坦度螺酮联合帕罗西汀治疗广泛性焦虑障碍的疗效和安全性观察

Efficacy and safety of tandospirone combined with paroxetine for patients with generalized anxiety disorder

目的探讨坦度螺酮联合帕罗西汀治疗广泛性焦虑障碍（GAD）的疗效和安全性。方法选择符合国际疾病分类与诊断标准第10版（ICD-10）诊断标准、广泛性焦虑障碍量表-7（GAD-7）得分6～11分，汉密尔顿焦虑量表（HAMA）≥14分的GAD患者120例，按随机数字表法分为坦度螺酮联合帕罗西汀组（A组）、单一坦度螺酮组（B组）、单一帕罗西汀组（C组）3组，排除中途脱落13例后，A组36例，B组35例，C组36例。治疗前评定GAD-7、HAMA量表基线值，治疗后第1、2、4、8周末评定HAMA、不良反应量表（TESS）。入组时及治疗后第2、8周末查心电图、血、尿常规、肝、肾功能。HAMA减分率〉50％为有效，〈50％无效，HAMA≤7分为痊愈。结果3组患者的性别、年龄、病程、唑吡坦使用例数、天数、剂量以及GAD-7及HAMA基线值比较差异均无统计学意义（均P〉O05）。3组患者治疗后第1、2、4周末HAMA得分均有明显下降，差异均有统计学意义（P〈0.05或0.01）。治疗后第8周末3组HAMA得分比较差异无统计学意义（P〉005）。经两两比较，治疗后第1、2、4周末HAMA得分呈现出A组〈B组〈C组的趋势，坦度螺酮联合帕罗西汀对GAD焦虑症状的改善快于单一坦度螺酮或帕罗西汀（P〈0．05或0．01）。经Ridit分析3组患者的临床治愈率比较差异无统计学意义（P〉0．05）。3组患者不良反应发生率、TESS得分比较差异无统计学意义（P〉0．05）。结论坦度螺酮联合帕罗西汀治疗GAD安全有效，对GAD焦虑症状的改善快于单一使用坦度螺酮或帕罗西汀，未观察到坦度螺酮联合帕罗西汀对GAD有增效作用。

Objective To evaluate the efficacy and safety of tandospirone combined with paroxetine for patients with generalized anxiety disorder （GAS）. Methods One hundred and twenty GAD patients with GAD-7 score of 6-11 and HAMA score ≥14 were enrolled in the study. Patients were randomly divided into tandospirone combined with paroxetine group （group A, n=36）, tanospirone group （group B, n=35） and paroxetine group （group C, n=36）, the treatment lasted for 8 weeks. The patients were evaluated with GAD-7 and HAMA before treatment and with HAMA and TESS on week 1, 2, 4, 8 after treatment. The rate of HAMA score reducing 〉50% was defined as effective, 〈50% as not effective, the score of HAMD ≤7 as recovery. Results There were no significance differences in sex, age and the duration of disease, duration of zolpidem administration, baseline scores of HAMA and GAD-7 among three groups（P 〉0.05）. The scores of HAMA reduced significantly in week 1, 2, 4 after treatment （P〈0.01 or P〈0.05） in all three groups, while no significant difference in week 8 weeks （P 〉0.05）. The HAMA scores of group A in week 1, 2, 4 after treatment were lower than those in group B, and the latter were lower than those in group C. Ridit analysis indicated that there were not significant differences in clinical cure rate, the adverse reaction rate and the TESS scores among three groups （P 〉0.05）. Conclusion Tandospirone combined with paroxetine for GAD is effective and safe, and is better than monotherapy of tandospirone or paroxetine.