中药解郁汤治疗抑郁症的临床研究

The Clinical Trial of the Traditional Chinese Medicine Jieyutang in Treatment of Depression

关键词:  解郁汤  帕罗西汀  抑郁症  疗效  安全性

Key words:  traditional Chinese medicine Jieyutang  paroxetine  depression  clinical efficacy  safety

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 符合CCMD-3诊断标准的抑郁症患者(HAMD-17项评分≥17)且经过帕罗西汀4周治疗仍未缓解(HAMD-17项评分≥14)入组，随机分为帕罗西汀合并解郁汤治疗组(实验组)及帕罗西汀继续治疗组(对照组)，观察8周，用汉密尔顿抑郁量表-17项(HAMD-17)、生活满意度量表(LSR)及副反应量表(TESS)判断疗效和不良反应及安全性。结果 符合方案集(PP)病人60例，实验及对照组各30例。治疗8周后，实验组与对照组的总有效率分别为83％和67％，两组之间存在显著差异(P<0.05)。与治疗前相比，两组在治疗2，4，6，8周HAMD-17总分及各因子均分均存在显著差异(P<0.01)；两组之间比较，HAMD总分在治疗4，6，8周存在显著差异，而各因子均分比较发现，阻滞分因子分在治疗8周存在差异，睡眠障碍分在6及8周存在差异。与治疗前相比，两组在治疗后4、6及8周LSR评分显著降低(P<0.01)；两组之间比较，LSR在治疗6及8周存在差异。TESS评分两组之间无差异。结论 解郁汤合并帕罗西汀比单用帕罗西汀治疗抑郁症更有效，主要表现在改善阻滞、睡眠障碍及生活满意度上，而且安全性高，不增加药物不良反应。

Abstract:

OBJECTIVE To evaluate the efficacy and safety of the traditional Chinese medicine Jieyutang in treatment of depressive disorder. METHODS Patients with depressive disorder (the HAMD-17 score ≥17) who have not recovered after 4 weeks paroxetine treatment (the HAMD-17 score≥14) were divided into two groups randomly and received traditional Chinese medicine Jieyutang combined with paroxetine treatment or paroxetine treatment for 8 weeks respectively. The Hamilton Rating Scale for Depression(HAMD-17), Life Satisfaction Rating Scale(LSR) and Treatment Emergent Symptoms Scale (TESS) were used to measure therapeutic efficacy and side effects. RESULTS 65 patients (intent to treat, ITT) were randomized into two groups (32 patients in combined treatment group, and 33 in paroxetine group). In ITT, per protocol (PP) set was 60 patients (30 in each group). After 8 weeks treatment, the effective rate of combined treatment and paroxetine group was 83% and 67%, respectively (P<0.05). The total and factors scores of HAMD-17 decreased significantly at 2, 4, 6 and 8 weeks after Jieyutang combined with paroxetine treatment or paroxetine treatment (P<0.01). There was significant difference on the total scores of HAMD-17 at 4, 6 and 8 weeks after treatment and the retardation factor score at 8 weeks after treatment and sleep disturbance factor score at 6 and 8 weeks after treatment between two groups. The LSR scores decreased significantly at 4, 6 and 8 weeks after treatment on two groups (P<0.01). There was significant difference on the scores of LSR between two groups after 6 and 8 weeks treatment. There was no significant difference on the total TESS after treatment between two groups. CONCLUSION Jieyutang combined with paroxetine treatment was more effective than only paroxetine treatment and on the improvement of retardation, sleep disturbance and Life satisfaction. The safety of Jieyutang combined with paroxetine treatment was higher and has less side effects.