Ushida Takahiro, Kanzaki Rumiko, Katayama Keishi, Ishikawa Akito
Aichi Medical University, Nagakute-shi, Aichi, Japan.
Scientific Affairs Division, Mundipharma K.K., Minato-ku, Tokyo, Japan.
Pain Pract. 2025 Jan;25(1):e13430. doi: 10.1111/papr.13430. Epub 2024 Oct 21.
A post-marketing surveillance was conducted to evaluate the safety and efficacy of the buprenorphine transdermal patch under actual clinical practice.
Of the 3017 patients included in the safety analysis, adverse drug reactions (ADRs) were observed in 1524 (50.5%), the most common being nausea, skin symptoms at the site of application, constipation, and vomiting. The incidences of respiratory depression and withdrawal symptoms were low, and no drug dependence was observed. Among the 2573 patients included in the efficacy analysis, the efficacy (≥2-point improvement in the numerical rating scale) rate was 74.4%, which was significantly higher in older adults (≥65 y.o) than in younger adults. Discontinuation was mostly caused by ADRs during the early initiation phase.
This study demonstrated the safety and efficacy of long-term administration of buprenorphine transdermal patches, suggesting that pain control is possible over the long term if attention is paid to ADRs in the early stages of administration.
开展一项上市后监测，以评估丁丙诺啡透皮贴剂在实际临床实践中的安全性和有效性。
在纳入安全性分析的3017例患者中，有1524例（50.5%）观察到药物不良反应（ADR），最常见的是恶心、用药部位皮肤症状、便秘和呕吐。呼吸抑制和戒断症状的发生率较低，未观察到药物依赖。在纳入有效性分析的2573例患者中，有效率（数字评定量表改善≥2分）为74.4%，老年人（≥65岁）的有效率显著高于年轻人。停药主要是在早期起始阶段由ADR引起的。
本研究证明了长期使用丁丙诺啡透皮贴剂的安全性和有效性，表明如果在给药早期关注ADR，长期控制疼痛是可能的。
