舒肝解郁胶囊与氟哌噻吨美利曲辛治疗青少年焦虑障碍的研究

Study of Shugan Jieyu capsule combined with ?upentixol-melitracen in the treatment of adolescents anxiety disorder

目的比较舒肝解郁胶囊和氟哌噻吨美利曲辛用于青少年焦虑障碍(AAD)治疗的疗效和安全性。方法 AAD患者90例随机分为舒肝解郁组、氟哌噻吨美利曲辛组和联合治疗组(舒肝解郁胶囊联合氟哌噻吨美利曲辛片),每组各30例。在治疗前和治疗第2、4和6周采用汉密尔顿焦虑量表(HAMA)评价疗效,同时观察不良反应,计算不良反应发生率。结果 88例患者完成治疗观察,各组治疗2、4和6周HAMA评分均较治疗前显著下降(P<0.05或0.01)。舒肝解郁组减分率和显效率与氟哌噻吨美利曲辛组相似,差异无统计学意义(P>0.05)。治疗第2周和第6周减分率和显效率,联合治疗组较氟哌噻吨美利曲辛组更高,差异有统计学意义(P<0.05)。与氟哌噻吨美利曲辛组(34.5%)相比,舒肝解郁组(10.3%)不良反应发生率较低,差异具有统计学意义(P<0.05),联合治疗组(36.7%)较氟哌噻吨美利曲辛组不良反应发生率未增加。结论舒肝解郁胶囊可明显改善AAD患者的症状,不良反应发生率低,舒肝解郁胶囊适合用于AAD的治疗。

ObJective To investigate the efficacy of Shugan Jieyu capsule combined with fiupentixol-melitracen in the treatment of adolescent anxiety disorder （AAD） and their safety. Methods A total of 90 cases AAD patients were randomly divided into 3 groups （n=30 of each group）： Shugan Jieyu group, flupentixol-melitracen group and combined group （Shugan Jieyu capsule plus flupentixol-melitracen tablets）. Before treatment and after 2, 4 and 6 weeks treatment, the effects were assessed with Hamilton anxiety scale （HAMA）, and the adverse symptoms were assessed with the incidence of adverse drugs reaction （ADRs）. Results A total of 88 cases completed 6 weeks treatment, 2, 4 and 6 weeks of HAMA scores in each group were lower than pre-treatment, the differences were significant （P〈0.05 or P〈0.01）.The effective rate and reducing score rate of Shugan Jieyu group were similar with flupentixol-melitracen group. The significant effective rate and reducing score rate in combined group were higher than those in the flupentixol-melitracen group, the differences were significant （P〈0.05）. The incidence of ADRs was 10.3% in Shugan Jieyu group less than 34.5% in flupentixol-melitracen group and 36.7% in combined group, the differences were significant （P〈0.05）. Conclusion Shugan Jieyu capsule is an effective and safe anti-anxiety drug for AAD.