背景:使用大麻治疗纤维肌痛综合征(FMS)尚未得到全面研究。因此,我们评估了短期和长期医用大麻(MC)治疗FMS的疗效和不良事件(AE).
方法:数据来自Ponderano(意大利;回顾性研究)疼痛诊所存档的医学报告。FMS患者,他们对常规治疗有抵抗力,已获得许可的MC,具有各种Δ-9-四氢大麻酚(THC)和大麻二酚(CBD)含量,作为粉末全花(煎煮或汽化)或油提取物。人口统计学和临床参数,包括数值评级量表(NRS),Oswestry残疾指数(ODI),医院焦虑抑郁量表,广泛疼痛指数(WPI)严重性评分(SyS),和副作用,在1、3和12个月后获得。使用Wilcoxon符号秩检验对配对数据进行数据分析。
结果:纳入38例患者。三十,18,12名患者继续治疗1、3和12个月,分别。在NRS中观察到显着改善(p<0.01),ODI,WPI,和SyS在1个月;在NRS中,ODI,和WPI在3个月;在NRS中,ODI,和SyS在12个月。根据FDA的说法,由于非严重的AE,17例患者(48.6%)中断了治疗。最常见的副作用是精神错乱(37%),头晕(14%),恶心/呕吐(14%),和躁动/刺激(14%)。以THC占优势的MC和杂种MC(具有相似的THC/CBD比率)施用的碾磨花的中位日剂量为200mg/天和400mg/天,分别。滴定3个月后,与THC显性MC品种一起施用的THC的中位数含量为46.2mg,以及作为杂种MC品种施用的THC+CBD,为23.6mg+38mg。3个月时,THC优势MC品种的油提取物中施用的THC含量中位数为9.7mg,而在杂交MC品种的油提取物中施用的THC+CBD为1.8mg+2mg。
结论:MC可能代表对常规治疗无反应的FMS患者的替代治疗。然而,其应用可能受到非严重AE发生率的限制.
BACKGROUND: The use of cannabis for treating fibromyalgia syndrome (FMS) has not been comprehensively investigated. Thus, we have assessed the efficacy and adverse events (AEs) of short- and long-term medical cannabis (MC) treatment for FMS.
METHODS: Data were obtained from medical
reports archived in the pain clinic of Ponderano (Italy; retrospective study). FMS patients, who were resistant to conventional therapy, received licensed MC with various Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) content, as powdered whole flowers (decoction or vaporization) or oil extracts. Demographic and clinical parameters, including Numerical Rating Scale (NRS), Oswestry Disability Index (ODI), Hospital Anxiety and Depression Scale, Widespread Pain Index (WPI), Severity Score (SyS), and side effects, were obtained after 1, 3, and 12 months. Data were analyzed with Wilcoxon signed-rank tests for paired data.
RESULTS: Thirty-eight patients were included. Thirty, 18, and 12 patients continued therapy for 1, 3, and 12 months, respectively. Significant improvements (p < 0.01) were observed in NRS, ODI, WPI, and SyS at 1 month; in NRS, ODI, and WPI at 3 months; and in NRS, ODI, and SyS at 12 months. Therapy was interrupted by 17 patients (48.6%) owing to nonserious AEs according to the FDA. The most common side effects were mental confusion (37%), dizziness (14%), nausea/vomiting (14%), and restlessness/irritation (14%). The median daily dose of milled flowers administered as THC-dominant MC and hybrid MC (with similar THC/CBD ratio) was 200 mg/day and 400 mg/day, respectively. After 3 months of titration, the median content of THC administered with THC-dominant MC cultivars was 46.2 mg, and of THC + CBD administered as a hybrid MC cultivar, was 23.6 mg + 38 mg. At 3 months, median THC content administered in the oil extract of the THC-dominant MC cultivars was 9.7 mg, while that of THC + CBD administered in the oil extract of the hybrid MC cultivars was 1.8 mg + 2 mg.
CONCLUSIONS: MC may represent an alternative treatment for patients with FMS who are unresponsive to conventional therapy. However, its application may be limited by the incidence of nonserious AEs.