枸橼酸坦度螺酮和盐酸丁螺环酮治疗第二代抗抑郁药所致性功能障碍的对照研究

Comparison of efficacy and safety between Tandospirone and Buspirone in treatment of sexual dysfunction associated with antidepressants

目的比较枸橼酸坦度螺酮和盐酸丁螺环酮治疗第二代抗抑郁药所致性功能障碍中的疗效和安全性。方法选取56例符合DSM-IV-TR药物所致性功能障碍诊断标准的患者,按照随机数字表法分为枸橼酸坦度螺酮研究组(研究组)和盐酸丁螺环酮标准对照组(对照组),每组28例。两组患者分别接受6周枸橼酸坦度螺酮(40mg/d)或盐酸丁螺环酮(40mg/d)治疗。基线时和治疗第2、4、6周采用亚利桑那性体验量表(ASEX)和不良反应量表(TESS)评定疗效和不良反应。结果两组患者ASEX总分在治疗第2、4、6周和基线相比均明显降低(均P<0.05),但两组间比较均无统计学差异(均P>0.05)。两组TESS总分在第2周均较基线明显增高(均P<0.05);对照组TESS总分在第2周高于研究组,且有统计学差异(P<0.05)。两组TESS总分在基线、治疗第4、6周均无统计学差异(均P>0.05)。结论枸橼酸坦度螺酮和盐酸丁螺环酮均能有效治疗抗抑郁药所致性功能障碍,且不良反应均较少,有较好的临床应用价值。

Objective To compare the efficacy and safety between Tandospirone and Buspirone in treatment of sexual dysfunction associated with antidepressants.Methods Fifty six patients,who received new generation antidepressant therapy for at least 8 weeks,and developed sexual dysfunction met the criteria of DSM-IV-TR,were enrolled in the study.Patients were randomly assigned to a 6-week trial with tandospirone（study group,n=28,40mg/d） or buspirone（control group,n=28,40mg/d）.Outcomes were evaluated by using Arizona Sexual Experience Scale（ASEX） for efficacy and Treatment Emergent Symptom Scale（TESS） for adverse effects at the baseline,and the end of wk2,wk4 and wk6.Results Compared to baseline,patients in both groups presented significantly improvement in sexual function at the end of wk2,wk4 and wk6（P〈0.05）.There were no significant in the total scores of the ASEXbetween the two groups after treatment.At wk2 the TESS score in both groups was higher than that of baseline（P〈0.05）,and TESS score in control group was higher than that in study group（P〈0.05）.However,there were no significant differences in TESS scores between baseline and those at wk4 and wk6 in both groups（P〈0.05）.Conclusion Tandospirone and buspirone are effective in treatment of antidepressant-associated sexual dysfunction with mild adverse effects.