利培酮与锂盐预防双相Ⅰ型障碍复发的长期随访对照研究

Follow-up comparison study of risperidone and lithium in preventing relapse of bipolar disorder type Ⅰ

目的通过与锂盐对照，观察利培酮对双相Ⅰ型障碍复发的预防效果及安全性。方法对113例病情缓解至少3个月、符合美国精神障碍诊断与统计手册第4版诊断标准的双相Ⅰ型障碍患者，在门诊按治疗药物随机给予利培酮（56例）或锂盐（57例）维持治疗。采用精神状况检查、Bech—Rafaelsen躁狂量表（BRMS）及汉密尔顿抑郁评定量表（17项，HAMD17）等观察两组患者维持治疗期间的复发情况，采用治疗中需处理的不良反应量表（TESS）及有关辅助检查观察药物不良反应。结果113例患者平均随访时间（801±326）d。利培酮组缓解率为38％（95％可信区间为27．2—48．8），平均缓解时间（603±288）d；锂盐组缓解率为64％（95％可信区间为56．3～71．5），平均缓解时间（783±221）d。利培酮组缓解率低于锂盐组（u=3．838，P〈0．05），复发时间早于锂盐组（t=2．392，P〈0．05）。结论利培酮对双相Ⅰ型障碍预防复发的总体效果不及锂盐。

Objective Compared with lithium, we examined the efficacy and safety of risperidone for preventing the relapse of bipolar disorder type Ⅰ. Methods There were 113 outpatients who were diagnosed of bipolar disorder type I according to the the 4th edition of Diagnostic and Statistical Manual of Mental Disorders criteria and had been in remission for at least 3 months and accepted maintaining treatment of risperidone or lithium randomly. The Bech-Rafaelsen Mania Rating Scale, Hamilton Rating Scale for Depression （ HAMD17 ） and Treatment Emergent Side Effect Scale were used to evaluate the severity and side effects. Results The average follow-up period were （801 ±326） days. In risperidone group, the average remission time was （603 ±288） days and the remission rate was 38% （95% CI 27.2 -48.8）. The average remission time was （783 ± 221 ） days and the remission rate of 64% （95% CI 56. 3 -71.5 ） in lithium group. The differences in remission time and rate between both groups were significant （all P 〈 0.05 ）. Conclusion The effect risperidone in preventing relapse of patients with bipolar disorder type Ⅰ is not as satisfied as that of lithium.