芬太尼透皮贴剂用于癌痛的上市后评价

目的：进一步验证芬太尼透皮贴剂用于癌痛的疗效、不良反应，并为临床用药提供参考。方法：采用多中心自身对照和无对照开放试验设计，对照药选用缓释吗啡，疗效评价标准为疼痛强度，疼痛缓解度。观察用药过程中出现的不良反应及剂量与疗程的关系。结果：共完成941例，其中自身对照试验169例，开放试验772例，开放试验组有7例因不良反应退出试验。结果显示经过剂量调整，芬太尼透皮贴剂可较好地缓解中度以上疼痛。主要不良反应为恶心、头晕、便秘等，临床表现与吗啡类似，发生率比吗啡低。随用药时间增加，芬太尼透皮贴剂的剂量有所增加，但大部分患者的用药剂量在25—50μg／h。结论：芬太尼透皮贴剂用于癌病具有与吗啡类似的疗效、不良反应小。我国患者每3日使用剂量多为25μg／h或50μg/h。

Post-Market Evaluation of Fentanyl Transdermal System on Cancer Pain

Objective:To expend the application of fentanyl transdermal system and accu-mulate more clinical experience.Methods:Advanced cancer patients with medium or severe chronic pain were recruited into an open crossover study controlled by sustained-release morphine and an open study.Pain intensity and pain relief were chosen to evaluate the efficacy.Dose adjustment and period of treatment were also recorded.Results:One hundred and sixty-nine patients participated in and finished the controlled study.Another772patients participated in the open study.Among them,7patients dropped out because of adverse drug events including drowsiness,delirium,dysphoria,topical skin allergy,dizziness,respiratory depression and severe phlegm.It showed that most patients could obtain good pain control with both transdermal fen-tanyl and sustained-release morphine.A fentanyl patch of25or50ug /h was enough to relieve medium to severe pain for3days.The average period of treatment was38days with9days as the minimum and159days as the maximum.It also had the trend that the dosage increased with time (P<0.01),but it had little clinical meaning.Main adverse drug events were nausea,dizziness and constipation with lower incidence than morphine.From the open study it was found that life quality was significantly improved after the treatment.Conclusion:This time we reas-sure the efficacy and safety of transdermal fentanyl in large scale and with longer period of treat-ment.This novel route of fentanyl administration may provide a convenient treatment for out-pa-tients and aid compliance.