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基于治疗药物监测的氨磺必利剂量校正浓度影响因素分析
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          王毅奇    1,2* ,常路瑶 ,付 冉 ,王玲娇 ,于 静 ,周春华 (1.河北医科大学第一医院临床药学部,石家
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          庄 050000;2.河北省人工智能临床药学技术创新中心,石家庄 050000)
          中图分类号  R969.3;R971 .41      文献标志码  A      文章编号  1001-0408(2022)24-3020-05
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          DOI  10.6039/j.issn.1001-0408.2022.24.15
          摘   要  目的  分析氨磺必利剂量校正浓度(C/D)的影响因素,为该药的临床合理应用提供参考。方法  回顾性收集河北医科大
          学第一医院精神卫生中心2021年3-11月进行氨磺必利治疗药物监测的精神分裂症住院患者的末次血药浓度监测结果及相关病
          历资料,分析其年龄、性别、体质量指数(BMI)、血清肌酐水平、联合用药对氨磺必利C/D值的影响。结果  共纳入精神分裂症住院
          患者133例,其氨磺必利中位剂量为600.00 mg/d,中位血清浓度为332.57 ng/mL,中位C/D值为0.61 ng·d/(mL·mg);49例患者的
          血清药物浓度在相关指南推荐参考范围(100~320 ng/mL)内,27例患者超过实验室警戒水平(640 ng/mL)。不同性别患者的给药
          剂量、血清药物浓度、C/D值比较,差异均无统计学意义(P>0.05);未成年患者的血清药物浓度显著低于成年患者(P<0.05),但其
          给药剂量、C/D 值与成年患者比较,差异均无统计学意义(P>0.05);肥胖(BMI>28 kg/m)患者的氨磺必利 C/D 值显著低于正常
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         (BMI为18.5~23.9 kg/m)患者;联用奥氮平、丙戊酸钠、苯二氮卓类药物均不会影响患者的氨磺必利C/D值(P>0.05);患者的血
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          清肌酐水平与氨磺必利给药剂量不相关(r=0.081,P>0.05),但与该药的 C/D 值呈正相关(r=0.285,P<0.05)。结论  患者的年
          龄、BMI、血清肌酐水平与氨磺必利的 C/D 值密切相关。临床在应用氨磺必利治疗精神分裂症时,应充分考虑患者的年龄、体质
          量、血清肌酐等因素,为患者制定个体化用药方案,以保证治疗的安全、有效。
          关键词  氨磺必利;治疗药物监测;剂量校正浓度;影响因素;联合用药

          Analysis  of  influential  factors  for  dose-corrected  trough  concentration  of  amisulpride  based  on  therapeutic
          drug monitoring
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          WANG Yiqi ,CHANG Luyao ,FU Ran ,WANG Lingjiao ,YU Jing ,ZHOU Chunhua (1. Dept.  of
          Clinical  Pharmacy,  the  First  Hospital  of  Hebei  Medical  University,  Shijiazhuang  050000,  China;2. The
          Technology  Innovation  Center  for  Artificial  Intelligence  in  Clinical  Pharmacy  of  Hebei  Province,  Shijiazhuang
          050000, China)
          ABSTRACT    OBJECTIVE  To  analyze  the  influential  factors  for  dose-corrected  trough  concentration (C/D)  of  amisulpride,  and
          to provide reference for rational use of it in clinic. METHODS The results of the last serum concentration monitoring and relevant
          medical  data  of  schizophrenic  inpatients  who  were  monitored  for  the  treatment  of  amisulpride  in  the  Mental  Health  Center  of  the
          First Hospital of Hebei Medical University from March to November 2021 were collected retrospectively and analyzed the effects of
          age, sex, body mass index (BMI), serum creatinine level, and combined medication on the C/D value of amisulpride. RESULTS
          A  total  of  133  schizophrenic  inpatients  were  included,  and  median  dose  of  amisulpride  was  600.00  mg/d,  median  serum
          concentration  was  332.57  ng/mL,  and  median  value  of  C/D  was  0.61  ng·d/(mL·mg). The  serum  concentration  of  49  patients  was
          within  the  recommended  range  of  relevant  guideline (100-320  ng/mL),  and  27  patients  exceeded  the  laboratory  warning
          concentration (640  ng/mL).  There  was  no  statistical  significance  in  drug  dose,  serum  concentration  or  C/D  value  among  the
          patients of different genders (P>0.05). The serum concentration of minor patients was significantly lower than that of adult patients
         (P<0.05), but there was no statistical significance in drug dose or C/D value between minor patients and adult patients (P>0.05).
          The C/D value of amisulpride in obese patients (BMI>28 kg/m) was significantly lower than that in normal patients (BMI 18.5-
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          23.9  kg/m);  the  combination  of  olanzapine,  sodium  valproate  and  benzodiazepines  did  not  affect  the  C/D  value  of  amisulpride
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         (P>0.05);  the  level  of  serum  creatinine  in  patients  was  not  related  to  the  dose  of  amisulpride (r=0.081,  P>0.05),  but  was
          positively related to the C/D value of the drug (r=0.285, P<0.05). CONCLUSIONS The age, BMI and serum creatinine level of
          patients are  closely related to  the  C/D  value of  amisulpride.  In  the  clinical  treatment  of  schizophrenia with  amisulpride,  we  should
          fully  consider  the  patient’s  age,  body  mass,  serum  creatinine  and  other  factors,  and  develop  a  personalized  drug  regimen  for
                                                              patients to ensure the safety and effectiveness of treatment.
              Δ 基金项目 河北省医学科学研究课题计划(No.20221440)               KEYWORDS    amisulpride;  therapeutic  drug  monitoring;
             *第一作者 药师。研究方向:临床药学。E-mail:1535773211@
          qq.com                                              dose-corrected  trough  concentration;  influential  factor;  drug
                                                              combination
              # 通信作者 主任药师,博士。研究方向:临床药学。E-mail:
          Zhouchunhua80@163.com


          · 3020 ·    China Pharmacy  2022 Vol. 33  No. 24                            中国药房  2022年第33卷第24期
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