Department of Radiology, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka 573-1191, Japan.
Support Care Cancer. 2011 May;19(5):691-5. doi: 10.1007/s00520-010-0890-1. Epub 2010 Jun 13.
The objective of the present prospective study was to compare the safety and efficacy of a 12-h method to a 6-h method in chronic cancer pain management.
Randomized, prospective clinical trial was conducted between December 2007 and June 2009, enrolling 90 patients with chronic cancer pain. Patients with chronic cancer pain were randomly assigned to the conversion from continuous intravenous infusion to transdermal fentanyl using two-step taper of the continuous intravenous infusion in 12 h (12-h method) or the conversion in 6 h (6-h method). The parameters assessed in the present study included pain intensity (on a scale of 0 to 10) and bolus use frequency, and the adverse effects were assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 3.
Pain intensity and the number of boluses during conversion remained stable in both arms. The incidence of adverse events was 25.6% in the 12-h method group and 2.3% in the 6-h method group (95% confidence interval, 0.01-0.55; p = 0.002). Adverse events occurred in four patients at 6-12 h, five patients at 12-18 h, two patients at 18-24 h, and one patient at 24-48 h after application.
Excellent safety profile and sustained efficacy are shown for the 6-h conversion method.
本前瞻性研究的目的是比较 12 小时法与 6 小时法在慢性癌痛管理中的安全性和疗效。
2007 年 12 月至 2009 年 6 月进行了随机、前瞻性临床试验，共纳入 90 例慢性癌痛患者。慢性癌痛患者被随机分配至采用两步法逐步减少持续静脉输注，在 12 小时（12 小时组）或 6 小时（6 小时组）内将持续静脉输注转换为经皮芬太尼。本研究评估的参数包括疼痛强度（0-10 分）和追加剂量使用频率，不良反应采用美国国立癌症研究所不良事件通用术语标准 3.0 版进行评估。
两组转换过程中的疼痛强度和追加剂量数均保持稳定。12 小时组不良反应发生率为 25.6%，6 小时组为 2.3%（95%置信区间，0.01-0.55；p = 0.002）。不良反应发生在应用后 6-12 小时 4 例，12-18 小时 5 例，18-24 小时 2 例，24-48 小时 1 例。
6 小时转换方法具有良好的安全性和持续疗效。
