve analysis, which is 1.55 ng·mL-1.
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目的： 探究系统性红斑狼疮（SLE）患者他克莫司血药谷浓度（C0）与疗效相关性，获得他克莫司在该人群治疗的有效浓度阈值，为临床用药的安全性和有效性提供参考。
方法： 回顾性收集我院2016年1月—2021年12月间应用他克莫司治疗的SLE患者的临床及实验室检查数据，包括人口统计学信息（性别、年龄、身高、体重）、病程、实验室检查结果、用药情况、血药浓度监测数据及临床反应，并进行疗效和安全性评价。分析C0与疗效相关性，受试者工作特征曲线（ROC）确定他克莫司有效浓度阈值。
结果： 本研究共纳入符合标准患者72例，收集176例次C0监测数据（0.1~10.3 ng·mL-1）。他克莫司日剂量与C0间存在弱相关性（r=0.326）；随着他克莫司用药时间的延长C0无显著性变化；补体C3在不同血药浓度组间存在差异（P<0.05），其他生化指标并未显现出显著差异。有效浓度研究分析了长期用药（他克莫司用药时间>3个月）的59例患者的124例次血药浓度监测结果，根据临床表现和生化指标分为有效组（76例次）和无效组（48例次）。二元logistics回归分析结果表明，C0对患者疗效有显著性影响（P<0.001）。ROC曲线下面积AUC为0.763（P<0.001，95%CI：0.674~0.851）。此时对应的截点为1.55 ng·mL-1，提示当C0>1.55 ng·mL-1时，临床疗效阳性概率较高。
结论： 本研究表明药物剂量可影响SLE患者的他克莫司血药浓度；他克莫司血药浓度与疗效存在相关性，ROC曲线分析初步确定其有效浓度的阈值为1.55 ng·mL-1。
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肇丽梅，女，教授，博士生导师，主要从事药动学与药物基因组学研究。E-mail:
zhaolm@sj-hospital.org。
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王成彬，男，硕士研究生，主要从事临床药理学研究。E-mail: 1049620316@qq.com。
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王成彬，男，硕士研究生，主要从事临床药理学研究。E-mail: 1049620316@qq.com。
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