丹红注射液治疗冠心病心绞痛研究中的问题与解决对策

冠心病心绞痛是一种常见的多基因复杂疾病,血瘀证是其主要证候。在世界范围内冠心病是目前最重要的死亡原因和疾病负担之一。尽管有诸多治疗方法和抗心绞痛药物出现,但一些患者仍然会经历心血管事件,而且由于症状频发所致生活质量受损的患者人数仍很高。在我国,中医药长期以来被广泛用于心血管疾病的临床治疗。随着中药制药技术的发展,越来越多的中药注射液被用于冠心病心绞痛的治疗。其中,丹红注射液是目前临床治疗冠心病心绞痛的有效药物。研究表明,丹红注射液辅助用于不同类型心绞痛,能减少心绞痛发作次数,缩短持续时间,减少心绞痛积分,提高心电图复查有效率和硝酸甘油片的用量等,且有较好的安全性。然而,当前丹红注射液治疗冠心病心绞痛的临床研究和药理机制研究中仍存在一些问题与不足。通过对研究现状进行分析发现,第一,多数临床研究方法学质量不高,缺乏良好的随机对照试验设计,仍需要严格设计的高质量临床试验来评价其有效性和安全性。第二,虽然研究表明,丹红注射液的药理机制可能涉及抗氧化、抗凝、抗炎、抗纤维化、抗血管增生、抗动脉硬化等,但丹红注射液治疗冠心病心绞痛的确切机制目前尚不清楚,还有待进一步的研究。因此,本研究提出应用模块药理学的分析框架可为进一步研究丹红注射液治疗冠心病心绞痛的多靶点作用提供新方法和新思路。

Effect of Danhong Injection in Treatment for Angina Pectoris in Coronary Heart Disease

Angina pectoris in coronary heart disease is a common complex polygenic disease. Its morbidity and mortality have been increasing year by year, threatening human health seriously. Despite of multiple treatment options including myocardial revascularization, pharmacotherapy (as organic nitrates, b-blockers, calcium channel antagonists), preventive therapies (lifestyle interventions, risk factor modification) and several alternative procedures, some patients still experience cardiovascular events and their quality of life is impaired. In China, traditional Chinese medicine (TCM) has been widely used to treat cardiovascular diseases for a long time. With the development of the pharmaceutical technology of TCM, more and more TCM injections have been used for the treatment of angina pectoris. Danhong injection (DHI), which is typically used to resolve blood stasis, has been widely used in clinical practice for the treatment of angina pectoris in China. Several clinical studies have also demonstrated that Danhong injection is an effective and safe option for the treatment of angina pectoris in coronary heart disease. However, there are still some problems existing in the clinical and basic researches of DHI treatment of angina pectoris in coronary heart disease. Firstly, most clinical trials were low-quality studies. There were several drawbacks in the methodological quality of most original clinical trials. Therefore, well-designed randomized controlled trials are needed in the future. Secondly, the underlying pharmacological mechanisms of DHI on angina pectoris in coronary heart disease remain unclear. Therefore, this modular pharmacology-based analysis can provide new insight into the multi-target mechanisms of pharmacological action in DHI treatment for angina pectoris in coronary heart disease.