长期使用芬太尼透皮贴剂的疗效和安全性分析  

Long-term efficacy and safety of fentanyl transdermal system

作　　者：林菁[1] 曹伟华[2] 李瑞娜[2] 李文苑[2] 黄木春[2] 

机构地区：[1]汕头大学医学院第一附属医院肿瘤科,广东省汕头市515041 [2]汕头大学医学院第一附属医院宁养院,广东省汕头市515041

出　　处：《中国组织工程研究》2015年第21期3344-3349,共6页Chinese Journal of Tissue Engineering Research

基　　金：李嘉诚基金会全国宁养医疗服务计划

摘　　要：背景:芬太尼透皮贴剂与口服吗啡控释片的止痛效果相近,近年来已被广泛用于晚期癌痛止痛治疗,但与芬太尼相关的严重不良反应事件屡有报道,其长期使用的安全性受到某些质疑。目的:探讨长期接受芬太尼透皮贴剂治疗对罹患晚期癌痛患者的临床疗效,并分析其安全性。方法:纳入309例晚期癌痛患者,其中男143例,女166例,年龄26-72岁,前2周使用口服缓释吗啡止痛,第3周开始改用芬太尼透皮贴剂止痛,直至第12周。采用自身前后对照方法,比较两种药物的止痛效果、使用过程中的不良反应和毒性反应及患者的接受程度。结果与结论:患者在使用口服缓释吗啡及芬太尼透皮贴剂期间疼痛均获得良好控制。使用口服吗啡缓释片治疗后,出现的不良反应依次为便秘、恶心、疲劳和食欲减退。在转换为芬太尼透皮贴后,便秘(χ2=5.22,P=0.02)、恶心(χ2=4.38,P=0.04)症状较口服吗啡缓释片治疗明显减轻,呕吐症状虽有所减轻但差异无显著性意义(χ2=2.7,P=0.10);有2.3%患者出现皮肤反应,更换贴片区域后好转,皮肤反应在使用后2-10周时有所减轻,一些不常见的不良反应如头痛、腹泻、呼吸困难、出汗增多等症状在增加剂量后初期出现。与口服缓释吗啡相比,91%患者偏爱或强烈偏爱芬太尼透皮贴剂止痛治疗。说明芬太尼透皮贴剂可以稳定地控制疼痛,减轻口服药物的不良反应,具有良好的患者依从性。BACKGROUND：Fentanyl transdermal system has analgesic effect similar to oral sustained-release morphine and has been widely used in advanced cancer pain management in several years. However, recent literatures about some serious adverse events associated with fentanyl transdermal system have been published, and the long-term safety of fentanyl transdermal system treatment is stil chalenged. OBJECTIVE：To observe the long-term clinical efficacy and safety of fentanyl transdermal system for pain management in patients with advanced cancer. METHODS：A total of 309 patients with advanced cancer pain were enroled, including 166 females and 143 males. The age ranged from 26-72 years old. Patients received oral sustained-release morphine for 2 weeks, and then were subject to fentanyl transdermal system for pain management at the 3rd week until the 12th week. A prospective study with self-contrast method was conducted to compare the analgesic effects of these two drugs, as wel as patient＇s acceptability, adverse events and toxicity in the administration course. RESULTS AND CONCLUSION： Stable pain relief was harvested throughout the oral administration of both sustained-release morphine and fentanyl transdermal system therapy. During the use of oral sustained-release morphine, adverse reactions appearing in sequence were constipation, nausea, fatigue and anorexia. After converting to fentanyl transdermal system, the symptoms of constipation （χ2=5.22,P=0.02） and nausea （χ2=4.38, P=0.04） significantly reduced, and vomiting was abated but showed no significant difference （χ2=2.7,P=0.10）. 2.3% of patients had skin reactions to the patches, and regressed after replacing the patch area. Skin reactions were aleviated at 2-10 weeks after oral administration of fentanyl transdermal system. Some uncommon adverse events including headache, diarrhea, dyspnoea, excessive sweating or other symptoms often occurred at the time of the initial dosage increase. Preference or strong preference for fentanyl transdermal s

关 键 词：生物材料 缓释材料 芬太尼透皮贴剂 晚期癌痛 疗效 不良反应 

分 类 号：R318[医药卫生—生物医学工程]