| 英文摘要 |
Background: NALDEBAIN®(dinalbuphine sebacate, 150 mg/2 mL) is an extended-release analgesic withκ-opioid agonist andμ-opioid antagonist activity. It has been approved in Taiwan since 2017 for managing post-operative pain. Its distinct pharmacologic profile may provide advantages over conventional opioids, particularly in reducing opioid-related adverse events such as postoperative nausea and vomiting (PONV), a common complication that may impede recovery. Although NALDEBAIN®is increasingly used in a variety of surgical procedures, the relationship with PONV is poorly understood. This retrospective review aims to assess the incidence, clinical features, and potential risk factors for PONV associated with NALDEBAIN®using clinical trial data and pharmacovigilance reports.
Methods: We reviewed data from 14 published clinical trials involving 569 patients treated with NALDEBAIN®and 47 pharmacovigilance case reports submitted to the Taiwan Adverse Drug Reaction Center between 2017 and 2025, which reported 65 adverse events. Reports were assessed for PONV-related outcomes such as nausea and vomiting. Incidence rates were calculated quantitatively, but intensity and causality were evaluated qualitatively. A comparative analysis was performed on trial data and pharmacovigilance reports, accounting for reporting variability.
Results: PONV rates varied across clinical trials, with nausea ranging from 1.8% to 45.0%, and vomiting ranging from 2.8% to 33.3%, with higher rates observed in laparoscopic procedures. The majority of cases were mild and manageable. Among 65 pharmacovigilance-reported adverse events, 15 (23%) were PONV-related and primarily affected female patients.
Conclusion: Current evidence suggests that NALDEBAIN®is not associated with an elevated risk of PONV. Reported incidences appear within expected ranges, though further confirmation is warranted. |
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