齐拉西酮注射液对精神障碍患者激越疗效和安全性的多中心研究

A multicenter study on the efficacy and safety of ziprasidone injection in the treatment of acute agitation symptoms of mental disorders

目的:观察齐拉西酮注射液治疗伴有激越症状不同精神障碍患者的疗效和安全性。方法:对85例精神分裂症伴有激越症状患者和59例其他精神疾病伴有激越症状患者,采用多中心、单臂、开放性、干预性研究。肌内注射齐拉西酮注射液后分别在治疗前、治疗后(2 h、24 h、48 h、72 h)进行行为活动评定量表(BARS)和总体印象量表(CGI)评定,并在基线和治疗后72 h进行阳性与阴性症状量表(PANSS)评定,评估疗效和药物不良反应。结果:两组患者治疗后,BARS分数具有时间与组别的交互作用(F=2.54,P=0.043),进一步比较发现精神分裂症患者组在24 h评分显著低于其他精神疾病患者[(4.28±1.64)vs(4.81±1.16),P=0.019]。BARS分数和CGI-SI分数具有时间效应,随时间推移而降低(F=67.59,P<0.0001;F=48.33,P<0.0001)。PANSS各项分数及总分显著降低(P均<0.05)。结论:齐拉西酮注射液对精神分裂症患者激越症状在24 h疗效优于其他精神疾病患者,齐拉西酮注射液对不同精神障碍伴有激越症状患者的总体疗效相当,具有起效迅速、安全性高的特点。

Objective:To observe the efficacy and safety of ziprasidone injection in the treatment of patients with different mental disorders and agitation symptoms.Method:In a multi-center,single-arm,open and interventional study,85 patients with schizophrenia and 59 patients with other mental disorders were treated with ziprasidone injection.The patients were assessed by Behavior Activity Rating Scale(BARS)and Clinical Global Impression-Severity of Illness(CGI)before treatment and at 2,24,48 and 72 hours after injection,assessed by Positive and Negative Syndrome Scale(PANSS)before treatment and at 72 hours after injection to evaluate the therapeutic effect.Results:After treatment,BARS scores showed time×group interaction effect(F=2.54,P=0.043).Further comparison indicated that the score of schizophrenia patients was significantly lower than that of other psychiatric patients at 24 hours[(4.28±1.64)vs(4.81±1.16),P=0.019].BARS scores and CGl-SI scores showed time effect with scores decrease with time(F=67.59,P<0.0001;F=48.33,P<0.0001).PANSS subscores and total score significantly decreased(all P<0.05).Conclusion:Ziprasidone injection has better efficacy in 24 hours of agitation symptoms in patients with schizophrenia than other mental disorders.Ziprasidone injection has similar overall efficacy in patients with agitation symptoms of different mental disorders,with rapid onset and high safety.