Department of Medicine and Surgery Sciences, University of Bologna, Bologna, Italy.
Department of Hypertension, Chair of Nephrology and Hypertension, Medical University of Lodz, Poland; Polish Mother's Memorial Hospital Research Institute (PMMHRI), Lodz, Poland; Cardiovascular Research Centre, University of Zielona Gora, Zielona Gora, Poland.
Pharmacol Res. 2019 May;143:1-16. doi: 10.1016/j.phrs.2019.02.028. Epub 2019 Mar 4.
Recently, concerns regarding the safety of red yeast rice (RYR) have been raised after the publication of some case reports claiming toxicity. Since the previous meta-analyses on the effects of RYR were mainly focused on its efficacy to improve lipid profile and other cardiovascular parameters, we carried out a meta-analysis on safety data derived from the available randomized controlled clinical trials (RCTs). Primary outcomes were musculoskeletal disorders (MuD). Secondary outcomes were non-musculoskeletal adverse events (Non-MuD) and serious adverse events (SAE). Subgroups analyses were carried out considering the intervention (RYR alone or in association with other nutraceutical compounds), monacolin K administered daily dose (≤3, 3.1-5 or >5 mg/day), follow-up (>12 or ≤12 weeks), with statin therapy or statin-intolerance and type of control treatment (placebo or statin treatment). Data were pooled from 53 RCTs comprising 112 treatment arms, which included 8535 subjects, with 4437 in the RYR arm and 4303 in the control one. Monacolin K administration was not associated with increased risk of MuD (odds ratio (OR) = 0.94, 95% confidence interval (CI) 0.53,1.65). Moreover, we showed reduced risk of Non-MuD (OR = 0.59, 95%CI 0.50, 0.69) and SAE (OR = 0.54, 95%CI 0.46, 0.64) vs. control. Subgroups analyses confirmed the high tolerability profile of RYR. Furthermore, increasing daily doses of monacolin K were negatively associated with increasing risk of Non-MuD (slope: -0.10; 95%CI: -0.17, -0.03; two-tailed p < 0.01). Based on our data, RYR use as lipid-lowering dietary supplement seems to be overall tolerable and safe in a large kind of moderately hypercolesterolaemic subjects.
最近，一些病例报告声称红曲米（RYR）有毒，引起了人们对其安全性的关注。由于之前关于 RYR 疗效的荟萃分析主要集中在改善血脂谱和其他心血管参数方面，我们对现有随机对照临床试验（RCT）的安全性数据进行了荟萃分析。主要结局是肌肉骨骼疾病（MuD）。次要结局是非肌肉骨骼不良事件（Non-MuD）和严重不良事件（SAE）。亚组分析考虑了干预措施（RYR 单独或与其他营养化合物联合使用）、每天给予的莫纳可林 K 剂量（≤3、3.1-5 或>5mg/天）、随访（>12 或≤12 周）、他汀类药物治疗或他汀类药物不耐受以及对照治疗类型（安慰剂或他汀类药物治疗）。数据来自 53 项 RCT，共包括 112 个治疗组，涉及 8535 名受试者，其中 RYR 组 4437 名，对照组 4303 名。莫纳可林 K 的给药与 MuD 风险增加无关（比值比（OR）=0.94，95%置信区间（CI）0.53，1.65）。此外，我们发现非 MuD（OR=0.59，95%CI 0.50，0.69）和 SAE（OR=0.54，95%CI 0.46，0.64）的风险降低。亚组分析证实了 RYR 的高耐受性。此外，莫纳可林 K 的日剂量增加与非 MuD 风险增加呈负相关（斜率：-0.10；95%CI：-0.17，-0.03；双侧 p<0.01）。根据我们的数据，RYR 作为降脂膳食补充剂使用，在一大类中度高胆固醇血症患者中总体上是耐受和安全的。
