目的:观察和探讨益心舒胶囊联合米氮平治疗卒中后抑郁气阴两虚兼血瘀型的临床疗效。方法将符合标准的160例卒中后抑郁患者随机分为治疗组和对照组,每组各80例。两组在脑血管病治疗基础上,治疗组给予益心舒胶囊3粒,口服,3次/d,米氮平30 mg,每晚顿服;对照组仅给予米氮平30 mg,每晚顿服,疗程均为8周。以汉密尔顿抑郁量表(HAMD)及其减分率判定抑郁疗效,以神经功能缺损(SSS)评分判定神经功能恢复情况,以Barthel指数(BI)评定患者日常生活能力(ADL)改善情况,并记录患者中医症候改善情况;所有患者均于治疗前及治疗后行血尿常规、肝肾功能、心电图检查,观察和记录患者不良反应发生情况。结果疗程结束后,治疗组HAMD有效率为91.25%,对照组为81.25%,优于对照组(P<0.05);两组SSS评分在治疗8周时都有下降,但治疗组改善情况优于对照组(P<0.05),且较对照组改善更快;两组BI评分在治疗8周后都明显提高,但治疗组提高优于对照组(P<0.05);与对照组相比,治疗组可有效改善患者的胸闷、心悸、神疲、乏力等临床症候。两组治疗前后血尿常规、肝肾功能、心电图检查无明显异常,治疗组不良反应发生率低于对照组。结论益心舒胶囊联合米氮平能明显改善卒中后抑郁患者抑郁症状,有利于神经功能恢复及日常生活能力的改善,较单一西药起效快,副作用小。
Objective To observe the clinical efficacy of Yixinshu capsule combined with mirtazapine in treatment of post stroke depression. Methods 160 patients with post stroke depression were randomly divided into treatment group and control group, each group had 80 cases. Two groups on the basis of conventional therapy, the treatment group was given Yixinshu capsule 3 pills, oral, three times a day after 30mg, QN;while the control group was treated with mirtazapine 30 mg, QN, treatment for 8 weeks. By Hamilton Depression Scale (HAMD) and the reduction rate of depression were used to evaluate efficacy, and neurological deficit (SSS) score was used to assess the recovery of nerve function, Barthel index (BI) were used to assess the daily living (ADL), and the improvement of TCM syndromes were recorded too. Adverse reaction were compared between two groups. Results After treatment, the HAMD efficiency of treatment group was 91.25% which was better than that in control group (P<0.05); SSS score of two group at 8 weeks has decreased, but the treatment group improved better than the control group (P<0.05);BI scores of the two groups have significantly improved, but the treatment group improved better than the control group(P<0.05);Compared with the control group, the treatment group can effectively improve the patients' chest, palpitation, fatigue, fatigue and other symptoms. Blood and urine routine, liver and kidney function, electrocardiogram examination of two groups showed no abnormalities, incidence of adverse reaction of treatment group was lower than the control group. Conclusion Yixinshu capsule combined with mirtazapine can significantly improve the depressive symptoms of patients with depression after stroke, which can improve the neurological function and activities of daily living, and fast acting, less side effects.