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学科主题: 临床医学
题名:
Sustained-Release Oxycodone Tablets for Moderate to Severe Painful Diabetic Peripheral Neuropathy: A Multicenter, Open-Labeled, Postmarketing Clinical Observation
作者: Yao Peng1; Meng Ling-Xin1; Ma Jia-Ming1; Ding Yuan-Yuan1; Wang Zhi-Bin1; Zhao Guo-Li2; Tao Rong3; Wu Yan-Xiang4; Wang Qiu-Shi5; Zhang Zhen6; Zhao Yong-Dong7,8; Zhang Shao-Wei8; Liu Jin-Feng9; Guo Hong-Jie10; Xu Gang11; Wu Bai-Shan12
关键词: Diabetic Peripheral Neuropathy ; Pain ; Analgesic ; Sustained-Release Oxycodone ; Opioid ; Adverse Reactions
刊名: PAIN MEDICINE
发表日期: 2012
DOI: 10.1111/j.1526-4637.2011.01274.x
卷: 13, 期:1, 页:107-114
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal
研究领域[WOS]: General & Internal Medicine
关键词[WOS]: MANAGEMENT
英文摘要:

Objective. To evaluate the efficacy and safety of sustained-release (SR) oxycodone tablets in the treatment of moderate to severe painful diabetic peripheral neuropathy (DPN).

Design. This was a multicenter, randomized, open-labeled study.

Setting. This study was completed in 12 hospitals in China.

Patients. A total of 80 Chinese patients undergoing moderate to severe painful DPN.

Interventions. An initial dose of 10 mg is recommended to be taken orally every 12 hours. Dose titration was done appropriately according to pain intensity and adverse reactions.

Outcome Measures. Data record included days, dosage, analgesic efficacy, quality of sleep, adverse events, and combination therapy when patients were treated with SR oxycodone tablets. The continuous observation period was 6 weeks.

Results. After medication for 1 week, pain was significantly (P < 0.01) relieved from 6.8 +/- 1.4 to 2.8 +/- 1.6. Onset time was within 45 minutes in nearly 60% of the patients, and within 1 hour in nearly 95% of that ones. More than 90% of the patients achieved stable analgesic dose within 3 days. After using SR oxycodone tablets for 1 week, sleep quality was significantly (P < 0.01) improved. In week 1, the average dose of SR oxycodone tablets was 16.63 +/- 7.79 mg. The average daily dose of most patients was about 20 mg after 2 weeks. In all the enrolled patients, 38 (47.5%) had adverse reactions. No serious adverse reactions took place.

Conclusion. The results of this clinical observation further elaborated the efficacy and safety of SR oxycodone tablets in the treatment of moderate to severe painful diabetic peripheral neuropathy in China.

语种: 英语
所属项目编号: 696
项目资助者: Mundipharma (China) Pharmaceutical Co. Ltd. ; Liaoning provincial medicine peak construction engineering project
WOS记录号: WOS:000298954200010
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/59165
Appears in Collections:北京大学第一临床医学院_期刊论文

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作者单位: 1.China Med Univ, Shengjing Hosp, Dept Pain Management, Shenyang, Peoples R China
2.Chinese Peoples Liberat Army Gen Hosp, Dept Pain Management, Beijing, Peoples R China
3.Henan Prov Peoples Hosp, Dept Pain Management, Zhengzhou, Peoples R China
4.Peoples Liberat Army, Dept Endocrinol, Shenyang, Peoples R China
5.China Med Univ, Hosp 1, Dept Pain Management, Shenyang, Peoples R China
6.So Med Univ, Zhujiang Hosp, Dept Endocrinol, Guangzhou, Guangdong, Peoples R China
7.Peoples Liberat Army, AF Gen Hosp, Dept Endocrinol, Beijing, Peoples R China
8.Peoples Liberat Army, Dept Endocrinol, Shenyang, Peoples R China
9.Harbin Med Coll, Hosp 2, Dept Pain Management, Harbin, Peoples R China
10.Peking Univ, Hosp 1, Cardiovascular Dept, Beijing 100871, Peoples R China
11.Dept Pain Management, Beijing, Peoples R China
12.N China Elect Power Hosp, Dept Pain Management, Beijing, Peoples R China

Recommended Citation:
Yao Peng,Meng Ling-Xin,Ma Jia-Ming,et al. Sustained-Release Oxycodone Tablets for Moderate to Severe Painful Diabetic Peripheral Neuropathy: A Multicenter, Open-Labeled, Postmarketing Clinical Observation[J]. PAIN MEDICINE,2012,13(1):107-114.
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