Monascus purpureus NTU 568 發酵產物對輕、中度高血壓病患調節血壓功效隨機雙盲人體試驗之研究

Abstract

高血壓與心血管疾病相關的併發症是國人重要的十大死因，患者一旦發現罹患高血壓，便需長期監控血壓並積極改善生活習慣，甚至服藥控制血壓。降血壓藥物多具有副作用，不當服用降壓藥物常會造成無法挽回的傷害。紅麴已有千年的使用歷史，紅麴發酵產物含有降血壓物質 γ-胺基丁酸 (γ-aminobutyric acid, GABA)，為抑制性神經傳導物質，可引起血管擴張。以 Monascus purpureus NTU 568 紅麴山藥發酵產物連續八週餵食自發性高血壓大鼠 (spontaneously hypertensive rats, SHR) 已被證實能顯著降低收縮壓 26 mmHg 與舒張壓 22 mmHg (p<0.05)，作用溫和且不會對肝腎造成損害。本研究以隨機雙盲試驗將輕、中度的高血壓患者分為安慰劑組與治療組，並給予治療組 M. purpureus NTU 568 紅麴山藥產品 8 週，觀察在人體臨床試驗輔助調節血壓的效果。結果顯示治療組 11 位受試者中有 4 位受試者的收縮壓下降 ≧ 10 mmHg，收縮壓由 141.6 ± 12.0 下降至 133.9 ± 14.4 mmHg，平均下降 7.7 mmHg。治療組 11 位受試者中有 5 位受試者舒張壓下降 ≧ 10 mmHg，舒張壓由 91.7 ± 8.1 下降至 84.8 ± 7.4 mmHg，平均下降 6.9 mmHg，試驗前後達顯著差異 (p<0.05)，但無組間差異。紅麴山藥不會對受試者肝、腎及肌肉組織造成損害亦無電解質失衡的現象。本研究亦發現紅麴山藥能有效降低治療組血清中三酸甘油酯及總膽固醇，並提升高密度脂蛋白膽固醇、減少低密度脂蛋白膽固醇的含量，達到心血管保健的效果。

Hypertension and cardiovascular complications are the leading cause of death of compatriots. Once patients suffer from hypertension, they need long-term monitoring of blood pressure and actively improve the living habits. Even more, take medication to control blood pressure. Antihypertensive drugs usually have side effects, improper use of antihypertensive medications often cause irreparable harm. The application of Monascus species in food, medicine, and industry dates back over a thousand years. Monascus-fermented products containing antihypertensive substance γ-amino butyric acid (GABA), an inhibitory neurotransmitter, can cause blood vessels to dilate. Oral administration of red mold dioscorea fermented by Monascus purpureus NTU 568 to spontaneously hypertensive rats (SHR) for eight weeks has been shown to significantly reduce systolic blood pressure 26 mmHg and diastolic blood pressure 22 mmHg (p<0.05) and will not have liver and kidney damage. In this study, a double-blind placebo-controlled model was undertaken. Patients with mild to moderate hypertension were randomly assigned to placebo and treatment groups. Treatment group was given red mold dioscorea (fermented by M. purpureus NTU 568) for 8 weeks to observe the effect of regulating blood pressure in human clinical trials. The results showed that systolic blood pressure of 4 subjects decreased greater than or equal to 10 mmHg in 11 subjects of treatment group. Systolic blood pressure decreased from 141.6 ± 12.0 to 133.9 ± 14.4 mmHg, the average dropped 7.7 mmHg. Diastolic blood pressure decreased from 91.7 ± 8.1 to 84.8 ± 7.4 mmHg, the average dropped 6.9 mmHg. Diastolic blood pressure of 5 subjects decreased greater than or equal to 10 mmHg in 11 subjects of treatment group. The result showed a significant difference (p<0.05), although there was no significant difference between the placebo and treatment groups. Red mold dioscorea did not cause electrolyte imbalance and damage between liver, kidney and muscle tissue of subjects. The study also found that red mold dioscorea treatment could effectively reduce serum triglycerides and total cholesterol, increase high-density lipoprotein cholesterol, and reduce low-density lipoprotein cholesterol levels to achieve cardiovascular health.