| 张燕,孙丽莎,李婵,崔小花,戴尊孝,郑璇.氨磺必利治疗精神分裂症的浓度参考范围和警戒值[J].四川精神卫生杂志,2022,35(1):31-36.Zhang Yan,Sun Lisha,Li Chan,Cui Xiaohua,Dai Zunxiao,Zheng Xuan,Discussion on the reference range and alert level of amisulpride in the treatment of schizophrenia[J].SICHUAN MENTAL HEALTH,2022,35(1):31-36 |
| 氨磺必利治疗精神分裂症的浓度参考范围和警戒值 |
| Discussion on the reference range and alert level of amisulpride in the treatment of schizophrenia |
| 投稿时间：2021-09-07 |
| DOI：10.11886/scjsws20210907006 |
| 中文关键词: 氨磺必利 参考范围 警戒值 不良反应 疗效 |
| 英文关键词:Amisulpride Reference range Alert level Adverse reaction Clinical efficacy |
| 基金项目:西安市科技计划项目（项目名称：西安市药学（精神卫生）重点实验室，项目编号：201805051ZD2CG35） |
|
| 摘要点击次数: |
| 全文下载次数: |
| 中文摘要: |
| 目的 探讨临床氨磺必利治疗精神分裂症提供可参考的浓度范围及警戒值。方法 纳入符合《国际疾病分类（第10版）》（ICD-10）诊断标准的精神分裂症患者为研究对象，均接受氨磺必利治疗。收集患者年龄、性别、治疗时间、单日给药剂量、临床诊断、氨磺必利浓度、治疗前后阳性症状量表（SAPS）、阴性症状量表（SANS）、阳性和阴性症状量表（PANSS）评分、出现的不良反应以及联合用药情况。比较不同疗效和不同剂量组氨磺必利浓度的差异，比较不同浓度组和是否联合用药组不良反应发生率。采用阴阳性预测值的方法探索氨磺必利浓度的参考范围及警戒值。结果 不同剂量组和不同疗效组的患者氨磺必利浓度差异均无统计学意义（F=0.745、1.343，P均>0.05），不同疗效组的患者单日给药剂量差异无统计学意义（F=0.902，P>0.05），氨磺必利疗效与浓度的相关性无统计学意义（r=0.023，P=0.744）；单一用药组和联合用药组的疗效和不良反应发生率差异均无统计学意义（F=2.198、0.095，P均>0.05），氨磺必利药物浓度与不良反应发生率呈非线性相关［y=100x/（78.13+x），r=0.960］。当氨磺必利浓度为100~600 ng/mL时，减分率均≥42%，参考界值有效率检出率均≥1.485，不良反应发生率均≤85%；当氨磺必利浓度为1400~1800 ng/mL时，浓度越高，减分率越低（均<42%），不良反应发生率越高（均>85%）。结论 推荐100~600 ng/mL作为氨磺必利的参考范围，1400 ng/mL作为警戒值，以保障氨磺必利的临床用药安全。 |
| 英文摘要: |
| Objective To study a therapeutic reference range and laboratory alert level of amisulpride in the clinical treatment of schizophrenia.Methods Patients who met the diagnostic criteria for schizophrenia in the International Classification of Diseases， tenth edition （ICD-10） were enrolled， and all patients received amisulpride treatment. Data including age， gender， duration of treatment， single daily dose， clinical diagnosis， amisulpride concentration， the scores of the Scale for the Assessment of Positive Symptoms （SAPS）， Scale for the Assessment of Negative Symptoms （SANS） and Positive and Negative Syndrome Scale （PANSS）， the adverse reaction rate and multitherapy were collected. The concentration of amisulpride was compared within different efficacy groups and different dosage groups， meantime， the incidence rate of adverse reactions was compared within different amisulpride concentration groups， and between monotherapy and multitherapy groups. Thereafter， the therapeutic reference range and laboratory alert level of amisulpride in the clinical treatment of schizophrenia were explored via estimating the negative and positive predictive values.Results The amisulpride concentration yielded no statistical difference within different dosage groups and different efficacy groups （F=0.745， 1.343， P>0.05）. The single daily dose among patients in different efficacy groups demonstrated no significant difference （F=0.902， P>0.05）. The correlation between amisulpride treatment efficacy and its concentration denoted no statistical significance （r=0.023， P=0.744）. The clinical efficacy and adverse reaction rate showed no significant difference between monotherapy group and multitherapy group （F=2.198， 0.095， P>0.05）. The concentration of amisulpride was not linearly correlated with the adverse reaction rates ［y=100x/（78.13+x）， r=0.960］. When amisulpride concentrations ranged from 100 to 600 ng/mL， the mean reduction rate was equal to or above 42%， the effective detection rate of the reference cut-off value was equal to or above 1.485， and the incidence of adverse reactions was equal to or below 85%. When amisulpride concentrations ranged from 1400 to 1800 ng/mL， there was a decreasing trend in reduction rate （all<42%） and an increasing trend in adverse reaction rate （all>85%） as the concentration of amisulpride increased.Conclusion A reference range of 100~600 ng/mL and an alert level of 1400 ng/mL are recommended for the clinical safety of amisulpride. |
| 查看全文 查看/发表评论 下载PDF阅读器 |
| 关闭 |