国产与进口芬太尼缓释透皮贴剂不良反应的随机自身交叉对照研究

Comparison of side effects between China-made transdermal fentanyl and imported Durogesic:a randomized self-crossover controlled trial

目的:比较国产与进口芬太尼缓释透皮贴剂治疗非癌性疼痛时的药物不良反应。方法:采用随机自身交叉对照方法,每例伴有疼痛的受试者先后使用国产或进口芬太尼缓释透皮贴剂,每贴含芬太尼2.5mg。在单剂量试验中,每个受试者各使用试验药和对照药1贴,在多剂量试验中,每个受试者试验药和对照药各连续使用2贴。26例使用单次剂量,22例使用连续2次剂量。结果:药物不良反应主要有:头晕、头痛、恶心、呕吐、便秘、瞌睡、皮肤瘙痒等。两组不良反应发生率无明显差异。结论:国产芬太尼缓释透皮贴剂与进口芬太尼缓释透皮贴剂治疗非癌性疼痛时的药物不良反应相似。

Objective：To compare the adverse reactions of domestic transdermal fentanyl and imported transdermal fentanyl （Durogesie） in non-cancer patients with pain. Methods： In a randomized self-crossover controlled trial, patients with pain received China - made transdermal fentanyl and imported Durogesic, with 2.5 mg fentanyl in one patch, in succession manner. Subjects were randomly assigned to single-dose program （n = 26, one dose of test drug and then reference drug） and two-dose program （ n = 22, two doses of test drug and then two doses of reference drug）. Results ：The side effects included dizziness,headache, nausea, vomiting, constipation, drowsiness,itching and so on. There was no significant difference between transdermal fentanyl and Durogesic. Conclusion：Domestic transdermal fentanyl is as well tolerated as imported Durogesic.