舒郁散治疗抑郁症临床研究

Clinical Study of Shuyusan in Treatment of Depression

目的观察舒郁散治疗抑郁症的临床疗效和安全性,评价其在抑郁症治疗中的作用。方法将187例抑郁症患者随机分为治疗组、西药对照组及中药对照组。治疗组服用舒郁散中药煎剂,每日1剂,分早晚2次口服;西药对照组服用盐酸氟西汀分散片(百忧解),20 mg/d,晨起口服;中药对照组服用中药煎剂加味逍遥散,每日1剂,分早晚2次口服。3组疗程均为6周。观察3组治疗前后中医证候积分、汉密顿抑郁量表(HAMD)评分、抑郁自评量表(SDS)评分及副反应量表(TESS)评分。结果治疗组和西药对照组治疗后中医证候、HAMD、SDS评分与治疗前相比均有明显改善,差异具有统计学意义(P<0.05);2组比较差异无统计学意义(P>0.05)。但治疗组不良反应明显小于西药对照组,差异具有统计学意义(P<0.05)。结论舒郁散能改善抑郁症患者的中医证候及HAMD、SDS评分,且不良反应少,是治疗抑郁症的有效方剂。

Objective To observe the clinical effective and safety of Shuyusan in treatment of major depression patient, and evaluate the response to treatment for depression patients. Methods A total of 187 patients with depression were randomly divided into 3 groups： treatment group （Shuyusan group）, western medicine control （Prozac group） and Chinese medicine control group （modified Xiaoyao Power group）. The therapy group was treated with Shuyusan for one does twice a day. The western medicine control group was treated with Prozac for 20 mg everyday. The Chinese medicine control group was treated with modified Xiaoyao Powder twice a day. The total therapeutic course of the three groups was 6 weeks. The efficacy indexes （TCM scores, HAMD scores, SDS scores） and safety indexs （TESS scores） were observed. Results After treatment, Shuyusan and Prozac obviously improved TCM sypotoms, and reduced HAMD scores and SDS scores significantly （P〈0.05）. There was no significant difference between Shuyusan group and Prozac group （P〉0.05）, but side effects in Shuyusan group was less than that in Prozac group （P〈0.05）. Conclusion Shuyusan is effective in treating depression patient, it could improve TCM symptom scores, reduce HAMD scores and SDS scores, with less side effects.