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154例肾病综合征患者环孢素 A 血药浓度监测及其对疗效、安全性的影响分析
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| 篇名： | 154例肾病综合征患者环孢素 A 血药浓度监测及其对疗效、安全性的影响分析 |
| TITLE： | |
| 摘要： | 目的：探讨肾病综合征（NS）患者环孢素A（CsA）血药浓度监测对其疗效及安全性的影响。方法：回顾性分析2014年1月－2017年8月中日友好医院肾内科治疗的154例接受CsA治疗并进行血药浓度监测的NS患者病历资料，并对其中63例初次使用CsA治疗的难治性NS成年住院患者初始治疗6个月内的血药浓度监测结果进行统计，以分析其与疗效及安全性的关系。结果：154例患者共计进行CsA血药浓度监测512次，平均3.32次/人，平均血药浓度为（125.98±105.13）ng/mL；血药浓度低于100 ng/mL的占44.14％。男性与女性患者平均监测次数、平均血药浓度及不同年龄段患者CsA平均血药浓度比较，差异均无统计学意义（P＞0.05）。63例初次使用CsA治疗的难治性NS成年住院患者在初始治疗6个月（诱导期）内进行血药浓度监测共计237次；有效组患者平均血药浓度显著高于无效组，血药浓度＜100 ng/mL的比例显著低于无效组（P＜0.05）。63例患者中有17例出现不良反应（发生率为26.98％）。发生不良反应的患者平均血药浓度显著高于未发生不良反应的患者，血药浓度＞150 ng/mL的监测次数所占比例显著高于未发生不良反应的患者（P＜0.05）；有效组与无效组患者不良反应发生率比较，差异无统计学意义（P＞0.05）；有效组中，发生与未发生不良反应的患者平均血药浓度比较，差异无统计学意义（P＞0.05），但发生不良反应的患者血药浓度＞150 ng/mL的监测次数所占比例显著高于未发生不良反应的患者（P＜0.05）。随着监测次数的增加，患者不良反应发生率呈逐渐下降趋势，但不同监测次数的患者不良反应发生率比较，差异均无统计学意义（P＞0.05）。结论：CsA药动学个体差异大，影响其血药浓度的因素较多，且其血药浓度的变化可影响疗效和安全性。在应用CsA治疗NS的过程中，很难根据经验确定CsA的用药剂量，临床应重视其血药浓度监测，并以监测结果为依据制订个体化给药方案，以提高疗效、减少不良反应的发生。 |
| ABSTRACT： | OBJECTIVE： To investigate the effects of blood concentration monitoring of cylosporin A （CsA） in patients with nephrotic syndrome （NS） on efficacy and safety. METHODS： The medical records of 154 NS patients receiving CsA and blood concentration monitoring in nephrology department of China-Japan Friendship Hospital during Jan. 2014-Aug. 2017 were analyzed retrospectively. The results of blood concentration monitoring in 63 adult inpatients with refractory NS receiving CsA for the first time within 6 months of initial treatment were analyzed statistically. The relationship of blood concentration monitoring with efficacy and safety was analyzed. RESULTS： The blood concentration of CsA in 154 patients were monitored for 512 times with an average of 3.32 times/person， and average blood concentration was （125.98±105.13）ng/mL. The patients with blood concentration of CsA＜100 ng/mL accounted for 44.14％. There was no statistical significance in average monitoring times or average blood concentration between male and female， average blood concentration of CsA among different age groups （P＞0.05）. The blood concentration was monitored for 237 times in 63 adult inpatients with refractory NS receiving CsA for the first time within 6 months of initial treatment （induction period）. Average blood concentration of effective group were significantly higher than ineffective group； the proportion of effective group with blood concentration＜100 ng/mL was significantly lower than that of ineffective group， with statistical significance （P＜0.05）. Among 63 patients， 17 patients suffered from ADR （the incidence of ADR was 26.98％）. The average blood concentrations of ADR patients were significantly higher than those without ADR； the monitoring times of ADR patients with blood concentration＞150 ng/mL was significantly higher than those without ADR， with statistical significance （P＜0.05）. There was no statistical significance in the incidence of ADR between effective group and ineffective group （P＞0.05）. Among effective group， there was no statistically significance in average blood concentration between ADR patients and patients without ADR （P＞0.05）； the monitoring times of ADR patients with blood concentration＞150 ng/mL was significantly higher than patients without ADR， with statistical significance （P＜0.05）. With the increase of monitoring times， the incidence of ADR decreased gradually. There was no statistical significance in the incidence of ADR among patients who were monitored for different times （P＞0.05）. CONCLUSIONS： The pharmacokinetics of CsA varies in different patients and many factors affect its blood concentration. The changes of blood concentration affect the efficacy and safety of CsA. It is difficult to determine the dosage of CsA based on experience in the treatment of NS with CsA. Great importance should be attached to blood concentration monitoring of CsA and the implementation of individualized dosage regimen based monitoring results so as to improve therapeutic efficacy and reduce the occurrence of ADR. |
| 期刊： | 2018年第29卷第20期 |
| 作者： | 李瑞莲，陈文倩，张丹，王晓雪，覃旺军，崔刚 |
| AUTHORS： | LI Ruilian，CHEN Wenqian，ZHANG Dan，WANG Xiaoxue，QIN Wangjun，CUI Gang |
| 关键字： | 肾病综合征；环孢素A；血药浓度监测；疗效；安全性 |
| KEYWORDS： | Nephrotic syndrome； CyclosporineA； Blood concentration monitoring； Efficacy； Safety |
| 阅读数： | 420 次 |
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