Mystakidou Kyriaki, Tsilika Eleni, Parpa Efi, Kouloulias Vassilios, Kouvaris Ioannis, Georgaki Stavroula, Vlahos Lambros
Pain Relief and Palliative Care Unit, Areteion Hospital, School of Medicine, University of Athens, Athens, Hellas.
Int J Cancer. 2003 Nov 10;107(3):486-92. doi: 10.1002/ijc.11416.
There is emerging data supporting the use of TTS-F (transdermal therapeutic system-fentanyl) in opioid naive patients. Our study examines the safety and efficacy of TTS-F in the long-term control of cancer pain in opioid naive patients and those transferring from oral morphine. Pain was assessed in 589 patients (Group A: 268 opioid naive, Group B: 321 transferring from morphine) using a Visual Analogue Scale (VAS; 0-10), based on selected questions from the Greek Brief Pain Inventory (GBPI). Overall treatment satisfaction was assessed on a 4-point scale. Quality of Life (QOL) and ECOG (0-4) status were also recorded. These were assessed in relation to TTS-F dose, pain type (neuropathic, combined, nociceptive), concomitant use of anti-inflammatory drugs and other demographic data. Of 589 patients, 59 (10%) withdrew as a result of inadequate pain satisfaction or for other reasons. There were no discontinuations due to side effects; no Grade 3-4 events occurred. A total of 530 continued on-study, 211 patients died during study period and 295 departed; all (506; 89%) were satisfied with their pain relief. Analysis of patients at baseline, 28 days, 6 and 12 month time points (n = 153 Group A; n = 214 Group B) with respect to QOL and pain measures indicated a statistically significant (p < 0.001) improvement in all measures across time independent of pain type, or any other patient characteristic(s). In patients with intolerable pain, transfer to TTS-F offers an efficient and safe long-term analgesic option. TTS-F offers durable long-term maintenance of pain relief with acceptable side effects in opioid naive patients. In general, TTS-F as a first line analgesic approach for carefully selected and monitored patients experiencing moderate to severe cancer pain should be considered.
有新出现的数据支持在未使用过阿片类药物的患者中使用透皮治疗系统 - 芬太尼(TTS - F)。我们的研究考察了TTS - F在未使用过阿片类药物的患者以及从口服吗啡转换过来的患者中长期控制癌痛的安全性和有效性。基于希腊简短疼痛量表(GBPI)中的选定问题,使用视觉模拟量表(VAS;0 - 10)对589例患者进行疼痛评估(A组:268例未使用过阿片类药物的患者,B组:321例从吗啡转换过来的患者)。总体治疗满意度采用4分制进行评估。还记录了生活质量(QOL)和东部肿瘤协作组(ECOG;0 - 4)状态。根据TTS - F剂量、疼痛类型(神经性、混合性、伤害性)、抗炎药物的联合使用情况以及其他人口统计学数据对这些进行评估。在589例患者中,59例(10%)因疼痛缓解不充分或其他原因退出。没有因副作用而停药的情况;没有发生3 - 4级事件。共有530例继续参与研究,211例患者在研究期间死亡,295例退出;所有(506例;89%)患者对疼痛缓解感到满意。对基线、28天、6个月和12个月时间点的患者(A组n = 153;B组n = 214)进行生活质量和疼痛指标分析,结果表明,无论疼痛类型或任何其他患者特征如何,所有指标随时间均有统计学显著改善(p < 0.001)。对于疼痛无法耐受的患者,转换为TTS - F提供了一种有效且安全的长期镇痛选择。TTS - F在未使用过阿片类药物的患者中能持久地长期维持疼痛缓解,且副作用可接受。一般来说,对于精心挑选和监测的中重度癌痛患者,应考虑将TTS - F作为一线镇痛方法。