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IR@PKUHSC  > 北京大学第二临床医学院  > 风湿免疫科  > 期刊论文
学科主题: 临床医学
题名:
Effectiveness and Safety of Transdermal Buprenorphine Versus Sustained-release Tramadol in Patients With Moderate to Severe Musculoskeletal Pain An 8-Week, Randomized, Double-Blind, Double-Dummy, Multicenter, Active-controlled, Noninferiority Study
作者: Leng, Xiaomei1; Li, Zhanguo2; Lv, Houshan3; Zheng, Yi4; Liu, Yi6; Dai, Kerong7; Yao, Chen5; Yan, Xiaoyan5; Zeng, Xiaofeng1
关键词: musculoskeletal pain ; buprenorphine transdermal system ; tramadol
刊名: CLINICAL JOURNAL OF PAIN
发表日期: 2015-07-01
DOI: 10.1097/AJP.0000000000000144
卷: 31, 期:7, 页:612-620
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Anesthesiology ; Clinical Neurology
研究领域[WOS]: Anesthesiology ; Neurosciences & Neurology
关键词[WOS]: LOW-BACK-PAIN ; CHRONIC NONCANCER PAIN ; 20 MU-G/H ; CHRONIC NONMALIGNANT PAIN ; QUALITY-OF-LIFE ; DELIVERY-SYSTEM ; OPIOID THERAPY ; OPEN-LABEL ; EFFICACY ; PLACEBO
英文摘要:

Objectives:The aim of this noninferiority study was to investigate clinical effectiveness and safety of buprenorphine transdermal system (BTDS) in patients with moderate to severe musculoskeletal pain inadequately controlled with nonsteroidal anti-inflammatory drugs, compared with sustained-release tramadol tablets.Materials and Methods:Eligible patients were randomized (1:1) to receive low-dose 7-day BTDS (5, 10, and 20 g/h, maximum dosage of 20 g/h) or sustained-release tramadol tablets (100 mg, maximum dosage of 400 mg/d) over an 8-week double-blind treatment period (3-week titration, 5-week maintenance). The primary endpoint was the difference in the visual analogue scale (VAS) pain scores from baseline to treatment completion. Noninferiority was assumed if the treatment difference on the VAS scale was within 1.5 cm, this threshold indicating a clinically meaningful result. ClinicalTrials.gov identifier: NCT01476774.Results:Two hundred eighty patients were randomized to BTDS (n=141) or to tramadol (n=139). Both treatments were associated with a significant reduction in pain by the end of the treatment. The least squares mean difference of the change from baseline in VAS scores between the BTDS and tramadol groups were 0.45 (95% confidence interval, -0.02 to 0.91), which was within the +/- 1.5 cm predefined threshold, indicating that the effectiveness of BTDS was not inferior to the effectiveness of sustained-release tramadol tablets. The incidence of adverse events was comparable between the 2 treatment groups.Conclusions:Our results suggest that BTDS is a good therapeutic option for patients experiencing chronic musculoskeletal pain of moderate to severe intensity that is insufficiently controlled by nonsteroidal anti-inflammatory drugs.

语种: 英语
项目资助者: Mundipharma (China) Pharmaceutical Co., Ltd
WOS记录号: WOS:000356588200003
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/67546
Appears in Collections:北京大学第二临床医学院_风湿免疫科_期刊论文

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作者单位: 1.Beijing Chao Yang Hosp, Dept Rheumatol, Beijing, Peoples R China
2.Beijing Union Med Coll Hosp, Dept Rheumatol, Beijing, Peoples R China
3.Peking Univ, Peoples Hosp, Dept Rheumatol, Beijing 100871, Peoples R China
4.Peking Univ, Peoples Hosp, Dept Orthoped, Beijing 100871, Peoples R China
5.Peking Univ, Clin Res Inst, Dept Med Stat, Beijing 100871, Peoples R China
6.Sichuan Univ, West China Hosp, Dept Rheumatol, Chengdu 610064, Sichuan Provinc, Peoples R China
7.Shanghai Jiao Tong Univ, Sch Med, Shanghai Peoples Hosp 9, Dept Orthoped, Shanghai 200030, Peoples R China

Recommended Citation:
Leng, Xiaomei,Li, Zhanguo,Lv, Houshan,et al. Effectiveness and Safety of Transdermal Buprenorphine Versus Sustained-release Tramadol in Patients With Moderate to Severe Musculoskeletal Pain An 8-Week, Randomized, Double-Blind, Double-Dummy, Multicenter, Active-controlled, Noninferiority Study[J]. CLINICAL JOURNAL OF PAIN,2015,31(7):612-620.
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