Apolone Giovanni, Bertetto Oscar, Caraceni Augusto, Corli Oscar, De Conno Franco, Labianca Roberto, Maltoni Marco, Nicora Mariaflavia, Torri Valter, Zucco Furio
Dipartimento di Oncologia, Istituto di Ricerche Farmacologiche Mario Negri, Via Eritrea 62, 20157 Milan, Italy.
Health Qual Life Outcomes. 2006 Feb 2;4:7. doi: 10.1186/1477-7525-4-7.
Management of pain related to advanced or metastatic cancer, although the availability of several pharmacological and non-pharmacological interventions and the existence of well-known guidelines and protocols, is often difficult and inadequate. Evidence of the relative effectiveness of current options for treating cancer pain from comparative randomized studies is scanty.
In the context of a wider project, a multicenter, open label, prospective Outcome Research study will be launched in Italy in 2006 to investigate the epidemiology of cancer pain and of its treatments, the quality of analgesic-drug therapy and the effectiveness of alternative analgesic strategies in a large, prospective, unselected cohort of cancer patients using the state-of-the art of patient-reported-outcomes. About 100 Italian centers will recruit 2500 patients with advanced/progressive/metastatic cancer with pain (related to the cancer disease) requiring analgesic treatments. Each center is expected to recruit 25 consecutive and eligible patients during the study inception period. Approximately two months will be allowed for subject recruitment and enrollment. Subject evaluation and follow-up will be for 3 months. The effect on outcomes of various therapeutic analgesic options administered by physicians, given the observational approach where patients are not assigned at random to different treatments, will be compared using the propensity score approach, allowing the adjustment for treatment selection bias. Later, after the launch of the observational study and on the basis of results, in specific subsamples of patients and in select centers of the network, a Randomized Controlled Trial will be carried out to formally compare the efficacy of alternative analgesic strategies, with particular emphasis on oral morphine (as comparator) and buprenorphine patch (as experimental arm). Results from the outcome (cohort) and experimental (Randomized Controlled Trial) studies will ensure both the external and internal validity.
尽管有多种药物和非药物干预措施可供使用，且存在知名的指南和方案，但晚期或转移性癌症相关疼痛的管理往往困难且不足。来自比较随机研究的关于当前癌症疼痛治疗方案相对有效性的证据很少。
在一个更广泛项目的背景下，2006年将在意大利开展一项多中心、开放标签、前瞻性结局研究，以调查癌症疼痛及其治疗的流行病学、镇痛药治疗质量以及在一个大型、前瞻性、未经过筛选的癌症患者队列中使用最新患者报告结局方法的替代镇痛策略的有效性。约100个意大利中心将招募2500名患有晚期/进展期/转移性癌症且伴有（与癌症疾病相关的）疼痛需要镇痛治疗的患者。每个中心预计在研究启动期招募25名连续且符合条件的患者。允许大约两个月的时间进行受试者招募和入组。受试者评估和随访将持续3个月。鉴于患者并非随机分配至不同治疗组的观察性研究方法，将使用倾向评分法比较医生给予的各种治疗性镇痛方案对结局的影响，以调整治疗选择偏倚。之后，在观察性研究启动并基于研究结果后，将在特定的患者亚组和网络中的选定中心开展一项随机对照试验，以正式比较替代镇痛策略的疗效，特别强调口服吗啡（作为对照）和丁丙诺啡透皮贴剂（作为试验组）。结局（队列）研究和实验（随机对照试验）研究的结果将确保外部有效性和内部有效性。
