title: Sustained-release oxycodone tablets for moderate to severe painful diabetic peripheral neuropathy: a multicenter, open-labeled, postmarketing clinical observation.
abstract: 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.
  
  
  METHODS
  This study was completed in 12 hospitals in China.
  
  
  METHODS
  A total of 80 Chinese patients undergoing moderate to severe painful DPN.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pain Management, Shengjing Hospital of China, Medical University, No.36, Sanhao Street, Heping District, Shenyang City 110004, China. yaopeng908@163.com
authors.forename: Peng
authors.initials: P
authors.lastname: Yao
authors.forename: Ling-Xin
authors.initials: LX
authors.lastname: Meng
authors.forename: Jia-Ming
authors.initials: JM
authors.lastname: Ma
authors.forename: Yuan-Yuan
authors.initials: YY
authors.lastname: Ding
authors.forename: Zhi-Bin
authors.initials: ZB
authors.lastname: Wang
authors.forename: Guo-Li
authors.initials: GL
authors.lastname: Zhao
authors.forename: Rong
authors.initials: R
authors.lastname: Tao
authors.forename: Yan-Xiang
authors.initials: YX
authors.lastname: Wu
authors.forename: Qiu-Shi
authors.initials: QS
authors.lastname: Wang
authors.forename: Zhen
authors.initials: Z
authors.lastname: Zhang
authors.forename: Yong-Dong
authors.initials: YD
authors.lastname: Zhao
authors.forename: Shao-Wei
authors.initials: SW
authors.lastname: Zhang
authors.forename: Jin-Feng
authors.initials: JF
authors.lastname: Liu
authors.forename: Hong-Jie
authors.initials: HJ
authors.lastname: Guo
authors.forename: Gang
authors.initials: G
authors.lastname: Xu
authors.forename: Bai-Shan
authors.initials: BS
authors.lastname: Wu
mesh_terms: D000368:Aged; D002681:China; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000503:physiopathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010098:Oxycodone / Q000008:administration & dosage*; D059408:Pain Management / Q000379:methods*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D013607:Tablets
chemical_list: D003692:Delayed-Action Preparations; D013607:Tablets; D010098:Oxycodone