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1.海南医科大学药学院,海口 571199
2.长沙市第三医院抗耐药微生物药物湖南省重点实验室,长沙 410015
3.海南省人民医院/海南医科大学附属海南医院药学部,海口 570311
硕士研究生。研究方向:临床药学、药代动力学。 E-mail:2514868927@qq.com
主任药师,硕士。研究方向:临床药学、药代动力学。E-mail:wangmin2020@muhn.edu.cn
收稿日期:2025-03-11,
修回日期:2025-06-06,
录用日期:2025-06-11,
纸质出版日期:2025-07-30
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符香香,钟莉莉,顾江帆,等.复方磺胺甲噁唑及其代谢物血药峰浓度与危重症患者临床疗效及不良反应的相关性研究[J].中国药房,2025,36(14):1775-1780.
FU Xiangxiang,ZHONG Lili,GU Jiangfan,et al.Study on the correlation of peak blood concentrations of compound sulfamethoxazole and its metabolites with clinical efficacy and adverse reactions in critically ill patients[J].ZHONGGUO YAOFANG,2025,36(14):1775-1780.
符香香,钟莉莉,顾江帆,等.复方磺胺甲噁唑及其代谢物血药峰浓度与危重症患者临床疗效及不良反应的相关性研究[J].中国药房,2025,36(14):1775-1780. DOI: 10.6039/j.issn.1001-0408.2025.14.15.
FU Xiangxiang,ZHONG Lili,GU Jiangfan,et al.Study on the correlation of peak blood concentrations of compound sulfamethoxazole and its metabolites with clinical efficacy and adverse reactions in critically ill patients[J].ZHONGGUO YAOFANG,2025,36(14):1775-1780. DOI: 10.6039/j.issn.1001-0408.2025.14.15.
目的
2
分析复方磺胺甲噁唑(简称“TMP/SMZ”)及其代谢物
N
-乙酰基磺胺甲噁唑(NSMZ)血药峰浓度(
c
max
)与危重症患者临床疗效及不良反应的相关性。
方法
2
回顾性收集2023年12月至2025年1月海南省人民医院重症监护室(ICU)使用TMP/SMZ治疗的危重症患者资料,按治疗后是否成功分为成功组和失败组。采用简单线性回归和Spearman相关分析法分析TMP
c
max
、SMZ
c
max
及NSMZ
c
max
与临床疗效及不良反应的相关性;采用受试者工作特征曲线(ROC)预测不良反应发生时的截断值。
结果
2
在入住ICU 24 h内急性生理与慢性健康评分Ⅱ(APACHE-Ⅱ)≥15分的危重症患者中,成功组患者的SMZ
c
max
显著高于失败组(
P
<0.05)。TMP/SMZ每日总剂量与TMP
c
max
、SMZ
c
max
呈正相关(
P
<0.05)。TMP
c
max
与肝毒性和肾毒性、SMZ
c
max
与肝毒性、NSMZ
c
max
与肾毒性有相关性(
P
<0.05)。TMP
c
max
预测肾毒性和肝毒性的截断值分别为7.25、6.63 μg/mL,SMZ
c
max
预测肝毒性的截断值为138.00 μg/mL,NSMZ
c
max
预测肾毒性的截断值为60.76 μg/mL。
结论
2
入住ICU 24 h内APACHE-Ⅱ≥15分的危重症患者中,SMZ
c
max
与治疗成功存在关联。TMP
c
max
≥6.63 μg/mL、SMZ
c
max
≥138.00 μg/mL时,患者的肝毒性发生风险显著增加;TMP
c
max
≥7.25 μg/mL、NSMZ
c
max
≥60.76 μg/mL时,患者的肾毒性发生风险显著增加。
OBJECTIVE
2
To analyze the correlation of the peak blood concentration (
c
max
) of compound sulfamethoxazole (TMP/SMZ) and its metabolite
N
-acetyl sulfamethoxazole (NSMZ) with clinical efficacy and adverse reactions in critically ill patients.
METHODS
2
The data of critically ill patients treated with TMP/SMZ in various ICU of Hainan General Hospital from December 2023 to January 2025 were retrospectively collected. The patients were divided into success group and failure group based on the treatment outcome. Simple linear regression and Spearman correlation analysis were used to analyze the correlation of TMP
c
max
, SMZ
c
max
, and NSMZ
c
max
with clinical efficacy and adverse reactions. The receiver operating characteristic curve (ROC) was used to determine the cutoff values of
c
max
for predicting the occurrence of adverse reactions.
RESULTS
2
Among critically ill patients with an acute physiology and chronic health evaluation Ⅱ (APACHE-Ⅱ) ≥15 points 24 h of check-in at ICU, SMZ
c
max
of success group was significantly higher than failure group (
P
<0.05). The daily total dose of TMP/SMZ was positively correlated with TMP
c
max
and SMZ
c
max
(
P
<0.05). TMP
c
max
was significantly correlated with hepatotoxicity and nephrotoxicity, SMZ
c
max
with hepatotoxicity, and NSMZ
c
max
with nephrotoxicity (
P
<0.05). The cutoff values of TMP
c
max
for predicting nephrotoxicity and hepatotoxicity were 7.25 μg/mL and 6.63 μg/mL, respectively. The cutoff value of SMZ
c
max
for predicting hepatotoxicity was 138.00 μg/mL, and that of NSMZ
c
max
for predicting nephrotoxicity was 60.76 μg/mL.
CONCLUSIONS
2
Among critically ill patients with an APACHE-Ⅱ ≥15 points 24 h of check-in at ICU, SMZ
c
max
is associated with treatment success. Hepatotoxicity risk significantly increases when TMP
c
max
≥6.63 μg/mL or SMZ
c
max
≥138.00 μg/mL; nephrotoxicity risk significantly increases when TMP
c
max
≥7.25 μg/mL or NSMZ
c
max
≥60.76 μg/mL.
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