七种抗精神病药对精神分裂症患者维持治疗一年的有效性及安全性研究

目的 比较氯丙嗪、舒必利、氯氮平、利培酮、奥氮平、奎硫平、阿立哌唑7种抗精神病药对精神分裂症患者1年维持治疗的有效性及安全性.方法 对服用7种药物之一、病程≤5年稳定期的1227例精神分裂症患者给予1年的维持治疗,以治疗中断率、中断前治疗时间并结合临床疗效评价抗精神病药的总体有效性,采用不良事件和实验室检查评价安全性,每间隔3个月评估1次.结果 随访1年,1227例患者中共有541例(44.1%)患者中断治疗.7个药物组间治疗中断率(P=0.283)及中断前治疗时间(P=0.400)的差异均无统计学意义(P>0.05);495例(40.3%)患者完成1年随访并达到临床痊愈标准,临床痊愈率在7个药物组间的差异无统计学意义(χ2=3.211,P>0.05).7个药物组总的不良反应发生率(88.3%～95.6%)的差异无统计学意义(χ2=8.345,P>0.05),但镇静作用(χ2=100.836)、锥体外系不良反应(χ2=68.074)、月经紊乱(χ2=71.295)及体质量增加(χ2=13.527)等不良反应在不同药物间的差别有统计学意义(P<0.01和0.05).结论 7种抗精神病药治疗精神分裂症患者1年的临床疗效相当,但药物的不良反应各异.

Maintenance treatment effectiveness of seven antipsychotic drugs in schizophrenic patients: a 1-year follow-up study

Objective To compare the effectiveness of seven antipsychotie agents including chlorpromazine, sulpiride, clozapine, risperidone, olanzapine, quetiapine, and aripiprazole to schizophrenia after 1 year maintenance treatment. Methods A total of 1227 patients suffering from schizophrenia for less than 5 years who took one of the seven medications as maintenance treatment were recruited at 10 China sites, and followed up to 1 year. The subjects were assessed at baseline and once every 3 months. The rates of treatment discontinuation and time to discontinuation combined with ehnical efficacy evaluation were as the outcome measurement. The self-reported adverse events and lab tests were administered to evaluate side effects. Results At the end of the study, 44.1% patients discontinued their treatment; and 40.3% patients completed the 1-year follow-up and attained clinical remission. There were no significant differences in the rate of discontinuation and time to discontinuation among the seven groups. There was no significant difference in the total rate of side effects among the seven treatment groups, with significantly different profiles in sedation, extrapyramidal symptoms, weight gain and menstrual irregularities. Conclusion The results indicate the clinical effectiveness of 1 year maintenance treatment of the 7 antipsychotic drugs are similar, with some difference in side effect profiles.