McMaster University Medical Centre, Rm 3U4, 1200 Main Street West, Hamilton, ON, L8N 3Z5, Canada.
Curr Hypertens Rep. 2010 Aug;12(4):276-81. doi: 10.1007/s11906-010-0127-1.
The idea of packaging and formulating several drugs commonly used in cardiovascular disease prevention into a single polypill is appealing. It is believed that the polypill would have several advantages over the separate use of several medications, enhancing acceptability and long-term adherence, with lower cost and easier accessibility. However, there are few data available on the efficacy and safety of polypill preparations for preventive purposes. The Indian Polycap Study (TIPS) was the first to systematically test the clinical application of the polypill; it included ramipril, hydrochlorothiazide, atenolol, aspirin, and simvastatin. Blood pressure and LDL levels were effectively lowered and antiplatelet function was demonstrated, but the effect of simvastatin was reduced because of an unexpected drug interaction. The polypill was well tolerated. Challenges to be resolved include the need to demonstrate conclusively the safety and efficacy of the polypill in large clinical end point trials.
将几种常用于心血管疾病预防的药物包装并配制成一种复方药的想法很有吸引力。人们认为，与分别使用几种药物相比，复方药具有以下几个优势，即提高了可接受性和长期依从性，降低了成本，且更容易获得。然而，关于复方药制剂在预防方面的疗效和安全性的数据却很少。印度复方胶囊研究（TIPS）首次系统地测试了复方药的临床应用；它包含雷米普利、氢氯噻嗪、阿替洛尔、阿司匹林和辛伐他汀。该研究有效降低了血压和 LDL 水平，并显示出抗血小板作用，但由于意外的药物相互作用，辛伐他汀的效果降低了。复方药耐受性良好。需要解决的挑战包括需要在大型临床终点试验中明确证明复方药的安全性和疗效。
