坦度螺酮治疗青少年考前焦虑的对照研究

目的评价坦度螺酮治疗青少年考前焦虑的临床疗效及安全性。方法多中心、开放、随机对照研究,为期6周。109例符合入组标准的青少年患者随机接受坦度螺酮(20～60mg/d)或舍曲林(25～200mg/d)治疗,分别于治疗前及治疗第2、4、6周末使用汉密尔顿焦虑量表(HAMA)评估。结果坦度螺酮与舍曲林的治愈率为28.1%、32.7%,有效率为75.4%、78.8%,差异均无统计学意义;第6周末坦度螺酮组HAMA躯体焦虑因子分减分率>舍曲林组分别为(71.8±2.1)%、(59.4±2.2)%,t=4.10,P<0.01。坦度螺酮组的主要不良反应为嗜睡(14%),舍曲林组的主要不良反应为疲劳感(11.5%)、恶心(11.5%)。结论坦度螺酮治疗青少年考前焦虑安全、有效,并可改善焦虑的躯体症状。

Clinical Efficacy of Tandospirone in Adolescents with Anxiety Pre-examination: a Randomized Controlled Trial

Objective It aim to verify the efficacy and safety of tandospirone, a specific serotonin 1A partial agonist, in treating adolescents with anxiety pre-examination. Methods In this 6-week, randomized controlled study, 109 adolescents met the criteria of CCMD-3 on GAD symptom severity were randomly assigned to treatment of sertraline or tandospirone. The effects of treatment over were assessed by the Hamilton Anxiety Scale （HAMA） before and after treatment 2, 4 and 6 weeks. Results The response rates after treatment 6-week were 75.4% for tandospirone and 78.8% for sertraline, but there was no significant difference on efficacy between two groups. Compared with sertraline, tandospirone had a greater reduction in somatic anxiety scores （P0.01）. An adverse effect of tandospirone was scarcely found. Common adverse effects included drowsiness （14%） in tandospirone group and fatigue （11.5%）, nausea （11.5%） in sertraline group. Conclusion It suggested promise for tandospirone as a new treatment of anxiety pre-examination in youths.