| 徐俊鹏;徐丹苹;王 侠.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[J].中国中西医结合杂志,2023,43(11):1297-1303 |
| 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 |
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| DOI：10.7661/j.cjim.20230507. 046 |
| 中文关键词: 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 |
| 英文关键词:Kuanxiong Aerosol warming and dredging prescription coronary heart disease qi stagnation and blood stasis syndrome anxiety and depression Chinese patent medicine randomized controlled trial integrative medicine |
| 基金项目:广东省中医院中医药科学技术研究专项（No.YN2014LN06） |
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| 中文摘要: |
| 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，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。 |
| 英文摘要: |
| 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 PHQ-9 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-pre-values 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），χ2=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 patients with QSBSS after PCI. |
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