title: Efficacy and tolerability of oxycodone hydrochloride controlled-release tablets in moderate to severe cancer pain.
abstract: OBJECTIVE
  Oxycodone is a semisynthetic opioid analgesic drug classed as a strong opioid. The controlled-release oxycodone tablet formulation (OCRT) was approved in China in 2004 for management of moderate to severe cancer pain. Few data about the efficacy of OCRT and clinical outcomes in Chinese patients taking this drug are available. The purpose of this study was to evaluate the efficacy and tolerability of this drug for relief of moderate to severe cancer pain in Chinese patients.
  
  
  METHODS
  This was a prospective, open-label, multicentre clinical trial carried out in ten hospitals in Zhejiang Province, China. Patients with cancer pain with a score > or =4 (numerical rating scale) were enrolled. They received oral OCRT at an initial dosage of 5mg every 12 hours for patients scoring 4-6 and 10mg every 12 hours for patients scoring > or =7. Doses were then titrated on an individual basis. Onset of analgesic action, pain score and quality-of-life (QOL) scores - including items measuring family understanding and support, sleep, mental state, appetite, fatigue, and activities of daily life - were evaluated. Adverse effects were also documented.
  
  
  RESULTS
  216 patients (126 males and 90 females) aged 22-84 years were enrolled. The total mean OCRT dosage was 445.2 +/- 361.6mg (range 130-2320mg). The daily dosages of the vast majority of cases (89%) were between 10mg and 30mg. Onset of analgesic action occurred within 1 hour in 198 cases (91.7%) following administration of OCRT. 82.4% of cases were titrated to a steady dosage level within 2 days following administration of the first dose of medication. Pain score decreased significantly (p < 0.01) from 7.1 +/- 1.2 at baseline to 2.3 +/- 1.2 one week after starting medication and 1.8 +/- 0.9 four weeks after starting medication. Scores on all six QOL items increased significantly (p < 0.01) compared with baseline but showed varying rates of improvement. Adverse events included constipation, nausea, vomiting, drowsiness and dysuria. These were noted most frequently in the first week (25.5% of patients) and lessened over time. No severe adverse events were noted.
  
  
  CONCLUSIONS
  We conclude that OCRT is well tolerated and effective in controlling moderate to severe cancer pain in Chinese patients.
authors.affiliation: Medical Oncology Department, Sir Run Run Shaw Hospital, Medical School of Zhejiang University, Hangzhou, China. panpanhongming@tom.com
authors.forename: Hongming
authors.initials: H
authors.lastname: Pan
authors.forename: Zaiyun
authors.initials: Z
authors.lastname: Zhang
authors.forename: Yiping
authors.initials: Y
authors.lastname: Zhang
authors.forename: Nong
authors.initials: N
authors.lastname: Xu
authors.forename: Liqin
authors.initials: L
authors.lastname: Lu
authors.forename: Chunfeng
authors.initials: C
authors.lastname: Dou
authors.forename: Yong
authors.initials: Y
authors.lastname: Guo
authors.forename: Shixiu
authors.initials: S
authors.lastname: Wu
authors.forename: Jianhua
authors.initials: J
authors.lastname: Yue
authors.forename: Dongping
authors.initials: D
authors.lastname: Wu
authors.forename: Yuechu
authors.initials: Y
authors.lastname: Dai
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010098:Oxycodone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy*; D012720:Severity of Illness Index
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D010098:Oxycodone