Schmidt-Wolf Gabriele, Cremer-Schaeffer Peter
Bundesinstitut für Arzneimittel und Medizinprodukte, Bundesopiumstelle, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2021 Mar;64(3):368-377. doi: 10.1007/s00103-021-03285-1. Epub 2021 Feb 9.
In Germany, physicians who prescribe medical cannabis flowers or cannabis-based medicines (narcotic prescription) at the expense of the statutory health insurance are obliged to take part in a noninterventional accompanying survey that runs until 31 March 2022.At the time of this interim evaluation, 11 May 2020, there were 10,010 complete datasets collected. The most frequently treated symptoms were pain (73%), followed by spasticity (10%), and anorexia/wasting (6%). Dronabinol (i.e., prescription drug or Marinol®) was most frequently (65%) prescribed, followed by cannabis flowers (18%), Sativex® (13%), cannabis extract (4%, with increasing frequency), and nabilone (0.3%). The 6485 cases treated with dronabinol already allows a subgroup evaluation concerning efficacy. The typical cannabis side effects of tiredness, dizziness, dry mouth, and nausea occur with all cannabis medicines, and correspond to those already known from the product information of the cannabis-based medicinal products authorized under the pharmaceutical law. The potentially serious adverse effects of depression, suicidal ideation, delusions, hallucinations, dissociation, and misperceptions were each reported with a frequency higher than 0.1%. There were remarkable differences between patients treated with cannabis flowers and those with other cannabis medicines.Patients treated with cannabis flowers are significantly younger and predominantly male. They are treated more often by general practitioners and internists, their diagnosis differs more often from the typical diagnoses (pain, spasticity, anorexia/wasting), and they have more prior experience with cannabis. The underreporting in the accompanying survey is mainly in this patient group.
在德国，由法定医疗保险支付费用开具医用大麻花或大麻类药物（麻醉处方）的医生，必须参与一项持续至2022年3月31日的非干预性随访调查。在本次中期评估时，即2020年5月11日，共收集到10,010份完整数据集。最常治疗的症状是疼痛（73%），其次是痉挛（10%）和厌食/消瘦（6%）。最常开具的是屈大麻酚（即处方药或商品名Marinol®）（65%），其次是大麻花（18%）、Sativex®（13%）、大麻提取物（4%，且频率在增加）和纳布隆（0.3%）。使用屈大麻酚治疗的6485例病例已可进行疗效亚组评估。所有大麻类药物都会出现典型的大麻副作用，如疲倦、头晕、口干和恶心，这与药品法授权的大麻类药用产品的产品信息中已知的副作用一致。抑郁、自杀意念、妄想、幻觉、分离和错觉等潜在严重不良反应的报告频率均高于0.1%。使用大麻花治疗的患者与使用其他大麻类药物治疗的患者之间存在显著差异。使用大麻花治疗的患者明显更年轻，且以男性为主。他们更多地由全科医生和内科医生治疗，其诊断与典型诊断（疼痛、痉挛、厌食/消瘦）的差异更常见，并且他们有更多使用大麻的既往经历。随访调查中的漏报主要出现在这一患者群体中。
