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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 compare the efficacy and safety of Shugan Jieyu capsule and flupentixol and melitracen in the treatment of adolescent Anxiety Disorder (AAD). Methods 90 patients with AAD were randomly divided into Shugan Jieyu group, flupenthixol and melitracen group and combined treatment group (Shugan Jieyu capsule combined with flupentixol and melitracen tablets), 30 cases in each group . The therapeutic effect was evaluated by Hamilton Anxiety Scale (HAMA) before treatment and at the 2nd, 4th and 6th week of treatment. Adverse reactions were observed and the incidence of adverse reactions was calculated. Results 88 patients completed the treatment observation. The HAMA scores at 2, 4 and 6 weeks after treatment in each group were significantly lower than those before treatment (P <0.05 or 0.01). Shugan Jieyu group reduction rate and significant efficiency and flupentixol MTV group similar, the difference was not statistically significant (P> 0.05). At week 2 and week 6, the reduction rates and effective rates were significantly higher in the combined treatment group than in the flupentixol and melitracen group, with significant differences (P <0.05). Compared with the flupenthixol-melitracen group (34.5%), the incidence of adverse reactions in Shugan Jieyu group (10.3%) was lower, with statistical significance (P <0.05) ) Did not increase the incidence of adverse reactions compared with flupentixol and melitracen. Conclusion Shugan Jieyu capsule can significantly improve the symptoms of patients with AAD, the incidence of adverse reactions is low, Shugan Jieyu capsules suitable for the treatment of AAD.