Sustained-Release Oxycodone Tablets for Moderate to Severe Painful Diabetic Peripheral Neuropathy: A Multicenter, Open-Labeled, Postmarketing Clinical Observation

作者：Peng Yao, Ling-xin Meng, Jiaming Ma, Yuan-Yuan Ding, Zhibin Wang, Guoli Zhao, Rong Tao, Yanxiang Wu, Qiushi Wang, Zhen Zhang, Yong-Dong Zhao, Shaowei Zhang, Jinfeng Liu, Hongjie Guo, Gang Xu, Wu Baishan · 发表于：Pain Medicine · 年份：2011 · DOI：10.1111/j.1526-4637.2011.01274.x · 被引用次数：10 · 研究领域：Pain Mechanisms and Treatments、Pain Management and Opioid Use、Chemical synthesis and alkaloids

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 10mg 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±7.79mg. The average daily dose of most patients was about 20mg 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...