目的:采用 PDCA 循环管理学方法构建利奈唑胺的安全用药模式,通过优化利奈唑胺给药方案、提高稳态谷浓度（Cminss）和24 h 血浆浓度-时间曲线下面积（AUC24）在目标范围内的达标率,减少危重症患者利奈唑胺诱导的血小板减少症（linezolid induced thrombocytopenia,LIT）等药物不良反应（adverse drug reaction,ADRs）的发生。方法:选取 2020 年 7 月—2022 年 6 月南京医科大学附属苏州医院重症监护病房和急诊重症监护病房的 199 例接受利奈唑胺治疗且监测 Cminss 的危重症患者作为研究对象,将其中 2020 年 7 月—2021 年 6 月未采用 PDCA 循环管理学方法进行药学服务的患者设为对照组（n=87）,将 2021 年 7 月—2022 年 6 月采用 PDCA 循环管理学方法进行药学服务的患者设为干预组（n=112）;分析和比较 2 组患者利奈唑胺的剂量方案调整情况、Cminss和 AUC24 的达标情况,以及 LIT 等 ADRs 的发生情况。结果:干预组患者调整利奈唑胺给药方案的比例远高于对照组（53.57% vs 29.88%,P=0.012）;与对照组相比,干预组患者利奈唑胺初始方案后 Cminss 在 2~7 mg/L目标范围内的达标率明显更高（46.43% vs 12.64%,P<0.001）;而且,干预组患者利奈唑胺初始方案后Cminss>10 mg/L的比例显著低于对照组（25.00% vs 58.62%,P<0.001）;干预组患者 AUC24 在 100~300 mg·h/L 内的占比明显高于对照组（51.78% vs 26.43%,P=0.012）;干预组患者初始方案后 AUC24>350 mg·h/L 的比例显著低于对照组（14.94% vs 55.35%,P<0.001）;对照组患者经利奈唑胺治疗后有 21 例发生 LIT,而干预组仅有 12 例,其差异有统计学意义（P=0.003）;干预组患者其他 ADRs 的发生率也低于对照组（0.89% vs 6.90%,P=0.031）。结论:通过 PDCA 循环管理的实施,利奈唑胺 Cminss 和 AUC24 的达标率明显提高,而 LIT 和其他 ADRs 的发生率则显著下降,从而增加了患者的用药安全。
Abstract
Objective: To estabilish a safe medication mode of linezolid by using PDCA cycle management method, and then optimize the dosage regimen of linezolid and improve the standard-reaching rate of steady-state minimum concentration (Cminss) and area under the plasma concentration-time curve from time 0-24 h (AUC24) within the target range, so as to reduce adverse drug reactions (ADRs) such as linezolid induced thrombocytopenia (LIT) in critical illness patients. Methods: 199 critical illness patients, treated with linezolid and monitored forCminss, were selected from the Intensive Care Unit and Emergency Intensive Care Unit of the Affiliated Suzhou Hospital of Nanjing Medical University from July 2020 to June 2022. Patients who did not use PDCA cycle management method for pharmaceutical care from July 2020 to June 2021 were set as the control group (n=87), and patients who used PDCA cycle management method for pharmaceutical care from July 2021 to June 2022 were set as the intervention group (n=112). The adjustment of the dosage regimen of linezolid, the standard-reaching rate of Cminss and AUC24, and the occurrence of ADRs such as LIT were analyzed and compared between the two groups. Results: The proportion of patients adjusting linezolid's dosage regimen in the intervention group was much higher than that in the control group (53.57% vs 29.88%,P=0.012). The proportion of patients in the intervention group with Cminss in the target range of 2-7 mg/L after the initial regimen of linezolid was significantly higher than that in the control group (46.43% vs 12.64%,P<0.001), while the proportion of patients in the intervention group with Cminss>10 mg/L after the initial regimen of linezolid was significantly lower than that in the control group (25.00% vs 58.62%,P<0.001). The proportion of linezolid's AUC24 within 100~300 mg·h/L in the intervention group was significantly higher than that in the control group (51.78% vs 26.43%,P=0.012), while the proportion of linezolid's AUC24>350 mg·h/L after the initial regimen in the intervention group was significantly lower than that in the control group (14.94% vs 55.35%,P<0.001). After treatment with linezolid, 21 cases of LIT occurred in the control group, while only 12 cases in the intervention group, the difference was statistically significant (P=0.003). The incidence of other ADRs was also lower in the intervention group than in the control group (0.89% vs 6.90%,P=0.031). Conclusion: Through the implementation of PDCA cycle management, the standard-reaching rate of linzolid Cminss and AUC24 was significantly improved, while the incidence of LIT and other ADRs was significantly decreased, thus increasing the medication safety of patients.
关键词
利奈唑胺 /
PDCA 循环法 /
药学服务模式 /
药学干预 /
治疗药物监测 /
稳态谷浓度
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Key words
linzolid /
PDCA cycle management method /
pharmaceutical care model /
pharmacists intervention /
therapeutic drug monitoring /
steady-state minimum concentration
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参考文献
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脚注
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基金
*1苏州科技项目（编号：SYSD2018243、SYSD2019189、SYSD202020191、SKJYD2021171、、SKJYD2021172）; 江苏省制药协会医院药学研究项目（编号：A201816、A201914、A201915、H202109）; 苏州柯角星卫青年科技项目（编号：KJXW2018024）; 医院药学研究项目（编号：Syhky201805）; 苏州关键临床疾病诊断和治疗专项技术项目（编号：LCZX202112）; 南京医科大学姑苏学院协同创新项目（编号：GSKY20210236）
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