芪参通络解郁方治疗2型糖尿病合并抑郁状态的临床观察

Clinical Observation of Qishen Tongluo Jieyu Decoction(芪参通络解郁方)in Treatment of Type 2 Diabetes Mellitus Complicated with Depressive State

目的客观评价芪参通络解郁方治疗2型糖尿病(type 2 diabetes mellitus,T2DM)合并抑郁状态的临床疗效及安全性。方法通过9条目患者健康问卷(Item 9 Patient Health Questionnaire,PHQ-9)对T2DM患者进行抑郁状态筛查,将符合轻至中度抑郁评分的患者随机分为观察组和对照组。在T2DM规范化治疗基础上,观察组加服芪参通络解郁方,对照组加服盐酸氟西汀,疗程均为8周,并通过PHQ-9、17条目汉密尔顿抑郁量表(Item 17 Hamilton Depression Scale,HAMD-17)、中医症状积分量表的减分率与症状评分,以及血糖水平评价疗效。结果干预8周后,①观察组总有效率优于对照组(P<0.05或P<0.01);②观察组可有效改善抑郁核心症状(P<0.05),且在改善部分抑郁心理、躯体症状方面优于对照组(P<0.01或P<0.05);③两组血糖水平较治疗前有所改善,且观察组更显著(P<0.01);④观察组未见明显不良反应。结论芪参通络解郁方治疗2型糖尿病合并抑郁状态安全有效。

Objective To evaluate the clinical efficacy and safety of Qishen Tongluo Jieyu Decoction(芪参通络解郁方) in the treatment of type 2 diabetes mellitus(T2 DM) complicated with depressive state.Methods T2 DM patients with mild to moderate depression scores that self-screened through PHQ-9 were randomly divided into observation group and control group.Based on standardized treatment for T2 DM, the observation group added Qishen Tongluo Jieyu Decoction, while the control group added fluoxetine hydrochloride.The efficacy was evaluated by the reduction rates and symptom scores of PHQ-9, HAMD-17, TCM symptom scale and the level of blood sugar after 8 weeks.Results①After 8 weeks of treatment, the total effective rates in the observation group were better than those of the control group(P<0.01 or P<0.05).②The observation group can effectively improve the core symptoms of depression(P<0.05), and was better than that of the control group in improving some of the psychological and physical symptoms of depression(P<0.01 or P<0.05).③Both groups stabilized blood glucose levels, and the effect of the observation group was more significant(P<0.01).④No obvious adverse reactions were observed in the observation group.Conclusion Qishen Tongluo Jieyu Decoction is safe and effective on treating T2 DM complicated with depressive state.