Graphene oxide nanomaterials are being developed for wide-ranging applications but are associated with potential safety concerns for human health. We conducted a double-blind randomized controlled study to determine how the inhalation of graphene oxide nanosheets affects acute pulmonary and cardiovascular function. Small and ultrasmall graphene oxide nanosheets at a concentration of 200 μg m⁻³ or filtered air were inhaled for 2 h by 14 young healthy volunteers in repeated visits. Overall, graphene oxide nanosheet exposure was well tolerated with no adverse effects. Heart rate, blood pressure, lung function and inflammatory markers were unaffected irrespective of graphene oxide particle size. Highly enriched blood proteomics analysis revealed very few differential plasma proteins and thrombus formation was mildly increased in an ex vivo model of arterial injury. Overall, acute inhalation of highly purified and thin nanometre-sized graphene oxide nanosheets was not associated with overt detrimental effects in healthy humans. These findings demonstrate the feasibility of carefully controlled human exposures at a clinical setting for risk assessment of graphene oxide, and lay the foundations for investigating the effects of other two-dimensional nanomaterials in humans. Clinicaltrials.gov ref: NCT03659864.

氧化石墨烯纳米材料正在开发用于广泛的应用，但与人类健康的潜在安全问题相关。我们进行了一项双盲随机对照研究，以确定吸入氧化石墨烯纳米片如何影响急性肺和心血管功能。14名年轻健康志愿者反复访视，吸入浓度为200 μg m ^{- 3}的小型和超小型氧化石墨烯纳米片或过滤空气2小时。总体而言，氧化石墨烯纳米片暴露的耐受性良好，没有不良影响。无论氧化石墨烯颗粒大小如何，心率、血压、肺功能和炎症标志物均不受影响。高富集的血液蛋白质组学分析显示，在动脉损伤的离体模型中，血浆蛋白的差异非常小，并且血栓形成略有增加。总体而言，急性吸入高度纯化的薄纳米级氧化石墨烯纳米片与健康人类的明显有害影响无关。这些发现证明了在临床环境中仔细控制人体暴露以进行氧化石墨烯风险评估的可行性，并为研究其他二维纳米材料对人体的影响奠定了基础。 ClinicalTrials.gov 参考号：NCT03659864。