Palao i Domenech R, Romanelli M, Tsiftsis D D, Slonková V, Jortikka A, Johannesen N, Ram A, Persson L M, Altindas M, Orsted H, Schäfer E
Department of Plastic Surgery, Hospital Vail d'Hebron, Barcelona, Spain.
J Wound Care. 2008 Aug;17(8):342, 344-8. doi: 10.12968/jowc.2008.17.8.30797.
To compare an ibuprofen-releasing foam dressing (Biatain Ibu, ColoplastA/S) with local best practice in the treatment of painful exuding wounds.
In this large-scale randomised comparative study, 853 patients were randomised to either ibuprofen-releasing foam (test) dressing (n=467) or local best practice (n=386). Primary endpoint was wound pain relief from day 1-7, assessed by the patients twice daily using a five-point verbal rating scale. Secondary endpoints were reduction in pain intensity from day 0-7 (assessed using an 11-point numeric box scale), quality of life (assessed using the WHO-5 well-being index and effect on health-related activities of daily living) and the incidence of adverse events.
After seven days significantly more patients in the experimental group experienced relief from temporary and persistent pain and a reduction in pain intensity,when compared with patients in the local best practice group (p<0.0001). They also experienced a greater improvement in quality of life. The number of adverse events in both groups was low.
The test dressing provided an appropriate wound healing environment, relieved temporary and persistent wound pain, and decreased pain intensity. It was also associated with an improvement in quality of life.
比较布洛芬缓释泡沫敷料（比亚坦布洛芬，康乐保公司）与局部最佳治疗方法对疼痛性渗出伤口的治疗效果。
在这项大规模随机对照研究中，853例患者被随机分为布洛芬缓释泡沫（试验）敷料组（n = 467）和局部最佳治疗方法组（n = 386）。主要终点是第1至7天伤口疼痛缓解情况，由患者每天使用五点语言评定量表评估两次。次要终点包括第0至7天疼痛强度的降低（使用11点数字量表评估）、生活质量（使用WHO-5幸福指数评估以及对与健康相关的日常生活活动的影响）和不良事件的发生率。
七天后，与局部最佳治疗方法组相比，试验组中更多患者的临时和持续性疼痛得到缓解，疼痛强度降低（p<0.0001）。他们的生活质量也有更大改善。两组的不良事件数量均较低。
试验敷料提供了适宜的伤口愈合环境，缓解了临时和持续性伤口疼痛，并降低了疼痛强度。它还与生活质量的改善相关。
