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学科主题临床医学
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
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
2015-07-01
DOI10.1097/AJP.0000000000000144
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
WOS记录号WOS:000356588200003
资助机构Mundipharma (China) Pharmaceutical Co., Ltd
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/400002259/67546
专题北京大学第二临床医学院_风湿免疫科
北京大学第一临床医学院_医学统计室
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
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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.
APA Leng, Xiaomei.,Li, Zhanguo.,Lv, Houshan.,Zheng, Yi.,Liu, Yi.,...&Zeng, Xiaofeng.(2015).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.CLINICAL JOURNAL OF PAIN,31(7),612-620.
MLA Leng, Xiaomei,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".CLINICAL JOURNAL OF PAIN 31.7(2015):612-620.
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