Objective To evaluate the efficacy and safety of low-dose Oxycodone and Acetaminophen Tablets in the treatment of moderate bone metastasis cancer pain and whether it is superior to the weak opioid drug codeine.
Methods Seventy-eight patients were randomly treated with Oxycodone and Acetaminophen Tablets(n=52) or codeine(n=26). The initial dose of Oxycodone and Acetaminophen Tablets was 1 tablet, Q12h. According to the outbreak of pain, 1 tablet Q8h was permitted, but not more than 3 tablets per day. If there was gastrointestinal bleeding, suspected abnormal liver or kidney function, Oxycodone and Acetaminophen Tablets should be discontinued. The initial dose of Codeine was 30mg Q12h. According to the outbreak of pain, Q8h could be used. The pain control and adverse reactions were observed in the short term (72 hours) and the long term (2 weeks). Pain severity was assessed by numerical rating scale (NRS).
Results Within 72 hours, the patients whose NRS score was reduced to 3 points in Oxycodone and Acetaminophen Tablets group were significantly more than those in Codeine group (88.46% vs. 45.45%, P=0.006). The long-term effect in Oxycodone and Acetaminophen group were similar to Codeine group (63.46% vs. 61.54%, P=0.868). The incidence of adverse reactions including nausea, vomiting, lethargy, constipation, etc. were low, without significant difference between two groups.
Conclusion Strong opioid drugs such as oxycodone could be used for moderate bone metastasis cancer pain. It is the first time to find that low-dose Oxycodone and Acetaminophen Tablets are more effective than weak opioid drugs codeine, with acceptable safety in long-term use.
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