摘要
目的评估丹参加葛根作为辅助治疗药物对冠状动脉粥样硬化性心脏病(冠心病)二级预防的疗效及安全性。方法符合入选标准的冠心病患者100例分为丹参、葛根胶囊治疗组(试验组)和安慰剂组(对照组),每组50例,进行为期6个月的随机、双盲临床研究。6个月后受试者再自愿选择参与6个月的开放试验,期间受试者口服丹参、葛根胶囊的剂量为1.5g/d。采用超声波血管扫描测量并评估肱动脉血流介导性血管舒张功能(flow mediated dilation,FMD)和颈动脉内-中膜厚度(intima-media thickness,IMT)。结果给药前,两组间基础指标均衡,治疗6个月后,两组的血压、血液学、血生化、叶酸及同型半胱氨酸水平与治疗前相比,差异无统计学意义(P>0.05);低密度脂蛋白胆固醇与治疗前相比均有轻度下降,差异有统计学意义[(2.6±0.7)mmol/Lvs.(2.7±0.9)mmol/L,P<0.05;(2.5±0.7)mmol/Lvs.(2.8±0.8)mmol/L,P<0.05];试验组治疗后FMD改善明显,差异有统计学意义(5.9%±1.0%vs.5.3%±1.2%,P<0.001),对照组治疗后FMD有一定程度改善(5.5%±1.0%vs.5.3%±1.1%,P<0.05)。IMT的改善仅发生在试验组,差异有统计学意义[(0.96±0.32)mmvs.(0.98±0.30)mm,P<0.05]。6个月开放试验结果显示,试验组FMD和IMT有进一步改善,差异有统计学意义[5.91%±0.95%vs.5.35%±1.21%,P<0.05;(0.964±0.316)mmvs.(0.979±0.303)mm,P<0.05]。研究期间8例出现不同程度不良反应:试验组2例;对照组6例,其中2例需要终止临床试验。结论丹参加葛根辅助治疗冠心病具有良好的耐受性,能有效改善血管功能和结构,可用于冠心病的二级预防。
Objectives We aimed to evaluate the efficacy and safety of salvia mihiorrhizae （Danshen） and puerariae lobata （Gegen） as adjuvant treatment in secondary prevention of coronary artery disease. Methods One hundred patients with coronary artery disease were randomized to adjunctive treatment with Danshen and Gegen capsules （D＆G group）or placebo （control group） for 6 months in double-blind parallel fashion, followed by optional open-label Danshen and Gegen（1.5 g/d） for 6 more months. Brachial flow-mediated dilation （FMD） and carotid intima-media thickness （IMT） were measured using ultrasound. Results Baseline characteristics were similar between the 2 groups. After 6 months treatment, there were no significant changes in blood pressures, blood hematological and biochemical profiles, folate and homocysteine levels in both groups when compared with baseline, but a mild decrease in low density lipoprotein cholesterol in both groups [ （ 2.6±0.7 ） mmol/L vs. （ 2.7±0.9 ） mmol/L, P〈0.05 ; （ 2.5 ±0.7 ） mmol/L vs. （ 2.8± 0.8）mmol/L, P〈0.05 ]. Braehial FMD improved after treating in D＆G group （5.9%±1.0% vs. 5.3%±1.2%, P〈0.001 ） and it less improved in control group （5.5 %± 1.0% vs.5.3 %± 1.1%, P〈0.05 ）. Improvement in carotid IMT was observed in D＆G group only and it has significance [（0.96±0.32）mm vs.（0.98±0.30）mm,P〈0.05]. After open-label D＆G treatment for 6 more months, further improvement in both brachial FMD and carotid IMT were observed in D＆G group, and they had significance[5.91%±0.95% vs. 5.35%±1.21% ,P〈0.05 ; （0.964±0.316）mm vs. （0.979±0.303）mm, P〈 0.05]. Eight adverse events were reported： 2 in D＆G group; 6 in eontrol group, among whieh, 2 patients required treatment termination. Conclusions Danshen and Gegen adjunetive treatment in patients with eoronary arter disease were well tolerated and effective in improving vascular function and structure. These two herbs may become a novel agent for secondary prevention.
出处
《岭南心血管病杂志》
2011年第1期48-52,共5页
South China Journal of Cardiovascular Diseases
基金
香港特别行政区大学教育资助委员会资助(项目编号:AoE/B-10/01)
