Bar-Lev Schleider Lihi, Mechoulam Raphael, Sikorin Inbal, Naftali Timna, Novack Victor
Clinical Research Center, Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Be'er Sheva, Israel.
Research Department, Tikun Olam - Cannbit Pharmaceuticals, Tel Aviv, Israel.
Front Med (Lausanne). 2022 Feb 9;9:827849. doi: 10.3389/fmed.2022.827849. eCollection 2022.
Despite the absence of rigorous prospective studies, there has been an increase in the use of cannabis-based medicinal products. During the study period, the use of medical cannabis in Israel was tightly regulated by national policy. Through a prospective study of approximately 10,000 patients, we aimed to characterize the medical cannabis patient population as well as to identify treatment adherence, safety, and effectiveness.
In this study of prescribed medical cannabis patients, adherence, safety, and effectiveness were assessed at 6 months. Treatment adherence was assessed by the proportion of patients purchasing the medication out of the total number of patients (excluding deceased cases and patients transferred to another cannabis clinic). Safety was assessed by the frequency of the side-effects, while effectiveness was defined as at least moderate improvement in the patient condition without treatment cessation or serious side-effects. The most frequent primary indications requiring therapy were cancer (49.1%), followed by non-specific pain (29.3%). The average age was 54.6 ± 20.9 years, 51.1% males; 30.2% of the patients reported prior experience with cannabis. During the study follow-up, 1,938 patients died (19.4%) and 1,735 stopped treatment (17.3%). Common side-effects, reported by 1,675 patients (34.2%), were: dizziness (8.2%), dry mouth (6.7%), increased appetite (4.7%), sleepiness (4.4%), and psychoactive effect (4.3%). Overall, 70.6% patients had treatment success at 6 months. Multivariable logistic regression analysis revealed that the following factors were associated with treatment success: cigarette smoking, prior experience with cannabis, active driving, working, and a young age. The main limitation of this study was the lack of data on safety and effectiveness of the treatment for patients who refused to undergo medical assessment even at baseline or died within the first 6 months.
We observed that supervised medical-cannabis treatment is associated with high adherence, improvement in quality of life, and a decrease in pain level with a low incidence of serious adverse events.
尽管缺乏严格的前瞻性研究，但基于大麻的药用产品的使用有所增加。在研究期间，以色列医用大麻的使用受到国家政策的严格监管。通过对约10000名患者的前瞻性研究，我们旨在描述医用大麻患者群体的特征，并确定治疗依从性、安全性和有效性。
在这项针对开具医用大麻处方患者的研究中，在6个月时评估依从性、安全性和有效性。治疗依从性通过购买药物的患者占患者总数的比例来评估（不包括死亡病例和转至另一家大麻诊所的患者）。安全性通过副作用的发生频率来评估，而有效性定义为患者病情至少有中度改善且未停止治疗或出现严重副作用。需要治疗的最常见主要适应症是癌症（49.1%），其次是非特异性疼痛（29.3%）。平均年龄为54.6±20.9岁，男性占51.1%；30.2%的患者报告有使用大麻的既往经历。在研究随访期间，1938名患者死亡（19.4%），1735名患者停止治疗（17.3%）。1675名患者（34.2%）报告的常见副作用有：头晕（8.2%）、口干（6.7%）、食欲增加（4.7%）、嗜睡（4.4%）和精神活性作用（4.3%）。总体而言，70.6%的患者在6个月时治疗成功。多变量逻辑回归分析显示，以下因素与治疗成功相关：吸烟、有使用大麻的既往经历、积极驾驶、工作和年轻。本研究的主要局限性在于缺乏关于即使在基线时也拒绝接受医学评估或在最初6个月内死亡的患者的治疗安全性和有效性的数据。
我们观察到，在监督下的医用大麻治疗与高依从性、生活质量改善以及疼痛水平降低相关，严重不良事件发生率较低。
