圣·约翰草提取物治疗轻中度抑郁症的多中心临床研究

目的：验证圣·约翰草提取物（ｎｅｕｒｏｓｔａｎ，路优泰）治疗轻中度抑郁症的疗效及安全性。方法：采用双盲、双模拟、随机、氟西汀对照、多中心的方法，以单相仰郁症或双相情感障碍的轻中度抑郁发作的抑郁症患者为入选对象．随机分为路优泰组６８例，予路优泰３００ｍｇ，ｔｉｄ，氟西汀安慰剂，ｑｄ；氟西汀组６７例，予氟西汀２０ ｍｇ，ｑｄ，路优泰安慰剂，ｔｉｄ。治疗时间均为 ６ｗｋ。疗效评定采用ＨＡＭＤ（１７项）及ＨＡＭＡ量表。安全性评价应用副反应量表（ＴＥＳＳ）、实验室检查及体检。结果：路优泰组治疗抑郁症的有效率为８３．８％，氟西汀组的有效率为８５．０％，２组之间无统计学差异。２组常见不良反应均较轻，不良反应发生率差异无统计学意义（Ｐ＞０．０５）．但路优泰组口干的发生率（１７．６％）显著低于氟西汀组（３５．８％）。结论：路优泰有良好的抗抑郁作用，疗效与氟西汀相当，不良反应轻，安全性高。

Multicenter study of St. John's wort extract in treatment of mild to moderate depression

AIM: To evaluate the efficacy and safety of St. John's wort extract (neurostan) in the treatment of mild to moderate depression. METHODS: There were 135 depressive patients enrolled in the study, 68 cases in neurostan group and 67 in fluoxetine group. The treatment dose of neurostan was 300 mg, tid, and fluoxetine was 20 mg, qd. The patients were treated with neurostan or fluoxetine for 6 wk. The rating scale of HAMD and HAMA were adopted to evaluate the efficacy of the antidepressants. The scale of TESS, lab examination and physical examination were conducted during the study to evaluate the safety of the investigated drugs. RESULTS: The response rates of neurostan and fluoxetine group were 83. 8% and 85. 0%, respectively. There was no statistically difference between 2 groups. Among the ad- verse drug reactions, the rate of dry mouth was lower in neurostan group than that in fluoxetine group. CONCLUSION: Neurostan is an effective and safe antidepressant.