Cappelli C, Reale G, Marucci G, Clerico A
Servizio Speciale di Oncologia Pediatrica, Università di Roma "La Sapienza", Roma, Italia.
Clin Ter. 2008 Jul-Aug;159(4):257-60.
Transdermal fentanyl delivery system (TFDS) offers advantages if oral administration of opioids is difficult because of progressive disease or poor compliance, in cancer patients (pts). The current study was conducted to assess the efficacy and safety of TFDS in a pediatric cancer population.
Twenty-one pts were enrolled between June 2004 and December 2005. TFDS was applied if pts had pain under non opioids treatment, according to our step-by-step "pain protocol". Starting dose of TFDS was decided considering the dose of the last non opioids drug used. All pts didn't receive other opioids therapy before TFDS. Degree of pain was assessed using visual and numeric scales.
Sixteen males and 5 females were studied, median age was 8 years (range 3-14 years). They were affected by moderate to severe pain, because of progressive and/or metastatic disease. Median starting dose was 50 microg/h (range 25-100 microg/h). Highest reached dose was 200 microg/h. In 75% of pts, starting dose was adequate. In other pts, optimal dosage was found within 36 hours. Thus, pain total control was obtained in 100% of pts, with a median delay, from starting TFDS, of 24 hours (range 12-48 hours). No toxicity was observed but a moderate lethargy, within the first 12 hours, in 30% of pts.
TFD was found to be an effective and safe system to treat pain in pediatric cancer pts. All pts and their families showed high compliance with TFDS. It could be also taken in account for outpatient therapy.
对于癌症患者,若因病情进展或依从性差导致口服阿片类药物困难,经皮芬太尼给药系统(TFDS)具有优势。本研究旨在评估TFDS在儿科癌症患者中的疗效和安全性。
2004年6月至2005年12月纳入21例患者。根据我们的逐步“疼痛方案”,若患者在非阿片类药物治疗下仍有疼痛,则应用TFDS。TFDS的起始剂量根据最后使用的非阿片类药物剂量确定。所有患者在使用TFDS前未接受其他阿片类药物治疗。使用视觉和数字量表评估疼痛程度。
研究对象为16例男性和5例女性,中位年龄为8岁(范围3 - 14岁)。他们因病情进展和/或转移而遭受中度至重度疼痛。中位起始剂量为50微克/小时(范围25 - 100微克/小时)。最高达到剂量为200微克/小时。75%的患者起始剂量合适。在其他患者中,36小时内找到了最佳剂量。因此,100%的患者实现了疼痛完全控制,从开始使用TFDS起,中位延迟时间为24小时(范围12 - 48小时)。未观察到毒性,但30%的患者在最初12小时内出现中度嗜睡。
发现TFD是治疗儿科癌症患者疼痛的有效且安全的系统。所有患者及其家属对TFDS表现出高度依从性。它也可考虑用于门诊治疗。