一项德国大麻药物在一项重大研究中缓解了慢性背痛,表明尽管联邦有限制,但美国仍有望予以批准。
A German cannabis drug eased chronic back pain in a major study, showing promise for U.S. approval despite federal restrictions.
对800名病人进行的一项大型研究发现,德国Vertanical公司研制了一种低剂量的大麻基药物,大大降低了慢性低背疼痛,与会者报告说,12周后几乎将2点疼痛降低11点,与安慰剂相比,统计学上有了显著改善。
A large study of 800 patients found a low-dose cannabis-based drug developed by German company Vertanical significantly reduced chronic lower-back pain, with participants reporting nearly a 2-point pain reduction on an 11-point scale after 12 weeks, a statistically significant improvement over placebo.
含有四氯环乙烷微剂量的药物还改善了睡眠和身体功能,没有虐待或依赖的迹象,由于诸如头晕和恶心等副作用,辍学率为17%,低于类阿片的典型水平。
The medication, containing microdoses of THC, also improved sleep and physical function, with no signs of abuse or dependence, and a dropout rate of 17% due to side effects like dizziness and nausea—lower than typical for opioids.
由于联邦对大麻的限制,美国不批准该药物,但欧洲的药典已经申请批准,并正在与美国的监管者合作进行林业发展局的审查。
The drug is not approved in the U.S. due to federal cannabis restrictions, but Vertanical has applied for approval in Europe and is collaborating with U.S. regulators to pursue FDA review.
在《自然》杂志上公布的研究结果增加了越来越多的证据,表明大麻衍生的治疗方法可以为慢性疼痛提供安全、有效的替代品。
The findings, published in Nature, add to growing evidence that cannabis-derived treatments may offer safe, effective alternatives for chronic pain.