坦度螺酮治疗广泛性焦虑及对生命质量影响：多中心开放性研究

Effectiveness of tandospirone in treatment of patients with general anxiety disorder and its impact on quality of life:a muiticenter open study

目的：观察坦度螺酮对广泛性焦虑症(GAD)的疗效及其对生命质量的影响。方法：多中心开放性研究。共入组广泛性焦虑症病人157例,完成的有效例数为122例。坦度螺酮剂量为30～60 mg·d^(-1),每日3次,疗程6 wk。采用汉密尔顿焦虑量表(HAMA)、临床总体评定量表-严重程度量表(CGI-SI)评定疗效,健康状况调查问卷量表(SF-36)评定生活质量。统计分析采用全分析集(FAS)分析,最接近一次观察的结转(LOCF)。结果：治疗1 wk后,HAMA总分和因子分显著低于治疗前(P＜0.01),治疗后总有效率67.4%；治疗前后SF-36各分量表得分均有显著改善(P＜0.01)；不良反应发生率为7.9%。结论：坦度螺酮对广泛性焦虑疗效肯定,不良反应较少,并能显著提高病人的生命质量。

AIM： To evaluate the efficacy of tandospirone in treatment of patients with generalized anxiety disorder （GAD） and its impact on quality of life. METHODS： It was a muhicenter open clinical trial. One hundred and fifty-seven patients who met with the including criteria were enrolled, 122 patients completed the trial. The dosage of tandospirone was 30-60 mg·d^-1,po,tid. Hamilton Anxiety Scale （HAMA） and clinical global impression-severity of illness （CGI-SI） were used to evaluate the efficacy,and medical outcomes study shortform-36 （SF-36） was also used to evaluate the quality of life as secondary efficacy measurement. Full analysis set （FAS） and last observation carry forward （LOCF） were used. RESULTS： The total scores and the two factor scores of HAMA were all significantly decreased after one week treatment （P 〈 0.01）.Clinical total effective rate was 67.4 %.The sub-test scores of SF-36 were all significantly improved at end-point than baseline evaluation. The incidence of adverse reactions was 7.9 %. CONCLUSION： Tandospirone had well efficacy and few adverse reactions in treating patients with GAD, and it could also significantly improve the quality of life of patients with GAD.