摘要
目的:考察不同的新型冠状病毒灭活方式对替考拉宁血药浓度的影响,评价未经灭活操作与经灭活操作后替考拉宁血药浓度结果的一致性。方法:以替考拉宁质控对照品、质控血浆样品和临床实测样本作为考察对象,分别经56℃水浴加热30 min或经紫外照射60 min后,考察质控对照品和质控血浆样品的稳定性;并采用组内相关系数、Passing-Bablok回归法和Bland-Altman分析法,对灭活前后临床实测标本浓度结果进行统计分析。结果:紫外灭活条件下,替考拉宁的质控对照品不稳定;湿热灭活法条件下,替考拉宁质控对照品和质控血浆样品均稳定。52例临床样本经湿热灭活与未灭活浓度结果的组内相关系数为0.994(P<0.001);Passing-Bablok回归方程为Y=0.9994X-0.214 2(R^(2)=0.996,n=52);96.15%(50/52)的检测数据在95%一致性界限内。3种统计结果均表明未经灭活操作与经湿热灭活法操作后,两者血药浓度结果的相关性与一致性良好。结论:替考拉宁的临床血药浓度检测标本可采用湿热病毒灭活法进行预处理,以减少实验室工作人员的病毒感染风险。
Objective: To investigate the effects of virus inactivation operation of SARS-CoV-2 on teicoplanin blood concentration, and to evaluate the consistency of clinical blood concentration of teicoplanin before and after virus inactivation operation. Methods: The standards, plasma quality controls and clinical samples of teicoplanin were selected as the research objects. The stability of the samples was observed after inactivation operation of SARS-CoV-2, which was heated in a water bath at 56℃ for 30 min or with ultraviolet(UV) radiation for 30 min. Intra-group correlation coefficient, passing-Bablok regression and Bland Altman analysis were used to analyze the concentrations of clinical samples before and after virus inactivation operation. Results: The standard products of teicoplanin were all unstable under UV inactivation operation, while the standard products and quality control samples of teicoplanin were all stable under damp heat inactivation. The correlation coefficient between damp heat inactivated and non-inactivated was 0.994(P<0.001) in 52 clinical samples. The Passing Bablok regression equation was Y=0.999 4X-0.214 2(R2=0.996, n=52), and 96.15% of the clinical samples were within the 95% consistency threshold. Statistical results showed that the correlation and consistency of the results of blood drug concentration before and after virus inactivation operation were without differences.Conclusion: Therapeutic drug monitoring samples of teicoplanin can be pretreated by damp heat virus inactivation method to reduce the risk of virus infection of laboratory staff.
作者
陈明
尹悦勤
唐原君
汪硕闻
范国荣
Chen Ming;Yin Yueqing;Tang Yuanjun;Wang Shuowen;Fan Guorong(Department of Clinical Pharmacy,Shanghai General Hospital,Shanghai Jiaotong University,Shanghai 200080,China;Shanghai University of Medicine&Health Sciences)
出处
《中国药师》
CAS
2021年第11期2098-2103,共6页
China Pharmacist
基金
上海交通大学医学院新型冠状病毒感染肺炎抗疫相关药事管理与合理用药研究专项基金(编号:JDYX2020KYZX004)
国家自然科学基金项目(编号:82003844)。
关键词
新型冠状病毒
病毒灭活操作
替考拉宁
治疗药物监测
一致性评价
SARS-CoV-2
Virus inactivation operation
Teicoplanin
Therapeutic drug monitoring
Consistency evaluation
作者简介
通信作者:汪硕闻,Tel:(201)63240090-4801,E-mail:wangshuowensy@163.com。
