【摘要】 目的评价国产甲磺酸齐拉西酮注射液治疗精神分裂症急性激越症状的疗效和安全性。方法将60例伴急性激越症状的精神分裂症患者随机分为观察组(n=30)和对照组(n=30),进行随机单盲临床对照研究。观察组给予国产甲磺酸剂拉西酮注射液10~20 mg肌肉注射,每日总量不超过40 mg;对照组给予氟哌啶醇注射液5~10 mg肌肉注射,4~6 h后可重复使用,每日总量不超过30 mg,每日注射不超过3次,疗程3 d。于治疗前、治疗后2 h、6 h、24 h、48 h及72 h评定阴性与阳性症状量表兴奋因子评分(PANSS-EC),于治疗前、治疗后72 h评定阳性和阴性症状量表(PAN-SS)。采用不良事件报告、锥体外系副反应量表和实验室检查评定疗效及副作用。结果治疗72 h后,2组PANSS和PANSS-EC总分都明显降低(P<0.05);观察组临床总有效率(30.0%)与对照组(20.0%)比较差别无统计学意义(P>0.05)。观察组不良反应发生率(30.0%)与对照组(36.7%)比较差别无统计学意义(P>0.05)。对照组肌强直的发生率明显高于观察组,差别有统计学意义(P<0.05)。结论国产甲磺酸齐拉西酮注射液能有效治疗精神分裂症的急性激越症状,疗效与氟哌啶醇相当。更多还原

【Abstract】 ObjectiveTo evaluate the efficacy and safety of domestic ziprasidone mesylate injection in the treatment of acute agitation of schizophrenia.Methods60 hospitalized patients who met schizophrenia were randomly divided into observation group and control group,each group was thirty cases.Patients in observation group were treated with ziprasidone mesylate injection 10-20 mg by intramscular injection.The total dose was no more than 40 mg.Patients in control group were given haloperidol 5-10 mg by intramscular injection at once.It could be used after 4-6 h.The total dose was no more than 30mg.The treatment duration was three days.The scores of excitatory factor of scale for the assessment of negative and positive symptoms(PANSS-EC) were assessed before treatment and 2 h,6 h,24 h,48 h and 72 h after treatment.The scores of scale for the assessment of negative and positive symptoms(PANSS) were assessed before treatment and 72 h after treatment.adverse events reporting,rating scales of subsidiary reaction of extrapyramidal system and labortory tests were used to evaluate the efficacy and side effect.Results72 hours after treatment,the total scores of PANSS-EC and PANSS in two groups were significantly reduced(P<0.05).Clinical effective rate of observation group was 30.0%,and the clinical effective rate of control group was 20.0%.There was no statistically significant between two groups(P>0.05).The incidence of side effect in observation group and control group was 30.0% and 36.7% respectively,there was no statistically significant between two groups(P>0.05).But the incidence of myotonia in control group was higher than that in observation group(P<0.05).ConclusionDomestic ziprasidone mesylate injection has effective curative effect in treating acute onset of schizophrenia.It is similar with haloperidol.更多还原