摘要
目的验证甲磺酸齐拉西酮注射液治疗精神分裂症急性激越症状的临床疗效和安全性。方法将64例具有急性激越症状的精神分裂症患者随机分为齐拉西酮组（研究组,32例）和氟哌啶醇组（对照组,32例）,进行开放式临床对照研究,患者入组后即给予臀大肌深部注射齐拉西酮注射液10mg或氟哌定醇注射液5~10mg,6~8小时后可重复使用;甲磺酸齐拉西酮和氟哌啶醇每日总量均不超过30mg,每日注射不超过3次,疗程3天。采用阳性和阴性症状量表（PANSS）、阳性与阴性症状量表兴奋因子（PANSS-EC）、临床总体印象量表（CGI）评分评价疗效;采用药物不良反应量表（TESS）、锥体外系副反应量表（SAS）评价副反应。结果治疗72小时后,齐拉西酮组和氟哌啶醇组的PANSS-EC总分均明显减低,齐拉西酮组PANSS-EC减分率为（47.79±12.94）%,氟哌啶醇组为（47.79±11.49）%,差异无统计学意义（t=0.063,P〉0.05）。齐拉西酮组临床总有效率为46.9%;氟哌啶醇组为40.6%,差异无统计学意义（χ2=0.063,P〉0.05）。齐拉西酮组不良反应发生率为28.1%,氟哌啶醇组65.6%,差异有统计学意义（χ2=9.035,P〉0.05）。结论甲磺酸齐拉西酮治疗精神分裂症的急性激越症状疗效明显,耐受性良好。
Objective： To estimate the clinical efficacy and safety of intramuscular mesylate ziprasidone in the treatment of acute agitation in schizophrenia. Methods： Sixty - four schizophrenic patients with acute agitation were divided into the intramuscular mesylate ziprasidone group as the study group （ n = 32 ） and the intramuscular haloperido] group as the control group （ n = 32 ）. The patients were treated with intramuscular mesyiate ziprasidone 10mg or intramuscular haloperidol 5 - 10mg by deep gluteal injection. The medicine could be repeated after 6 - 8 hours. The daily total does of mesylate ziprasidone was no more than 30 mg and the daily total dose of haloperidol was no more than 30 mg. The daily injection was not more than three times and thetreatment course was 3 days. The efficacy was assessed with PANSS, PANSS - EC and CGI and the side effects were assessed with TESS and Simpson - Angus Scale. Results ： After 72 hours of treatment, the scores of PANSS- EC of ziprasidone group and haloperidol group were significantly lower. The decreasing rates on PANSS - EC of ziprasidone group and haloperidol group were [ （47.96 ± 12.94） % vs. （47.79 ± 11.49） % , t = 0.063 ,P 〉 0.05 ]. The response rate was 46.9% in ziprasidone group and 40.6% in haloperidol group and there was no difference between the two groups. The side effects rate was 28.1% in ziprasidone group and 65. 6% in haloperidol group which was significant different between the two groups （X2 = 9. 035, P 〈 0.05 ） . Conclusion：Intramuscular mesylate ziprasidone is effective and safe in the treatment of acute agitation in schizophrenia.
出处
《上海精神医学》
2008年第6期363-366,共4页
Shanghai Archives of Psychiatry
