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Sustained-release oxycodone tablets for moderate to severe painful diabetic peripheral neuropathy: a multicenter,
Peng Yao1, Ling-Xin Meng, Jia-Ming Ma
1Department of Pain Management, Shengjing Hospital of China, Medical University, No.36, Sanhao Street, Heping District, Shenyang City 110004, China. yaopeng908@163.com
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 efficacy and safety of SR oxycodone tablets in the treatment of moderate to severe painful diabetic peripheral neuropathy in China.
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