Aviram Joshua, Atzmony Daniella, Eisenberg Elon
Syqe Medical LTD, Tel-Aviv, Israel.
Institute of Pain Medicine, Rambam Health Care Campus, Haifa, Israel.
Pain Rep. 2022 May 17;7(3):e1011. doi: 10.1097/PR9.0000000000001011. eCollection 2022 May-Jun.
Preliminary clinical studies on medical cannabis (MC) treatment using the Syqe Inhaler showed short-term effectiveness and safety at very low and precise doses of MC.
Here, we retrospectively analyzed "real-life" long-term data collected in real time on the potential effectiveness and safety of MC administered with this device.
Patients were monitored by Syqe's patient support program. (-)-Δ-trans-Tetrahydrocannabinol (Δ-THC) served as a dosage marker for full-spectrum MC. Pain intensity was evaluated using a numeric pain scale (NPS) from baseline to 120 days after treatment initiation. The change in quality of life (QoL) from baseline was evaluated. Adverse events (AEs) were followed up continuously for 15 months.
Of the 143 patients (mean age 62 ± 17 years; 54% males) included in the analysis, most (72%) were diagnosed with chronic neuropathic pain. The stable daily dose, after a mean 26 ± 10 days of titration was 1,500 ± 688 μg aerosolized Δ-THC. Significant pain reduction, ranging from 22.8% in the intent-to-treat population to 28.4% in the population that reported baseline pain intensity ≥8 points on the NPS ( < 0.001), was observed. Ninety-two percent of patients reported improved QoL. Adverse events were reported mostly during the titration phase (34% of patients) and declined to ≤4% at 3 to 15 months. Only 7% of patients reported psychoactive AEs (anxiety and restlessness).
Medical cannabis treatment with the Syqe Inhaler demonstrated overall long-term pain reduction, QoL improvement, and a superior AE profile compared with administration of MC by conventional routes. Additional follow-up in a larger population is warranted.
使用Syqe吸入器进行医用大麻（MC）治疗的初步临床研究表明，在极低且精确的MC剂量下具有短期有效性和安全性。
在此，我们回顾性分析了通过该设备实时收集的关于MC潜在有效性和安全性的“真实生活”长期数据。
患者由Syqe的患者支持计划进行监测。（-）-Δ-反式-四氢大麻酚（Δ-THC）用作全谱MC的剂量标记物。使用数字疼痛量表（NPS）从基线到治疗开始后120天评估疼痛强度。评估从基线开始的生活质量（QoL）变化。对不良事件（AE）进行连续15个月的随访。
纳入分析的143例患者（平均年龄62±17岁；54%为男性）中，大多数（72%）被诊断为慢性神经性疼痛。经过平均26±10天的滴定后，稳定的每日剂量为雾化Δ-THC 1500±688μg。观察到疼痛显著减轻，在意向性治疗人群中为22.8%，在NPS上报告基线疼痛强度≥8分的人群中为28.4%（<0.001）。92%的患者报告生活质量有所改善。不良事件大多在滴定阶段报告（34%的患者），在第3至15个月降至≤4%。只有7%的患者报告有精神活性不良事件（焦虑和躁动）。
与通过传统途径使用MC相比，使用Syqe吸入器进行医用大麻治疗显示出总体长期疼痛减轻、生活质量改善以及更好的不良事件特征。有必要在更大规模人群中进行进一步随访。
