Pharmaceutical company Microkhim, Kyiv, Ukraine.
Clinical and Diagnostic Center Pharmbiotest, Kyiv, Ukraine.
Br J Clin Pharmacol. 2024 Jul;90(7):1728-1740. doi: 10.1111/bcp.16077. Epub 2024 Apr 22.
Our previous 3-period crossover study in healthy volunteers comparing the pharmacokinetics of nalbuphine nasal spray Apain with parenteral nalbuphine solution demonstrated high bioavailability of the nasal spray and close similarity of pharmacokinetic profiles after intranasal and intramuscular administration, especially within 30 min postdose. The aim of the present study was a noninferiority assessment of nalbuphine nasal spray vs. intramuscular injection for pain relief in postoperative patients.
Ninety orthopaedic and traumatology patients were enrolled in this double-blind, randomized study of the effectiveness and tolerance of a single 10.5 mg dose of nalbuphine nasal spray vs. 10 mg intramuscular injection. The summed pain intensity difference (SPID) calculated using visual analogue scale scores was the primary study endpoint.
Of 90 subjects enrolled, the per-protocol efficacy population comprised 79 patients; 6 patients in the reference group and 5 patients in the test group were excluded due to remedication. The mean values of study endpoints with 95% confidence interval were as follows in reference and test groups, respectively: SPID = 228.08 (205.73-250.43) vs. 248.73 9 (225.83-271.63), time to pain relief onset = 0.28 h (0.25-0.31) vs. 0.27 h (0.25-0.29), duration of analgesia = 5.55 h (5.17-5.93) vs. 5.51 h (5.10-5.92), area under the curve = 119.30 (91.17-147.43) vs. 99.81 (74.52-107.10). No statistically significant differences were revealed.
Nalbuphine nasal spray Apain has been proven to be a safe, noninvasive alternative to intramuscular nalbuphine to relieve severe postoperative pain. Designed for self-administration and dose-adjusting, the noncontrolled opioid analgesic nalbuphine spray can be used for patient-controlled analgesia in out-of-hospital, field and home settings.
我们之前在健康志愿者中进行的一项三周期交叉研究比较了纳布啡鼻喷剂 Apain 与纳布啡注射剂的药代动力学，结果表明鼻喷剂具有很高的生物利用度，并且经鼻腔和肌肉给药后的药代动力学特征非常相似，尤其是在给药后 30 分钟内。本研究的目的是评估纳布啡鼻喷剂与肌肉注射用于术后患者镇痛的非劣效性。
90 名骨科和创伤科患者参与了这项双盲、随机研究，评估了单次 10.5mg 纳布啡鼻喷剂与 10mg 肌肉注射的疗效和耐受性。使用视觉模拟评分计算的总和疼痛强度差值（SPID）是主要研究终点。
90 名入组患者中，符合方案的疗效人群包括 79 名患者；参考组中有 6 名患者和试验组中有 5 名患者因补救治疗而被排除。参考组和试验组的研究终点平均值及其 95%置信区间分别为：SPID=228.08（205.73-250.43）与 248.739（225.83-271.63），疼痛缓解起效时间=0.28h（0.25-0.31）与 0.27h（0.25-0.29），镇痛持续时间=5.55h（5.17-5.93）与 5.51h（5.10-5.92），曲线下面积=119.30（91.17-147.43）与 99.81（74.52-107.10）。未发现统计学差异。
纳布啡鼻喷剂 Apain 已被证明是一种安全、非侵入性的肌肉注射纳布啡替代方案，可用于缓解严重的术后疼痛。设计用于自我给药和剂量调整的非控制阿片类镇痛纳布啡喷雾可用于院外、现场和家庭环境中的患者自控镇痛。
