Abstract:
Objective Opioids are the first choice for the management of moderate-to-severe cancer pain. However, timing of and method of dose adjustment in the titration of prolonged-release opioids require further exploration. Therefore, This study aimed to evaluate the efficacy and safety of a 12 h titration of oxycodone hydrochloride prolonged-release tablets in patients with moderate-to-severe cancer pain.
Methods We screened 114 patients with moderate-to-severe cancer pain (numerical rating scale score ≥4 points) and opioid intolerance who were admitted to 24 hospitals in Zhejiang Province between Febrary 2018 and December 2019. Of these, 87 patients who experienced more than one episode of breakthrough cancer pain were selected, and on the basis of the adjustment time of the oxycodone hydrochloride prolonged-release tablets, they were categorized into the experimental (12 h titration, n=45) and control (24 h titration, n=42) groups. The experimental group initially received oxycodone hydrochloride prolonged-release tablets (10 mg) and immediate-release morphine for pain relief according to the pain condition. After 12 h, the dose was adjusted according to the amount of immediate-release morphine as follows: background dose+amount of immediate-release morphine within 12 h. The control group received oxycodone hydrochloride prolonged-release tablets (10 mg: q12h) as the starting dose, and immediate-release morphine was administered according to the pain situation. After 24 h, the dose was adjusted as follows: (background dose+immediate-release morphine dose within 24 h)/2. At 24 h, 48 h, and 72 h, the pain relief rate, incidence of adverse reactions, use of immediate-release morphine and its dosage, quality of life score, and satisfaction with analgesia were compared between the two groups.
Results Both the experimental and the control groups had a higher pain relief rate at 24 h,48 h, and 72 h after administration, no statistical differences were noted between the two groups (P>0.05). The frequencies and doses of remedial analgesia at 24 h, 48 h, and 72 h were significantly reduced in the experimental group as compared with the control group (P<0.05). In both groups, most adverse reactions were mild-to-moderate, and their incidence did not differ significantly between the two groups (P>0.05). The level of satisfaction with analgesia was high, and did not differ significantly between the two groups (P>0.05).
Conclusions In the titration of oxycodone hydrochloride prolonged-release tablets in patients with moderate-to-severe cancer pain, a 12 h dose adjustment can effectively reduce the frequency and doses of remedial analgesia, maintain a high analgesic relief rate, promote high analgesic satisfaction, and offer good safety.