芬太尼透皮贴剂治疗中重度癌痛433例临床观察

Clinical Evaluation on Transdermal Fentanyl in Treatment of Four Hundred and Thirty-three Patients with Moderate and Severe Cancer Pain

目的:进一步评价芬太尼透皮贴剂治疗中、重度疼痛的疗效、安全性及对生活质量的影响,为临床合理用药提供参考资料。方法:采用多中心随机开放方法,对433例中、重度疼痛患者使用芬太尼透皮贴剂进行观察,芬太尼的初始剂量是2.5mg或参照吗啡芬太尼折算表计算,贴膜每3日更换1次,在使用期间根据疼痛情况进行剂量调整,直到患者无痛或基本无痛。结果:可评价患者336例,其癌痛缓解率100%,41.6%的患者第1次使用后未再进行剂量调整,57.3%的患者调整过1～3次。芬太尼的中位剂量7.5mg,其中92.9%患者在2.5～10mg之内。不良反应轻,主要为恶心、便秘、头晕、呕吐、嗜睡、排尿困难等。治疗后生活质量有明显改善。结论:芬太尼透皮贴剂治疗中、重度疼痛的疗效显著,使用方便,不良反应轻,能明显改善患者的生活质量,绝大多数患者的调整次数在3次以内,大多数患者的使用剂量在每3天2.5～10mg。

Objective: Further evaluate the effect, safety of transdermal fentanyl (Durogesic) and the influence to the quality of life in patients with cancer pain in order to help the clinical use. Methods: Four hundred thirty-three patients with moderate or severe cancer pain were treated with transdermal fentanyl. The initial dose of transdermal fentanyl was 2.5mg or according to NCCN guides. Transdermal fentanyl was changed every 3 days. The dosage was adjusted by pain intensity in order to obtain pain free or mild pain. The period of observation was 45 days. Results: Cancer pain relief was 100% in 336 evaluated patients. Dosage adjustment was not needed in 41.6% patients after the initial use, in 57.3% patients adjusted 1 to 3 times. The median dosage of transdermal fentanyl is 7.5mg. The range of dosage was from 2.5mg to 7.5mg in 92.9% patients. The adverse reaction was mild. The main adverse events were nausea, constipation, dizziness, vomiting, dysuria. There was a significant improvement for quality of life in the patients after treatment. Conclusion: Transdermal fentanyl is an effective, convenient and safe medication for relief of moderate or severe cancer pain. It can improve the quality of life in the patients with cancer pain. The adjusting times in the majority of the patients is within 3 times. The dosage of transdermal fentanyl in most patients is from 2.5mg to 10mg every 3 days.