机构：[1]Department of Cardiology, Peking University First Hospital, Beijing, China[2]National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China[3]Institute for Biomedicine, Anhui Medical University, Hefei, China[4]Department of Neurology, Peking University First Hospital, Beijing, China[5]Department of Population, Family, and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland[6]Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland[7]Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland[8]School of Health Administration, Anhui Medical University, Hefei, China[9]Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Center, Beijing, China[10]Department of Neurology, First People’s Hospital, Lianyungang, China[11]Department of Neurology, First Affiliated Hospital of Anhui Medical University, Hefei, China[12]Department of Neurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China广东省中医院[13]Department of Pharmacy, Peking University First Hospital, Beijing, China[14]Department of Cardiology, Peking University People’s Hospital, Beijing, China[15]Department of Geriatric Cardiology, General Hospital of the People’s Liberation Army, Beijing, China[16]Department of Cardiology, Second Affiliated Hospital, Nanchang University, Nanchang, China[17]Department of Cardiology, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China[18]Department of Cardiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China北京朝阳医院[19]Department of Cardiology, Xiangya Hospital, Central South University, Changsha, China[20]Department of Cardiology, First Hospital of Shanxi Medical University, Taiyuan, China[21]Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xi’an, China[22]Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China[23]State Key Laboratory of Medical Genomics, Shanghai Key Laboratory of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China[24]Department of Physiology and Pathophysiology, School of Basic Medical Sciences, Peking University, Beijing, China[25]Shanghai Institute of Cardiovascular Diseases, Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China[26]Department of Cardiology, Tangdu Hospital, Fourth Military Medical University, Xi’an, China[27]Division of Hypertension, Fu-wai Hospital, Beijing, China[28]Beijing Hypertension League Institute, Beijing, China
Importance: Uncertainty remains about the efficacy of folic acid therapy for the primary prevention of stroke because of limited and inconsistent data. Objective: To test the primary hypothesis that therapy with enalapril and folic acid is more effective in reducing first stroke than enalapril alone among Chinese adults with hypertension. Design, Setting, and Participants: The China Stroke Primary Prevention Trial, a randomized, double-blind clinical trial conducted from May 19, 2008, to August 24, 2013, in 32 communities in Jiangsu and Anhui provinces in China. A total of 20 702 adults with hypertension without history of stroke ormyocardial infarction (MI) participated in the study. Interventions: Eligible participants, stratified by MTHFR C677T genotypes (CC, CT, and TT), were randomly assigned to receive double-blind daily treatment with a single-pill combination containing enalapril, 10mg, and folic acid, 0.8mg (n = 10 348) or a tablet containing enalapril, 10mg, alone (n = 10 354). Main Outcomes and Measures: The primary outcomewas first stroke. Secondary outcomes included first ischemic stroke; first hemorrhagic stroke; MI; a composite of cardiovascular events consisting of cardiovascular death, MI, and stroke; and all-cause death. Results: During a median treatment duration of 4.5 years, compared with the enalapril alone group, the enalapril-folic acid group had a significant risk reduction in first stroke (2.7%of participants in the enalapril-folic acid group vs 3.4%in the enalapril alone group; hazard ratio [HR], 0.79; 95%CI, 0.68-0.93), first ischemic stroke (2.2%with enalapril-folic acid vs 2.8% with enalapril alone; HR, 0.76; 95%CI, 0.64-0.91), and composite cardiovascular events consisting of cardiovascular death, MI, and stroke (3.1% with enalapril-folic acid vs 3.9% with enalapril alone; HR, 0.80; 95%CI, 0.69-0.92). The risks of hemorrhagic stroke (HR, 0.93; 95%CI, 0.65-1.34), MI (HR, 1.04; 95%CI, 0.60-1.82), and all-cause deaths (HR, 0.94; 95%CI, 0.81-1.10) did not differ significantly between the 2 treatment groups. There were no significant differences between the 2 treatment groups in the frequencies of adverse events. Conclusions and Relevance: Among adults with hypertension in China without a history of stroke or MI, the combined use of enalapril and folic acid, compared with enalapril alone, significantly reduced the risk of first stroke. These findings are consistent with benefits from folate use among adults with hypertension and low baseline folate levels.
基金：
The trial was jointly supported
by Shenzhen AUSA Pharmed Co Ltd and national,
municipal, and private funding, including from the
National Science and Technology Major Projects
Specialized for “Major New Drugs Innovation and
Development” during the 12th Five-Year Plan
Period: China Stroke Primary Prevention Trial (grant
zx09101105); the Major State Basic Research
Development Program of China (973 program)
(2012 CB517703); Clinical Center (grant
zx09401013); Projects of National Natural Science
Foundation of China (grants 81473052, 81441091,
and 81402735); National Clinical Research Center
for Kidney Disease, Nanfang Hospital, Nanfang
Medical University, Guangzhou, China; State Key
Laboratory for Organ Failure Research, Nanfang
Hospital, Nanfang Medical University, Guangzhou,
China; and research grants from the Department of
Development and Reform, Shenzhen Municipal
Government (grant SFG 20201744).
第一作者机构：[1]Department of Cardiology, Peking University First Hospital, Beijing, China[*1]Department of Cardiology, Peking University First Hospital, No. 8 Xishiku St, Xicheng District, Beijing 100034, China
通讯作者：
通讯机构：[1]Department of Cardiology, Peking University First Hospital, Beijing, China[2]National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China[*1]Department of Cardiology, Peking University First Hospital, No. 8 Xishiku St, Xicheng District, Beijing 100034, China[*2]National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China
推荐引用方式(GB/T 7714)：
Yong Huo,Jianping Li,Xianhui Qin,et al.Efficacy of Folic Acid Therapy in Primary Prevention of Stroke Among Adults With Hypertension in China The CSPPT Randomized Clinical Trial[J].JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.2015,313(13):1325-1335.doi:10.1001/jama.2015.2274.
APA：
Yong Huo,Jianping Li,Xianhui Qin,Yining Huang,XiaobinWang...&for the CSPPT Investigators.(2015).Efficacy of Folic Acid Therapy in Primary Prevention of Stroke Among Adults With Hypertension in China The CSPPT Randomized Clinical Trial.JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION,313,(13)
MLA：
Yong Huo,et al."Efficacy of Folic Acid Therapy in Primary Prevention of Stroke Among Adults With Hypertension in China The CSPPT Randomized Clinical Trial".JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 313..13(2015):1325-1335
医学