《中国康复理论与实践》

《中国康复理论与实践》 ›› 2009, Vol. 15 ›› Issue (06): 556-558.

• 临床研究 • 上一篇    下一篇

齐拉西酮与利培酮口腔崩解片治疗首发精神分裂症患者随机、双盲、双模拟平行对照研究

徐娟;刘晓梅;邱大宏;陈东萍;黄群明;郑远松   

  1. 广东惠州市第二人民医院，广东惠州市 516001
  • 收稿日期:2009-03-02 出版日期:2009-06-01 发布日期:2009-06-01

A Randomized, Double Blind, Double Dummy Parallel Controlled Study in Schizophrenia Treated with Ziprasidone Tablets and Risperidone Orally Disintegrating Tablets

XU Juan, LIU Xiao-mei, QIU Da-hong, et al   

  1. Huizhou Second People's Hospital, Huizhou 516001, Guangdong, China
  • Received:2009-03-02 Published:2009-06-01 Online:2009-06-01

PDF (PC)

被引次数

8

摘要： 目的 比较齐拉西酮片与利培酮口腔崩解片治疗首发精神分裂症的疗效和安全性。方法 采用随机、双盲、双模拟平行对照的方法，对符合中国精神障碍分类诊断标准第3版(CCMD-3)精神分裂症诊断标准的首发精神分裂症患者，随机分为齐拉西酮片组和利培酮口腔崩解片组，齐拉西酮片和利培酮口腔崩解片最低剂量分别为40 mg/d和2 mg/d，最高剂量分别为160 mg/d和8 mg/d，每日分两次服用。进行为期8周的双盲双模拟对照研究。采用阳性症状与阴性症状量表(PANSS)、临床总体印象量表(CGI)评定疗效、采用副反应量表(TESS)评定副反应。结果 114例首发精神分裂症患者完成研究，齐拉西酮组55例，利培酮口腔崩解片组59例。治疗8周后，齐拉西酮组显效率为65.5%，有效率为92.7%；利培酮口腔崩解片组显效率为67.8%，有效率为93.2%。两组疗效在统计学上无显著性差异(P>0.05)。齐拉西酮片组和利培酮口腔崩解片组副反应的发生率分别为36.4%和32.2%，严重程度多为轻度。而锥体外系副反应发生率利培酮口腔崩解片组(11.9%)多于齐拉西酮组(3.6%)，但全部副反应在两组间的差异不具有统计学意义。结论 齐拉西酮片和利培酮口腔崩解片对精神分裂症疗效和副反应相当。

关键词: 精神分裂症, 齐拉西酮, 利培酮

Abstract: Objective To compare efficacy and safety of ziprasidone tablets and risperidone orally disintegrating tablets in the treatment of schizophrenia.Methods The randomized, double blind, double dummy parallel controlled was designed for this study. All cases were diagnosed as schizophrenia in accordance with the Chinese Classification and Diagnostic Criteria of Mental Disorder-3(CCMD-3) diagnosis standard and randomized into two groups which were treated with ziprasidone tablets or risperidone orally disintegrating tablets for 8 weeks. The initial doses of ziprasidone tablets risperidone and orally disintegrating tablets were 40 mg and 2 mg per day, respectively; and the effective doses range of ziprasidone tablets and risperidone orally disintegrating tablets were 40～160 mg and 2～8 mg per day, respectively. The Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI) and Treatment Emergent Side-effect Scale (TESS) were used to evaluate efficacy and side effects before and at the ends of 2, 4, 6, 8 weeks treatment，respectively. Results 114 adult schizophrenia patients were recruited in this study, including 55 patients in ziprasidone group and 59 patients in risperidone group. After 8 weeks treatment, the significant efficacy rates of ziprasidone group and risperidone group were 65.5% and 67.8%, respectively. The efficacy rates of ziprasidone group and risperidone group were 92.7% and 93.2%, respectively. There was no significant difference between the two groups (P＞0.05). All of the side effects observed in this study were slight. The incidence rates of side effect were 36.4% and 32.2% of ziprasidone group and risperidone group, respectively. Electrocardiogram (ECG) abnormality was only observed in ziprasidone group (7.3%). Accordingly, the extrapyramidal side syndrome (EPS) incidence rate of risperidone group (11.9%) was higher than ziprasidone group (3.6%). The difference between the two groups was not statistically significant (P＞0.05).Conclusion Both of the two medicines were effective and safe in treatment of schizophrenia.

Key words: schizophrenia, ziprasidone, risperidone