【摘要】 目的评价解郁汤治疗抑郁症的临床疗效和安全性。方法96例符合CCMD-3诊断标准的抑郁症患者入组,随机分入解郁汤治疗组48例及氟西汀对照组48例,观察8周,使用汉密尔顿抑郁量表(24项版本)(HAMD)判断疗效,并记录不良反应。结果85例完成试验(解郁汤组43例,对照组42例,分别脱落5例及6例),结果显示:在试验结束时,解郁汤组有效率为60%,与氟西汀对照组(65%)无显著差异(P>0.05);解郁汤组HAMD减分(-10.56±3.95),氟西汀组HAMD减分(-11.82±3.82),两组比较无显著差异(P>0.05);解郁汤组在治疗后第7dHAMD评分及因子分(焦虑、躯体症状及睡眠紊乱评分)与氟西汀组比较有显著差异(P<0.05);两组均有较高的耐受性,多数不良反应为轻中度。结论解郁汤治疗抑郁症有效,耐受性好,不良反应少,尤其适合于有明显焦虑和失眠的轻、中度抑郁症患者。更多还原

【Abstract】 Objective To study the efficacy and tolerability of Jieyutang in outpatients with major depression during 8 weeks.Methods This is a randomized,parallel positive controlled clinical trial for 8 weeks.96 patients who met with the including criteria were enrolled,48 cases in Jieyutong group,48 cases in Fluoxetine group.Efficacy was assessed with the Hamilton Rating Scale for Depression (HAMD-24),and tolerability was assessed from adverse events.Results Of 96 patients randomized,43 on Jieyutong and 42 on fluoxetine,were included in the efficacy analysis.The mean changes from baseline to endpoint in Hamilton score (-10.56±3.95 for Jieyutong and -11.82±3.82 for fluoxetine)and the rate response at endpoint(60% versus 65%)were no differences in two groups.The Jieyutong group showed more reduction in HAMD Factor I (Anxiety/Somatization),Factor VI(Sleep Disturbance) in the first weeks.There were few discontinuations due to treatment-related adverse events,and both was well tolerated.Conclusion Jieyutong was effective,safe and well tolerated to patients with major depression.Jieyutong has an earlier onset of action for factors such as anxiety/Somatization and sleep disturbance,and maybe prefer to such patients.更多还原