基于治疗药物监测的奥氮平片2个集采批次的临床应用分析

Clinical Utilization Analysis of Two Central-Purchased Batches of Olanzapine Tablets Based on Therapeutic Drug Monitoring

目的:分析奥氮平片“4+7”试点批次(A批次)和“4+7”扩围批次(B批次)的血药浓度剂量比和临床使用情况。方法:通过某院实验室检验系统和电子病历系统收集2019年8月~2020年5月、2020年7月~2021年4月均服用奥氮平片患者的病例资料。采用SPSS 23软件对奥氮平片2个集采批次的血药浓度剂量比进行统计学分析,分析联合用药变化情况。结果:共纳入患者93例,服用奥氮平片A批次和B批次后的血药浓度分别为58.00(33.49~75.36)ng/ml和49.72(27.87~70.56)ng/ml(P<0.01);血药浓度剂量比分别为4.74(3.33~6.52)d/L和4.07(2.99~5.32)d/L(P<0.01)。由A批次奥氮平片换用B批次后,23例(24.73%)患者增加了奥氮平片的使用剂量,平均剂量增加(5.76±2.86)mg/d;15例(16.13%)患者加用其他抗精神病药,其中5例(5.38%)患者增加奥氮平片使用剂量的同时,加用其他抗精神病药;7例(7.53%)患者加用降压药;8例(8.60%)患者加用调脂药辛伐他汀或阿托伐他汀钙。22例(23.66%)患者减少了奥氮平片使用剂量,平均减少剂量(5.40±2.92)mg/d,13例(13.98%)患者停用苯二氮类药物。结论:2个集采批次的奥氮平片的总体血药浓度都在推荐浓度范围内。虽然血药浓度剂量比和联合用药情况有一定差异,但同等剂量下都能维持患者病情稳定,为临床用药调整和集采政策落实提供了相关参考依据。

Objective:To analyze the plasma concentration-dose ratio and clinical utilization of"4+7"pilot batch(batch A)and"4+7"expanded batch(batch B)of olanzapine tablets.Methods:Medical data of patients who were treated with olanzapine during August 2019 to May 2020 and during July 2020 to April 2021 were collected from laboratory system and electronic medical record system.The plasma concentrationdose ratio of olanzapine tablets was analyzed for two central-purchsed batches by SPSS 23 software,and the changes compared to combined use of olanzapine tablets were analyzed.Results:93 patients were enrolled in the study.The plasma concentration of olanzapine was 58.00(33.49~75.36)ng/ml and 49.72(27.87~70.56)ng/ml respectively(P<0.01),and the plasma concentration-dose ratio was 4.74(3.33~6.52)d/L and 4.07(2.99~5.32)d/L,respectively(P<0.01),in patients treated with the batch A and batch B.Of the patients who swichted to batch B treatment from batch A,23 patients(24.73%)increased the dose of olanzapine tablets with an average increase of(5.76±2.86)mg/d,and 15 patients received other antipsychotics among which 5 patients increased the dose of olanzapine tablets with the addition of other antipsychotics,7 patients(7.53%)additionally took antihypertensive drugs,and 8 patients(8.60%)administered lipid-lowering drugs simvastatin or atorvastatin calcium.Twenty-two patients(23.66%)reduced the dose of olanzapine tablets,with an average dose reduction of(5.40±2.92)mg/d,and 13 patients(13.98%)discontinued benzodiazepines.Conclusion:The olanzapine tablet's overall plasma concentration of the two central-purchase batches were both within the recommended concentration range.There were some differences in plasma concentration-dose ratio of olanzapine tablets between the two central-purchased batches,but patient's condition can be maintained stable at the same dose,which provided reference for the adjustment of clinical medication and the implementation of the central procurement policy implementation.