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红曲霉菌用于他汀类药物和依折麦布不耐受的杂合子家族性高胆固醇血症患者:一项临床研究。

Monascus purpureus for statin and ezetimibe intolerant heterozygous familial hypercholesterolaemia patients: A clinical study.

作者信息

Stefanutti Claudia, Mazza Fabio, Mesce Dario, Morozzi Claudia, Di Giacomo Serafina, Vitale Marco, Pergolini Mario

机构信息

Extracorporeal Therapeutic Techniques, Lipid Clinic and Atherosclerosis Prevention Centre, Department of Molecular Medicine, University of Rome 'Sapienza', Umberto I Hospital, Rome, Italy.

Extracorporeal Therapeutic Techniques, Lipid Clinic and Atherosclerosis Prevention Centre, Department of Molecular Medicine, University of Rome 'Sapienza', Umberto I Hospital, Rome, Italy.

出版信息

Atheroscler Suppl. 2017 Nov;30:86-91. doi: 10.1016/j.atherosclerosissup.2017.05.021.

DOI:10.1016/j.atherosclerosissup.2017.05.021
PMID:29096866
Abstract

BACKGROUND

Hypercholesterolaemia is a major risk factor for cardiovascular disease and requires effective therapy in affected patients. Statins, the mainstay of lipid-lowering therapy, can cause side effects, including myalgia, in some patients. Ezetimibe, is frequently used as an add-on therapy for statins, and is also used as a monotherapy in statin-intolerant patients, however elevations in liver transaminases can occur. We examined the lipid-lowering efficacy of the natural fungal product Monascus purpureus (MP), which contains the natural statin monacolin K.

METHODS

Fifty-five patients with familial hypercholesterolaemia who had discontinued statins due to muscle symptoms. Patients were placed on a lipid-lowering diet cholesterol-lowering diet (1500-1800 kcal daily, 30% lipids, 19% proteins and 52% carbohydrates). MP was added to the diet at a dose of 300 mg (providing monacolin K 10 mg). Patients were followed for 12 months. Lipid profiles and adverse event data were collected in the normal course of patient care.

RESULTS

After 6 months of treatment with MP and diet therapy, statistically significant changes in low-density lipoprotein cholesterol were evident (-17% for males, -16% for females; p < 0.005) Levels fell to -24% and -27% respectively at 12 months. No patients experienced elevated serum aminotransferases or C-reactive protein levels.

CONCLUSIONS

MP is a viable option for lipid-lowering therapy in statin-intolerant patients with hypercholesterolaemia, with good efficacy and safety profiles.

摘要

背景

高胆固醇血症是心血管疾病的主要危险因素,患病患者需要接受有效治疗。他汀类药物是降脂治疗的主要药物,但在部分患者中会引发副作用,包括肌痛。依折麦布常作为他汀类药物的附加治疗药物,也用于不耐受他汀类药物的患者的单一治疗,但可能会导致肝转氨酶升高。我们研究了天然真菌产物红曲(MP)的降脂效果,其含有天然他汀类药物莫纳可林K。

方法

55例因肌肉症状停用他汀类药物的家族性高胆固醇血症患者。患者采用降脂饮食(每日1500 - 1800千卡,3​​0%为脂质,19%为蛋白质,52%为碳水化合物)。MP以300毫克的剂量添加到饮食中(提供10毫克莫纳可林K)。对患者进行12个月的随访。在患者常规护理过程中收集血脂谱和不良事件数据。

结果

经过6个月的MP和饮食治疗后,低密度脂蛋白胆固醇有明显的统计学显著变化(男性为-17%,女性为-16%;p < 0.005)。在12个月时,水平分别降至-24%和-27%。没有患者出现血清转氨酶或C反应蛋白水平升高。

结论

对于不耐受他汀类药物的高胆固醇血症患者,MP是一种可行的降脂治疗选择,具有良好的疗效和安全性。

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