Effectiveness of Fentanyl Transdermal Patch (Fentanyl-TTS, $Durogegic^{(R)}$) for Radiotherapy Induced Pain and Cancer Pain: Multi-center Trial

방사선치료로 인한 통증 및 암성통증에 대한 듀로제식의 효과: 다기관연구

  • 신성수 (울산대학교 의과대학 서울아산병원) ;
  • 최은경 (울산대학교 의과대학 서울아산병원) ;
  • 김종훈 (울산대학교 의과대학 서울아산병원) ;
  • 안승도 (울산대학교 의과대학 서울아산병원) ;
  • 이상욱 (울산대학교 의과대학 서울아산병원) ;
  • 김연실 (카톨릭대학교 의과대학 강남성모병원) ;
  • 이규찬 (가천대학교병원) ;
  • 이창걸 (연세대학교 의과대학 신촌세브란스병원) ;
  • 노준규 (인하대학교병원) ;
  • 전미선 (아주대학교병원) ;
  • 오영택 (아주대학교병원) ;
  • 김옥배 (계명대학교병원) ;
  • 허승재 (성균관대학교 의과대학 삼성서울병원)
  • Published : 2006.12.31

Abstract

$\underline{Purpose}$: To evaluate the effectiveness and safety of fentanyl-TTS in the management of radiotherapy induced acute pain and cancer pain treated with radiotherapy. $\underline{Materials\;and\;Methods}$: Our study was open labelled prospective phase IV multi-center study. the study population included patients with more 4 numeric rating scale(NRS) score pain although managed with other analgesics or more than 6 NRS score pain without analgesics. Patients divided into two groups; patients with radiotherapy induced pain (Group A) and patients with cancer pain treated with radiotherapy (Group B). All patients received 25 ug/hr of fentanyl transdermal patch. Primary end point was pain relief; second end points were change in patient quality of life, a degree of satisfaction for patients and clinician, side effects. $\underline{Results}$: Between March 2005 and June 2005, 312 patients from 26 participating institutes were registered, but 249 patients completed this study. Total number of patients in each group was 185 in Group A, 64 in Group B. Mean age was 60 years and male to female ratio was 76:24. Severe pain NRS score at 2 weeks after the application of fentanyl was decreased from 7.03 to 4.01, p=0.003. There was a significant improvement in insomnia, social functioning, and quality of life. A degree of satisfaction for patients and clinician was very high. The most common reasons of patients' satisfactions was good pain control. Ninety six patients reported side effect. Nausea was the most common side effect. There was no serious side effect. $\underline{Conclusion}$: Fentanyl-TTS was effective in both relieving pain with good tolerability and improving the quality of life for patients with radiotherapy induced acute pain and cancer pain treated with radiotherapy. The satisfaction of the patients and doctors was good. There was no major side effect.

목 적: 방사선치료로 인해 발생하는 점막염, 식도염 등의 통증과 암성 통증을 가진 환자에 대한 듀로제식의 통증 완화 및 일상생활 개선 효과를 알아보고자 하였다. 대상 및 방법: 다기관 전향적 4상 임상시험으로 방사선치료로 인한 통증을 호소하거나(A군) 암성통증으로 방사선치료를 시행 받고 있는 환자(B군) 중에 진통제를 복용 중임에도 숫자등급평가(Numeric rating scale, NRS)가 4 이상 이거나 진통제 복용 없이 NRS가 6 이상인 환자를 대상으로 듀로제식 25 ug/hr을 처방한 후에 1주일과 2주일 후에 통증횟수와 강도변화, 통증이 일상생활에 미치는 영향평가, 피험자와 임상의 만족도 평가, 그리고 이상반응 평가를 시행하였다. 결 과: 2005년 3월 28일부터 6월 15일까지 26개 기관에서 총 312명의 피험자를 등록하였고 그 중 249명이 임상시험을 완료하였는데 A군은 185명, B군은 64명이였다. 평균 연령은 60세였고, 남자가 189명, 여자가 60명이였다. 2주 후 가장 심한 통증의 강도 변화를 보면 A군에서 6.9에서 3.9로 B군에서는 7.1에서 3.9로 통계적으로 유의하게(p=0.003) 감소하였고 일상생활의 미치는 영향을 보기 위한 수면방해 정도와 일상적인 일의 저하 그리고 삶의 질의 저하는 투여 2주 후에 모두 호전되었다. 연하통증의 변화는 A군에서만 유의하게 투여 후 호전되었으며 피험자의 만족도는 매우 만족이 A에서 47%, B군에서 41%로 좋았고 만족 이유는 진통효과 우수, 전반적 만족, 편리성 순이었다. 임상의 만족도는 매우만족이 50% 정도로 좋았다. 이상반응은 A군에서 40% B군에서 34%로 총 38%에서 나타났고 오심이 30%로 가장 많았고 소양증 16%, 어지러움 14%, 변비 10% 순이었다. 중대한 이상반응은 없었다. 결 론: 듀로제식의 통증완화 효과 일상생활 개선효과는 우수하였고 피험자와 임상의의 만족도도 좋았고 중대한 이상반응도 없었다.

Keywords

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