Radbruch L, Sabatowski R, Petzke F, Brunsch-Radbruch A, Grond S, Lehmann K A
Department of Anaesthesiology, University of Cologne, Germany.
Palliat Med. 2001 Jul;15(4):309-21. doi: 10.1191/026921601678320296.
Transdermal fentanyl was released in Germany in 1995. From October 1996 to February 1998 transdermal treatment was documented for 1005 patients (506 men and 499 women with a mean age of 60 years, range 20-92 years) with chronic pain in an open survey including 290 physicians from hospitals and general practitioners throughout Germany. Most patients suffered from cancer pain and only 11 patients had chronic pain from non-malignant disease. Physicians were asked to complete a questionnaire for patients treated with transdermal fentanyl on initiation of therapy (day 0), and days 3, 6, 18, 30 thereafter, followed by monthly follow-up intervals. Patients were asked to complete a pain diary. Transdermal therapy was documented from day 0 for 824 patients, while 181 patients had been treated with transdermal fentanyl before admission in the survey. Most of the other 824 patients had been treated with other step 3 opioids (55% of the patients) or step 2 opioids (23%) before conversion to transdermal fentanyl, whereas 8% had been treated only with non-opioids and 14% had received analgesics only as required or not at all before initiation of transdermal therapy. The most important reasons for switching to transdermal opioid therapy were insufficient pain relief with the previous medication followed by a variety of gastrointestinal symptoms impeding oral analgesic therapy. Initial fentanyl doses ranged from 0.6 to 9.6 mg/day (25 to 400 microg/h) with a median of 1.2 mg/day (50 microg/h). Median doses slowly increased throughout the observation period to 2.4 mg/day (100 microg/h) after 4 months of treatment. Most patients continued transdermal therapy until the time of death (47% of patients). Other reasons for discontinuation were inadequate pain relief (10%), pain relief with other analgesic regimens (10%), other symptoms than pain (5%), rejection of transdermal therapy by the patient (6%) or miscellaneous (16%). Adverse events were documented as the reason for discontinuation of transdermal therapy in 49 patients (5%). Dyspnoea was documented for seven patients as the reason for discontinuation. One of these patients, as well as another patient with an episode of apnoea, had to be treated with artificial respiration for several hours, but both patients recovered without sequelae. Transdermal therapy with fentanyl was safe and efficient in this national survey. Transdermal fentanyl can be recommended for treatment of moderate to severe cancer pain and probably may even be used as a first-line drug on step 3 of the World Health Organization recommendations in selected patient groups.
透皮芬太尼于1995年在德国上市。在一项开放性调查中,对1996年10月至1998年2月期间的1005例慢性疼痛患者(506例男性和499例女性,平均年龄60岁,年龄范围20 - 92岁)进行了透皮治疗记录,该调查涵盖了德国各地医院的290名医生和全科医生。大多数患者患有癌痛,只有11例患者患有非恶性疾病引起的慢性疼痛。要求医生在治疗开始时(第0天)以及之后的第3、6、18、30天,对接受透皮芬太尼治疗的患者填写一份问卷,随后每月进行随访。要求患者填写疼痛日记。824例患者从第0天开始记录透皮治疗情况,而181例患者在本次调查入院前已接受过透皮芬太尼治疗。在转换为透皮芬太尼治疗之前,其他824例患者中的大多数曾接受过其他三阶阿片类药物(55%的患者)或二阶阿片类药物(23%)治疗,而8%的患者仅接受过非阿片类药物治疗,14%的患者在开始透皮治疗前仅按需接受过镇痛药治疗或根本未接受过治疗。转换为透皮阿片类药物治疗的最重要原因是先前药物止痛效果不佳,其次是各种胃肠道症状妨碍口服镇痛治疗。初始芬太尼剂量范围为0.6至9.6毫克/天(25至400微克/小时),中位数为1.2毫克/天(50微克/小时)。在整个观察期内,中位数剂量缓慢增加,治疗4个月后达到2.4毫克/天(100微克/小时)。大多数患者持续接受透皮治疗直至死亡(47%的患者)。其他停药原因包括止痛效果不佳(10%)、其他镇痛方案止痛有效(10%)、疼痛以外的其他症状(5%)、患者拒绝透皮治疗(6%)或其他杂项原因(16%)。49例患者(5%)因不良事件被记录为停用透皮治疗的原因。有7例患者因呼吸困难被记录为停药原因。其中1例患者以及另1例出现呼吸暂停发作的患者必须接受数小时的人工呼吸治疗,但两名患者均康复且无后遗症。在这项全国性调查中,芬太尼透皮治疗安全有效。透皮芬太尼可推荐用于治疗中度至重度癌痛,甚至在某些特定患者群体中可能可作为世界卫生组织推荐的三阶治疗的一线药物使用。