清心解瘀方干预高炎症反应性稳定性冠心病随机双盲安慰剂对照研究  

Clinical Study of Qingxin Jieyu Decoction for Stable Coronary Heart Disease Patients with Elevated Inflammatory Reaction:A Randomized,Double-Blinded and Placebo Controlled Trial

作　　者：高翔 李思铭[2] 高铸烨[2] 李金根 于美丽 张贺[2] 张艳 张杰 李秋忆 徐浩[2] GAO Xiang;LI Si-ming;GAO Zhu-ye;LI Jin-gen;YU Mei-li;ZHANG He;ZHANG Yan;ZHANG Jie;LI Qiu-yi;XU Hao(Internal Medicine Division,Tieying Hospital of Fengtai District,Beijing 100079;Xiyuan Hospital,China Academy of Chinese Medical Sciences,National Clinical Research Center for Chinese Medicine Cardiology,Beijing 100091;Cardiovascular Department,Dongzhimen Hospital,The First Affiliated Hospital of Beijing University of Chinese Medicine,Beijing 100700;Cardiovascular Department,Beijing First Hospital of Integrated Chinese and Western Medicine,Beijing 100026;Graduate School,China Academy of Chinese Medical Sciences,Beijing 100700;Graduate School,Beijing University of Chinese Medicine,Beijing 100029)

机构地区：[1]北京市丰台区铁营医院内科,北京100079 [2]中国中医科学院西苑医院,国家中医心血管病临床医学研究中心,北京100091 [3]北京中医药大学东直门医院心血管科,北京100700 [4]北京市第一中西医结合医院心血管科,北京100026 [5]中国中医科学院研究生院,北京100700 [6]北京中医药大学研究生院,北京100029

出　　处：《中国中西医结合杂志》2022年第8期947-953,共7页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：首都临床特色应用研究专项(No.Z151100004015090);中国中医科学院中医药科技重大成果引导项目(No.ZZ13-ZD-03)。

摘　　要：目的以超敏C反应蛋白(hs-CRP)等炎症标记物为主要指标,评价清心解瘀方干预高炎症反应性稳定性冠心病患者的疗效及安全性。方法本研究采用随机、双盲、安慰剂对照的临床试验方法。筛查560例稳定性冠心病患者,选择72例高炎症反应性稳定性冠心病患者区组随机分为试验组和对照组,每组36例。试验组给予清心解瘀方颗粒剂加西药常规治疗,对照组给予安慰剂加西药常规治疗,疗程为6个月,随访6个月。观察两组治疗前后主要指标hs-CRP和其他炎症因子白介素-6(lL-6)、肿瘤坏死因子α(TNF-α)、抗原CD40配体(sCD40L)、可溶性血管细胞黏附分子-1(sVCAM-1)、基质金属蛋白酶-9(MMP-9)、单核细胞趋化蛋白1(MCP-1)、心绞痛分级、中医主症及血瘀证计分等次要指标的变化及不良反应。结果最终69例患者完成了试验,试验组34例,对照组35例。与本组治疗前比较,试验组血瘀证计分、心绞痛分级、胸闷、胸痛、乏力症状计分及hs-CRP、IL-6、sCD40L、MMP-9、sVCAM-1、MCP-1水平下降(P<0.05),对照组血瘀证计分、心绞痛分级、胸闷、胸痛症状计分及hsCRP、IL-6、sVCAM-1、MCP-1水平下降(P<0.05);与对照组同期比较,试验组血瘀证计分、心绞痛分级、胸闷、胸痛、乏力症状计分及hs-CRP、IL-6、sCD40L、MMP-9降低值均优于对照组(P<0.05)。治疗过程中未发现明显不良反应。结论在常规西药治疗基础上,加用清心解瘀方治疗6个月,不仅能改善心绞痛程度、血瘀证计分及胸痛、胸闷、乏力临床症状,还可进一步降低高炎症反应性稳定性冠心病患者血清hs-CRP及IL-6、MMP-9,s CD40L炎症因子水平,提示清心解瘀方有较好的抑制炎症反应的作用。Objective To evaluate the effectiveness and safety of Qingxin Jieyu Decoction(QXJYD)for stable coronary heart disease(CHD)patients with elevated inflammatory reaction using high sensitivity C reactive protein(hs-CRP)and other inflammatory markers as outcome measures.Methods A randomized,double-blinded,placebo-controlled study design was adopted.Totally 72 eligible stable CHD patients screened out of 560 patients with stable CHD were randomly assigned to the experimental group and the control group,36 cases in each group.The experimental group was treated with QXJYD on the basis of conventional Western medicine treatment,while the control group was treated with placebo on the basis of conventional Western medicine treatment.Patients were treated for 6 months,and followed up for another 6 months.The primary outcome hs-CRP,secondary outcomes including interleukin-6(lL-6),tumor necrosis factor-alpha(TNF-α),soluble cluster of differentiation 40 ligand(sCD40L),solvable vascular cell adhesion molecule-1(sVCAM-1),matrix metalloproteinase-9(MMP-9),monocyte chemoattractant protein-1(MCP-1),Chinese medicine symptoms,angina pectoris grade,blood stasis scores,and adverse reactions were assessed before and after treatment.Results Totally 69 cases completed the trial procedure,34 in the experimental group and 35 in the control group.Compared with before treatment,angina pectoris grade,blood stasis syndrome(BSS)scores and symptoms such as chest pain,chest distress and fatigue were all improved as well as the levels of hs-CRP,IL-6,sCD40L,MMP-9,sVCAM-1,and MCP-1 were statistically reduced in the experimental group(P<0.05).Angina pectoris grade,BSS scores and symptoms such as chest pain,chest distress were all improved and the levels of hs-CRP,IL-6,sVCAM-1,MCP-1 were reduced in the control group(P<0.05).Better effect in improving angina pectoris grade,BSS scores and symptoms such as chest pain,chest distress,fatigue and the reduction levels of hs-CRP,IL-6,sCD40L,MMP-9 were obtained in the experimental group compared with the contr

关 键 词：清心解瘀方 稳定性冠心病 超敏C反应蛋白 炎症因子 血瘀证 

分 类 号：R541.4[医药卫生—心血管疾病]