喹硫平联合碳酸锂或丙戊酸钠治疗双相躁狂的多中心随机对照研究

目的:探讨喹硫平合并碳酸锂或丙戊酸钠治疗双相躁狂的疗效和安全性。方法:将符合CCMD-3和DSM-IV的双相障碍诊断标准的100例研究对象随机分成2组,53例喹硫平组应用喹硫平合并碳酸锂或丙戊酸钠,47例对照组单一使用碳酸锂或丙戊酸钠,治疗观察6 wk。采用Beck-Rafaelsen躁狂量表(BRMS)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:喹硫平组的45例(85％)和对照组的40例(85％)完成了6 wk的治疗观察,喹硫平组在治疗wk 1末的减分率比对照组显著,这种差异在1～6 wk一直存在,而且wk 6结束后的临床有效率(BRMS减分率≥50％)、痊愈率(BRMS<11)也显著高于对照组。喹硫平合并碳酸锂或丙戊酸钠常见的不良反应有头晕、头痛、嗜睡、心悸、口干、直立性低血压、便秘。结论:喹硫平合并碳酸锂或丙戊酸钠治疗双相躁狂的疗效比单一使用心境稳定剂好。

Quetiapine combined with lithium carbonate or sodium valproate for treatment of bipolar mania: a randomized, multicenter, and controlled study

AIM: To study the efficacy and safety of quetiapine combined with lithium carbonate or sodium valproate in the treatment of patients with bipolar mania. METHODS: One hundred patients met with the diagnositic criteria of bipolar mania in CCMD-3 and DSM-IV were randomly divided into study group (quetiapine combined with lithium carbonate or sodium valproate) 53 patients, and control group (lithium carbonate or sodium valproate alone) 47 patients, and observed the outcomes for 6 wk of each. The Beck-Rafaelsen Manic Scale (BRMS) and TESS were separately used for the assessments of efficacy and safety. RESULTS: Forty-five patients (85 %) of 53 in the study group and the 40 patients (85 %) of 47 in the control group completed the study. A significantly greater mean reduction with it's rate in total BRMS score was observed at different periods time in study group comparing with those in the control group. The response rate (≥50 % BRMS improvement) was significantly higher in the study group than in control group (79.2 % vs 46.8 %, P < 0.01) , as well as the proportion of patients achieving clinical remission (BRMS < 11) (58.4 % vs 29.8 %, P < 0.01). The mean therapeutic dose of quetiapine was (655±s 151) mg·d-1 in patients met with the response criteria. Common adverse reactions in the study group included dizziness, headache, somnolence, palpitation, dry mouth, postural hypotension, constipation. CONCLUSION: The effects of quetiapine combined with lithium carbonate or sodium valproate in the treatment of bipolar manic episode are better than those of lithium carbonate or sodium valproate used alone.