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目的:评估基于脾胃理论结合六经辨证思想诊治抑郁症在改善抑郁情绪的同时,对焦虑情绪、睡眠质量及生存质量的综合疗效.方法:采用RCT方案,收集轻中度抑郁症患者共120例,观察组76例予补中益气丸合半夏泻心汤/小柴胡汤/当归四逆汤/温氏奔豚汤中药颗粒剂治疗,对照组44例予左洛复50 mg/d治疗.治疗第1周、2周、3周、4周及结束治疗后第4周随访期予HAMD-17,第2周、4周及随访期予SAS、PSQI及WHOQOL-BREF评估.结果:①治疗4周后及随访期观察组与对照组HAMD-17总分减分率相当,差异无统计学意义.②经重复性测量,观察组SAS、PSQI及WHOQOL-BREF总分各时点与基线比较变化程度较对照组更大,差异有统计学意义(P<0.01).结论:从脾胃理论结合六经辨证思想诊治抑郁症在改善抑郁情绪的同时,对焦虑情绪、睡眠质量及生存质量亦有一定改善.“,”Objective:To evaluate the comprehensive curative effect of the depression treatment based on the theory of spleen and stomach in combination with syndrome differentiation of the six meridians ,especially the effect on anxiety,quality of sleep and life. Method:Randomized clinical trial(RCT) was conducted. There were 120 patients with mild to moderate depression. The observation group with 76 cases ,was treated with Buzhong Yiqi pill,combined with Banxia Xiexin decoction,or Xiaochaihu decoction,or Danggui Sini decoc-tion,or Wenshi Bentun decoction. The control group with 44 cases was treated with zoloft 50 mg per day. Patients were evaluated with HAMD-17 on the 1st,2nd,3rd,4th week and 4 weeks after the treatment. Also patients were evaluated with SAS,PSQI and WHOQOL-BREF on the 2nd and 4th week as well as during the follow-up. Results:①The reduction of HAMD-17 score showed no statistical difference between two groups 4 weeks after the treatment. ②According to the repetitive measurement of SAS,PSQI,WHOQOL-BREF,the curative effect in the observation group was better than that in the control group ,with statistically significant difference(P<0.01). Conclusion:Depression treatment based on the theory of spleen and stomach in combi-nation with syndrome differentiation of six meridi-ans can relieve depression,also has certain effect on anxiety,quality of sleep and life.