芬太尼透皮贴剂在未用过阿片类药物与使用过吗啡治疗的癌痛患者中的应用

The treatment of cancer pain in morphine pretreated and opioid naIve patients with Transdermal Fentanyl

目的评价未接受过阿片类药物与使用过吗啡治疗的肿瘤患者使用芬太尼透皮贴剂治疗癌痛的疗效和安全性。方法采用多中心开放性研究,共431例伴有中、重度疼痛的恶性肿瘤患者,其中使用过吗啡治疗组109例,未使用过阿片组322例。使用芬太尼透皮贴剂止痛,初始剂量为25ug/h或参照吗啡与芬太尼剂量转换公式计算,期间根据疼痛情况进行剂量调整。记录疼痛变化、不良反应及生活质量改善情况。结果两组患者治疗前后的疼痛评分和生活质量均有明显改善,两组间的疼痛改善的差异没有统计学意义(P>0.05)。两组不良反应相似,主要有恶心、头晕、便秘等,副作用轻微。结论芬太尼透皮贴剂可作为中重度癌痛的一线治疗方案,对于癌痛的治疗可越过二阶梯药物直接使用芬太尼透皮贴剂。

Objective To evaluate the efficacy and safety of Transdermal Fentanyl in the treatment of opioid naIve and morphine pretreated cancer patients. Method It's an open label and multi-center study. The 431 patients with moderate to severe cancer pains, who had either used no opioid before (n=322), or morphine (n=109),were evaluated in the present trial. All patients started with Transdermal Fentanyl either with 25 ug/h or using Fentanyl conversion chart provided by manufacture. During the study, the Fentanyl dosage was adjusted according to routine pain intensity evaluation. Changes of pain intensity (VAS), side effects and quality of life were documented. Results Both groups have good changes of VAS and quality of life. The pain control between two comparable groups has no statistic significance (P > 0.05). Minor side effects were found in both groups, such as nausea, dizziness, and constipation. Conclusion Transdermal Fentanyl can be used as first line drug of choice for patients with moderate to severe cancer pains. StepⅡ of the WHO analgesic ladder could be skipped in these patients.