Chinese Journal of Tissue Engineering Research ›› 2015, Vol. 19 ›› Issue (21): 3344-3349.doi: 10.3969/j.issn.2095-4344.2015.21.012

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Long-term efficacy and safety of fentanyl transdermal system  

Lin Jing1, Cao Wei-hua2, Li Rui-na2, Li Wen-yuan2, Huang Mu-chun2   

  1. 1Department of Oncology, First Affiliated Hospital of Shantou University Medical College, Shantou 515041, Guangdong Province, China; 
    2Hospice Unit, First Affiliated Hospital of Shantou University Medical College, Shantou 515041, Guangdong Province, China
  • Online:2015-05-21 Published:2015-05-21
  • About author:Lin Jing, M.D., Attending physician, Department of Oncology, First Affiliated Hospital of Shantou University Medical College, Shantou 515041, Guangdong Province, China

Abstract:

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 still challenged.
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 enrolled, 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 well 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 alleviated 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 system in comparison to previous oral sustained-release morphine was reported by 91% of patients. These results demonstrate that fentanyl transdermal patches can provide stable pain relief for advanced cancer patients with good acceptability, and mitigate the incidence of adverse events due to oral drugs.

中国组织工程研究杂志出版内容重点:生物材料;骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性;组织工程

Key words: Delayed-Action Preparations, Fentanyl, Transdermal Patch, Morphine

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