不同剂量舒肝解郁胶囊治疗轻中度抑郁症的多中心、随机、开放、对照研究

发布时间：2018-11-12 07:43

【摘要】：目的评价不同剂量舒肝解郁胶囊治疗轻、中度抑郁症的有效性和安全性。方法采用多中心、随机、开放、平行对照的研究方法。患者随机分为研究组和对照组。研究组每日2次舒肝解郁胶囊(每粒0.36 g)强化治疗:第1周每次4粒,第2周每次3粒,第3~6周每次2粒。对照组为常规治疗组,舒肝解郁胶囊每日2次、每次2粒。两组均连续口服用药6周。以汉密尔顿抑郁量表17项(HAMD-17)总分、总分减分率为主要评价指标。安全性评价采用研究者经验效度、患者自评和实验室检查。结果实际纳入研究组70例,对照组86例。经过6周治疗,研究组和对照组总有效率分别为90%和84%,痊愈率分别为79%和64%,组间比较均无显著差异(P0.05)。研究组抑郁症状改善(HAMD-17总分变化差异)趋势优于对照组(P0.01)。治疗1周末研究组HAMD-17减分率优于对照组[(17.98±15.63)%vs.(12.21±12.62)%,P0.05],治疗2、4、6周末组间有非常显著差异(P0.01)。两组不良反应发生率无显著差异(P0.05)。结论舒肝解郁胶囊治疗轻、中度抑郁症的抑郁症状和伴随的焦虑症状安全、有效,首周剂量加倍能显著加快抑郁症状缓解速度,提高最终改善程度。
[Abstract]:Objective to evaluate the efficacy and safety of Shugan Jieyu capsule in the treatment of mild and moderate depression. Methods A multicenter, randomized, open and parallel controlled study was used. The patients were randomly divided into study group and control group. In the study group, Shugan jiayu capsule (0.36 g per capsule) was treated twice daily: 4 capsules per week 1, 3 capsules per second week, 2 capsules at the 6th week of 3th week. The control group was treated with 2 capsules of Shugan Jieyu capsule twice a day. Both groups were treated orally for 6 weeks. The total score of 17 items of Hamilton Depression scale (HAMD-17) and the rate of total score reduction were taken as the main evaluation index. The safety assessment was conducted with the researcher's empirical validity, patient self-assessment and laboratory examination. Results 70 cases were included in the study group and 86 cases in the control group. After 6 weeks of treatment, the total effective rate of the study group and the control group were 90% and 84%, the cure rate was 79% and 64%, respectively. There was no significant difference between the two groups (P0.05). The improvement of depressive symptoms (the difference of total score of HAMD-17) was better in the study group than in the control group (P0.01). At the end of 1 week, the HAMD-17 reduction rate of the study group was better than that of the control group [(17.98 卤15.63)% vs. (12.21 卤12.62)%, P0.05]. There was a very significant difference between the two groups at the end of 6 weeks (P0.01). There was no significant difference in the incidence of adverse reactions between the two groups (P0.05). Conclusion Shugan Jieyu capsule is safe and effective in the treatment of depressive symptoms and associated anxiety symptoms in mild and moderate depression. Doubling the first week dose can significantly accelerate the relief rate of depressive symptoms and improve the degree of final improvement.
【作者单位】：同济大学附属同济医院;上海交通大学医学院附属精神卫生中心;复旦大学附属中山医院;浙江省同德医院;
【分类号】：R749.4

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