Sloan P A, Moulin D E, Hays H
Department of Anesthesiology, University of Kentucky Hospital, Lexington 40536, USA.
J Pain Symptom Manage. 1998 Aug;16(2):102-11. doi: 10.1016/s0885-3924(98)00044-x.
Fentanyl has been incorporated into a transdermal therapeutic system (TTS) containing a rate-limiting membrane that provides constant release of the opioid. TTS fentanyl provides continuous opioid delivery for up to 72 hr without the need for special equipment. After Institutional Review Board approval, 53 patients with cancer pain requiring 45 mg or more of oral morphine daily were admitted into an open-label, prospective, multicenter evaluation of TTS fentanyl for the relief of pain. After a 1-week stabilization on oral morphine, patients were transferred from morphine to an appropriate dose of TTS-fentanyl (25, 50, 75, or 100 micrograms/hr) administered as a transdermal patch every 3 days. TTS fentanyl was titrated to pain relief, and patients were followed up for as long as 3 months. Pain relief and the side effects of the medications were assessed daily. Twenty-six men and 27 women with a mean (+/- SD) age of 61 (+/- 12) years entered the study; 23 patients completed the full 84-day study. The mean duration of TTS fentanyl use was 58 +/- 32 days. The mean (+/- SEM) daily morphine dose during the last 2 days of stabilization was 189 (+/- 20) mg, and the mean initial fentanyl patch dose was 58 (+/- 6) micrograms/hr. The mean daily morphine dose taken "as needed" for breakthrough pain at study completion was 35 mg. The mean final fentanyl dosage at study completion was 169 (+/- 29) micrograms/hr. Pain relief was rated as good or excellent by 82% of patients during the treatment period. When asked to compare pain relief during the first month of TTS-fentanyl use to that provided by their last analgesic before study entry, 63% preferred TTS fentanyl. Side effects considered related to the fentanyl patch were nausea (13%), vomiting (8%), skin rash (8%), and drowsiness (4%). Thirty percent of patients reported adverse experiences related to the fentanyl patch, and 17% had to be discontinued from the study. We conclude that TTS fentanyl administered every 3 days for the treatment of cancer pain is effective, safe, and well tolerated by most patients.
芬太尼已被纳入一种经皮治疗系统（TTS），该系统包含一个限速膜，可实现阿片类药物的持续释放。经皮芬太尼可连续给药长达72小时，无需特殊设备。经机构审查委员会批准，53例每日需要45毫克或更多口服吗啡的癌症疼痛患者被纳入一项开放标签、前瞻性、多中心的经皮芬太尼缓解疼痛评估研究。在口服吗啡稳定治疗1周后，患者从吗啡转换为每3天经皮贴剂给予适当剂量的经皮芬太尼（25、50、75或100微克/小时）。经皮芬太尼根据疼痛缓解情况进行滴定，患者随访长达3个月。每天评估疼痛缓解情况和药物副作用。26名男性和27名女性，平均（±标准差）年龄为61（±12）岁，进入研究；23名患者完成了为期84天的完整研究。经皮芬太尼的平均使用时间为58±32天。稳定治疗最后2天的平均（±标准误）每日吗啡剂量为189（±20）毫克，经皮芬太尼贴剂的平均初始剂量为58（±6）微克/小时。研究结束时，用于突破性疼痛的“按需”服用的平均每日吗啡剂量为35毫克。研究结束时经皮芬太尼的平均最终剂量为169（±29）微克/小时。在治疗期间，82%的患者将疼痛缓解评为良好或优秀。当被要求比较经皮芬太尼使用第一个月的疼痛缓解情况与研究入组前最后一种镇痛药的疼痛缓解情况时，63%的患者更喜欢经皮芬太尼。被认为与芬太尼贴剂相关的副作用包括恶心（13%）
