逍遥散加味联合丁螺环酮治疗广泛性焦虑症对照研究

A control study of modified xiaoyao san combined with buspirone in the treatment of generalized anxiety disorder

目的探讨逍遥散加味联合丁螺环酮治疗广泛性焦虑症的临床疗效及安全性。方法将75例广泛性焦虑症患者随机分为两组，研究组37例，口服逍遥散加味汤剂联合丁螺环酮治疗；对照组38例，单用丁螺环酮治疗，观察8周。于治疗前及治疗1周、2周、4周、8周末采用焦虑自评量表、汉密顿焦虑量表评定临床疗效，副反应量表评定不良反应。结果治疗后两组焦虑自评量表、汉密顿焦虑量表评分均较治疗前显著下降，但研究组治疗各时段均较对照组下降更显著（P〈0．05或0．01）；治疗8周末研究组显效率73．0％、总有效率86．4％，对照组分别为50．0％、76．3％，研究组显效率显著高于对照组（x^2=4．17，P〈0．05）；研究组各项不良反应发生率均低于对照组。结论逍遥散加味联合丁螺环酮治疗广泛性焦虑症起效快，疗效显著，安全性高，依从性好，显著优于单用丁螺环酮治疗。

Objective To explore the efficacy and safety of modified xiaoyao san combined with buspirone in the treatment of generalized anxiety disorder （GAD）. Methods Seventy-five GAD patients were ran- domly divided into research group （n=37） taking orally modified xiaoyao san combined with buspirone and control group （n=38） doing buspirone only for 8 weeks. Clinical efficacies were assessed with the Self-rating Anxiety Scale （SAS） and Hamilton Anxiety Scale （HAMA） at baseline and at the end of the 1^st, 2^nd, 4^th and 8^th week and adverse reactions with the Treatment Emergent Symptom Scale （TESS）. Results After treatment the SAS and HAMA scores of both groups lowered more significantly compared with pre- treatment, so did those in research than in control group in each period （P〈0.05 or 0.01） ; at the end of the 8^th week, obvious and total effective rate were respectively 73.0% and 86.4% in research and 50.0% and 76.3G in control group, obvious effective rate in the former was significantly higher than the latter （Z2 24.17,P〈0.05）; incidences of adverse reactions were lower in research than in control group. Conclusion Modified xiaoyao san combined with buspirone takes effect more rapidly and has more notable efficacy, higher safety and better compliance in the treatment of generalized anxiety disorder compared with single buspirone.