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首页> 外文期刊>Oncology: International Journal of Cancer Research and Treatment >Use of TTS fentanyl as a single opioid for cancer pain relief: a safety and efficacy clinical trial in patients naive to mild or strong opioids.
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Use of TTS fentanyl as a single opioid for cancer pain relief: a safety and efficacy clinical trial in patients naive to mild or strong opioids.

机译：使用TTS芬太尼作为单一的阿片类药物缓解癌症疼痛：对于初次接受轻度或强阿片类药物的患者的安全性和有效性临床试验。

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BACKGROUND: Up to now, a transdermal therapeutic system (TTS) of fentanyl has been applied to cancer patients on opioid analgesics previously treated with mild opioids or morphine. The aim of this study was to investigate the efficacy and safety of TTS fentanyl (patch) administration as an analgesic to patients treated with opioid analgesics for moderate-to-severe cancer pain, with immediate-release oral morphine only as rescue medication. The prior analgesic medication of the patients did not include mild or strong opioids. METHODS: The study group consisted of 113 patients (54 men and 59 women; age range: 21-87 years, mean +/- SD 61.3 +/- 14.84 years) with undertreated chronic cancer pain. The study period was 42 days. The patients were hospitalized for the first 3 days of the study; thereafter they were transferred to their home for the rest of the study. Daily cards were completed, noting their pain score (0-10 VAS), nausea, vomiting, constipation, skin reactions, dizziness or any other complaints. Vital signs were also recorded. Data assessments were made at baseline, on days 1, 2 and 3 (during hospitalization) and thereafter on days 7, 14, 21, 28, 35, and 42 after hospital discharge. The initial TTS fentanyl delivery rate was chosen depending on the patient's analgesic requirements. All patients were given an oral morphine solution (5-10 mg), every 4-6 h, for the first 12 h, as rescue medication. RESULTS: Baseline pain score was between 6 and 10 (mean +/- SD 7.1 +/- 1.7). The initial TTS fentanyl delivery rate was between 25 and 50 microg/h (mean +/- SD 36.5 +/- 15.7). On day 3, 95 patients (84%) reported a pain score < or = 3 (mean +/- SD 0.5 +/- 0.8), 14 patients (12.4%) a pain score of 4 and 4 patients (3.5%) of 5-8. No adverse effects suggesting the discontinuation of the study were reported. From day 7 until the completion of the study, the mean pain score was between 1.3 and 0.16 while the TTS fentanyl delivery rate on day 42 was between 25 and 400 microg/h (mean +/- SD 122.1 +/- 81.2 microg/h). CONCLUSION: Analgesic treatment with TTS fentanyl used as a single opioid is effective and safe for cancer pain relief, given that is cautiously applied, in patients requiring strong opioid analgesics even if they were naive to strong or mild opioids. Copyright 2002 S. Karger AG, Basel
机译：背景：到目前为止，芬太尼的透皮治疗系统（TTS）已被应用于癌症患者，这些患者先前接受过轻度阿片类药物或吗啡治疗的阿片类镇痛药。这项研究的目的是研究使用TTS芬太尼（贴剂）作为镇痛药对接受阿片类镇痛药治疗中度至重度癌症疼痛的患者的镇痛效果和安全性，仅使用速释口服吗啡作为急救药物。患者先前的止痛药不包括轻度或强效阿片类药物。方法：研究组由113例患有慢性癌症疼痛的患者组成（54例男性和59例女性;年龄范围：21-87岁，平均+/- SD 61.3 +/- 14.84岁）。研究期为42天。患者在研究的前三天住院;之后，他们被转移到家中进行其余的研究。填写每日卡，记录他们的疼痛评分（0-10 VAS），恶心，呕吐，便秘，皮肤反应，头晕或任何其他不适。还记录了生命体征。在基线，出院后的第1、2和3天（住院期间）以及此后的第7、14、21、28、35和42天进行数据评估。根据患者的镇痛要求选择初始TTS芬太尼输送速率。所有患者在最初的12小时内每4-6小时口服一次吗啡溶液（5-10 mg）作为急救药物。结果：基线疼痛评分在6到10之间（平均+/- SD 7.1 +/- 1.7）。最初的TTS芬太尼递送速率为25至50微克/小时（平均+/- SD 36.5 +/- 15.7）。在第3天，有95位患者（84％）的疼痛评分小于或等于3（平均+/- SD 0.5 +/- 0.8），有14位患者（12.4％）的疼痛评分为4，有4位患者（3.5％） 5-8。没有不良反应提示研究终止。从第7天到研究结束，平均疼痛评分在1.3到0.16之间，而第42天的TTS芬太尼递送速率在25到400 microg / h之间（平均+/- SD 122.1 +/- 81.2 microg / h ）。结论：将TTS芬太尼作为单一阿片类药物进行镇痛治疗可有效且安全地缓解癌症疼痛，即使谨慎使用，即使是初次使用强或轻度阿片类药物的患者也需要强力阿片类镇痛药。版权所有2002 S. Karger AG，巴塞尔

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