宽胸气雾剂治疗冠心病经皮冠状动脉介入术后气滞血瘀证焦虑和(或)抑郁随机对照研究  

Treatment of Depression and/or Anxiety in Coronary Heart Disease Patients with Qi Stagnation and Blood Stasis Syndrome After Percutaneous Coronary Intervention by Kuanxiong Aerosol:A Randomized Controlled Trial

作　　者：徐俊鹏 徐丹苹[1,2] 王侠 XU Jun-peng;XU Dan-ping;and WANG Xia(The Second Clinical College of Guangzhou University of Chinese Medicine,Guangzhou,510405;The Integrated Traditional and Western Medicine Postdoctoral Station,Fujian University of Traditional Chinese Medicine,Fuzhou,350122)

机构地区：[1]广州中医药大学第二临床医学院,广州510405 [2]福建中医药大学中西医结合博士后流动站,福州350122

出　　处：《中国中西医结合杂志》2023年第11期1297-1303,共7页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：广东省中医院中医药科学技术研究专项(No.YN2014LN06)。

摘　　要：目的观察宽胸气雾剂治疗冠心病经皮冠状动脉介入治疗(PCI)术后气滞血瘀证焦虑和(或)抑郁患者的疗效和安全性。方法纳入冠心病PCI术后气滞血瘀证焦虑和(或)抑郁患者64例,按1∶1随机分成试验组和对照组,每组32例。试验组给予标准西医治疗加宽胸气雾剂,对照组给予标准西医治疗,治疗周期为4周。观察广泛性焦虑筛查量表(GAD-7)、抑郁症筛查量表(PHQ-9)、西雅图心绞痛量表(SAQ)和加拿大心血管病学会(CCS)心绞痛分级的改变及不良反应发生情况。结果最终试验组和对照组各30例患者完成随访。与本组治疗前比较,治疗后试验组GAD-7和PHQ-9评分均降低(P<0.01),SAQ五项评分的躯体活动受限、心绞痛稳定状态、心绞痛发作情况和疾病认知程度评分均升高(P<0.01),对照组疾病认知程度评分升高,心绞痛发作情况评分降低(P<0.05)。治疗后与对照组比较,试验组GAD-7和PHQ-9评分更低(P<0.05,P<0.01),前后差值更大(P<0.01),SAQ五项评分中躯体活动受限、心绞痛稳定状态、心绞痛发作情况和治疗满意程度方面评分升高(P<0.05),其中心绞痛发作情况和疾病认知程度的治疗前后得分差值变化更大(P<0.01)。治疗后试验组CCS心绞痛分级的总改善率为81.48%(22/27),高于对照组60.00%(15/25,χ^(2)=3.93,P=0.047)。试验中无不良反应。结论宽胸气雾剂对冠心病PCI术后气滞血瘀证焦虑和(或)抑郁患者有改善心绞痛和抗郁证的作用,安全性良好。Objective To observe the clinical efficacy and safety of Kuanxiong Aerosol(KA)for treatment depression and/or anxiety in coronary heart disease(CHD)patients with qi stagnation and blood stasis syndrome(QSBSS)after percutaneous coronary intervention(PCI).Methods Totally 64 depression and/or anxiety CHD patients with QSBSS were randomly assigned to the control group and the experimental group in the ratio of 1:1,32 in each group.Patients in the control group received conventional Western medicine,while those in experimental group additionally received KA.The therapeutic course for all was 4 weeks.Changes of Generalized Anxiety Disorder-7(GAD-7),Patient Health Questionnaire-9(PHQ-9),Seattle Angina Questionnaire(SAQ),Canadian Cardiovascular Society(CCS)Functional Classification of Angina,and adverse events were observed before and after treatment.Results Finally,30 patients in both groups completed follow-up.Compared with before treatment in the same group,the scores of GAD-7 and PHQ9 decreased(P<0.01)in experimental group.In five items of the SAQ,the scores of physical limitation,anginal stability,anginal frequency and disease perception increased in experimental group(P<0.01),while the scores of disease perception increased and anginal frequency decreased in control group(P<0.05).Compared with the control group after treatment,the scores of GAD-7 and PHQ-9 were obviously lower in the experimental group(P<0.05,P<0.01),post-prevalues were more obviously highter(P<0.01).In five items of the SAQ,the scores of physical limitation,anginal stability,anginal frequency,and treatment satisfaction increased(P<0.05),change of anginal frequency and disease perception post-pre-values increased(P<0.01).The total improvement rate of the CCS Functional Classification of Angina in experimental group was 81.48%(22/27),which was higher than that of the controls[60.00%(15/25),χ^(2)=3.93,P=0.047].There was no adverse events during the whole trial.Conclusion KA showed good safety in treating angina and depression and/or anxiety in CHD p

关 键 词：宽胸气雾剂 芳香温通 冠心病 气滞血瘀 郁证 中成药 随机对照试验 中西医结合 

分 类 号：R541.4[医药卫生—心血管疾病]