齐拉西酮联合心境稳定剂治疗双相障碍躁狂发作和混合发作

Ziprasidone plus a mood stabilizer in subjects with patients with manic or mixed episode of bipolar disorders

目的:探讨齐拉西酮合并碳酸锂或丙戊酸钠治疗躁狂发作和混合发作的疗效和安全性。方法:对符合CCMD-3躁狂发作和混合发作诊断标准的68例研究对象随机分成两组,试验组应用齐拉西酮合并碳酸锂或丙戊酸钠,对照组单一使用碳酸锂或丙戊酸钠,治疗观察6周。采用杨氏躁狂量表(YMRS)评定疗效,以副反应量表(TESS)及实验室有关辅助检查评价安全性。结果:两组在治疗前后症状均有显著降低(F=9.05,P<0.01;F=6.10,P<0.01)。试验组在治疗第1周末的减分率比对照组显著,这种差异在1～6周持续存在,而且第6周结束后的临床痊愈率也显著高于对照组。试验组治疗1周末、治疗2周末、治疗4周末、治疗6周末YMRS分别是21.4±8.4、14.6±5.5、8.9±3.3、6.5±3.4,对照组分别是23.9±7.2、20.9±8.1、17.8±7.8、12.8±8.9,组间差异有统计学意义(P<0.01)。试验组的症状减分变化分别是6.1±3.5、12.9±4.8、20.1±5.3、21.4±5.5,对照组分别是2.1±3.0,6.8±4.5、11.5±5.6、14.4±5.3,组间比较差异有统计学意义(P<0.01)。两组间有效率差异有统计学意义(68.5%vs 48.5%,χ2=4.47,P<0.05)。两组间痊愈率差异具有统计学意义(54.3%vs 18.2%,χ2=9.52,P<0.01)。但是两组间均没有严重的药物副作用,因无疗效和副作用导致的脱落率两组差异无统计学意义。结论:齐拉西酮合并碳酸锂或丙戊酸钠治疗躁狂发作和混合发作双相障碍的疗效比较理想,比单一使用心境稳定剂可能更好。

AIM： To explore efficacy and safe- ty of ziprasidone combining lithium carbonate or valproate in the treatment of patients with manic and mixed episode of bipolar disorders. METH- ODS： The 68 patients meeting criteria of manic episode or mixed episode of bipolar disorder in CCMD-3 were randomly divided into experiment group（ combination of ziprasidone and lithium carbonate or valproate） and control group （ sin- gle using of lithium carbonate or valproate） and observed for 6 weeks. The Yong Manic Rating Scale（YMRS） and treatment emergent symptom scale（TESS） were individually used for the as- sessment of efficacy and safety. RESULTS： The score of YMRS was decreased significantly in the both groups after treatment（F= 9.05, P〈0.01 ; F=6.10,P〈0.01）. And the score of YMRS at 1st weekend in experiment group was signifi- cantly higher than that in control group, and this difference sustained for 6 weeks. The cure rate in experiment group was higher than that in control group after treating for 6 weeks. The scores of YMRS in experiment group were 21.4 ± 8.4, 14.6±5.5,8.9±3.3,6.5±3.4,respectively at 1 weekend, 2 weekend and 3 weekend; and the scores of YMRS in control group were 23.9±7.2,20.9± 8.1,17.8±7.8,12.8± 8.9, respec- tively. There was significant difference between the experiment group and control group （P 〈 0.01）. The changes of decreasing score of symp- toms were in experiment group 6.1 ±3.5,12.9 ±4.8,20.1±5.3,21.4±5.5; and the changes of decreasing score of symptoms in control group were 2.1±3.0,6.8±4.5,11.5±5.6,14.4±5.3, respectively. There was significant differ- ence between the experiment group and control group（P〈0.01）. The effective rate and cure rate in experiment group was significantly higher than that in control group（68.5% vs 48.5%,X2 =4.47,P〈0.05;54.3%vs 18.2%,x2=9.52,P 〈0.01）. Both groups have not serious side effects. There were no difference in dropout rate due to less efficacy and side effects. CONCLU- SION： The effects of ziprasidone combination with lithium carbonate or valproate in the treat- ment of manic episode and mixed episode of bi- polar disorder is better than that of single lithi- um carbonate or valproate.