Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University School of Oncology, Beijing Cancer Hospital & Institute, Beijing 100142, China;
Chin J Cancer Res. 2011 Dec;23(4):317-22. doi: 10.1007/s11670-011-0317-7.
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.
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 μg/h titrated with opioid or according to National Comprehensive Cancer Network (NCCN) guidelines. Transdermal fentanyl was changed every three days.
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).
The new TDF is effective and safe in treating patients with moderate to severe cancer pain, and can significantly improve the quality of life.
尽管一种新的芬太尼基质配方已在全球范围内用于癌症疼痛管理，但获得的关于其在中国患者中使用的疗效和临床结果的数据很少。本研究旨在评估新系统在中重度癌症疼痛中国患者中的疗效和安全性。
共纳入 474 例中重度癌症疼痛患者，使用新的透皮芬太尼基质贴剂（TDF）治疗 2 周。所有患者均记录疼痛强度、不良反应、生活质量（QOL）、依从性和总体满意度。芬太尼的初始剂量为 25μg/h，根据阿片类药物或国家综合癌症网络（NCCN）指南进行滴定。每 3 天更换一次透皮芬太尼。
治疗 2 周后，459 例可评估患者的平均疼痛强度从 5.63±1.26 显著降至 2.03±1.46（P<0.0001）。完全缓解率为 91.29%，其中中度缓解率为 53.16%，明显缓解率为 25.49%，完全缓解率为 12.64%。不良反应发生率为 33.75%，其中 18.78%为中度，3.80%为重度。最常见的不良反应是便秘和恶心。未观察到致命事件。治疗后生活质量显著改善（P<0.0001）。
新的 TDF 治疗中重度癌症疼痛有效且安全，可显著改善生活质量。
