OKSIKODON S KONTROLIRANIM OTPUŠTANJEM AKTIVNE TVARI U LIJEČENJU KRONIČNE MIŠIĆNO-KOŠTANE BOLI – PRELIMINARNA ISKUSTVA JEDNOGA REUMATOLOŠKOG CENTRA

Simeon Grazio, Frane Grubišić, Vladimir Knež, Hana Skala Kavanagh, Tomislav Nemčić

In the etiology of non-malignant pain, a signifi cant proportion is constituted by patients with pain originatng in the musculoskeletal system. Th e use of strong opioids in the treatment of non-malignant pain is still controversial. Th erefore, the aim of this study was to establish the effi cacy and safety of oxycodone with a controlled release of the active substance (CR) in the treatment of patients with chronic, not well-controlled musculoskeletal pain.
Here we present our preliminary results. In this prospective, open, single-center study conducted at a rheumatology center we enrolled consecutive patients with musculoskeletal pain due to a variety of musculoskeletal diseases (osteoarthritis, pain in the lower back, spondyloarthritis), who suff ered from moderate to severe pain despite previous analgesic therapy (with NSAIDs, weak opioids, or a fi xed combination of paracetamol and weak opioids). Patients were switched to therapy with oxycodone CR and followed for 14 days. Th e starting dose of oxycodone CR was 10 mg, and later the dose was adapted as necessary. Th e primary endpoint was to assess the eff ectiveness of oxycodone CR on pain intensity, and the secondary goal was
to assess the effi ciency on the general health of the patient (both on a horizontal visual analogue scale, VAS 0 = best, 10 = worst). Fift een patients (12 women, 3 men), with a mean age of 61 ± 12 years and a diagnosis of osteoarthritis, pain in the lower back, or infl ammatory arthritis, were included in the study. Th e duration of pain was 41 ± 12 months. Th e average intensity of pain before oxycodone CR treatment was 7.87 ± 2.28 (range 7-10), and at the end of the study it was 5.92 ± 2.43 (range 4-9) (p=0.069). General health was rated 7.27 ± 2.14 (range 3-10) before the start and 6.00 ±
1.53 (range 3-9) at the end of the study (p=0.028). In one patient the treatment was discontinued due to dizziness and nausea, and one patient voluntarily left the study because of fear and the subjective impression of no adequate pain control aft er 2 days of treatment. Th e oxycodone side-eff ect profi le was as expected. Results of our preliminary study show that in patients with chronic non-malignant pain which is not well controlled
by simple analgesics, NSAIDs, and weak opioids, treatment with oxycodone CR contributed to a signifi cant reduction in the level of pain and improved the general health of the subjects.

U etiologiji nemaligne boli znatan udio bolesnika ima boli podrijetla mišićno-koštanog sustava. Uporaba jakih opioida u liječenju nemaligne boli još je prijeporna. Stoga je cilj istraživanja bio utvrditi učinkovitost i podnošljivost oksikodona s postupnim otpuštanjem aktivne tvari (CR) u liječenju bolesnika s nedovoljno kontroliranom boli mišićno-koštanog podrijetla, a u ovom radu iznose se preliminarni rezultati. U ovome prospektivnom, otvorenom, opservacijskom istraživanju jednoga reumatološkog centra tercijarne zaštite konsekutivno su bili uključeni bolesnici s različitim bolestima mišićno-koštanog podrijetla koji su unatoč primjeni lijekova protiv boli osjećali umjerenu do jaku bol. Bolesnici su bili prebačeni na terapiju oksikodonom CR i praćeni 14 dana. Početna doza lijeka bila je 10 mg na dan, a potom je doza ovisno o potrebi povisivana. Primarni cilj bio je ispitati učinkovitost oksikodona na intenzitet boli, a sekundarni cilj istraživanja bio je ispitati učinkovitost na opće zdravlje bolesnika (oboje na vizualno-analognoj skali, VAS 0 – 10). U studiju je bilo uključeno 15 bolesnika (12 žena, 3 muškarca) prosječne dobi 61 ± 12 godina, s dijagnozama osteoartritisa, lumboishialgije i upalnih artritisa. Bol je trajala 41 ± 12 mjeseci. Prije početka liječenja oksikodonom CR jačina boli bila je 7,87 ± 2,28 (raspon 7 – 10), a na kraju praćenja 5,92 ± 2,43 (raspon 4 – 9) (p = 0,069). Također, opće zdravstveno stanje bilo je ocijenjeno 7,27 ± 2,14 (raspon 3 – 10) prije početka, a 6,00 ± 1,53 (raspon 3 – 9) na kraju praćenja (p = 0,028). Dva su bolesnika tijekom istraživanja prekinula primjenu lijeka; jedan zbog nuspojava (mučnina i vrtoglavica), a drugi zbog straha i mišljenja da mu lijek nakon 2 dana primjene nedovoljno smanjuje bol. Profi l nuspojava oksikodona bio je očekivan. Rezultati našeg preliminarnog istraživanja pokazuju da je u bolesnika s kroničnom nemalignom boli mišićno-koštanog podrijetla, u kojih bol nije dobro kontrolirana jednostavnim analgeticima, nesteroidnim antireumaticima i slabim opijatima, liječenje oksikodonom s kontroliranim otpuštanjem aktivne tvari znatno smanjilo razinu boli i poboljšalo opće zdravlje bolesnika.