疏肝解郁汤治疗脑卒中后抑郁:一项随机、对照、开放研究

Shuganjieyu decoction in the treatment of post-stroke depression:a randomized,controlled and open study

目的观察疏肝解郁汤治疗脑卒中后抑郁的临床疗效。方法将2017年6月至2018年6月马鞍山十七冶医院就诊的60例脑卒中后抑郁病人按随机数字表法及分配隐藏方案(信封法)分为治疗组(n=30)和对照组(n=30),所有病例均给予基础治疗,治疗组病人在基础治疗上加用盐酸氟西汀及疏肝解郁汤,对照组仅用盐酸氟西汀治疗,疗程均为4周。观察治疗前后两组病人卒中后美国国立卫生研究院卒中量表(NIHSS)评分,汉密尔顿抑郁(HAMD)量表评分,蒙哥马利—艾斯伯格抑郁量表(MADRS)评分,抑郁症状中医症候和日常生活能力量表(ADL)评分,并记录不良反应。结果两组脑卒中后抑郁病人治疗4周后,HAMD评分[对照组:(11.53±2.84)分,治疗组:(9.33±2.28)分]、MADRS评分[对照组:(17.13±4.64)分,治疗组:(14.20±4.90)分]、NIHSS评分[对照组:(7.53±2.13)分,治疗组:(5.43±1.61)分]、ADL评分[对照组:(55.67±10.65)分,治疗组:(73.83±7.15)分]和中医症候均较治疗前有明显好转(P<0.01),并且治疗组好转较为明显(P<0.01或P<0.05),两组不良反应发生率比较差异无统计学意义[治疗组:13.33%,对照组:6.67%,χ^2=0.74,P=0.39]。结论疏肝解郁汤可以明显减轻脑卒中后抑郁病人抑郁症状,改善中医证候,同时具有帮助神经功能康复及提升病人日常生活能力的作用,而且具有很好的安全性。

Objective To observe the clinical efficacy of Shuganjieyu decoction on post-stroke depression.Methods Sixty patients with post-stroke depression treated in Ma’anshan Shiqiye Hospital from June 2017 to June 2018 were randomly assigned into the treatment group(n=30)and the control group(n=30)according to the random number table method and the allocation of concealment plan(envelope method).All patients were given basic treatment.Patients in the treatment group were additionally treated with fluoxetine hydrochloride and Shuganjieyu decoction,while patients in the control group were treated with fluoxetine hydrochloride.Both groups were treated for 4 weeks.National Institutes of Health Stroke Scale(NIHSS),Hamilton Depression Scale(HAMD),Montgomery-Asperger Depression Scale(MADRS),the TCM symptoms of post-stroke depression,and Activities of Daily Living Scale(ADL)were used for the observation of patients before and after treatment,and adverse reactions were recorded.Results After 4 weeks of treatment,HAMD scores[control group:(11.53±2.84)points,treatment group:(9.33±2.28)points],MADRS scores[control group:(17.13±4.64)points,treatment group:(14.20±4.90)points],NIHSS scores[control group:(7.53±2.13)points,treatment group:(5.43±1.61)points],ADL scores[control group:(55.67±10.65)points,treatment group:(73.83±7.15)points]and TCM symptom scores of the two groups of patients with post-stroke depression were significantly improved,compared with those before treatment(P<0.01),and the treatment group improved more obviously(P<0.01 or P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups[treatment group:13.33%,control group:6.67%,χ^2=0.74,P=0.39].Conclusion Shuganjieyu decoction can significantly reduce depressive symptoms and improve traditional Chinese medicine syndromes,and at the same time has the effect of helping neurological rehabilitation and improving activity of daily living of patients with post-stroke depression,which has high safety.