西酞普兰合并氯氮平治疗精神分裂症阴性症状的临床研究

A Randomized, Placebo - controlled Clinical Trial of Combined Citalopram and Clozapine in the Treatment of Negative Symptoms of Schizophrenia

目的:观察西酞普兰合并氯氮平治疗精神分裂症阴性症状的疗效和不良反应。方法:将61例精神分裂症阴性症状患者随机分为研究组(西酞普兰+氯氮平)和对照组(氯氮平+安慰剂),进行双盲研究。在治疗前、治疗后3、6、9、12周末,采用阳性和阴性症状量表(PANSS)和药物治疗不良反应量表(TESS)评定疗效和不良反应。结果:治疗12周末,研究组的显效率高于对照组(56．7％比25．8％,X2= 6．00,P=0．014)。从第3周末起,阴性因子分、一般精神病理分和总分均为研究组小于对照组(P<0．05或P<0．01),但是各时点阳性因子分的组间差异均不显著(P>0．05)。两组的不良反应发生率差异无统计学意义。结论:西酞普兰合并氯氮平治疗精神分裂症阴性症状的疗效比单用氯氮平好,并且不增加不良反应。

Objective： To observe the efficacy and safety of citalopram combined with dozapine in the treatment of negative symptoms in schizophrenia. Methods： In this double - blinded, placebo - controlled clinical trial, 61 inpatients with schizophrenia were randomized to Group A treated with citalopram and clozapine and Group B with clozapine and placebo. Efficacy and safety were assessed with the Positive and Negative Syndrome Scale （ PANSS ） and Treatment Emergent Symptoms Scale （TESS） respectively before and 3, 6, 9, 12 weeks after treatment. Results： More patients in group A improved significantly than in group B （ 56. 7% vs 25.8% , χ^2 = 6.00, P = 0. 014 ） . Since week 3, the total score, Negative Symptom subscale score and General Pathology subscale score were lower than those in group B （ P 〈0. 05 or P 〈0. 01 ） . The difference of Positive Syndrome subscale score between two groups was not statistically significant. The rate of side effects in both groups were similar. Conclusion： The combined eitalopram and clozapine is more effective than Clozapine in the treatment of negative symptoms of schizophrenia while it does not increase the rate of side effects.