만성 요통 환자에 대한 펜타닐 매트릭스 패치의 임상적 유용성 = Clinical Usefulness of Fentanyl Matrix Patch for the Patients with Chronic Low Back Pain

다국어 초록 (Multilingual Abstract)

Study Design: Prospective observational study.
Objectives: The aim of this study was to examine the usefulness of a fentanyl matrix patch in the management of chronic low back pain.
Summary of Literature Review: Chronic low back pain is a significant disabling disease with high medical costs and socioeconomicaleffects. Oral medication is a fundamental tool for conservative treatment. The fentanyl matrix patch is currently regarded as analternative method for oral medication, however, the usefulness of the fentanyl matrix patch has not been fully evaluated.
Materials and Methods: From September 2008 to May 2009, a multicenter, open, prospective observational study was conducted.
The inclusion criteria included chronic pain patients that did not respond to conservative pain management. The clinical usefulness wasevaluated with pain intensity, and the KEQ-5D (Korean version of Euro QoL-5 dimension).
Results: Overall, 538 patients were included in this study. The pain intensity decreased about 1.84 ± 1.91 at the second visit and furtherdecreased by about 2.52 ± 2.34 at the third visit (p<0.0001). The KEQ-5D score decreased about 0.12 ± 0.18 at the second visit, anddecreased further to 0.18 ± 0.24 at the third visit (p<0.0001). The number of patients with adverse effects was 121 (22.49%).
Conclusions: The fentanyl matrix patch improves the pain and disability in patients with chronic low back pain. It is a useful alternativemethod for the management of chronic low back pain.

국문 초록 (Abstract)

연구 계획: 전향적 관찰 연구목적: 만성 요통을 호소하는 환자에 대해서 펜타닐 매트릭스 패치를 투여한 후에 삶의 질 개선 정도, 평균 통증 강도 개선 정도, 수면 방해 개선 정도, 일상 생활 및 사회 생활 지장 정도, 연구자와 환자의 평가 및 약물에 대한 환자의 선호도 등을 평가하고자 하였다.
선행문의 요약: 만성 요통을 호소하는 환자에 대해서 펜타닐 매트릭스 의 유용성과 안정성에 대한 전행적 보고는 드물다.
대상 및 방법: 본 연구는 다기관, 개방적, 전향적, 관찰 연구로서, 2008년 9월 23일부터 2009년 5월 11일까지 전국 80개 병원에서 20세 이상으로 펜타닐 매트릭스의 허가 사항 범위 내에서 투여 가능하며, 보존적 통증 치료에도 불구하고 지속되는 만성 통증을 호소하는 환자 1,771명을 대상으로 하였다. 안전성 평가로서 투약 중에 발생한 신체 검사, 혈액검사, 일반 소변검사와 간기능 검사에서 검사수치의 변동 등을 분석하였다. 유용성 평가로서 통증 강도의 변화, 통증의 완화 정도, 통증에 대한 치료와 관련된 삶의 질의 개선 정도를 조사하였다.
결과: 연구를 완료한 피험자 중 만성요통 환자는 538명(30.59%)이였다. 만성 통증 강도는 2차 방문에서는 1.84±1.91, 3차 방문에서는 2.52±2.34 의감소가 관찰되었다(p<0.0001). KEQ-5D 점수는 2차 방문에서 1차 방문에 대비해 0.12±0.18(p<0.0001), 3차 방문에서는 0.18±0.24점의 차이를 보였다(p<0.0001). 만성 요통 진단명을 가진 피험자 538 중 총 121명(22.49%)에서 149건의 이상반응이 발생하였고, 총 5명(0.93%)에서 6건의 중대한 이상반응이 보고되었다. 약물유해반응은 총 53명(9.85%)에서 65건이 발생하였다.
결론: 만성 요통을 호소하는 환자에 대해서 펜타닐 매트릭스 패치를 투여한 후에 삶의 질 개선 정도와 평균 통증 강도 개선 정도 모두 기초 평가에 비해서 유의하게 호전되는 것이 관찰되었다.

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