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KMID : 0939920140460040331
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2014 Volume.46 No. 4 p.331 ~ p.338
Clinical Usefulness of Hydromorphone-OROS in Improving Sleep Disturbances in Korean Cancer Patients: A Multicenter, Prospective, Open-Label Study
Shin Seong-Hoon

Lee Ho-Sup
Kim Yang-Soo
Choi Young-Jin
Kim Sung-Hyun
Kwon Hyuk-Chan
Oh Sung-Yong
Kang Jung-Hun
Sohn Chang-Hak
Lee Sang-Min
Baek Jin-Ho
Min Young-Joo
Kim Choong-Rak
Chung Joo-Seop
Abstract
Purpose: To evaluate the efficacy of hydromorphone-OROS (HM-OROS) in reducing sleep disturbance and relieving cancer pain.

Materials and Methods: One hundred twenty cancer patients with pain (numeric rating scale [NRS] ¡Ã 4) and sleep disturbance (NRS ¡Ã 4) were evaluated. The initial HM-OROS dosing was based on previous opioid dose (HM-OROS:oral morphine=1:5). Dose adjustment of the study drug was permitted at the investigator¡¯s discretion. Pain intensity, number of breakthrough pain episodes, and quality of sleep were evaluated.

Results: A total of 120 patients received at least one dose of HM-OROS; 74 of them completed the final assessment. Compared to the previous opioids, HM-OROS reduced the average pain NRS from 5.3 to 4.1 (p < 0.01), worst pain NRS from 6.7 to 5.4 (p < 0.01), sleep disturbance NRS from 5.9 to 4.1 (p < 0.01), incidence of breakthrough pain at night from 2.63 to 1.53 times (p < 0.001), and immediate-release opioids use for the management of breakthrough pain from 0.83 to 0.39 times per night (p = 0.001). Of the 74 patients who completed the treatment, 83.7% indicated that they preferred HM-OROS to the previous medication. The adverse events (AEs) were somnolence, asthenia, constipation, dizziness, and nausea.

Conclusion: HM-OROS was efficacious in reducing cancer pain and associated sleep disturbances. The AEs were manageable.
KEYWORD
Cancer pain, Sleep disturbance, Hydromorphone-OROS (HM-OROS)
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