【摘要】 目的观察红景天胶囊治疗轻中度抑郁症心脾两虚证的疗效及安全性。方法将220例轻中度抑郁症心脾两虚证患者随机分为安慰剂组73例、红景天小剂量组73例、红景天大剂量组74例。安慰剂组每日服用安慰剂1.2g,红景天小剂量组每日服用红景天胶囊和安慰剂各0.6 g,红景天大剂量组每日服用红景天胶囊1.2 g。各组分别在治疗前及治疗2、4、8周进行汉密尔顿抑郁量表(HAMD)、贝克抑郁量表(BDI)、疗效指数(EI)评估,并观察安全性。结果安慰剂组各时间点间HAMD评分、BDI评分及EI差异均无统计学意义(P>0.05);与前一时间点比较,红景天大、小剂量组各时间点HAMD评分、BDI评分均降低,EI均升高(P<0.05);与安慰剂组同时间比较,红景天大、小剂量组治疗2、4、8周HAMD评分、BDI评分均降低,EI升高,且红景天大剂量组改善程度均优于小剂量组(P<0.05)。各组患者均未出现严重不良事件。结论红景天胶囊具有改善轻中度抑郁的作用,且安全性较好,其1.2 g/d较0.6 g/d疗效更为显著。更多还原

【Abstract】 Objective To observe the effect and safety of Hongjingtian [Rhodiola] capsule in treating mild or moderate major depressive disorder with deficiency of both heart and spleen. Methods Totally 220 mild or moderate major depressive disorder( MDD) patients with deficiency of both heart and spleen syndrome were randomized into placebo group( 73 cases),small dose Hongjingtian group( 73 cases) and large dose Hongjingtian group( 74 cases).The placebo group was given placebo 1. 2 g every day. The small dose Hongjingtian group was given Hongjingtian capsule 0. 6 g and placebo 0. 6 g every day. The large dose Hongjingtian group was given Hongjingtian capsule 1. 2 g every day. Hamilton Depression Scale( HAMD),Beck Depression Inventory( BDI) and Effectiveness Index( EI) was evaluated before and after treatment of 2,4 and 8 weeks. The safety was examined. Results The difference of HAMD score,BDI score and EI at each time point in the placebo group was not significant( P > 0. 05). Compared with the previous time point,HAMD score and BDI score at each time point decreased in the small and large dose Hongjingtian groups,while EI increased( P < 0. 05). Compared with the placebo group at the same time point,HAMD score and BDI score after treatment for 2,4 and 8 weeks decreased in the small and large dose Hongjingtian groups,while EI increased. Moreover,the improvement in the large dose Hongjingtian group was superior to that in the small dose Hongjingtian group( P < 0. 05). No serious side effect was found in each group. Conclusion Hongjingtian capsule might improve mild or moderate depression with good safety. The effect of dose 1. 2 g/d seemed to be superior to that of dose 0. 6 g/d.更多还原