齐拉西酮与利培酮治疗急性期精神分裂症的随机对照研究

Randomized controlled study on ziprasidone and risperidone in treatment of schizophrenia

目的比较齐拉西酮和利培酮对急性期精神分裂症患者的疗效和安全性。方法对90例精神分裂症急性发作的住院患者,随机设计使用齐拉西酮(80～120mg/d,分两次服用)、利培酮(4～6mg/d,分两次服用)治疗8周,疗效评价指标采用阳性症状量表和阴性症状量表(PANSS),安全性指标采用体质量指数、空腹血糖、心电图QT间期以及药物不良反应量表(TESS)来评定。结果在疗效上,两组有效率分别为86.7%和88.1%,差异无统计学意义。齐拉西酮治疗阳性症状稍差于利培酮,治疗阴性症状比利培酮效果要好,但二者差异均无统计学意义。在安全性方面,齐拉西酮较少引起静坐不能、体质量改变,与利培酮相比差异有统计学意义(P<0.05)。结论齐拉西酮和利培酮的疗效相近,但齐拉西酮比利培酮较少引起静坐不能、体质量改变,具有安全性方面的优势。

Objective To evaluate the efficacy and safety of ziprasidone and risperidone in treating schizophre nia. Methods All 90 inpatients were randomly assigned to ziprasidone （n=46,the averaged dosage was 94.9 mg/d） or risperidone （n=44,the averaged dosage was 4.9 mg/d） treatment for 8 weeks. The efficacy was evaluated with the Positive and Negative Symptom Scale（PANSS）, the safety was assessed with the Treatment Emergent Symptom Scale（TESS） ,biochemical index and electrocardiogram. Results The response rate were 86. 7% and 88. 1 % in ziprasidone and risperidone groups respectively, the positive and negative symptoms were significantly improved（P〈0.05） after 8 weeks treatment in the two groups. The incidence of adverse events was 31.1 % in ziprasidone group and 38.0% in risperidone group. Ziprasidone induced less akathisia and body mass change than risperidone,there is a significant difference between two groups（P〈0.05）. Conclusion Ziprasidone has the similar therapeutic effect to risperidone in the treatment of schizophrenia,which is safe and generally well-tolerated.