乌灵胶囊联合黛力新治疗脑卒中后抑郁疗效和安全性的随机对照研究

目的：观察乌灵胶囊联合黛力新治疗脑卒中后抑郁的临床疗效和安全性。方法：采用平行对照研究方法，将卒中后抑郁病人随机分为乌灵胶囊组（n=39），给予乌灵胶囊，每次3粒，3次/d；黛力新组（n=37），给予黛力新片，每次10．5mg．2次/d，早上、中午各服1次；联合组（n=38）．在黛力新治疗基础上，加服乌灵胶囊。6周为1个疗程，于治疗前，治疗后2、4、6周用汉密顿抑郁量表（Hamilton Depression Scale，HAMD）评估疗效一治疗副反应量表（Treatment Emergent sympton Scale．TESS）评定药物的不良反应，并检测血常规、尿常规、肝肾功能及心电图等。结果：乌灵胶囊组、黛力新组、联合治疗组总有效率分别为64．1％、64．9％和89．5％，乌灵胶囊组和黛力新组两组疗效差异无统计学意义（P〉0．05），联合组疗效优于另两组（P〈0．05）。单纯应用乌灵胶囊组未见不良反应，应用黛力新的两组不良反应发生率均为9％。结论：乌灵胶囊联合黛力新治疗脑卒中后抑郁疗效优于单药治疗。

Efficacy and safety of Deanxit combined with Wuling Capsule in treating poststroke depression: A randomized controlled trial

OBJECTIVE: To evaluate the safety and efficacy of Wuling Capsule combined with Deanxit in treating post-stroke depression (PSD). METHODS: One hundred and fourteen patients with PSD were randomly divided into Wuling Capsule-treated group (n=39), Deanxit-treated group (n=37) and Wuling Capsule plus Deanxit-treated group (n=38). Patients in Wuling Capsule-treated group were administered with three Wuling Capsules three times a day, and patients in Deanxit-treated group were administered with Deanxit 10.5 mg twice daily, while patients in the Wuling Capsule plus Deanxit-treated group were administered with both Wuling Capsule and Deanxit. Patients in the three groups were all treated for six weeks. Treatment efficacy was evaluated with Hamilton Depression Scale (HAMD) and the side effects were evaluated with Treatment Emergent Symptom Scale (TESS) before treatment and after 2-, 4-, and 6-week treatment. The blood and urine routine examinations were performed, and the hepatorenal functions and electrocardiogram were examined as well. RESULTS: There was no statistical difference in the total efficacy rate between Wuling Capsule-treated group and Deanxit-treated group (64.1% vs 64.9%, P>0.05), but the total efficacy rate of Wuling Capsule plus Deanxit-treated group was higher than that of the monotherapy (89.5% vs 64.1%, 89.5% vs 64.9%, P<0.05). There were no significant side effects in Wuling Capsule-treated group, while the incidence of side effects was 9% in both groups administered with Deanxit. CONCLUSION: The efficacy of Wuling Capsule plus Deanxit is better than that of the monotherapy in treating PSD.