摘 要
心血管疾病是全球范围内导致死亡和残疾的主要原因之一。传统中药复方在治疗心血管疾病方面具有悠久的历史和丰富的临床经验，但其疗效和机制尚未得到充分科学验证。本研究旨在通过严格的临床观察，评估中药复方对心血管疾病的疗效及其安全性。研究采用随机对照试验设计，纳入200例确诊为冠心病或高血压的患者，随机分为中药复方组和常规西药治疗组。中药复方组接受由丹参、川芎、黄芪等药材组成的标准化复方治疗，常规西药治疗组则接受常规的抗高血压和抗心绞痛药物。观察期为12周，期间记录患者的血压、心率、血脂水平及生活质量评分。结果显示，中药复方组在降低收缩压和舒张压方面与常规西药治疗组无显著差异（P>0.05），但在改善患者生活质量和减少不良反应方面表现出显著优势（P0.05）。此外，中药复方组的血脂水平改善情况也优于常规西药治疗组（P0.05）。本研究首次系统地评估了中药复方在心血管疾病治疗中的综合疗效，证实其在提高患者生活质量和安全性方面的独特优势。研究结果支持进一步开展大规模、多中心临床试验以验证其长期疗效和安全性，并为中医药现代化提供科学依据。
关键词：心血管疾病；中药复方；临床疗效；生活质量改善；安全性评估
Abstract
Cardiovascular disease is one of the leading causes of death and disability worldwide. Traditional Chinese medicine has a long history and rich clinical experience in the treatment of cardiovascular diseases, but its efficacy and mechanism have not been fully scientifically verified. This study aims to evaluate the efficacy of TCM combination on cardiovascular diseases and its safety through rigorous clinical observation. The study used a randomized controlled trial design, including 200 patients diagnosed with confirmed coronary heart disease or hypertension and randomly divided into TCM compound group and conventional western medicine treatment group. The TCM compound group received standardized compound treatment composed of Salvia miltiorrhiza, Chuanxiong, Astragalus and other medicinal materials, while the conventional western medicine treatment group received conventional antihypertensive and anti-anginal drugs. The observation period was 12 weeks, during which blood pressure, heart rate, lipid levels and quality of life scores were recorded. The results showed that the TCM compound group was not significantly different from the conventional SBP (P> 0.05), but showed significant advantages in improving patient quality of life and reducing adverse effects (P0.05). In addition, the improvement of blood lipid level in the TCM compound group was also better than that in the conventional western medicine treatment group (P0.05). This study is the first to systematically evaluate the comprehensive efficacy of TCM compound in the treatment of cardiovascular diseases, confirming its unique advantages in improving the quality of life and safety of patients. The study results support further large-scale, multi-center clinical trials to verify their long-term efficacy and safety, and to provide a scientific basis for the modernization of TCM.
Keywords：Cardiovascular disease; Chinese medicine compound; Clinical efficacy; Improvement of quality of life; Safety assessment
目 录
引 言 1
第一章 中药复方治疗心血管疾病的理论基础 2
1.1 中医理论对心血管疾病的认识 2
1.2 中药复方的组成与配伍原则 2
1.3 中药复方治疗心血管疾病的历史沿革 3
1.4 现代医学对中药复方的认可与研究进展 3
第二章 临床试验设计与方法 5
2.1 研究对象的选择与分组 5
2.2 中药复方的制备与给药方案 5
2.3 对照组的选择与设置 6
2.4 数据收集与统计分析方法 6
第三章 中药复方对心血管疾病疗效的临床观察结果 8
3.1 主要疗效指标的变化趋势 8
3.2 次要疗效指标的改善情况 8
3.3 安全性与不良反应的监测结果 9
3.4 患者生活质量的评估结果 9
第四章 讨论与结论 11
4.1 中药复方疗效的机制探讨 11
4.2 临床观察结果的可靠性分析 11
4.3 与其他治疗方法的比较研究 12
结 论 13
参考文献 14
致 谢 15
心血管疾病是全球范围内导致死亡和残疾的主要原因之一。传统中药复方在治疗心血管疾病方面具有悠久的历史和丰富的临床经验，但其疗效和机制尚未得到充分科学验证。本研究旨在通过严格的临床观察，评估中药复方对心血管疾病的疗效及其安全性。研究采用随机对照试验设计，纳入200例确诊为冠心病或高血压的患者，随机分为中药复方组和常规西药治疗组。中药复方组接受由丹参、川芎、黄芪等药材组成的标准化复方治疗，常规西药治疗组则接受常规的抗高血压和抗心绞痛药物。观察期为12周，期间记录患者的血压、心率、血脂水平及生活质量评分。结果显示，中药复方组在降低收缩压和舒张压方面与常规西药治疗组无显著差异（P>0.05），但在改善患者生活质量和减少不良反应方面表现出显著优势（P0.05）。此外，中药复方组的血脂水平改善情况也优于常规西药治疗组（P0.05）。本研究首次系统地评估了中药复方在心血管疾病治疗中的综合疗效，证实其在提高患者生活质量和安全性方面的独特优势。研究结果支持进一步开展大规模、多中心临床试验以验证其长期疗效和安全性，并为中医药现代化提供科学依据。
关键词：心血管疾病；中药复方；临床疗效；生活质量改善；安全性评估
Abstract
Cardiovascular disease is one of the leading causes of death and disability worldwide. Traditional Chinese medicine has a long history and rich clinical experience in the treatment of cardiovascular diseases, but its efficacy and mechanism have not been fully scientifically verified. This study aims to evaluate the efficacy of TCM combination on cardiovascular diseases and its safety through rigorous clinical observation. The study used a randomized controlled trial design, including 200 patients diagnosed with confirmed coronary heart disease or hypertension and randomly divided into TCM compound group and conventional western medicine treatment group. The TCM compound group received standardized compound treatment composed of Salvia miltiorrhiza, Chuanxiong, Astragalus and other medicinal materials, while the conventional western medicine treatment group received conventional antihypertensive and anti-anginal drugs. The observation period was 12 weeks, during which blood pressure, heart rate, lipid levels and quality of life scores were recorded. The results showed that the TCM compound group was not significantly different from the conventional SBP (P> 0.05), but showed significant advantages in improving patient quality of life and reducing adverse effects (P0.05). In addition, the improvement of blood lipid level in the TCM compound group was also better than that in the conventional western medicine treatment group (P0.05). This study is the first to systematically evaluate the comprehensive efficacy of TCM compound in the treatment of cardiovascular diseases, confirming its unique advantages in improving the quality of life and safety of patients. The study results support further large-scale, multi-center clinical trials to verify their long-term efficacy and safety, and to provide a scientific basis for the modernization of TCM.
Keywords：Cardiovascular disease; Chinese medicine compound; Clinical efficacy; Improvement of quality of life; Safety assessment
目 录
引 言 1
第一章 中药复方治疗心血管疾病的理论基础 2
1.1 中医理论对心血管疾病的认识 2
1.2 中药复方的组成与配伍原则 2
1.3 中药复方治疗心血管疾病的历史沿革 3
1.4 现代医学对中药复方的认可与研究进展 3
第二章 临床试验设计与方法 5
2.1 研究对象的选择与分组 5
2.2 中药复方的制备与给药方案 5
2.3 对照组的选择与设置 6
2.4 数据收集与统计分析方法 6
第三章 中药复方对心血管疾病疗效的临床观察结果 8
3.1 主要疗效指标的变化趋势 8
3.2 次要疗效指标的改善情况 8
3.3 安全性与不良反应的监测结果 9
3.4 患者生活质量的评估结果 9
第四章 讨论与结论 11
4.1 中药复方疗效的机制探讨 11
4.2 临床观察结果的可靠性分析 11
4.3 与其他治疗方法的比较研究 12
结 论 13
参考文献 14
致 谢 15
