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目的探索二甲双胍对氯氮平血药浓度及疗效的影响。方法对精神分裂症合并糖尿病,单一服用氯氮平治疗的64例患者,随机分为两组,对照组32例延用氯氮平治疗(200～500mg/日),研究组32例在延用氯氮平(剂量不变)的同时,合用二甲双胍(0.5～1.0g/日)治疗,治疗12周,以阳性症状与阴性症状量表(PANSS)评定疗效,用高效液相色普法(HPLC)测定氯氮平稳态血药浓度。结果合用二甲双胍治疗组(研究组),在合用前、第8周末、12周末,与对照组比较,氯氮平血药浓度差异无统计学意义(P﹥0.05),合用二甲双胍治疗12周后PANSS总分均显著下降,差异有统计学意义(t值=3.37,P﹤0.05),阳性症状评分下降,差异有统计学意义(P﹤0.05);阴性症状评分下降,差异有统计学意义(P﹤0.05)。结论二甲双胍合用氯氮平治疗精神分裂症合并糖尿病患者时,不影响氯氮平的血药浓度及疗效。
Objective To explore the effect of metformin on clozapine concentration and efficacy. Methods Sixty-four patients with schizophrenia with diabetes mellitus and clozapine alone were randomly divided into two groups, 32 patients in the control group were treated with clozapine (200-500 mg / day), 32 in the study group Clozapine (unchanged dose), while treated with metformin (0.5 ~ 1.0g / day) for 12 weeks. The curative effect was evaluated by Positive Symptom and Negative Symptom Scale (PANSS) Determination of steady-state blood levels of clozapine. Results Compared with the control group, the plasma concentration of clozapine in the combination group (study group) before treatment, the end of the 8th week and the end of the 12th week showed no significant difference (P> 0.05). After 12 weeks of metformin treatment, PANSS (T = 3.37, P <0.05), positive symptom scores decreased, the difference was statistically significant (P <0.05); negative symptom scores decreased, the difference was statistically significant (P <0.05). Conclusion Metformin combined with clozapine in the treatment of schizophrenia with diabetes, does not affect the clozapine concentration and efficacy.