奎硫平联合丙戊酸镁缓释片治疗难治性精神分裂症对照研究

A control study on quetiapine combined with magnesium valproate extended-release tablets in the treatment of refractory schizophrenia

目的探讨奎硫平联合丙戊酸镁缓释片治疗难治性精神分裂症的临床疗效和安全性。方法将57例难治性精神分裂症患者随机分为实验组28例，对照组29例，实验组口服奎硫平联合丙戊酸镁缓释片治疗，对照组口服奎硫平联合安慰剂治疗，观察12周。于治疗前及治疗第2周、4周、8周、12周末采用阳性与阴性症状量表评定临床疗效，副反应量表评定不良反应。结果治疗后两组阳性与阴性症状量表总分均较治疗前有显著下降（P〈0．01），治疗8周、12周末实验组较对照组下降更显著（P〈0．05）。治疗12周末，实验组显效率39．29％，有效率78．57％；对照组分别为20．69％、44．83％。实验组疗效显著优于对照组（χ^26．79，P〈0．05）。两组不良反应程度均轻微，发生率均无显著性差异（P目〉0．05）。结论奎硫平联合丙戊酸镁缓释片治疗难治性精神分裂症较单用奎硫平治疗疗效更显著，且不增加不良反应，安全性高。

Objective To explore the efficacy and safety of quetiapine combined with magnesium valproare extended-release tablets in the treatment of refractory schizophrenia. Methods Fifty-seven patients with refractory schizophrenia were randomly divided into experimental（n： 28） and control group（n=29）, the former took orally quetiapine plus magnesium valproate extended-release tablets and the latter did quetiapine plus placebo for 12 weeks. Efficacies were assessed with the Positive and Negative Syndrome Scale （PANSS） and adverse reactions with the Treatment Emergent Symptom ScaLe（TESS） before treatment and at the end of the 2nd, 4th, 8th and 12th week. Results After treatment, the PANSS total scores of both groups lowered more significantly compared with pretreatment（P〈0.01）, so did in the experimental than in the control group at the end of the 8th and 12th week（P〈0.01）. At the end of the 12th week, obviously effective and effective rates were 39.29% and 78.57% in the experimental and 20.69% and 44.3% in the control group, respectively, the former were better than the latter（χ^2=6.79,P〈0.05）. Adverse reactions of both groups were mild and their incidences had no significant difference（all P〈0.05）. Conclusion Quetiapine plus magnesium valproate extended release tablets has better curative effect than quetiapine only, does not increase adverse reactions and has higher safety in the treatment of refractory schizophrenia.