Orlando， FL–健康个体可以通过服用一种单一的药片将其心血管疾病危险性降低50-60%，这种药片包括三种最小剂量的降压药物、他汀以及阿司匹林，被称之为polypill，效果显著且无副作用，这是来自第58届ACC会议上的报道。

    Indian Polycap Study (TIPS)是首次评价这种polipill的耐受性以及对心血管危险因素的有效改变的实验，共纳入2053例研究对象。在三个月的研究期间，研究者比较了polypill以及其他八种降压、降胆固醇和心率的药物的效果。复合药片(PolycapTM)包括低剂量的噻嗪类（12.5mg/天）、阿替洛尔(50mg/天)、雷米普利(5mg/天)、辛发他汀(20 mg/天) 以及阿司匹林(100mg/天)，能够显著降低低密度脂蛋白胆固醇、血压和血小板聚集率。“使人吃一片药便可以控制多种危险因素的想法令人振奋，这将是我所知的心血管预防的又一伟大革命，” 来自McMaster 大学的加拿大皇家内科医师学会会员Salim Yusuf医生说，“在该研究之前，没有数据表明可以将五种活性成分整合成一片药片，其可行性、多种成分之间的生物药效以及相互作用均尚不得知，但是我们发现这种复合药片确实起作用。而且其副作用较单独服用一种或两种药物并无显著性差异。”

    研究者被随机分为Polycap组（n=400）和其他八种药物的任意一种，每组（单用阿司匹林、单用辛发他汀、单用氢氯噻嗪、三种降压药物的两两组合、单用三种降压药物以及三种降压药物加上阿司匹林）包括200人。研究者纳入来自印度的50个中心，时间为2007年3月5日至2008年8月5日。受试者的平均年龄为54岁，1/3的人患有糖尿病，平均血压为134/85 mmHg，平均胆固醇水平为180 mg/dl，HDL为44 mg/dl，LDL 为117 mg/dl。

    研究表明Polycap的耐受性良好，没有明显证据表明增加活性成分的数量。“一种药物的副作用可被另外的药物的有效作用抵消，” Yusuf说。与未接受降血压药物治疗组比较，Polycap可降低收缩压7.4 mmHg，舒张压5.6 mmHg；与三种降压药物合用的降压效果类似。随着降压药物种类的增加，血压降低的幅度增加（一种药物降低2.2/1.3 mmHg，两种药物降低4.7/3.6，三种药物降低6.3/4.5）。较以前的研究相比，polypill的降压效果较好，这主要由于本研究纳入的受试者大部分都是血压正常的人。据Yusuf 博士分析，就该血压正常的人群分析，血压下降能够从理论上降低24%的冠心病危险性，降低33%脑卒中的危险性。Polypill能够降低LDL0.70 mmol/L，较单用辛发他汀的LDL水平更低(0.83 mmol/L; p<0.04)；这两组均较未用辛发他汀组显著降低(p<0.001)。应用polypill对心率的下降幅度(7.0 beats/min)与应用阿替洛尔对心率的下降幅度(7.0 beats/min)相似，均较未应用阿替洛尔组下降幅度大(p<0.001)。

    “该研究为进一步更大规模的开展提供关键信息，为进一步发展降压药物、他汀类、阿司匹林的合理组合剂型奠定基础，” Yusuf说。具体完整的实验结果将会刊登在Lancet杂志。

（张丽洁 吕树铮  首都医科大学附属北京安贞医院）

英文原文：
POLYPILL MAY HALVE CARDIOVASCULAR RISK WITH NO ADDITIONAL SIDE AFFECTS
Results Set Stage for Larger， Definitive Trials

Orlando， FL–Healthy individuals may be able to cut their risk of cardiovascular disease by 50 to 60 percent by taking a single pill that combines three blood pressure (BP) lowering drugs at low doses， a statin， and aspirin (called the ―polypill‖) with no additional side effects， according to research presented today at the American College of Cardiology’s 58th annual scientific session. ACC.09 is the premier cardiovascular medical meeting， connecting cardiologists and cardiovascular specialists to the latest and most innovative findings in cardiovascular science.

The Indian Polycap Study (TIPS)—the first to evaluate the tolerability of the polypill and test whether it leads to meaningful changes in cardiovascular risk factors—enrolled 2，053 participants. During the three-month study， researchers compared the impact of the polypill and eight other pharmacologic therapies on BP， blood cholesterol levels and heart rate， among other measures. The combination pill (PolycapTM)， which includes low doses of thiazide (12.5 mg/day)， atenolol (50 mg/day)， ramipril (5 mg/day)， simvastatin (20 mg/day) and aspirin (100 mg/day)， significantly reduces LDL cholesterol， BP and platelet aggregability. ―The thought that people might be able to take a single pill to reduce multiple cardiovascular risk factors has generated a lot of excitement; it could revolutionize heart disease prevention as we know it，‖ said Salim Yusuf， DPhil， FRCPC， of the Population Health Research Institute at McMaster University and Hamilton Health Sciences， Hamilton， ON， Canada， and co-chair and principal investigator of the study. ―Before this study， there were no data about whether it was even possible to put five active ingredients into a single pill， in terms of feasibility， the bioavailability of different agents and possible interactions， and we found that it works. And side effects with the polypill were no different than when taking one or two medications.‖

Participants were randomized to the Polycap (n=400) group or to one of eight other study arms， each with about 200 individuals， which included aspirin alone， simvastatin alone， hydrochlorthiazide alone， three combinations of the two BP lowering drugs， three BP lowering drugs alone， and an arm with three BP lowering drugs plus aspirin. Patients were recruited from 50 centers in India between March 5， 2007 and August 5， 2008. The mean age of the participants was 54 years， one-third had diabetes， mean baseline BP was 134/85 mmHg， mean cholesterol was 180 mg/dl， HDL 44 mg/dl， and LDL 117 mg/dl. There were several exclusion criteria. The polycap was well tolerated and there was no evidence of problems with increasing number of active components in the pill. ―The side effects of one drug may be counteracted by beneficial effects of another， so the rate of stopping medications was the same，‖ Yusuf said. Compared to groups not receiving BP lowering agents， the polycap reduced systolic BP by 7.4 mmHg and diastolic BP by 5.6 mmHg; this was similar to when 3 BP lowering drugs were used， with or without aspirin. BP reductions increased with the number of BP lowering drugs used (2.2/1.3 mmHg with one drug， 4.7/3.6 with two drugs， and 6.3/4.5 with three drugs). While the effects of the polypill on BP were lower than what was projected by previous investigators， who expected a 20/11 mmHg reduction， this is likely because most participants in the present study were not hypertensive. Still， BP reductions among this group could theoretically lead to about a 24 percent risk reduction in CHD and 33 percent risk reduction in strokes in those with average BP levels， according to Dr. Yusuf. Polycap reduced LDL by 0.70 mmol/L， which was slightly less than that with simvastatin used alone (0.83 mmol/L; p<0.04); both of which were greater than groups without simvastatin (p<0.001). The reductions in heart rate with polycap (7.0 beats/min) and other arms using atenolol (7.0 beats/min) were similar; and both were significantly greater than that in arms without atenolol (p<0.001). ―This trial is a critical first step to inform the design of larger， more definitive studies， as well as further development of appropriate combinations of BP lowering drugs with statins and aspirin，‖ said Yusuf， who led the study jointly with Prem Pais， M.D. at St. John’s Medical College， Bangalore， India. Complete study findings are being published simultaneously in The Lancet. The study was sponsored by Cadila Pharmaceuticals， India， which played no role in data collection， analysis or interpretation.