托吡酯与碳酸锂治疗躁狂症的双盲对照研究

目的为探讨碳酸锂与托吡酯治疗躁狂症的疗效及安全性。方法采用随机双盲、对照研究，对符合入组标准的96例躁狂症患者单一服用碳酸锂、托吡酯治疗。并在入组前和入组后1、2、4周进行血、尿、肝功能检查、心电图、血压、体重的检查及BRMS、CGI、TESS量表评定，疗程最终为4周。结果托吡酯有效率80．85％，碳酸锂有效率87．76％，二者无明显差异（P〈0．05），托吡酯组BRMS、CGI—SI评分疗后4周极显著低于治疗前（P〈0．01），且与碳酸锂组无明显差异（P〉0．05），在第2周时BRMS评分显著低于治疗前（P〈0．05），第2周就有明显的疗效，托吡酯的平均治疗剂量为（261．35±52．38mg）；碳酸锂组在副反应方面特别是消化系统、神经系统高于托吡酯组，有显著差异（P〈0．05或P〈0．01），而托吡酯组体重下降明显多于碳酸锂组（P〈0．01）。结论托吡酯在第2周就见效，疗效与碳酸锂相当，不良反应少，安全、有效，因有降低体重的作用，易为大多数女患者所接受。

A double blind and comparative study of topiramate and lithium carbonate in the treatment of mania

Objective To explore the effect and safety of lithium carbonate and topiramate in the treatment of mania. Methods A total of 96 mania patients were randomly divided into two groups with double blind. BRMS, CGI, and TESS were assessed, and blood, urine, liver function, electrocardiogram, blood pressure, body weight were inspected at 1st, 2nd, 4th weekend after treatment. Results The effective rate of topiramate was 80.85 % and the rate of lithium carbonate was 87.76 %, there had no significant difference（P〈0.05）between two groups. In both groups,BRMS, CGI-SI scores at the 4th weekend after treatment were significantly lower than those before treatment. Topiramate took into effect at the 2nd weekend, and the score of BRMS was remarkably lower than that before the treatment （P〈0.05）. The side effects of lithium carbonate group were higher than those of topiramate, especially in digestive system and nervous system, but lose of body weight in topiramate group was significantly larger than that in lithium carbonate group （P〈0.01）. Conclusion Topiramate takes into effect at the 2nd week, and has similar curative effect with lithium carbonate. Topiramate should be accepted by female patients because of response safety, efficacy, and the function of reducing body weight.