Ren N N, Chen H J, Li Y, Mcgowan G W, Lin Y G
Guangdong Online Hospital Clinic, Guangdong 2nd Provincial People's Hospital, Guangzhou 510317, China.
Department of Traditional Chinese Medicine, the 3rd Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, China.
Zhonghua Yi Xue Za Zhi. 2017 Jul 11;97(26):2038-2042. doi: 10.3760/cma.j.issn.0376-2491.2017.26.005.
To evaluate the efficacy of oral nattokinase (NK) in the reduction of common carotid artery intimal medial thickness (CCA-IMT) and carotid artery plaque size and in lowering blood lipids, and to explore the underlying mechanism of actions of NK and its potential clinical use. All enrolled patients were from the Out-Patient Clinic of the Department of TCM at the 3(rd) Affiliated Hospital of Sun Yat-sen University. Using randomised picking method, all patients were randomly assigned to one of two groups, NK and Statin (ST) group. NK Group-patients were given NK at a daily dose of 6 000 FU and ST Group-patients were treated with statin (simvastatin 20 mg) daily. The treatment course was 26 weeks. CCA-IMT, carotid plaque size and blood lipid profile of the patients were measured before and after treatment. A total of 82 patients were enrolled in the study and 76 patients (NK 39, ST 37) completed the study. Following the treatments for 26 weeks, there was a significant reduction in CCA-IMT and carotid plaque size in both groups compared with the baseline before treatment. The carotid plaque size and CCA-IMT reduced from(0.25±0.12)cm(2) to (0.16±0.10)cm(2) and from (1.13±0.12)mm to (1.01±0.11)mm, repectively. The reduction in the NK group was significantly profound (<0.01, 36.6% reduction in plaque size in NK group versus 11.5% change in ST group). Both treatments reduced total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and triglyceride (TG). While the reduction in both groups was shown to be statistically significant (<0.01), the reduction of TC, LDL-C and TG in ST group was significantly greater (<0.05). In addition, NK significantly increased the level of high-density lipoprotein cholesterol (HDL-C) (<0.05), in contrast, HDL-C in the ST group did not change. The lipid lowering effect observed in the NK group was not correlated to the reduction of CCA-IMT and carotid artery plaque size (=0.35, =0.09). Our findings from this pioneer clinical study suggests that daily NK supplementation is an effective way to manage the progression of atherosclerosis and potentially may be a better alternative to statins which are commonly used to reduce atherosclerosis and further to prevent cardiovascular attack and stroke in patients. The mechanism underlying the reduction of carotid atherosclerosis by NK may be independent from its lipid-lowering effect, which is different from that of statins.
评估口服纳豆激酶（NK）在降低颈总动脉内膜中层厚度（CCA-IMT）、减小颈动脉斑块大小以及降低血脂方面的疗效，并探讨NK的潜在作用机制及其临床应用潜力。所有入组患者均来自中山大学附属第三医院中医门诊。采用随机抽签法，将所有患者随机分为两组，即NK组和他汀类药物（ST）组。NK组患者每日服用剂量为6000FU的NK，ST组患者每日服用他汀类药物（辛伐他汀20mg）。疗程为26周。在治疗前后测量患者的CCA-IMT、颈动脉斑块大小和血脂谱。共有82例患者纳入本研究，76例患者（NK组39例，ST组37例）完成研究。经过26周的治疗，与治疗前的基线相比，两组的CCA-IMT和颈动脉斑块大小均显著减小。颈动脉斑块大小和CCA-IMT分别从（0.25±0.12）cm²降至（0.16±0.10）cm²，从（1.13±0.12）mm降至（1.01±0.11）mm。NK组的减小更为显著（P<0.01，NK组斑块大小减小36.6%，而ST组变化为11.5%）。两种治疗均降低了总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）和甘油三酯（TG）。虽然两组的降低均具有统计学意义（P<0.01），但ST组的TC、LDL-C和TG降低更为显著（P<0.05）。此外，NK显著提高了高密度脂蛋白胆固醇（HDL-C）水平（P<0.05），相比之下，ST组的HDL-C没有变化。NK组观察到的降脂效果与CCA-IMT和颈动脉斑块大小的减小无关（r=0.35，P=0.09）。我们这项开创性临床研究的结果表明，每日补充NK是控制动脉粥样硬化进展的有效方法，并且可能是他汀类药物的更好替代选择，他汀类药物常用于降低动脉粥样硬化风险以及进一步预防患者发生心血管疾病发作和中风。NK降低颈动脉粥样硬化的潜在机制可能与其降脂作用无关，这与他汀类药物不同。
