舒肝颗粒治疗焦虑障碍的疗效

Effects of Shugan Granule in treatment of anxiety disorders

目的观察舒肝颗粒对焦虑障碍的疗效。方法采用开放性病例对照研究，将177例焦虑障碍患者分为舒肝组、联合组和西药组，分别治疗观察6周，于治疗前、治疗后2、4、6周分别采用HAMA、CGI及TESS量表评价3组患者的I临床疗效及不良反应情况。结果选择入舒肝组的患者平均年龄偏大，女性占79％，治疗前HAMA总分较低，平均病程偏短，接受舒肝颗粒治疗后6周HAMA总分均显著下降（P〈0．05）；联合组与西药组均于治疗4周后HAMA总分显著下降（P〈0．05或P〈0．01），两组HAMA降分值比较差异无统计学意义（P〉0．05）；3组患者疗效指数（E1）评分比较，差异有统计学意义（P〈0．05），第2周西药组低于于舒肝组和联合组，第4周舒肝组患者E1评分低于其他两组，差异均有统计学意义（P均〈0．05）；3组治疗的安全性比较发现，舒肝组各类不良事件的发生率明显低于其他两组，差异有统计学意义（P〈0．05）；临床观察发现治疗早期舒肝组、联合组的苯二氮革类药使用率明显低于西药组（P〈0．05）。结论舒肝颗粒对轻中度焦虑患者有一定的治疗作用，虽然其临床起效缓慢，但其不良反应发生率低，与抗焦虑或抗抑郁药联合使用可减少苯二氮革类药的滥用。

Objective To evaluate the rtherapeutic effect of Shugan Granule on anxiety disorder. Methods Use openness medical case of illness contrast research, 177 anxiety disorder patients were di- vided into Shugan group, combined group and western medicine group. The treatment effect was as- sessed using Hamilton anxiety scale （ HAMA）, clinical global inventory （CGI） and treatment emergent symptom scale（TESS） before and after treatment at weeks 2, 4, and 6. Both clinical therapeutic effect and adverse reactions were evaluated for the three treatment groups. Results In Shugan group, the average age of the patients was relatively older; women contributed 79%; HAMA scores was low before treatment; the average course of disease was shorter; the HAMA scores were significantly decreased （P 〈 0.05） after 6 weeks treatment with Shugan Granule. The combined group and western medicine group were treated for 4 weeks before the score of HAMA decreased significantly （P 〈 0.05 or P ~ 0.01）. The reduction in HAMA scores showed no significant difference （P 〉 0.05） between the two groups. In comparison of the three groups, the EI scores were significantly different （F = 0. 415, P〈 0.05） ; At 2nd week, western medicine group had lower score than that in Shugan group and com- bined group. The difference was statistically significant （P〈 0.05）. At 4th week, Shugan group showed lower EI scores than the other two groups. The difference was significant （P 〈 0.05）. In comparison of safety for the three groups, the Shugan group had lower rate of adverse events than the other two groups. The difference was statistically significant （P 〈0.05 or P 〈0.01）. From clinical observation, the utilization ratio of benzodiazepine was significantly lower in Shugan group and combined group than in western medicine group （P〈 0.05）. Conclusions Shugan Granule has positive treatment effect on patients with mild to moderate anxiety. Although its clinical effect take place slowly, its incidence rate of adverse reactions is low. Combined use of Shugan Granule with anxiolytics or antidepressants may reduce benzodiazepine drug misuse.