Payne R, Coluzzi P, Hart L, Simmonds M, Lyss A, Rauck R, Berris R, Busch M A, Nordbrook E, Loseth D B, Portenoy R K
Pain and Palliative Care Service, Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
J Pain Symptom Manage. 2001 Jul;22(1):575-83. doi: 10.1016/s0885-3924(01)00306-2.
This open-label study evaluated the long-term safety and tolerability of oral transmucosal fentanyl citrate (OTFC) in ambulatory cancer patients with breakthrough pain undergoing cancer care at 32 university- or community-based practices. Patients had participated in a previous short-term titration trial of OTFC, were experiencing at least one episode per day of breakthrough pain, and had achieved relief of their breakthrough pain with an opioid. Patients received OTFC units at a starting dosage strength determined in the short-term trial (200-1600 microg). Outcome measures included number of successfully treated breakthrough pains, global satisfaction rating (0 = poor through 4 = excellent), and side effects. In total, 41,766 units of OTFC were used to treat 38,595 episodes of breakthrough pain in 155 patients. Number of treatment days ranged from 1 to 423 (mean, 91 days). Patients averaged 2.9 breakthrough pain episodes per day. About 92% of episodes were successfully treated with OTFC and there was no trend toward decreased effectiveness over time. Most patients (61%) did not require dose escalation during treatment. Global satisfaction ratings were consistently above 3, indicating very good to excellent relief. Common adverse events associated with OTFC were somnolence (9%), constipation (8%), nausea (8%), dizziness (8%), and vomiting (5%). Six patients (4%) discontinued therapy due to an OTFC-related adverse event. There were no reports of abuse and no concerns about the safety of the drug raised by patients or families. OTFC was used safely and effectively during long-term treatment of breakthrough pain in cancer patients at home.
这项开放标签研究评估了口服黏膜芬太尼柠檬酸盐（OTFC）在32家大学或社区医疗机构接受癌症护理且有突破性疼痛的门诊癌症患者中的长期安全性和耐受性。患者曾参与过OTFC的短期滴定试验，每天至少经历一次突破性疼痛，且使用阿片类药物可缓解突破性疼痛。患者接受的OTFC起始剂量强度由短期试验确定（200 - 1600微克）。结果指标包括成功治疗的突破性疼痛次数、总体满意度评分（0 = 差至4 = 优）以及副作用。总共使用了41,766单位的OTFC来治疗155例患者的38,595次突破性疼痛发作。治疗天数从1天到423天不等（平均91天）。患者平均每天有2.9次突破性疼痛发作。约92%的发作通过OTFC成功治疗，且随着时间推移没有疗效降低的趋势。大多数患者（61%）在治疗期间不需要增加剂量。总体满意度评分始终高于3，表明缓解效果非常好至极好。与OTFC相关的常见不良事件有嗜睡（9%）、便秘（8%）、恶心（8%）、头晕（8%）和呕吐（5%）。6例患者（4%）因与OTFC相关的不良事件而停药。没有滥用报告，患者或家属也未对药物安全性表示担忧。在家中对癌症患者突破性疼痛进行长期治疗期间，OTFC的使用安全有效。
