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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。
Objective To evaluate the efficacy and safety of Salvia miltiorrhiza with Radix Puerariae as adjuvant therapy on secondary prevention of coronary atherosclerotic heart disease (CHD). Methods One hundred patients with coronary heart disease who meet the inclusion criteria were divided into three groups: Salviae Miltiorrhizae, Gegen Capsule (experimental group) and placebo (control group), 50 patients in each group. The patients were randomized, double-blind clinical study. Subjects then volunteered to participate in the 6-month open trial after 6 months. During this period, the subjects took salvia and gegen capsules at a dose of 1.5 g / d. Brachial artery flow-mediated dilation (FMD) and carotid intima-media thickness (IMT) were measured and evaluated using ultrasound vascular scanning. Results Before the administration, the basic indexes were balanced. After 6 months of treatment, there was no significant difference in blood pressure, hematology, blood biochemistry, folic acid and homocysteine between the two groups before treatment (P > 0.05). LDL cholesterol decreased slightly compared with those before treatment ([(2.6 ± 0.7) mmol / L vs (2.7 ± 0.9) mmol / L, P < ± 0.7) mmol / L vs (2.8 ± 0.8) mmol / L, P <0.05]. The FMD of the experimental group improved significantly after treatment (5.9% ± 1.0% vs.5.3% ± 1.2%, P < 0.001). The FMD in the control group improved to some extent (5.5% ± 1.0% vs.5.3% ± 1.1%, P <0.05). IMT improvement occurred only in the experimental group, the difference was statistically significant [(0.96 ± 0.32) mm vs (0.98 ± 0.30) mm, P <0.05]. The result of 6 months’ open trial showed that the FMD and IMT in the experimental group were further improved with the difference statistically significant [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]. There were 8 adverse reactions in the study during the study period: 2 in the test group and 6 in the control group, of which 2 required termination of the clinical trial. Conclusion Radix Salviae puerarin adjuvant treatment of coronary heart disease has good tolerance, can effectively improve vascular function and structure, can be used for secondary prevention of coronary heart disease.