Ripamonti Carla, Fagnoni Elena, Campa Tiziana, Brunelli Cinzia, De Conno Franco
Rehabilitation and Palliative Care Operative Unit, National Cancer Institute, Milan, Italy.
Support Care Cancer. 2006 May;14(5):400-7. doi: 10.1007/s00520-005-0918-0. Epub 2006 Feb 17.
World Health Organization (WHO) guidelines, Agency for Health Care Policy and Research (AHCPR) clinical practice guidelines, and EAPC recommendations indicate oral route of opioid administration as the preferred route. Transdermal administration of opioids is considered an alternative when patients cannot take medications orally. Moreover, WHO and EAPC indicate orally administered morphine as the first-choice drug for the treatment of moderate to severe cancer-related pain. However, we can see that in Italy there is an increasing use of transdermal fentanyl (TF) as first-choice strong opioid (and route) even when oral administration of opioids is possible.
The aims of this study are to describe the modality in the use of TF administration in two settings of care, taking into consideration (1) the drugs previously taken by the patients, (2) the reasons for switching from any drug to TF, (3) the conversion ratio used, and (4) the frequency of "inappropriate use of transdermal fentanyl according to the WHO guidelines and the EAPC recommendations", i.e., switching to fentanyl patch from any drug, even if there were no contraindications in using oral morphine. The settings of care considered were the out-patient palliative care unit (OP-PCU) and the oncological wards (OWs) of the National Cancer Institute (NCI) of Milan.
The clinical charts of 98 patients prescribed with and given fentanyl patch for the first time at the NCI of Milan in 2002 were reviewed and the data gathered were grouped according to the administration of fentanyl at the OP-PCU (63 out-patients) or at the OWs (35 in-patients). Summary descriptive statistics and bar and box plots have been used. Fisher two-tailed exact text was applied to test the differences between in- and out-patients.
Before switching to TF, (1) in-patients were more frequently treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and weak opioids (mostly tramadol) in respect to the out-patients (44.1 vs 25.8%) who were mostly treated with oral morphine (48.4 vs 20.6%) (p=0.045), and (2) 88.7% of the out-patients were treated with oral opioids and only 1.6% with parenteral opioids in respect to OWs where 69.7% were on oral opioids and 18.2% on parenteral opioids (p=0.006). In 29% of out-patients and in 53% of in-patients, changing to fentanyl patch was considered as "inappropriate" (p=0.028) according to the WHO guidelines and the EAPC recommendations. No statistically significant differences between the two settings were observed regarding the reasons for switching and the conversion ratio used.
There is a trend to use fentanyl patch as first-choice strong opioid in cancer patients in situations such as titration phase, in the presence of instable pain, and in the absence of dysphagia or gastrointestinal symptoms where the use of oral morphine is, however, not contraindicated.
世界卫生组织（WHO）指南、医疗保健政策与研究机构（AHCPR）临床实践指南以及欧洲姑息治疗协会（EAPC）的建议均指出，阿片类药物的口服给药途径为首选途径。当患者无法口服药物时，阿片类药物的透皮给药被视为一种替代方法。此外，WHO和EAPC指出口服吗啡是治疗中度至重度癌症相关疼痛的首选药物。然而，我们可以看到，在意大利，即使可以口服阿片类药物，透皮芬太尼（TF）作为首选强效阿片类药物（及给药途径）的使用也在增加。
本研究的目的是描述在两种护理环境中使用TF给药的方式，同时考虑：（1）患者先前服用的药物；（2）从任何药物转换为TF的原因；（3）使用的转换比率；（4）“根据WHO指南和EAPC建议不适当使用透皮芬太尼”的频率，即从任何药物转换为芬太尼透皮贴剂，即使使用口服吗啡没有禁忌证。所考虑的护理环境为米兰国家癌症研究所（NCI）的门诊姑息治疗单元（OP - PCU）和肿瘤病房（OWs）。
回顾了2002年在米兰NCI首次开具并使用芬太尼透皮贴剂的98例患者的临床病历，并根据在OP - PCU（63例门诊患者）或OWs（35例住院患者）使用芬太尼的情况对收集的数据进行分组。使用了汇总描述性统计以及条形图和箱线图。采用Fisher双侧精确检验来检验住院患者和门诊患者之间的差异。
在转换为TF之前，（1）住院患者使用非甾体抗炎药（NSAIDs）和弱阿片类药物（主要是曲马多）的频率高于门诊患者（分别为44.1%和25.8%），门诊患者主要使用口服吗啡（分别为48.4%和20.6%）（p = 0.045）；（2）门诊患者中88.7%接受口服阿片类药物治疗，仅1.6%接受胃肠外阿片类药物治疗，而在OWs中，69.7%接受口服阿片类药物治疗，18.2%接受胃肠外阿片类药物治疗（p = 0.006）。根据WHO指南和EAPC建议，29%的门诊患者和53%的住院患者转换为芬太尼透皮贴剂被视为“不适当”（p = 0.028）。在转换原因和使用的转换比率方面，两种环境之间未观察到统计学上的显著差异。
在癌症患者的滴定阶段、疼痛不稳定、无吞咽困难或胃肠道症状（而此时使用口服吗啡并无禁忌）等情况下，存在将芬太尼透皮贴剂作为首选强效阿片类药物使用的趋势。
