Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials.
Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials.
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DOI：
10.1038/s41386-020-0667-2
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发表时间：
2020-10
期刊：
影响因子：
--
通讯作者：
McGuire P
中科院分区：
文献类型：
--
作者：
Chesney E;Oliver D;Green A;Sovi S;Wilson J;Englund A;Freeman TP;McGuire P
大麻二酚（CBD）正在被研究作为几种医学疾病的治疗方法，但其安全性尚不确定。我们对CBD在所有医学适应症中的不良反应进行了首次系统回顾和荟萃分析。纳入持续≥7天的双盲随机安慰剂对照临床试验。12项试验为meta分析提供了803名参与者的数据。与安慰剂相比，CBD与任何原因（OR 2.61, 95% CI: 1.38-4.96）或不良事件（OR 2.65, 95% CI: 1.04-6.80）、严重不良事件（OR 2.30, 95% CI: 1.18-4.48）、肝功能异常相关的严重不良事件（OR 11.19, 95% CI: 2.09-60.02）或肺炎相关的严重不良事件（OR 5.37, 95% CI: 1.17-24.65）、任何不良事件（OR 1.55, 95% CI: 1.03-2.33）、食欲下降相关的不良事件（OR 3.56, 95% CI: 1.56）相关。1.94-6.53)、腹泻（OR 2.61, 95% CI: 1.46-4.67）、嗜睡（OR 2.23, 95% CI: 1.07-4.64）和镇静（OR 4.21, 95% CI: 1.18-15.01）。与肝功能异常、嗜睡、镇静和肺炎的关联仅限于儿童癫痫研究，在这些研究中，CBD可能与氯巴唑和/或丙戊酸钠等其他药物相互作用。在排除儿童癫痫研究后，与CBD治疗相关的唯一不良结局是腹泻（OR 5.03, 95% CI: 1.44-17.61）。总之，临床试验的现有数据表明，CBD耐受性良好，严重的不良反应相对较少，但与其他药物的相互作用应仔细监测。需要从儿童癫痫综合征以外的临床试验和非处方CBD产品的研究中获得更多的安全性数据，以评估临床试验得出的结论是否可以更广泛地应用。
Cannabidiol (CBD) is being investigated as a treatment for several medical disorders but there is uncertainty about its safety. We conducted the first systematic review and meta-analysis of the adverse effects of CBD across all medical indications. Double-blind randomized placebo-controlled clinical trials lasting ≥7 days were included. Twelve trials contributed data from 803 participants to the meta-analysis. Compared with placebo, CBD was associated with an increased likelihood of withdrawal for any reason (OR 2.61, 95% CI: 1.38–4.96) or due to adverse events (OR 2.65, 95% CI: 1.04–6.80), any serious adverse event (OR 2.30, 95% CI: 1.18–4.48), serious adverse events related to abnormal liver function tests (OR 11.19, 95% CI: 2.09–60.02) or pneumonia (OR 5.37, 95% CI: 1.17–24.65), any adverse event (OR 1.55, 95% CI: 1.03–2.33), adverse events due to decreased appetite (OR 3.56, 95% CI: 1.94–6.53), diarrhoea (OR 2.61, 95% CI: 1.46–4.67), somnolence (OR 2.23, 95% CI: 1.07–4.64) and sedation (OR 4.21, 95% CI: 1.18–15.01). Associations with abnormal liver function tests, somnolence, sedation and pneumonia were limited to childhood epilepsy studies, where CBD may have interacted with other medications such as clobazam and/or sodium valproate. After excluding studies in childhood epilepsy, the only adverse outcome associated with CBD treatment was diarrhoea (OR 5.03, 95% CI: 1.44–17.61). In summary, the available data from clinical trials suggest that CBD is well tolerated and has relatively few serious adverse effects, however interactions with other medications should be monitored carefully. Additional safety data from clinical trials outside of childhood epilepsy syndromes and from studies of over-the-counter CBD products are needed to assess whether the conclusions drawn from clinical trials can be applied more broadly.
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