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  

Efficacy and safety of different doses of Shuganjieyu capsules in treating mild or moderate depressive disorder: a multicenter, random, open, and controlled trial

作　　者：姚军[1] 李清伟[1,2] 季建林[3] 张海音[2] 冯斌 吴文源[1] 

机构地区：[1]同济大学附属同济医院,上海200065 [2]上海交通大学医学院附属精神卫生中心,上海200030 [3]复旦大学附属中山医院,上海200032 [4]浙江省同德医院,浙江杭州310012

出　　处：《中国新药与临床杂志》2014年第8期568-572,共5页Chinese Journal of New Drugs and Clinical Remedies

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（P〉0.05）。研究组抑郁症状改善（HAMD-17总分变化差异）趋势优于对照组（P〈0.01）。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）%,P〈0.05],治疗2、4、6周末组间有非常显著差异（P〈0.01）。两组不良反应发生率无显著差异（P〉0.05）。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。AIM To explore the efficacy and safety of different dosages of Shuganjieyu capsule on mild or moderate depression. METHODS A muhicenter, randomized, open, parallel controlled trial was conducted. Patients were divided into trial group and control group. The trial group was exposed with Shuganjieyu intensive treatment 2 times a day： week 1, 4 capsules each time; week 2, 3 capsules each time; week 3 - 6, 2 capsules each time. The control group was given regular treatment： 2 times a day, 2 capsules each time. The whole study lasted 6 weeks for both groups. Primary efficacy was evaluated by the total score and score-changed rate of HAMD- 17 as well safety by investigator empirical validity, self-report and laboratory tests for patients. RESULTS Actually 70 patients were recruited in the trial group and 86 patients in the control group. After the 6-week treatment, the total effective rates for the trial group and control group were 90% and 84% respectively, and the cute rates were 79% and 64% respectively, with no statistical difference between the two groups （P 〉 0.05） . The improving trend （the change of HAMD-17 scores） of the trial group was better than that of the control group （P 〈 0.01） . At the end of 1 week treatment, the HAMD-17 score-changed rate of the trial group was bigger than that of the control group （（17.98 ±15.63）% vs. （12.21 ± 12.62）%, P 〈 0.05）; at the end of 2, 4, 6 weeks treatment, the two groups had significant differences （P 〈 0.01 ） Incidences of adverse reactions did not show significant difference between the two groups （P 〉 0.05） . CONCLUSION Shuganjieyu capsule is effective and safe for mild to moderate depression and the accompanied anxiety symptoms. Doubled dose in the first week of treatment can significantly enhance the relief rate of depression symptom and the ultimate improvement degree.

关 键 词：舒肝解郁胶囊 抑郁症 随机对照试验 多中心研究 

分 类 号：R749.4[医药卫生—神经病学与精神病学]