乌灵胶囊治疗焦虑、抑郁状态的随机双盲对照研究  

A randomized study on comparing effect and safety of wuling capsule and deanxit in patients with anxiety or depression status

作　　者：史丽丽[1] 赵晓晖[1] 王瑛[2] 张捷[3] 张海音[4] 吴恺[5] 冯斌[6] 魏镜[1] 

机构地区：[1]中国医学科学院北京协和医院心理医学科,100730 [2]上海交通大学医学院附属瑞金医院神经科 [3]首都医科大学附属北京中医医院心身科 [4]上海精神卫生中心精神科 [5]卫生部北京医院神经科 [6]浙江省立同德医院精神科

出　　处：《中华神经科杂志》2009年第11期776-779,共4页Chinese Journal of Neurology

摘　　要：目的观察乌灵胶囊治疗焦虑或抑郁状态的疗效与安全性。方法采用多中心随机双盲双模拟平行对照研究方法，治疗组67例患者口服乌灵胶囊3粒，3次／d；对照组73例患者口服氟哌噻吨美利曲辛1片，2次／d。于治疗前及治疗后第1、2、4、6周分别以汉密尔顿焦虑量表（HAMA）、汉密尔顿抑郁量表（HAMD）、匹兹堡睡眠质量指数（PSQI）、治疗时出现的症状量表（TESS）及实验室检查评估疗效与安全性以验证乌灵胶囊的非劣效性。结果治疗1周后2组HAMA和HAMD评分均较基线时改善，6周末HAMA评分：乌灵胶囊组（9．0±5．4）分、对照组（10．3±5．4）分；HAMD评分：乌灵胶囊组（9．1±5．6）分、对照组（10．5±5．7）分，2组比较差异均无统计学意义（分别F：2．11，P=0．148；F=1．61，P=0．207）。乌灵胶囊组和对照组治疗抑郁或焦虑的临床显效率和临床治愈率差异也无统计学意义。在治疗后PSQI评分：乌灵胶囊组（4．1±4．5）分、对照组（5．0±4．2）分，2组问差异无统计学意义（F=0．72，P=0．192）。常见不良反应为消化和神经系统症状，多数为轻中度、一过性。结论乌灵胶囊治疗轻度焦虑或抑郁状态具有肯定的疗效，安全性良好。Objective To evaluate the efficacy and safety of wuling capsule compared with deanxit in treatment of patients with depression or anxiety status. Methods A total of 139 patients with depression or anxiety status were enrolled in a multi-center double blind clinical trial. All patients were randomized into two groups, 67 patients in wuling capsule group and 73 patients in deanxit group. Efficacy and adverse effects were evaluated with Hamilton Anxiety Scale （HAMA）, Hamilton Depression Scale （HAMD）, Pittsburgh Sleep Quality Index （PSQI） and Treatment Emergent Symptoms Scale （TESS） before treatment and 1, 2, 4, 6 weeks after treatment to verify the noninferiority of wuling capsule. Results There was no significant difference in score decline of HAMA and HAMD between the two groups （HAMA： wuling vs deanxit group： 9.0 ± 5.4 vs 10. 3 ± 5.4, F =2. 11, P =0. 148; HAMD： wuling vs deanxit： 9. 1 ±5.6 vs 10. 5 ± 5.7, F = 1.61, P =0. 207）. There was no significant difference in response rate and remission rate between the two groups. No significant difference was found in score decline of PSQI between the two groups （wuling vs deanxit group： 4. 1 ±_ 4. 5 vs 5.0 ± 4. 2, F = 0. 72, P = 0. 192）. The incidence of adverse events was 41% in the wuling group and 55% in the deanxit group respectively. The main adverse effects were symptoms of gastrointestinal and neurology system. Conclusion Safe and well tolerated, wuling capsule improves the anxiety, depression and insomnia symptoms of patients with depression or anxiety status.

关 键 词：焦虑 抑郁 氟哌噻吨 随机对照试验 

分 类 号：R686[医药卫生—骨科学]