运用重复一点法研究氯氮平个体化给药方案

Research on the individualized administration of clozapine

目的 :研究氯氮平的个体化给药方案。方法 :60名精神分裂症患者随机分成实验组和对照组 ,实验组服用重复一点法计算的氯氮平剂量 ,对照组服用 6mg·kg- 1固定剂量 ,于 2 ,4,6,8周末用简明精神科量表 (BPRS)和不良反应量表 (TESS)评定临床疗效和不良反应 ,并测定各周稳态氯氮平和去甲氯氮平浓度。结果 :实验组与对照组所用剂量统计学上无显著性差异(P >0 .0 5) ,但男性实验组与对照组剂量差异有显著性 (P <0 .0 5) ,两组BPRS减分值和有效率差异无显著性 (P >0 .0 5)。两组各周TESS增分值差异有显著性 (P <0 .0 5) ,BPRS减分值与氯氮平浓度、氯氮平和去甲氯氮平浓度之和未发现显著性相关(P >0 .0 5) ,TESS增分值与氯氮平浓度、氯氮平和去甲氯氮平浓度之和显著相关 (P <0 .0 1)。结论

OBJECTIVE To study the individualized administration of clozapine.METHODS 60 patients with schizophrenic disorder were randomly trial or controlled group, with administration from calculation of repeated one-point method or fix dose 6 mg·kg -1 respectively. Therapeutic efficacy was measured by BPRS and the adverse event was rated by TESS. Steady serum level of clozapine and norclozapi ne were monitored at the end of 2, 4, 6, 8 week. RESULTS No significiant difference was found at the clozapine dose of trial and controll ed group (P> 0.05 ), but significant difference was found at the dose of male trial and male controlled group (P< 0.01 ). No difference was found in the decreased score of BPRS and the rate of recovery between trial and contro lled group(P> 0.05 ). Difference was found in the increased score of TESS between trial and controlled group at the end of 2,4,6,8 week(P< 0.05 ). No significant correlation was found between the score of BPRS and the serum cl ozapine and the sum of serum clozapine and norclozapine level(P> 0.05 ),b ut was found in TESS (P< 0.01 ).CONCLUSIONS Repeated one-point method was practicable in the individualized administration of clozapine.