Tawfik Mohamed Omar, Bryuzgin Vladimir, Kourteva Galina
National Cancer Institute, Cairo University, Cairo, Egypt.
Curr Med Res Opin. 2004 Mar;20(3):259-67. doi: 10.1185/030079903125003026.
To determine the safety and efficacy of transdermal fentanyl for pain relief in cancer patients and to compare the effects on patients according to whether they had previously received strong opioids, weak opioids or non-opioid analgesia.
Cancer patients requiring strong analgesia were recruited into an open-label, multicentre study, conducted in eight countries. Patients received transdermal fentanyl treatment for 28 days. Pain severity, overall satisfaction with pain control, convenience of use of patches and treatment preferences were recorded daily.
Of the 292 participants, 135 had previously received a strong opioid, 84 had previously received a weak opioid and 73 had received no regular opioids. Thirty-eight patients did not complete the study, mainly due to adverse events. For all groups the proportion of patients with 'good to excellent' pain control increased after transdermal fentanyl treatment. Transdermal fentanyl was well tolerated, with the most common treatment-related adverse events being nausea, vomiting and constipation. The percentage of strong-opioid-tolerant patients with constipation decreased following transdermal fentanyl treatment and increased slightly in the strong-opioid-naïve groups. Most patients rated the convenience of the patches as 'good to excellent', and most preferred transdermal fentanyl to their previous therapy.
Transdermal fentanyl is an effective and well-tolerated treatment for cancer-related pain for patients regardless of whether they have previously received opioids. Previous guidelines have often advocated initial dose finding with short-acting opioids but this study demonstrates that such a complex titration and conversion schedule may not be necessary,and that treatment may be initiated directly with long-acting formulations such as transdermal fentanyl when previous analgesic therapy fails to provide adequate relief.
确定透皮芬太尼用于癌症患者镇痛的安全性和有效性，并根据患者先前是否接受过强阿片类药物、弱阿片类药物或非阿片类镇痛治疗来比较其对患者的影响。
招募需要强效镇痛的癌症患者参加一项在八个国家进行的开放标签、多中心研究。患者接受透皮芬太尼治疗28天。每天记录疼痛严重程度、对疼痛控制的总体满意度、贴剂使用的便利性以及治疗偏好。
292名参与者中，135人先前接受过强阿片类药物治疗，84人先前接受过弱阿片类药物治疗，73人未接受过常规阿片类药物治疗。38名患者未完成研究，主要原因是不良事件。对于所有组，透皮芬太尼治疗后疼痛控制为“良好至优秀”的患者比例增加。透皮芬太尼耐受性良好，最常见的与治疗相关的不良事件是恶心、呕吐和便秘。透皮芬太尼治疗后，对强阿片类药物耐受的便秘患者比例下降，在未使用过强阿片类药物的组中略有增加。大多数患者将贴剂的便利性评为“良好至优秀”，并且大多数患者比起先前的治疗更喜欢透皮芬太尼。
无论患者先前是否接受过阿片类药物治疗，透皮芬太尼都是一种有效且耐受性良好的癌症相关疼痛治疗方法。先前的指南通常主张使用短效阿片类药物来确定初始剂量，但本研究表明，这样复杂的滴定和转换方案可能没有必要，并且当先前的镇痛治疗未能提供充分缓解时，可直接使用长效制剂如透皮芬太尼开始治疗。
