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A randomized, double-blind, double-dummy, multicenter, controlled trial on brotizolam intervention in outpatients with insomnia
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
2013-10-01
DOI10.3109/13651501.2012.735242
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
WOS记录号WOS:000325765900002
项目编号2012ZX09303-003
资助机构Boehringer-Ingelheim Pharmaceuticals, Inc. (BIPI) ; Clinical tech-platform for evaluation of new drug in Psychiatry (CPEP)
引用统计
被引频次:1[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/54688
专题北京大学第三临床医学院
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
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GB/T 7714
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.
APA Yan, Xiaolei.,Huang, Shuzhen.,Ma, Cui.,Shen, Yang.,Gu, Niufan.,...&Li, Huafang.(2013).A randomized, double-blind, double-dummy, multicenter, controlled trial on brotizolam intervention in outpatients with insomnia.INTERNATIONAL JOURNAL OF PSYCHIATRY IN CLINICAL PRACTICE,17(4),239-243.
MLA Yan, Xiaolei,et al."A randomized, double-blind, double-dummy, multicenter, controlled trial on brotizolam intervention in outpatients with insomnia".INTERNATIONAL JOURNAL OF PSYCHIATRY IN CLINICAL PRACTICE 17.4(2013):239-243.
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