Department of Medicine, Cambridge Health Alliance, Somerville, MA, USA.
Department of Medicine, Harvard Medical School, Boston, MA, USA.
Clin Toxicol (Phila). 2022 Oct;60(10):1156-1158. doi: 10.1080/15563650.2022.2109485. Epub 2022 Aug 12.
Centrophenoxine (meclofenoxate) is prescribed in China and elsewhere to treat a variety of conditions including alcoholism and dementia, but the US Food and Drug Administration has not approved the drug for any indication. We designed our study to determine the presence and quantity of centrophenoxine in dietary supplements sold over-the-counter in the US.
Supplements were included in our study if the label included (a) the term "dietary supplement" and (b) "centrophenoxine" as a declared ingredient. Supplements were purchased online, and powder from each dietary supplement product was reconstituted in methanol and analyzed using ultra high-performance liquid chromatography.
Seven products were analyzed. Centrophenoxine was present in all products in dosages ranging from 79 to 251 mg per serving. Consumers following the maximum recommended daily intake on the label would be exposed to 237 to 752 mg of centrophenoxine per day. Only 1 of 7 products (14%) listed a quantity of centrophenoxine on the label within ±10% of the actual amount.
Clinicians should be aware and advise patients that cognitive enhancement supplements may contain unapproved and prohibited drugs.
在中国和其他地方，氯甲酚（meclofenoxate）被开处方用于治疗各种疾病，包括酗酒和痴呆症，但美国食品和药物管理局尚未批准该药物用于任何适应症。我们设计了这项研究，以确定在美国非处方销售的膳食补充剂中是否存在氯甲酚及其含量。
如果标签包含 (a)“膳食补充剂”和 (b)“氯甲酚”作为声明成分，则将补充剂纳入我们的研究中。补充剂是在网上购买的，每个膳食补充剂产品的粉末都在甲醇中重新配制，并使用超高效液相色谱进行分析。
分析了 7 种产品。所有产品中均存在氯甲酚，剂量范围为每份 79 至 251 毫克。按照标签上的最大推荐日摄入量服用的消费者每天将接触到 237 至 752 毫克的氯甲酚。在标签上列出的 7 种产品中，只有 1 种（14%）的实际含量在±10%以内。
临床医生应注意并告知患者，认知增强补充剂可能含有未经批准和禁用的药物。
