Mazzanti Gabriela, Moro Paola Angela, Raschi Emanuel, Da Cas Roberto, Menniti-Ippolito Francesca
Department of Physiology and Pharmacology 'Vittorio Erspamer', Sapienza University of Rome, Piazzale Aldo Moro 5, 00185, Rome, Italy.
Poison Control Center, Niguarda Ca' Grande Hospital, Piazza Ospedale Maggiore 3, 20162, Milan, Italy.
Br J Clin Pharmacol. 2017 Apr;83(4):894-908. doi: 10.1111/bcp.13171. Epub 2017 Jan 19.
Red yeast rice (RYR) is contained in dietary supplements for patients with dyslipidemia. RYR supplements contain monacolin K, which is chemically identical to lovastatin, a licensed drug with a well-known risk profile. We aim to describe the safety profile of RYR by analysing spontaneous reports of suspected adverse reactions (ARs).
Within the Italian Surveillance System of Natural Health Products, suspected ARs were collected and evaluated by a multidisciplinary group of experts to assess causality using the WHO-UMC system or the CIOMS/RUCAM score, for hepatic reactions. The public version of the WHO-Vigibase was also queried.
From April 2002 to September 2015, out of 1261 total reports, 52 reports concerning 55 ARs to RYR dietary supplements were collected. ARs consisted in myalgia and/or increase in creatine phosphokinase (19), rhabdomyolysis (1), liver injury (10), gastrointestinal reactions (12), cutaneous reactions (9) and other reactions (4). Women were involved in 70% of cases. In 13 cases, the reaction required hospitalization, and 28 patients were taking other medications. Dechallenge was positive in 40 reactions (73%), rechallenge was positive in 7. Causality resulted as certain (1), probable (31, 56%), possible (18, 34%), unlikely (3) or unassessable (2). Similar distribution emerged from the WHO-Vigibase.
The potential safety signals of myopathies and liver injury raise the hypothesis that the safety profile of RYR is similar to that of statins. Continuous monitoring of dietary supplements should be promoted to finally characterize their risk profile, thus supporting regulatory bodies for appropriate actions.
血脂异常患者的膳食补充剂中含有红曲米（RYR）。RYR补充剂含有莫纳可林K，其化学结构与洛伐他汀相同，洛伐他汀是一种有明确风险特征的许可药物。我们旨在通过分析疑似不良反应（ARs）的自发报告来描述RYR的安全性。
在意大利天然保健品监测系统内，收集疑似ARs并由多学科专家小组进行评估，使用WHO-UMC系统或CIOMS/RUCAM评分来评估肝反应的因果关系。还查询了WHO-Vigibase的公开版本。
2002年4月至2015年9月，在总共1261份报告中，收集到52份关于RYR膳食补充剂的55例ARs报告。ARs包括肌痛和/或肌酸磷酸激酶升高（19例）、横纹肌溶解（1例）、肝损伤（10例）、胃肠道反应（12例）、皮肤反应（9例）和其他反应（4例）。70%的病例涉及女性。13例反应需要住院治疗，28例患者正在服用其他药物。40例反应（73%）撤药后反应阳性，7例再激发反应阳性。因果关系判定为肯定（1例）、很可能（31例，56%）、可能（18例，34%）、不太可能（3例）或无法评估（2例）。WHO-Vigibase也出现了类似的分布情况。
肌病和肝损伤的潜在安全信号提出了RYR安全性与他汀类药物相似的假设。应促进对膳食补充剂的持续监测，以最终确定其风险特征，从而支持监管机构采取适当行动。
