口服枸橼酸芬太尼透粘膜制剂用于肿瘤患者爆发性疼痛长期治疗的安全性和有效性：ECODIR研究
[Safety and efficacy of oral trans-mucosal fentanyl citrate in the long-term treatment of breakthrough pain in oncology patients: the ECODIR study].
作者信息
Valentín Maganto Vicente, Camps Herrero Carlos, Carulla Torrent Joan, Cassinello Espinosa Javier, Dorta Delgado Javier, Jara Sánchez Carlos, Moreno Nogueira José Andrés
机构信息
Servicio de Oncología Médica, Hospital Universitario 12 de Octubre, Avenida Cordoba km 4500, 28045 Madrid, Spain.
出版信息
Clin Transl Oncol. 2005 Jun;7(5):205-12. doi: 10.1007/BF02712818.
INTRODUCTION
Oral trans-mucosal fentanyl citrate (OTFC) is the one drug specifically developed for the management of breakthrough pain. This study assesses the long-term safety and efficacy of OTFC standard clinical conditions. Patients and methods. Six-month observational study performed on cancer patients with episodes of breakthrough pain. Safety was assessed by recording the advent of adverse events and efficacy by the evaluating the intensity of breakthrough pain.
RESULTS
174 cancer patients were recruited into the study. All adverse reactions reported were mild or moderate. OTFC was significantly faster (time to the commencement of pain relief: 12.7 +/- 11.4 vs 32.7 +/- 18.4 minutes; p < 0.001) and potent (post-treatment pain intensity: 3.4 +/- 1.5 vs 4.3 +/- 1.5; p < 0.001) than the previously-used drugs.
CONCLUSIONS
This observational study confirms the good safety profile of OTFC as well as its effectiveness over long-term period treatment of breakthrough pain.
引言
口腔黏膜芬太尼枸橼酸盐（OTFC）是一种专门为治疗爆发性疼痛而研发的药物。本研究评估了OTFC在标准临床条件下的长期安全性和有效性。患者与方法。对患有爆发性疼痛发作的癌症患者进行了为期六个月的观察性研究。通过记录不良事件的出现来评估安全性，并通过评估爆发性疼痛的强度来评估有效性。
结果
174名癌症患者被纳入研究。报告的所有不良反应均为轻度或中度。OTFC比先前使用的药物起效显著更快（疼痛缓解开始时间：12.7±11.4分钟对32.7±18.4分钟；p<0.001）且效力更强（治疗后疼痛强度：3.4±1.5对4.3±1.5；p<0.001）。
结论
这项观察性研究证实了OTFC良好的安全性以及其在长期治疗爆发性疼痛方面的有效性。
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