目的：壽美降脂一號 (LipoCol Forte) 源自於紅麴菌 (Monascus purpureus Went) 發酵而來，紅麴常用於他汀類替代選擇治療高脂血症。本研究將評估壽美降脂一號於高血脂症患者的臨床療效與安全性。
方法：本研究為回溯性病歷回顧研究，研究族群為某醫學中心中醫部病患資料，觀察時間為2015 年2 月至2017 年12 月。研究對象為研究期間初次使用壽美降脂一號的病患，連續服用每日1.2 g，治療12 週後，評估總膽固醇 (total cholesterol, TC)、低密度脂蛋白膽固醇 (low-density lipoprotein cholesterol, LDL-C)、高密度脂蛋白膽固醇 (high-density lipoprotein cholesterol, HDL-C)、三酸甘油脂 (triglyceride, TG) 為療效指標；麩草酸轉胺酶 (glutamic-oxaloacetic transaminase, GOT)、麩丙酮轉胺酶 (glutamic-pyruvic transaminase, GPT)、肌酸激酶 (creatine phosphokinase, CPK) 為安全性指標。
結果：於研究期間共收入117 位初次使用壽美降脂一號病患，口服壽美降脂一號12週後，血清TC、LDL-C、HDL-C 和TG 分別下降26.89 ± 42.44 mg/dL (n = 88, p < 0.01)、22.07 ± 35.56 mg/dL (n = 81, p < 0.01)、2.29 ± 8.95 mg/dL (n = 80, p = 0.03)、0.86 ± 107.50 mg/dL (n = 88, p = 0.94)。GOT 和GPT 分別上升0.67 ± 6.61 IU/L (n = 73, p = 0.39)、0.40 ± 10.57 IU/L (n = 81, p = 0.73) 上升，CPK 下降4.28 ± 37.43 IU/L (n = 7, p = 0.77)。
結論：壽美降脂一號可降低血清TC 和LDL-C，在高血脂治療耐受性良好且安全、有效。

Objective: The LipoCol Forte is derived from the fermentation of Monascus purpureus Went, which is often used in statin alternative therapy for hyperlipidemia. This study will evaluate the clinical efficacy and safety of LipoCol Forte in patients with hyperlipidemia.
Methods: This study is a retrospective review of medical records. The study population is the data of patients from the Chinese Medical Department of a medical center. The observation time was from February 2015 to December 2017. The subjects were the patients who used the LipoCol Forte for the first time during the study period, taking 1.2 g daily for 12 weeks, and evaluated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG), which were effective indicators; glutamic-oxaloacetic transaminase (GOT), glutamic-pyruvic transaminase (GPT), and creatine phosphokinase (CPK) were safety indicators.
Results: During the study period, a total of 117 patients with the LipoCol Forte were used for the first time. After 12 weeks of oral administration of the LipoCol Forte, serum TC, LDL-C, HDL-C, and TG decreased by 26.89 ± 42.44 mg/dL (n = 88, p < 0.01), 22.07 ± 35.56 mg/dL (n = 81, p < 0.01), 2.29 ± 8.95 mg/dL (n = 80, p = 0.03), 0.86 ± 107.50 mg/dL (n = 88, p = 0.94). GOT and GPT increased by 0.67 ± 6.61 IU/L (n = 73, p = 0.39), 0.40 ± 10.57 IU/L (n = 81, p = 0.73), and CPK decreased by 4.28 ± 37.43 IU/L (n = 7, p = 0.77).
Conclusions: The LipoCol Forte can reduce serum TC and LDL-C, and is well tolerated, safe and effective in hyperlipidemia treatment.


Summited for publication: 2019.10.26; Accepted for publication: 2020.5.22