Natural Science Center for Basic Research and Development, Hiroshima University, Hiroshima, Japan.
Department of Anesthesia and Pain Medicine, Dokkyo Medical University School of Medicine, Tochigi, Japan.
Clin Drug Investig. 2021 Dec;41(12):1087-1098. doi: 10.1007/s40261-021-01097-4. Epub 2021 Nov 16.
Transdermal fentanyl is not yet approved for pediatric and adolescent use in Japan.
Serum fentanyl concentration and the safety and efficacy of once-a-day fentanyl citrate patch were investigated in pediatric and adolescent patients with cancer pain.
In this open-label, uncontrolled study, cancer patients aged 2-19 years being treated with strong opioid analgesics were switched to fentanyl citrate patch for 2 weeks. Serum fentanyl concentration was measured at steady state, and severity of pain was evaluated.
Eleven patients (four patients aged 2-5 years and seven patients aged 6-19 years) were enrolled. No patient received a dose exceeding 2 mg. Mean serum fentanyl concentrations after administration of 0.5 mg, 1 mg, and 2 mg were 144 pg/mL (n = 4), 277 pg/mL (n = 3), and 2070 pg/mL (n = 4), respectively. All patients were included in the efficacy and safety analysis, but one patient was excluded from the pharmacokinetic analysis because blood was sampled on the day after blood transfusion. A subgroup analysis showed that the mean serum fentanyl concentration tended to be higher in pre-school patients (aged 2-5 years) than in school-aged and adolescent patients (aged 6-19 years) and than in reports of adult patients (aged 20 years and above) who received the same dose. No respiratory adverse events were observed, and pain was well controlled.
Fentanyl citrate patch tended to result in a higher serum fentanyl concentration in pre-school patients than in school-aged, adolescent, and adult patients who received the same dose. The patch provided adequate pain control, was well tolerated, and did not cause respiratory adverse events.
JPRN-JapicCTI-183909.
透皮芬太尼在日本尚未被批准用于儿科和青少年人群。
研究枸橼酸芬太尼贴剂在日本儿科和青少年癌症疼痛患者中的血清芬太尼浓度、安全性和疗效。
在这项开放标签、非对照研究中，正在接受强阿片类镇痛药治疗的癌症患者转换为使用枸橼酸芬太尼贴剂，治疗 2 周。在稳态时测量血清芬太尼浓度，并评估疼痛严重程度。
共纳入 11 例患者（4 例 2-5 岁，7 例 6-19 岁）。没有患者的剂量超过 2 mg。分别给予 0.5 mg、1 mg 和 2 mg 后，患者的平均血清芬太尼浓度分别为 144 pg/mL（n=4）、277 pg/mL（n=3）和 2070 pg/mL（n=4）。所有患者均纳入疗效和安全性分析，但由于在输血后第 1 天采集了血液，1 例患者被排除在药代动力学分析之外。亚组分析显示，学龄前患者（2-5 岁）的平均血清芬太尼浓度较学龄期和青少年患者（6-19 岁）以及接受相同剂量的成年患者（20 岁及以上）高。未观察到呼吸不良事件，疼痛得到良好控制。
与接受相同剂量的学龄期、青少年和成年患者相比，枸橼酸芬太尼贴剂在学龄前患者中更容易导致较高的血清芬太尼浓度。该贴剂提供了充分的疼痛控制，耐受性良好，且未引起呼吸不良事件。
JPRN-JapicCTI-183909。
