坦度螺酮辅助治疗难治性抑郁症疗效及安全性观察

Efficacy and safety of tandospirone in the adjunctive therapy of refractory depression

目的探讨不同剂量坦度螺酮辅助治疗难治性抑郁症的疗效及安全性。方法将60例难治性抑郁症患者在原抗抑郁剂帕罗西汀治疗的基础上,随机分为单用帕罗西汀组(对照组)、帕罗西汀联合不同剂量坦度螺酮(分别为20 mg、30 mg、60 mg)组(3个研究组),每组各15例,疗程8周;采用4级临床疗效、汉密尔顿抑郁量表(HAMD)、汉密尔顿焦虑量表(HAMA)观察疗效;临床疗效总评量表(CGI)进行总体评价;采用不良反应症状量表(TESS)评定不良反应;采用视觉模拟评分(VAS)对性功能障碍进行自我评价。结果 1治疗8周后各组HAMA、HAMD、CGI总分及因子分都较治疗前明显降低,差异均有统计学意义(P<0.05);2研究组各组起效均比对照组快,差异均有统计学意义(P<0.05);研究组各组之间比较差异均无统计学意义(P>0.05);3治疗2周、4周、8周时研究组各组的因子分和总分均明显低于对照组,差异有统计学意义(P<0.05或P<0.01);4治疗8周后对照组与研究各组性功能障碍有效率比较,差异有统计学意义(P<0.05);5四组的不良反应接近。结论坦度螺酮辅助治疗难治性抑郁症疗效肯定,起效快;坦度螺酮对抗抑郁剂所致的性功能障碍疗效较好。

Objective To explore the efficacy and safety of tandospirone in the adjunctive therapy of refrac-tory depression. Methods Sixty patients of refractory depression were equally divided into four groups： control group, study group 1, study group 2 and study group 3. The patients in the study group 1, 2 and 3 were treated with paroxeting combining with 20 mg/d, 30 mg/d and 60 mg/d tandospirone, respectively, while the control group was treated with paroxeting only. All the patients were treated for eight weeks. The clinical efficacy was observed by 4 grade clinical effects, HAMD and HAMA. The total efficacy was evaluated by CGI. TESS was applied to assess ad-verse reactions, and VAS was used for self-evaluation of sexual dysfunction. Results Firstly, both total scores and factor scores of HAMA, HAMD and CGI were significantly decreased after 8 weeks of treatment （P〈0.05）. Secondly, the study groups all had significantly faster curative effect than control group （P〈0.05）, while there was no statistically significant difference between the study groups. Thirdly, after 2, 4, 8 weeks of treatment, both total scores and factor scores were significantly lower than those in the control group （P〈0.05 or P〈0.01）. Fourthly, the study groups had a significantly better curative effect of sexual dysfunction than the control group. Fifthly, there was no statistically signif-icant difference between the four groups in adverse reactions. Conclusion Tandospirone had a good curative effect in the treatment of refractory depression, which can alleviate the sexual dysfunction caused by antidepressants.