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Comparison of Oral Controlled-release Morphine with Transdermal Fentanyl in Terminal Cancer Pain

口服長效嗎啡及經皮膚吸收Fentanyl貼片於末期癌病疼痛治療之比較

摘要


Background: Controlled-release morphine (MST) given twice daily provides a simpler and more convenient treatment regimen than 4-hourly opioid administration for the control of cancer pain. Recently, a new formulation of transdermal fentanyl (TDF) has been developed which provides a new route for the treatment of cancer pain. The present study was designed to compare the analgesic efficacy, safety and adverse effects of MST and TDF in the management of chronic cancer pain. Methods: In this open, comparative and randomized study, patients were treated with oral morphine hydrochloride immediate-release (MHIR) in the stabilization phase and then the prescription was switched to MST or TDF for 14 days in the treatment phase. Oral MHIR was provided as rescue medication for breakthrough pain. Assessments of the pain intensity, pain frequency, degree of pain improvement, profile of mood states, quality of sleep, activity status and adverse effects were performed before and after the stabilization phase and before and after the treatment phase. Results: Forty of 47 cancer patients completed the study with 20 patients in each group. There were significant (p <0.05) improvements in pain intensity, pain frequency, mood states and quality of sleep in both groups before and after treatment, while improvement in the activity status was not significant. No specific adverse effect were encountered except for drowsiness which occurred in 6 patients treated with MST and 5 treated with TDF (p<0.05). Insomnia was significantly improved (p <0.05) with both regimens compared with that in the period before treatment. There were no significant differences between the two study groups in analgesic efficacy or adverse effects. Conclusions: These results suggest that TDF and MST are safe and effective analgesics for the management of chronic cancer pain. However, TDF provides a simpler and more convenient treatment route for those patients with severe nausea, vomiting or dysphagia.

並列摘要


背景:根據過去對癌病疼痛治療之研究得知,每天服用兩次之長效型嗎啡比傳統短效型嗎啡來得簡單方便。而最近發展出來的經皮fentanyl貼片,是一種可以達到相同止痛目的的新途徑。本研究主要目的在比較酚它尼疼痛貼片與長效型嗎啡在慢性癌病疼痛治療上之止痛效果、安全性及副作用。方法:在此開放、比較及隨機之研究中,所有病人在進入穩定期均給予口服短效型嗎啡,待穩定後則換算為長效型嗎啡或fentanyl疼痛貼片並進入十四天的治療期。而口服短效型嗎啡則用作治療期中之中間痛備用藥物。本研究並於穩定期前後及治療期中作治療效果之評估,其項目包括:疼痛程度、頻率、改善程度、情緒狀況、睡眠品質、活動情形及副作用等。結果:在47位末期癌症病人中,有40位完成本研究,兩組各有20位病人。結果顯示,在治療前後除活動情形外,疼痛程度、頻率、睡眠品質等均有明顯之改善(p<0.05)。且除了在長效型嗎啡組有6位及疼痛貼片組有5位出現明顯之嗜睡情況出現外(p<0.05)並沒有特別之其他副作用。相反地,在治療前已有之失眠情況有明顯之改善(p<0.05)。兩組之間在止痛效果及副作用中,並沒有明顯之差異。結論:本研究結果證實,fentanyl疼痛貼片與長效型嗎啡在慢性癌病疼痛之治療上,有著相同的安全性及止痛效果。fentanyl貼片對於一些有嚴重嘔吐及吞嚥困難之病人,不失為一個簡單且方便之方法。

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