背景與目的 我國人群高血壓患病率呈上升趨勢,但血壓控制率很低。為優(yōu)化高血壓治療方案,提高血壓達(dá)標(biāo)率,減少心腦血管事件,由劉力生教授任主席的中國高血壓綜合研究協(xié)作組特制定了以下中國高血壓綜合干預(yù)研究方案。
對象與方法 符合以下4項(xiàng)者進(jìn)入試驗(yàn):原發(fā)性高血壓,年齡50~79歲,至少伴有一項(xiàng)心血管病危險(xiǎn)因素,知情同意。采用多中心隨機(jī)對照盲終點(diǎn)評估臨床試驗(yàn)方法,12?000例患者被隨機(jī)分為初始小劑量氨氯地平+替米沙坦組或小劑量氨氯地平+利尿劑組;對其中血總膽固醇4.0~6.1 mmol/L者隨機(jī)分為小劑量他汀組或常規(guī)處理組;按社區(qū)隨機(jī)分為強(qiáng)化生活方式干預(yù)區(qū)或常規(guī)干預(yù)區(qū)。研究主要終點(diǎn)是非致命性卒中/心梗、心血管性死亡復(fù)合事件。定期隨訪,計(jì)劃隨訪4年。
預(yù)期結(jié)果 累積主要終點(diǎn)事件500例,血壓控制率達(dá)到70%,優(yōu)化治療組降低心血管事件20%,明顯改善不良生活方式。全國150家協(xié)作醫(yī)院共同研究,預(yù)計(jì)2011年完成試驗(yàn)。
引用本文: 王文,馬麗媛,張宇清,鄧卿,劉明波,劉力生,代表CHIEF研究協(xié)作組. 中國高血壓綜合干預(yù)研究方案——起始聯(lián)合降壓、適度調(diào)脂和生活方式綜合干預(yù)的全國多中心隨機(jī)對照試驗(yàn). 中國循證醫(yī)學(xué)雜志, 2007, 07(11): 810-815. doi: 復(fù)制
1. | National Center for Cardiovascular Diseases of China. 2005 report on cardiovascular diseases in China. Beijing: Encyclopedia of China Publishing House. 2006. |
2. | 衛(wèi)生部心血管病防治研究中心. 中國心血管病報(bào)告2005. 北京: 中國大百科全書出版社. 2006. |
3. | Liu L, Zhang Y, Liu G, et al; FEVER Study Group. The Felodipine Event Reduction (FEVER) Study: a randomized long-term placebo-controlled trial in Chinese hypertensive patients. J Hypertens, 2005, 23(12): 2157-2172. |
4. | Julius S, Kjeldsen SE, Weber M, et al; VALUE trial group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet, 2004, 363(9426): 2022-2031. |
5. | Weber MA, Bakris GL, Dahlöf B, et al. Baseline characteristics in the Avoiding Cardiovascular events through Combination therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial: a hypertensive population at high cardiovascular risk. Blood Press, 2007, 16(1): 13-19. |
6. | Sever PS, Dahlof B, Poulter NR, et al; ASCOT investigators. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet, 2003, 361(9364): 1149-1158. |
7. | Messerli FH, Staessen JA. Amlodipine better than lisinopril? How one randomized clinical trial ended fallacies from observational studies. Hypertension, 2006, 48(3): 359-361. |
- 1. National Center for Cardiovascular Diseases of China. 2005 report on cardiovascular diseases in China. Beijing: Encyclopedia of China Publishing House. 2006.
- 2. 衛(wèi)生部心血管病防治研究中心. 中國心血管病報(bào)告2005. 北京: 中國大百科全書出版社. 2006.
- 3. Liu L, Zhang Y, Liu G, et al; FEVER Study Group. The Felodipine Event Reduction (FEVER) Study: a randomized long-term placebo-controlled trial in Chinese hypertensive patients. J Hypertens, 2005, 23(12): 2157-2172.
- 4. Julius S, Kjeldsen SE, Weber M, et al; VALUE trial group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet, 2004, 363(9426): 2022-2031.
- 5. Weber MA, Bakris GL, Dahlöf B, et al. Baseline characteristics in the Avoiding Cardiovascular events through Combination therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial: a hypertensive population at high cardiovascular risk. Blood Press, 2007, 16(1): 13-19.
- 6. Sever PS, Dahlof B, Poulter NR, et al; ASCOT investigators. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet, 2003, 361(9364): 1149-1158.
- 7. Messerli FH, Staessen JA. Amlodipine better than lisinopril? How one randomized clinical trial ended fallacies from observational studies. Hypertension, 2006, 48(3): 359-361.