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Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China
Gao Yan2; Ning Guang3; Jia Wei-ping4; Zhou Zhi-guang5; Xu Zhang-rong6; Liu Zhi-min7; Liu Chao8; Ma Jian-hua9; Li Qiang10; Cheng Lu-lu11; Wen Chong-yuan12; Zhang Shu-yu12; Zhang Qi; Desaiah, Durisala; Skljarevski, Vladimir1
关键词Clinical Trial Duloxetine Diabetic Peripheral Neuropathic Pain Chinese Patients
刊名CHINESE MEDICAL JOURNAL
2010-11-20
DOI10.3760/cma.j.issn.0366-6999.2010.22.003
123期:22页:3184-3192
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Medicine, General & Internal
资助者Eli Lilly and Company, Indianapolis, Indiana, USA ; Boehringer Ingelheim Pharmaceuticals, Germany ; Eli Lilly and Company, Indianapolis, Indiana, USA ; Boehringer Ingelheim Pharmaceuticals, Germany
研究领域[WOS]General & Internal Medicine
关键词[WOS]MAJOR DEPRESSIVE DISORDER ; TRIAL COMPARING DULOXETINE ; QUALITY-OF-LIFE ; DOUBLE-BLIND ; CLINICAL-TRIALS ; ERECTILE DYSFUNCTION ; ROUTINE CARE ; EFFICACY ; SAFETY ; FIBROMYALGIA
英文摘要

Background Duloxetine, a selective serotonin and noradrenaline reuptake inhibitor, has been shown to be effective in treatment of diabetic peripheral neuropathic pain and approved for the management of patients with diabetic peripheral neuropathic pain (DPNP) in the United States, European Union, and many other countries This study assessed the efficacy and safety of duloxetine in Chinese patients with diabetic peripheral neuropathic pain

Methods This double-blind, randomized, placebo-controlled, flexible-dose study treated adult patients with diabetic peripheral neuropathic pain and baseline Brief Pain Inventory (BPI) 24-hour average pain severity ratings with duloxetine 60 mg to 120 mg once daily or placebo for 12 weeks Dose adjustments of duloxetine or matching placebo were based upon investigator′s judgment of clinical response Change from baseline to endpoint in BPI average pain was the primary efficacy outcome Secondary outcome measures included BPI-seventy and -Interference, Patient Global Impression of Improvement, Clinical Global Impressions of Severity, EuroQol 5 Dimensions, Athens Insomnia Scale, and safety measures

Results Of 215 patients randomized, 88 4% and 82 1% of patients in placebo and duloxetine groups, respectively, completed the study Mean change from baseline to endpoint in BPI average pain was not statistically different between the treatment groups (P=0 124) Duloxetine-treated patients showed significantly greater pain reduction compared with those in placebo group at weeks 1, 2, and 4 (P=0 004, P=0 009, and P=0 006, respectively), but not at weeks 8 (P=0 125) and 12 (P=0 107) Duloxetine-treated patients experienced statistically significant improvement in Patient Global Impression of Improvement, Clinical Global Impression of Severity, area under the curve for pain relief, BPI-severity pain right now, and BPI-interference walking ability Patients treated with duloxetine 120 mg once daily showed significantly greater pain reduction on the Brief Pain Inventory average pain score relative to placebo Duloxetine-treated patients reported nausea, somnolence, anorexia, and dysuria significantly more than placebo

Conclusions Although the primary study endpoint was not achieved, the overall observed response pattern suggests the efficacy of duloxetine in the treatment of Chinese patients with diabetic peripheral neuropathic pain The safety profile for duloxetine is similar to that reported in other global trials Chin Med J 2010,123(22) 3184-3192

语种英语
资助者Eli Lilly and Company, Indianapolis, Indiana, USA ; Boehringer Ingelheim Pharmaceuticals, Germany ; Eli Lilly and Company, Indianapolis, Indiana, USA ; Boehringer Ingelheim Pharmaceuticals, Germany
WOS记录号WOS:000284925300003
引用统计
被引频次:19[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/400002259/55115
专题北京大学第一临床医学院_内分泌内科
作者单位1.Eli Lilly & Co, Lilly Corp Ctr, Lilly Res Labs, Indianapolis, IN 46285 USA
2.Peking Univ, Hosp 1, Dept Endocrinol, Beijing 100034, Peoples R China
3.Shanghai Jiao Tong Univ, Sch Med, Shanghai Ruijin Hosp, Dept Endocrinol, Shanghai 200025, Peoples R China
4.Shanghai Jiao Tong Univ, Sch Med, Shanghai Peoples Hosp 6, Dept Endocrinol, Shanghai 200233, Peoples R China
5.Cent S Univ, Xiangya Hosp 2, Dept Endocrinol, Changsha 410011, Hunan, Peoples R China
6.306 Hosp Peoples Liberat Army, Dept Endocrinol, Beijing 100101, Peoples R China
7.Second Mil Med Univ, Chang Zheng Hosp, Dept Endocrinol, Shanghai 200003, Peoples R China
8.Nanjing Med Univ, Affiliated Hosp 1, Dept Endocrinol, Nanjing 210029, Jiangsu, Peoples R China
9.Nanjing Med Univ, Nanjing Hosp 1, Dept Endocrinol, Nanjing 210006, Jiangsu, Peoples R China
10.Harbin Med Univ, Affiliated Hosp 2, Dept Endocrinol, Harbin 150086, Heilongliang, Peoples R China
11.Huazhong Univ Sci & Technol, Union Hosp, Dept Endocrinol, Wuhan 430022, Hubei, Peoples R China
12.Wuhan Univ, Renmin Hosp, Dept Endocrinol, Wuhan 430060, Hubei, Peoples R China
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Gao Yan,Ning Guang,Jia Wei-ping,et al. Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China[J]. CHINESE MEDICAL JOURNAL,2010,123(22):3184-3192.
APA Gao Yan.,Ning Guang.,Jia Wei-ping.,Zhou Zhi-guang.,Xu Zhang-rong.,...&Skljarevski, Vladimir.(2010).Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China.CHINESE MEDICAL JOURNAL,123(22),3184-3192.
MLA Gao Yan,et al."Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China".CHINESE MEDICAL JOURNAL 123.22(2010):3184-3192.
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