Department of Anesthesia and Pain Medicine, Dokkyo Medical University School of Medicine, Tochigi, Japan.
Showa University, Tokyo, Japan.
Clin Drug Investig. 2020 Nov;40(11):1041-1052. doi: 10.1007/s40261-020-00965-9.
The use of transdermal fentanyl for opioid-naïve patients is restricted, however, transdermal fentanyl is a useful opioid analgesic for patients in whom oral administration is difficult or for those with renal failure. In this study, the efficacy and safety of fentanyl citrate patches was evaluated in opioid-naïve patients suffering from cancer pain.
An open-label uncontrolled study was conducted in opioid-naïve patients with cancer pain unable to be controlled by non-opioid analgesics. Fentanyl citrate patches starting at a low dose (0.5 mg/patch, corresponding to 6.25 μg/h fentanyl delivered) were applied once/day for up to 14 days. The analgesic effect was assessed every day from the visual analogue scale pain score and the number of doses of rescue medication. When improvement of the analgesic effect was "significant" or "moderate" at a certain dose for three consecutive days, the patient was classified as a "responder" and was considered to have "completed" the study.
A fentanyl citrate patch was administered to 208 of 209 enrolled patients. In the full-analysis set, 87.0% of the patients were "responders" (95% confidence interval 81.7-91.3%). In 148 patients, the optimum dose was low (0.5 mg in 99, and 1 mg in 49), with patients finishing the study on days 4-8. Following dose escalation to 4 mg, respiratory depression occurred in one patient; however, this was considered a mild adverse event.
A low-dose fentanyl citrate patch was effective in the management of cancer pain in opioid-naïve patients and was well tolerated.
JPRN-JapicCTI-173717.
尽管透皮芬太尼可用于治疗阿片类药物初治患者，但对于口服给药困难或患有肾功能衰竭的患者，透皮芬太尼是一种有用的阿片类镇痛药。在这项研究中，评估了柠檬酸芬太尼贴剂在阿片类药物初治的癌症疼痛患者中的疗效和安全性。
在无法通过非阿片类镇痛药控制的阿片类药物初治的癌症疼痛患者中进行了一项开放性、非对照研究。从低剂量（0.5 毫克/贴，相当于 6.25 微克/小时芬太尼释放）开始，每天一次使用柠檬酸芬太尼贴剂，最多使用 14 天。每天根据视觉模拟评分疼痛量表和急救药物的剂量评估镇痛效果。当在某一剂量下连续三天镇痛效果“显著”或“中度”改善时，患者被归类为“应答者”，并被认为“完成”了研究。
209 名入组患者中有 208 名接受了柠檬酸芬太尼贴剂治疗。在全分析集（FAS）中，87.0%的患者为“应答者”（95%置信区间为 81.7%至 91.3%）。在 148 名患者中，最佳剂量为低剂量（99 例为 0.5 毫克，49 例为 1 毫克），患者在第 4-8 天完成了研究。在剂量增加至 4 毫克后，1 名患者出现呼吸抑制，但这被认为是轻度不良事件。
低剂量柠檬酸芬太尼贴剂对阿片类药物初治的癌症疼痛患者有效，且耐受性良好。
JPRN-JapicCTI-173717。
