Multicenter Clinical Study for Evaluation of Efficacy and Safety of Transdermal Fentanyl Matrix Patch in Treatment of Moderate to Severe Cancer Pain in 474 Chinese Cancer Patients

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Zhu Yulin ¹ Song Guohong ¹ Liu Duanqi ² Xi Zhang ³ Liu Kuifeng ⁴ Zang Aihua ⁵ Ying Cheng ⁶ Cao Guochun ⁷ Jun Liang ⁸ Ma Xuezhen ⁹ Xin Ding ¹⁰ Wang Bin ¹¹ Li Weilian ¹² Hu Zuowei ¹³ Gang Feng ¹⁴ Huang Jiangjin ¹⁵ Xiao Zheng ¹⁶ Jiao Shunchang ¹⁷ Rong Wu ¹⁸ Jun Ren ¹ ^*

文摘	Objective: Although a new matrix formulation fentanyl has been used throughout the world for cancer pain management, few data about its efficacy and clinical outcomes associated with its use in Chinese patients have been obtained. This study aimed to assess the efficacy and safety of the new system in Chinese patients with moderate to severe cancer pain. Methods: A total of 474 patients with moderate to severe cancer pain were enrolled in this study and were treated with the new transdermal fentanyl matrix patch (TDF) up to 2 weeks. All the patients were asked to record pain intensity, side effects, quality of life (QOL), adherence and global satisfaction. The initial dose of fentanyl was 25 g/h titrated with opioid or according to National Comprehensive Cancer Network (NCCN) guidelines. Transdermal fentanyl was changed every three days. Results: After 2 weeks. The mean pain intensity of the 459 evaluated patients decreased significantly from 5.63-1.26 to 2.03-1.46 (P<0.0001). The total remission rate was 91.29%, of which moderate remission rate 53.16%, obvious remission rate 25.49% and complete remission rate 12.64%. The rate of adverse events was 33.75%, 18.78% of which were moderate and 3.80% were severe. The most frequent adverse events were constipation and nausea. No fatal events were observed. The quality of life was remarkably improved after the treatment (P<0.0001). Conclusion: The new TDF is effective and safe in treating patients with moderate to severe cancer pain, and can significantly improve the quality of life.
来源	Chinese Journal of Cancer Research ,2011,23(4):317-322 【核心库】
关键词	Transdermal fentanyl matrix patch (TDF) ; Cancer pain ; Efficacy ; Safety ; Quality of life
地址	1. Department of Breast Oncology, Peking University School of Oncology, Beijing Cancer Hospital & Institute, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing, 100142 2. The PLA Military General Hospital of Beijing, Beijing, 100009 3. No. 3 People’s Hospital of Chengdu, Chengdu, 610031 4. The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, 510080 5. Hubei Cancer Hospital, Wuhan, 430079 6. Jilin Cancer Hospital, Changchun, 130012 7. Jiangsu Cancer Hospital, Nanjing, 210009 8. The Affiliated Hospital of Medical College Qingdao University, Qingdao, 266003 9. Qingdao Cancer Hospital, Qingdao, 266042 10. Shanghai Huaihai Hospital, Shanghai, 200031 11. Suzhou Municipal Hospital, Suzhou, 215001 12. Tianjin People’s Hospital, Tianjin, 300121 13. Wuhan Integrated TCM & Western Medicine Hospital, Wuhan, 430070 14. Pu Ai Hospital of Wuhan City, Wuhan, 430070 15. Second Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, 310009 16. Zhejiang Cancer Hospital, Hangzhou, 310022 17. The General Hospital of the People’s Liberation Army, Beijing, 100853 18. Shengjing Hospital of China Medical University, Shenyang, 110004
语种	英文
文献类型	研究性论文
ISSN	1000-9604
学科	肿瘤学
文献收藏号	CSCD:4406493