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目的 观察精神分裂症患者单用氯氮平(CLOZ)及其与氯丙嗪(CPZ)合用时,氯氮平及其代谢产物N甲基氮氮平(N-CLOZ)的药物动力学、临床疗效和不良反应。方法 共有51例精神分裂症患者入组,按入院顺序分成两组,试验组27例,对照组24例。试验组先单用氯氮平75mg Bid×2.对照组先单用氯氮平75mg Bid×2W.后改用剂量至150rag Bid×2W,观察期4W。试验纽于服药之前及服后0.5h、1h、3h、7h、12h、20h、28h采静脉血,进行氯氮平及N—去甲基氯氮平药动学参数测定。有11例在治疗2w后与4W后早晨服药之前采脑脊液(csF)一次。结果:合用氧丙嗪时,氧氮平及N—去甲基氯氮平的药时曲线下面积(AUc)显著较大,清除率(CL)显著减少,N—去甲基氯氮平的峰浓度(C_(max))显著较大,CSF中氯氮平浓度显著增加(p<0.05)。经4W治疗,试验组病人显效率为37.0%,对照组为29.2%,两者之间无显著性差异。用TESS评价不良反应,两组之间无显著性差异。结论 本研究提示氯氮平合用氮丙嗪治疗精神分裂症有一定依据。
Objective To investigate the pharmacokinetics of clozapine and its metabolite N-methyl-N-clozapine (N-CLOZ) in patients with schizophrenia combined with clozapine (CLOZ) and its combination with chlorpromazine (CPZ) Efficacy and adverse reactions. Methods A total of 51 patients with schizophrenia were enrolled in the study. They were divided into two groups according to admission sequence: 27 cases in trial group and 24 cases in control group. The experimental group first with clozapine 75mg Bid × 2. Control group first with clozapine 75mg Bid × 2W. After the switch to the dose to 150rag Bid × 2W, observation period 4W. Test Niuyao before taking the drug and after serving 0.5h, 1h, 3h, 7h, 12h, 20h, 28h venous blood, clozapine and N-desmethyl clozapine pharmacokinetic parameters were measured. Eleven patients received cerebrospinal fluid (CSF) once 2 weeks after treatment and 4 days after taking the medication in the morning. RESULTS: When oxpirtine was administered, the area under the curve (AUc) of oxazepam and N-desmethylclozapine was significantly larger and the clearance (CL) was significantly reduced. The N-desmethylclozapine The peak concentration (C max) was significantly larger and the concentration of clozapine in CSF was significantly increased (p <0.05). After 4W treatment, the test group patients markedly effective rate was 37.0%, 29.2% in the control group, no significant difference between the two. Adverse reactions were evaluated using TESS, with no significant difference between the two groups. Conclusions This study suggests that clozapine may be associated with azathiazide in the treatment of schizophrenia.