加味逍遥胶囊治疗抑郁症及对HAMD量表因子影响的临床研究

Clinical study of Jiawei Xiaoyao capsule in the treatment of depression and effects to the HAMD scale factor

目的:研究加味逍遥胶囊治疗轻中度抑郁症的有效性及对HAMD量表因子的影响。方法:采用多中心随机双盲安慰剂对照方法,共入组127例轻中度抑郁症患者,中药组(加味逍遥胶囊+舍曲林安慰剂)65例,西药组(舍曲林+加味逍遥胶囊安慰剂)62例,疗程8周。以汉密尔顿抑郁量表总分差值及各因子症状比较作为疗效评价指标,副反应量表评定不良反应。结果:基于HAMD抑郁量表总分差值评估,各访视时点2组临床疗效比较差异无统计学意义(P>0.05);但治疗后2组躯体性焦虑、胃肠道、偏执及强迫症状比较差异有统计学意义(P>0.05)。中药组脱落病例少于西药组,不良反应引起的痛苦低于西药组(P<0.05)。结论:加味逍遥胶囊治疗轻中度抑郁症疗效与舍曲林相当;在改善躯体性焦虑、胃肠道症状、偏执及强迫症状方面有明显优势,不良反应引起的痛苦小,依从性好。

Objective： To study the efficacy and influence on Hamilton Depression Scale （HAMD）scale factor of JiaWeiXiaoYao （JWXY）capsule in the treatment of mild to moderate depression. Methods： A multicenter randomized, double-blind and placebo controlled trial recruited 127 patients with mild to moderate depression. They received JWXY capsule and Sertraline placebo （ n = 65 ） or Sertraline and JWXY capsule placebo （ n = 62）. Either of them got different treatment for 8 weeks. The efficacy was evaluated by total score difference of Hamihon Depression Scale（HAMD） and the symptom compare of every HAMD factor. Adverse reactions was evaluated by Treatment Emergent Symptom Scale（TESS）. Results There was no significant difference between the two groups in scores of HAMD total score difference at every interview point（P 〉 0.05）, but there were significant differences （P 〈 0. 05） between the two groups in scores of somatic anxiety, gastrointestinal symptoms, paranoia and forced symptoms after treatment. Smaller cases felled off Chinese medicine group than that in Western medicine group,the pains of adverse reactions in Chinese medicine group were lower than that in western medicine group （P 〈 0. 05）. Conclusion JWXY capsule shows the effect equivalent to that of Sertraline in the treatment of mild to moderate depression. However, JWXY capsule has obvious advantages of improving some symptoms of somatic anxiety, gastrointestinal, paranoia and forced compared to Sertraline, and it has smaller pain of adverse reactions compared with sertraline, compliance is good.