齐拉西酮注射液治疗精神分裂症急性兴奋临床研究

A clinical study of intramuscular ziprasidone in treating acute agitation in schizophrenia

目的观察齐拉西酮注射液治疗精神分裂症患者急性兴奋的疗效和安全性。方法将急性精神分裂症兴奋患者71例分为两组,治疗组36例予齐拉西酮肌内注射,对照组35例予氟哌啶醇肌内注射,患者入组后即给予齐拉西酮注射液10mg或氟哌啶醇注射液5-10mg肌内注射,4-6h后可重复使用,齐拉西酮及氟哌啶醇每日总量均不超过40mg/d,观察疗程均为3天。采用阳性和阴性症状量表（PANSS）中兴奋因子（PANSS-EC）的变化评定临床疗效,副反应量表（TESS）评定不良反应。于治疗前、治疗第2、6、24、48、72小时分别评定PANSS-EC,副反应量表（TESS）,治疗前及治疗结束时分别评定血、尿、生化常规及心电图。结果治疗72小时,齐拉西酮组的PANSS-EC总分明显降低,PANSS-EC减分率为（71±27）%,临床总有效率为52.7%;氟哌啶醇组的PANSS-EC减分率为（67±24）%,临床总有效率为45.7%,两组的差异均无统计学意义（P均〉0.05）;齐拉西酮组总的不良反应发生率41.7%,氟哌啶醇组为54.3%,两组的差异无统计学意义（P〉0.05）;齐拉西酮组的心脏不良反应发生率19.4%,氟哌啶醇组为14.3%,两组的差异无统计学意义（P〉0.05）;氟哌啶醇组的锥体外系的发生率明显高于齐拉西酮组,差异有统计学意义（P〈0.05）。结论齐拉西酮注射液治疗精神分裂症急性兴奋疗效肯定,安全性高。

Objective： To determine the efficacy and safety of injection ziprasidone in the treatment of acute agitation in schizophrenia. Methods： Seventy - one inpatients were randomly divided into ziprasidone group and haloperidol group, 36 patients were treated with ziprasidone injection and 35 were treated with haloperidol injection. The Patients were treated with injection ziprasidone 10mg or haloperidol 5 - 10mg as soon as hospitalized and the maximum dosage of ziprasidone or haloperidol was 40mg daily. The observation duration was 72 hours. The Positive and Negative Syndrome Scale （ PANSS）, PANSS - Exiciting Factor （ PANSS - EC ） and Treament Emergent Symptom Scale（TESS） were used to evaluate the efficacy and side -effect. Results： The total score of PANSS - EC in the ziprasidone group was significantly reduced at 72 hours after treatment. There were no significant differences in the reduction of PANSS - EC score [ （71± 27 ） % vs. （67 ± 24 ） % ] and the response rates （ 52.7% vs. 45.7% ） between the ziprasidone and haloperidol group （ P 〉 0.05 ）. The total incidence of side effects in ziprasidone group was not significantly different from haloperidol group （41.7% vs. 54.3% ）. And the incidence rate of extrapyramidal symptoms was lower in ziprasidone group than in haloperidol group（P 〈 0.05 ）. Conclusion ：Ziprasidone is effective and safe in treating acute agitation schizophrenia.