【作者】 郭刚；

【导师】 刘向群；

【作者基本信息】 山东中医药大学 ， 中西医结合临床， 2011， 博士

【摘要】 目的：以西医常规治疗为对照，观察基于“虚-瘀-毒”病机基础的中药复方（益气活血解毒方）治疗冠心病不稳定性心绞痛（UA）的临床疗效与安全性，并从抑制血小板活化、调节血脂、保护血管内皮、抗炎、抗氧化等环节深入探讨其作用机制。方法：符合纳入病例标准的冠心病不稳定性心绞痛患者60例，以随机数字表法分为益气活血解毒组（治疗组）和常规西药治疗组（对照组），每组30例。对照组给予常规西药治疗，治疗组在常规西药治疗的基础上，联合益气活血解毒方（药用黄芪、党参、丹参、当归、川芎、黄连），每日1剂，分2次服用。观察治疗14天后，两组患者心绞痛疗效总有效率、心电图有效率、硝酸甘油停减率、中医证候总有效率的差异、心功能和安全性指标（血、尿常规，肝肾功能），以及治疗前后血小板活化指标（CD62p，vWF）、血脂水平（TC，TG，LDL-C，HDL-C）、血管内皮因子（ET-1，NO，CGRP）、炎症因子（Hs-CRP，TNF-α）、氧化应激指标（SOD，MDA）的变化。结果：1.临床疗效及安全性比较：用药14天后，益气活血解毒组患者心绞痛疗效总有效率和显效率分别为93.3%和63.3%，对照组分别为86.7%和33.3%，益气活血解毒组显效率显著优于对照组（P＜0.05）；治疗组心电图总有效率、硝酸甘油停减率分别为77.3％和47.8％，治疗组显著优于对照组（P＜0.05）；两组中医症状总疗效分别为90%和60%，治疗组显著优于对照组（P＜0.01），且治疗组对胸痛、疲乏、心烦易怒、失眠多梦和大便干结等症状的疗效均优于对照组（P＜0.05或P＜0.01）；治疗前后心功能比较，对照组治疗后各收缩、舒张功能指标虽有改善的趋势，但无统计学意义，治疗组治疗后EF、SV、PFVE均显著升高（P＜0.05或P＜0.01），PFVA显著降低（P＜0.05）；两组治疗前后均未发生任何严重不良反应，且血、尿常规，肝肾功能无显著变化（P＞0.05）。2.机制探讨：用药14天后，两组患者血清TC、LDL-C水平均显著下降，组间比较治疗组降低LDL-C的作用显著优于对照组（P＜0.05）；治疗后两组患者血清CD62p、vWF下降幅度明显（P＜0.05或P＜0.01），且治疗组降低CD62p的幅度大于对照组（P＜0.05）；治疗后两组血清ET-1水平均显著降低，NO水平显著升高（P＜0.05或P＜0.01），治疗组CGRP水平显著升高（P＜0.05），而对照组未见显著性变化；治疗后Hs-CRP，TNF-α均显著下降，且治疗组降低Hs-CRP幅度显著大于对照组；治疗后治疗组血清SOD活性显著升高，MDA浓度显著降低，而对照组无显著变化，治疗组升高血清SOD活性的作用显著优于对照组（P＜0.05）。结论：基于“虚-瘀-毒”病机基础的中药复方（益气活血解毒方）治疗冠心病不稳定性心绞痛（UA）的临床确切，安全性高，其机制可能与抑制血小板活化、调节血脂、保护血管内皮、抗炎、抗氧化等环节有关，值得进一步研究。更多还原

【Abstract】 Objective: To observe the effect of complex prescription basedon “deficiency-stasis-toxin” pathogenisis (Qi-supplementing,blood-activating and toxin-resolving prescription) on patients with unstableangina pectoris (UA) of CHD, and discuss its mechanism from inhibitingactivation of platelet, regulating blood lipids, protecting endothelium,anti-inflammation and anti-oxidation. Methods:60cases of UA (according tothe diagnosis criterion) were randomly divided into two groups:Qi-supplementing, blood-activating and toxin-resolving group (treatmentgroup,30cases) and conventional west medicine group (control group,30cases). Patients in the control group were administrated with conventionalwestern medicine, and patients in the treatment group were combined withQi-supplementing, blood-activating and toxin-resolving prescription(composed with Huangqi, Dangshen, Danshen, Danggui, Chuanxiong and Huanglian),one dose daily, tow time a day. After14days of treatment, to observe theeffect on total effective rate of angina effect, effective rate of EKG,discontinue rate of nitroglycerin, total effective rate of TCM syndrome, heartfunction and its security indexes (blood and urina routine, liver and kidneyfunction); and to detect the changes of platelet activation indexes (CD62p，vWF), blood lipid level (TC，TG，LDL-C，HDL-C), vascular endothelial factors (ET-1，NO，CGRP), inflammatory factor (Hs-CRP，TNF-α), oxidative indexes (SOD，MDA). Results:1. Clincal effect and safety: After14days of treatment, totaleffective rate and obvious effective rate were93.3%and63.3%compared withcontrol group86.7%and33.3%, and the obvious effective rate in treatmentgroup was superior to control group (P＜0.05); effective rate of EKG anddiscontinue rate of nitroglycerin in treatment group were77.3％and47.8％, and was superior to those of control group; total effective rate of TCMsymptoms in treatment group (90%) was superior to control group (60%), andthe effect in improving TCM symptoms such as chest pain, tiredness, upsetandirritability, insomnia and dreamful sleep and dry stool is superior to controlgroup (P＜0.05or P＜0.01); heart function comparation, EF、SV、PFVE elevatedand PFVA reduced in treatment group (P＜0.05或P＜0.01), and the effect inimproving heart function was superior to that of control group. There was nochanges of blood and urina routine, liver and kidney function.2. Mechanismexploration: TC and LDL-C reduced in both group, and the treatment group wassuperior to control group in lowering LDL-C (P＜0.05); CD62p and vWF reducedin both group, and the treatment group was superior to control group inlowering CD62p (P＜0.05); ET-1reduced, NO elevated in both group(P＜0.05or P＜0.01), and CGRP elevated in treatment group (P＜0.05); Hs-CRP，TNF-α reduced in both group, and the treatment group was superior to control groupin lowering Hs-CRP (P＜0.05); SOD elevated and MDA reduced in threatment group,but there was no changes in control group, and the treatment group was superiorto control group in elevating SOD. Conclusion: Qi-supplementing,blood-activating and toxin-resolving prescription based on the “deficiency-stasis-toxin” pathogenisis has good clinical effect and safety in treatingunstable angina pectoris of CHD, and its mechanism might related withinhibiting platelet activation, regulating blood lipid, protecting vascularendothelium, anti-inflammation and anti-oxidation, and deserved furtherstudies.更多还原