Center for the Evaluation and Research on Pain (CERP), Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Clin J Pain. 2009 Oct;25(8):671-82. doi: 10.1097/AJP.0b013e3181a38f9d.
Pain still afflicts most cancer patients, mainly in the metastatic phases, and under-treatment is well documented. Transdermal delivery systems (TDS) containing fentanyl or buprenorphine could potentiality have advantages over oral and parenteral routes, but evidence from comparative trials are scanty. In the framework of a wider initiative, an Outcome Research Study was carried out in Italy in 2006 to evaluate the effects of various analgesic options, particularly buprenorphine TDS.
This is a multicenter, open-label, prospective, nonrandomized study. Data were collected using a web-based standardized system, with a follow-up up of to 3 months. Pain intensity, the primary outcomes of the study, was measured using 11-point numerical rating scales from the Brief Pain Inventory.
One-hundred ten centers recruited 1801 cases, most of which (60%) were receiving a strong opioid at the time of inclusion. Of these, 257 had TDS buprenorphine as first choice. Of the remaining 709 patients who at the time of inclusion were not on a strong opioid, 325 changed to a strong opioid and in 43% it was TDS buprenorphine. During the follow-up, physicians had to increase the dosage to control pain (average increase between 16% and 17%). About 34% of patients had an improvement of at least 2 points in worst pain, 15% had a 20% improvement in pain relief, and 40% in satisfaction. Results were in line with those of patients receiving other World Health Organization-level III opioids.
Despite the limitations owing to the observational design, these findings may be useful to clinicians to judge the value of the drug under evaluation better and to help researchers design further comparative studies.
疼痛仍然困扰着大多数癌症患者，主要是在转移阶段，而且治疗不足的情况有据可查。含有芬太尼或丁丙诺啡的透皮给药系统（TDS）相对于口服和肠胃外途径可能具有优势，但来自比较试验的证据很少。在一项更广泛的倡议框架内，意大利于 2006 年开展了一项疗效研究，以评估各种镇痛选择的效果，特别是丁丙诺啡 TDS。
这是一项多中心、开放性、前瞻性、非随机研究。使用基于网络的标准化系统收集数据，并进行长达 3 个月的随访。使用Brief Pain Inventory 的 11 点数字评分量表来衡量疼痛强度，这是该研究的主要结果。
110 个中心共招募了 1801 例患者，其中大多数（60%）在入组时正在使用强阿片类药物。在这些患者中，有 257 例将丁丙诺啡 TDS 作为首选药物。在其余 709 例入组时未使用强阿片类药物的患者中，有 325 例改用强阿片类药物，其中 43%为丁丙诺啡 TDS。在随访期间，医生不得不增加剂量以控制疼痛（平均增加 16%至 17%）。约 34%的患者在最痛方面至少改善了 2 分，15%的患者疼痛缓解改善了 20%，40%的患者满意度提高。结果与接受其他世界卫生组织三级阿片类药物的患者相似。
尽管由于观察设计的限制，但这些发现可能有助于临床医生更好地判断评估药物的价值，并帮助研究人员设计进一步的比较研究。
