星瑙灵治疗轻中度焦虑症抑郁症的随机对照开放研究

摘要

Objective:To evaluate the efficacy and safety of Seniovita coated tablets in the treatment of the pa-tients with mild and moderate anxiety and/or depression . Methods:A total of 322 patients with mild and moderate anxiety and/or depression were randomly divided into Seniovita group (n=162) and control group (n=160) . The Seniovita group was orally given Seniovita (2 tablets, tid), and the controlled group was orally given Deanxit (1 tablet, bid). The efficacy of the 2 groups were evaluated with Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) before and 2, 4, 6, 8 week after the treatment. Results:There was a significant decline in HAMA score and HAMD score in the 2 groups at 2nd week after treatment ( <0.05). There was no significant difference between the 2 groups in HAMA score and HAMD after the treatment ( >0.05). At 8th week after the treatment, there was no significant difference between the 2 groups in the obvious effective rate and the curative rate. Conclusion:Seniovita coated tablet is safe and effective in treating anxiety and depression.%目的：观察星瑙灵片治疗轻中度焦虑症、抑郁症的疗效与安全性。方法：322例轻中度焦虑症、抑郁症患者随机分为星瑙灵组162例和对照组160例，星瑙灵组口服星瑙灵片，每次2片，一日3次；对照组口服氟哌噻吨美利曲辛片，每次1片，每日2次。疗程均为8周。于治疗前和治疗后第2、4、6、8周分别以汉密尔顿焦虑量表（HAMA）、汉密尔顿抑郁量表（HAMD）评估疗效。结果：治疗2周后，2组的HAMA评分和HAMD评分均明显下降（<0.05），2组间差异无统计学意义（>0.05）。治疗8周后，星瑙灵组的显效率和治愈率与对照组比较差异无统计学意义（>0.05）。结论：星瑙灵治疗轻中度焦虑症、抑郁症安全有效。