齐拉西酮注射液治疗躁狂发作激越症状的研究

目的：以氟哌啶醇注射液为对照，评价齐拉西酮注射液治疗躁狂发作急性期激越患者的疗效及安全性。方法：符合ICD-10双相I型躁狂发作诊断标准的患者70例，随机分配到齐拉西酮注射液治疗组（试验组）和氟哌啶醇注射液治疗组（对照组）各35例，对患者进行基线评价，以及肌注治疗后的2、12、24、48和72h的评价。采用PANSS兴奋因子量表评价主要疗效，采用副反应症状量表（TESS量表）评定药物的不良反应。结果：两组72h时试验组总有效率为71．43％，对照组总有效率为68．57％。药物治疗72h后与基线比较，试验组PANSS兴奋因子得分减分平均为（11．32±4．15）分，对照组PANSS兴奋因子得分减分平均为（11．76±4．23）分。两组主要疗效指标差异无统计学意义（P〉0．05）。试验组锥体外系不良反应较对照组明显减少，TESS量表评分在治疗前后差异无统计学意义（P〉0．05）；对照组出现锥体外系不良反应较多，治疗前后差异有统计学意义（P〈0．05）。结论：甲磺酸齐拉西酮注射液可快速有效控制躁狂发作的激越症状，疗效与氟哌啶醇注射液相当，但安全性更高。

Study of ziprasidone injection in the treatment of agitated patients with manic episodein

Objective： Choosing haloperidol injection as control,to evaluate the efficacy and safety ofziprasidone injection in the treatment of agitated patients with manic episodein acute phase. Method ： Manic episodepatients who conform to ICD - 10bipolar I diagnostic criteria are randomly and evenly assigned toziprasidone injection treatment group （test group） and haloperidol injection treatment group （control group）. Baseline evaluation and evaluation of 72 h, 2 weeks, 4weeks, and 8 weeks after intramuscular injection are ran on the patients. PANSS excitation factor scale is used to evaluate the main efficacy, and the emergent symptoms scale （TESS scale） is used to evaluate the adverse reaction. Result： Each group has 35 subjects. Compared with the baseline, after 72 h＇ streatment, the PANSS excitatory factor scoreof test group has an average reduction of 11.32± 4.15, while that of control group has an average reduction of 11.76 ± 4.23. The main efficacy index shows no statisticallysignificant difference between the two groups （ P 〉 0.05 ）. Extrapyramidal adverse reaction of test group is much less than that of control group. TESS score shows no significant difference before and after the treatment （ P 〉 0.05 ） ; control group shows more extrapyramidal adverse reactions, and there is statistically significant difference before and after treatment （ P 〈 0.05 ）. Conclusion ： Manic episode can befast and effectivelycontrolled byziprasidonemesylateinjection, with similar efficacy ofhaloperidol injeetio, but the former has higher safety.