髄膜下ナルブヒネは、病院前の救急状態における急性疼痛の改善に有効であることが示された；ガンマシンチグラフィを用いた従来の筋肉内注射との比較研究

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Injury.2020 Jun;S0020-1383(20)30538-6. doi: 10.1016/j.injury.2020.06.031.Epub 2020-06-20.

髄膜下ナルブヒネは、病院前の救急状態における急性疼痛の改善に有効であることが示された；ガンマシンチグラフィを用いた従来の筋肉内注射との比較研究

Submental nalbuphine exhibits improved efficacy in ameliorating acute pain in prehospital emergent conditions; a comparative study with conventional intramuscular using gamma scintigraphy.

Kushagra Khanna
Ritu Karwasra
Sandeep Choudhary
Deeksha Sharma
Nitin Sharma
Puja Nagpal
Varsha Chorsiya
Dhruv Kumar Nishad
Harvinder Popli
Aseem Bhatnagar

PMID: 32591214 DOI: 10.1016/j.injury.2020.06.031.

抄録

背景:

ナルブヒネ（NLB）は、カッパ拮抗薬とミュー部分拮抗薬であり、オピオイド離脱依存症、オピオイド誘発性痒疹、緊急鎮痛薬として広く使用されています。

BACKGROUND: Nalbuphine (NLB) is a kappa-agonist and mu-partial antagonist, widely used for opioid withdrawal de-addiction, opioid-induced pruritis and as emergent analgesia.

目的:

本研究の目的は、緊急時の迅速な管理を可能にするために、認知下ルートを介した疼痛感作に対するNLBの安全性と有効性を評価することであった。

OBJECTIVE: The present study aimed to assess the safety and efficacy of NLB in pain sensitization, through a submental route so as to provide faster management in emergent situations.

MATERIALS & METHODS: In-vivo efficacy and safety studies of NLB-submental injection were assessed in Sprague-Dawley(SD) rats. For eddy's hot plate study, animals were allocated into three groups, the first group served as normal control; group II received NLB (through submental route at 1.2 mg/kg); group III received NLB (through intramuscular route at 1.2 mg/kg). Response latency (in terms of response latency) was measured at 10, 30 & 60 min in all the experimental groups. Safety studies were carried out according to OECD 423. In-vitro release study was conducted using a cellulose dialysis membrane (12,000 KDa). The biodistribution and release kinetics studies were carried out using gamma scintigraphy studies in New Zealand rabbits and humans respectively.

結果:

RESULTS: The response latency of NLB from the submental route was found to be 7.17 (SD 1.47) seconds and in the case of the intramuscular route it was calculated as 4.00 (SD 1.26) seconds at 10 min. The data depicts the better efficacy of submental injection in ameliorating pain than the intramuscular injection. Toxicity studies predict the safe profile through a submental route. The release kinetics in humans of submental NLB was 46% faster as compared to the intramuscular site of injection. The NLB injection through both routes was compared by non-invasive gamma scintigraphy technique and we found that submental injection has faster (within 10 min) onset of action & distributes rapidly.

結論:

NLBの髄膜下ルートは、筋肉内ルートよりも迅速で効果的である。したがって、緊急時のシナリオ（静脈または午前中のルートが危険にさらされている）では、即時の救済が必要な場合には、髄膜下ルートが好ましい選択であると結論付けている。

CONCLUSION: The submental route of NLB is faster, more efficacious than the intramuscular route. Thus, we conclude that in the case of emergent scenarios (i.v or i.m. route is compromised), where immediate relief is necessary, the submental route is a preferred choice.