益气散聚方治疗代谢综合征肥胖高危人群的临床研究

Clinical research of Yiqi Sanju Formula in treating central obese men at high risk of metabolic syndrome

目的:观察益气散聚方在“聚证”学说指导下治疗代谢综合征肥胖高危人群的临床疗效。方法:以30名健康志愿者为参照,将45名中心性肥胖患者随机分为中药组和安慰剂组,分别予益气散聚方和安慰剂治疗10周,观察治疗前后一般状况、胰岛素抵抗、相关炎症因子及纤溶系统因子变化。结果:与对照组相比,肥胖人群胰岛素抵抗指数、C反应蛋白、游离脂肪酸、纤溶酶原激活物抑制物1均有升高,组织纤溶酶原激活物下降;治疗后,中药组体质量指数、腰围、腰臀比及胰岛素抵抗指数、C反应蛋白、游离脂肪酸、纤溶酶原激活物抑制物1均明显改善,与安慰剂组相比,差异有统计学意义。结论:益气散聚方可明显降低代谢综合征肥胖高危人群肥胖和胰岛素抵抗程度,并能改善炎症状态、纤溶系统功能,减轻致动脉粥样硬化的危险性。

Objective： To observe the therapeutic effects of Yiqi Sanju Formula （YQSJF）, a compound Chinese herbal medicine, on central obese men at high risk of metabolic syndrome （MS）. Methods： Compared with 30 healthy male volunteers, 45 central obese men were separated randomly into two groups and received the interventions with YQSJF and placebo respectively for 10 weeks. Baseline characteristics, insulin resistance, inflammation cytokines and plasminogen activator inhibitor-1 （PAI-1） and tissue plasminogen activator （t-PA） were evaluated before and after treatment. Results： The score of homeostatic model assessment for insulin resistance （HOMA-IR） and the levels of C reactive protein （CRP）, free fatty acid （FFA） and PAI-1 in obese men were higher than those in the control group, while t-PA was lower. After treatment, compared with placebo group, body mass index, waist, and waist-to-hip ratio were decreased significantly in subjects who received YQSJF （ P 〈0.01）. The score of HOMA-IR and the levels of CRP, FFA and PAI-1 were decreased significantly, and the level of t-PA was increased significantly （ P 〈0.01）. Conclusion： YQSJF can reduce obesity and insulin resistance in central obese men at high risk of MS and improve inflammation and fibrinolysis, which indicates that it can reduce the risk of atherosclerosis.