齐拉西酮治疗急性期住院精神分裂症患者的疗效和安全性研究

Efficacy and safety of ziprasidone in treatment of schizophrenic inpatients in acute phase

目的观察齐拉西酮治疗急性期精神分裂症的疗效和不良反应。方法入组31例急性期精神分裂症患者,予齐拉西酮（80~160 mg/d）治疗8周,治疗前4周,可根据临床需要合并使用改良电休克治疗。在治疗基线,4周末和8周末评定阳性和阴性症状量表、临床疗效总评量表和不良反应量表。结果 28例患者完成研究。与基线时相比较,治疗4周末和8周末阳性和阴性症状量表评分显著降低（均P〈0.01）。治疗4周末和8周末QTc间期与基线时相比较差异无统计学意义（t=1.09,P=0.28;t=0.81,P=0.43）,但催乳素水平比基线时显著升高（t=3.62,P=0.001;t=4.02,P=0.000）;治疗8周末体质量与基线时体质量比较差异无统计学意义（P〉0.05）。结论齐拉西酮能有效治疗急性期精神分裂症的阳性和阴性症状,对体质量、QTc间期无明显影响。

Objective To investigate the efficacy and adverse reaction of ziprasidone for treatment of schizophrenia in acute phase. Methods Thirty-one schizophrenic inpatients in acute phase were included in the study, and were given ziprasidone for 8-week treatment. Modified Electra Convulsive Therapy（MECT） was used according to clinical need in the first 4 weeks. Positive and Negative Syndrome Scale（PANSS）, Clinical Global Impres-sion（CGI） scale and Treatment Emergent Symptom Scale（TESS） were used for evaluation at baseline, the end of 4and 8 weeks of the treatment. Results Twenty-eight patients completed the study. The PANSS score was significantly lower at the end of 4 and 8 weeks compared with that at the baseline（all P〈0.01）. No statistically significant difference was found in QTc interval at the end of 4 and 8 weeks compared with that at the baseline, respectively（ t=1.09,P=0.28; t=0.81, P=0.43）. However, the prolactin level increased significantly in QTc interval at the end of 4 and 8weeks compared with that at the baseline, respectively（t=3.62, P=0.001; t =4.02, P =0.000）. The body weight at the end of 8 weeks did not differ statistically significant compared with that at the baseline（ P〉0.05）. Conclusion Ziprasidone is effective in treating positive and negative symptoms of schizophrenia in acute phase, without significant effects on the body weight and QTc interval.