低剂量芬太尼透皮贴剂在阿片未耐受中重度癌痛病人中的疗效及安全性

The efficacy and safety of low-dose transdermal fentanyl for moderate-to-severe cancer pain in opioid naive patients

目的:探究低剂量芬太尼透皮贴剂(12.5μg/h)在阿片未耐受中重度癌痛病人中的疗效与安全性。方法:自2017年11月至2019年12月在全国11家三级医院开展了一项单臂、非随机、开放、前瞻性的多中心研究,共纳入285例阿片未耐受中重度的癌痛病人。入组病人均给予低剂量芬太尼透皮贴剂(12.5μg/h)进行治疗,每3天进行疼痛评估。治疗前后评估肿瘤病人的生活质量与认知功能,同时记录不良反应及不良事件发生情况。结果:此研究共完成试验267人,病人的疼痛总缓解率达98.1%。始终使用低剂量芬太尼透皮贴剂(fentanyl transdermal patch,TDF)治疗有效的亚组病人共78人,占比29.2%;低剂量组病人的疼痛治疗反应率在1周内优于其他剂量组(P=0.0018)。不良反应的发生率为便秘7.9%、恶心11.2%、呕吐4.1%、嗜睡1.9%、尿潴留1.5%,无谵妄、呼吸困难发生。经低剂量芬太尼透皮贴剂治疗后,中重度癌痛病人的生活质量得到改善,认知功能未受损。结论:低剂量芬太尼贴剂可有效缓解阿片未耐受病人的中重度疼痛,不良反应轻微,可显著改善疼痛病人的生活质量,对认知功能影响小。

Objective:The aim of this study was to explore the efficacy and tolerability of low dose of fentanyl transdermal patch(TDF)(12.5μg/h)in opioid naive patients with moderate-to-severe cancer pain,and evaluate the influence on quality of life and cognitive function.Methods:A prospective,single-arm,non-randomized,open-label,multicenter trial was conducted with 285 opioid-naive patients with moderate-to-severe cancer pain in 11 tertiary hospitals in China's Mainland.The initial analgesic dose of TDF was 12.5μg/h,pain assessment(pain score,pain relief and pain response rate)was performed every 3 days for a total of 9 cycles.Adverse reactions and events were monitored over 24 days.In the meantime,quality of life and cognitive function of the patients were evaluated.Results:Of the 285 patients,267 completed the trial.The total pain relief rate was 98.1%.There were 78 patients(29.2%)in the low-dose group,and the pain response rate of the low-dose group was better than that in other group within one week(P=0.0018).The adverse effects were mild.The most common adverse reactions were constipation 7.9%,followed with nausea 11.2%,vomiting 4.1%,drowsiness 1.9%,and urine retention 1.5%.There was no difference in the incidence of adverse reactions between the low-dose group and the other group.Meanwhile,TDF improved the quality of life of patients with moderate-to-severe cancer pain without impairing cognitive function.Conclusion:Low-dose TDF is effective for opioid-naive patients with moderate-to-severe cancer pain.Adverse reactions are mild and the quality of life of patients is improved with little loss on cognitive function.