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学科主题: 临床医学
题名:
A randomized, double-blind, double-dummy, multicenter, controlled trial on brotizolam intervention in outpatients with insomnia
作者: Yan, Xiaolei1; Huang, Shuzhen2; Ma, Cui3; Shen, Yang4; Gu, Niufan1; Chen, Haibo5; Wu, Wenyuan6; Li, Shunwei7; Hong, Zhen8; Li, Huafang1
关键词: Brotizolam ; efficacy ; insomnia ; randomized control study ; safety
刊名: INTERNATIONAL JOURNAL OF PSYCHIATRY IN CLINICAL PRACTICE
发表日期: 2013-10-01
DOI: 10.3109/13651501.2012.735242
卷: 17, 期:4, 页:239-243
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Psychiatry
研究领域[WOS]: Psychiatry
关键词[WOS]: SLEEP ; PREVALENCE ; TRIAZOLAM
英文摘要:

Aim. To investigate the efficacy and safety of brotizolam in outpatients with insomnia. Methods. This randomized, double-blind, double-dummy, multicenter, controlled trial recruited 253 outpatients randomized to receive either brotizolam (n = 126) or estazolam (n = 127) for 14 days followed by 1 week of follow-up for rebound detection. Sleep Dysfunction Rating Scale (SDRS) and Clinical General Impression Scale were applied for efficacy evaluation. Safety evaluation was based on data regarding vital signs, physical examination, lab tests, ECG and collection of adverse events. Results. Full Analyses Set (FAS) and Safety Set (SS) included data of 251 subjects, with 126 from brotizolam group and 125 from estazolam group. Per Protocol Set (PPS) analysis included data of 235 subjects, with 121 and 114 from each group. Aft er 14 days of treatment, there was no difference with statistical significance between the two groups regarding SDRS total score change from baseline. FAS and PPS analysis showed that the brotizolam is non-inferior to estazolam in efficacy evaluation. There was also no difference with statistical significance regarding rebound rate between brotizolam and estazolam group in FAS. The rate of adverse event in two groups was with no statistically significant difference in SS. Conclusion. Brotizolam is effective and safe in relieving the symptoms of insomnia.

语种: 英语
所属项目编号: 2012ZX09303-003
项目资助者: Boehringer-Ingelheim Pharmaceuticals, Inc. (BIPI) ; Clinical tech-platform for evaluation of new drug in Psychiatry (CPEP)
WOS记录号: WOS:000325765900002
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/54688
Appears in Collections:北京大学第三临床医学院_期刊论文

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作者单位: 1.Guangzhou Mental Hlth Hosp, Guangzhou, Guangdong, Peoples R China
2.Peking Univ, Hosp 3, Beijing 100871, Peoples R China
3.Beijing Hosp, Minist Publ Hlth, Beijing, Peoples R China
4.Tongji Univ, Tongji Hosp, Shanghai 200092, Peoples R China
5.Fudan Univ, Huashan Hosp, Shanghai 200433, Peoples R China
6.Shanghai Jiao Tong Univ, Sch Med, Shanghai Mental Hlth Ctr, Shanghai 200030, Peoples R China
7.Capital Med Univ, Beijing Anding Hosp, Beijing, Peoples R China
8.Beijing Union Med Coll Hosp, Beijing, Peoples R China

Recommended Citation:
Yan, Xiaolei,Huang, Shuzhen,Ma, Cui,et al. A randomized, double-blind, double-dummy, multicenter, controlled trial on brotizolam intervention in outpatients with insomnia[J]. INTERNATIONAL JOURNAL OF PSYCHIATRY IN CLINICAL PRACTICE,2013,17(4):239-243.
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