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学科主题: 临床医学
题名:
Efficacy of Folic Acid Therapy in Primary Prevention of Stroke Among Adults With Hypertension in China The CSPPT Randomized Clinical Trial
作者: Huo, Yong1; Li, Jianping1; Qin, Xianhui2,3; Huang, Yining4; Wang, Xiaobin5; Gottesman, Rebecca F.6,7; Tang, Genfu3,8; Wang, Binyan2,3; Chen, Dafang9; He, Mingli10; Fu, Jia11; Cai, Yefeng12; Shi, Xiuli11; Zhang, Yan1; Cui, Yimin13; Sun, Ningling14; Li, Xiaoying15; Cheng, Xiaoshu16; Wang, Jian′ an17; Yang, Xinchun18; Yang, Tianlun19; Xiao, Chuanshi20; Zhao, Gang21; Dong, Qiang22; Zhu, Dingliang23; Wang, Xian24; Ge, Junbo25; Zhao, Lianyou26; Hu, Dayi14; Liu, Lisheng27,28; Hou, Fan Fan2; CSPPT Investigators
刊名: JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
发表日期: 2015-04-07
DOI: 10.1001/jama.2015.2274
卷: 313, 期:13, 页:1325-1335
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal
研究领域[WOS]: General & Internal Medicine
关键词[WOS]: PLACEBO-CONTROLLED TRIAL ; TRANSIENT ISCHEMIC ATTACK ; B-VITAMINS ; CARDIOVASCULAR EVENTS ; MYOCARDIAL-INFARCTION ; LOWERING HOMOCYSTEINE ; VASCULAR-DISEASE ; MORTALITY ; RISK ; METAANALYSIS
英文摘要:

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 or myocardial 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, 10 mg, and folic acid, 0.8 mg (n = 10 348) or a tablet containing enalapril,10 mg, alone (n = 10 354).

MAIN OUTCOMES AND MEASURES The primary outcome was 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% Cl, 0.68-0.93), first ischemic stroke (2.2% with enalapril-folic acid vs 2.8% with enalapril alone; HR, 0.76; 95% Cl, 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% Cl, 0.69-0.92). The risks of hemorrhagic stroke (HR, 0.93; 95% Cl, 0.65-1.34), MI (HR, 1.04; 95% Cl, 0.60-1.82), and all-cause deaths (HR, 0.94; 95% Cl, 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.

语种: 英语
所属项目编号: 2012 CB517703 ; zx09401013 ; 81473052 ; 81441091 ; 81402735 ; zx09101105 ; SFG 20201744
项目资助者: Shenzhen AUSA Pharmed Co Ltd ; Major State Basic Research Development Program of China (973 program) ; Clinical Center ; National Natural Science Foundation of China ; National Clinical Research Center for Kidney Disease, Nanfang Hospital, Nanfang Medical University, Guangzhou, China ; 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 ; State Key Laboratory for Organ Failure Research, Nanfang Hospital, Nanfang Medical University, Guangzhou, China ; Department of Development and Reform, Shenzhen Municipal Government
WOS记录号: WOS:000352315900019
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/67374
Appears in Collections:北京大学第一临床医学院_心血管内科_期刊论文

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作者单位: 1.First Peoples Hosp, Dept Neurol, Lianyungang, Peoples R China
2.Peking Univ, Hosp 1, Dept Pharm, Beijing 100034, Peoples R China
3.Anhui Med Univ, Inst Biomed, Hefei, Peoples R China
4.Anhui Med Univ, Sch Hlth Adm, Hefei, Peoples R China
5.Peking Univ, Hosp 1, Dept Cardiol, Beijing 100034, Peoples R China
6.Southern Med Univ, Natl Clin Res Ctr Kidney Dis, State Key Lab Organ Failure Res, Renal Div,Nanfang Hosp, Guangzhou, Guangdong, Peoples R China
7.Peking Univ, Hosp 1, Dept Neurol, Beijing 100034, Peoples R China
8.Johns Hopkins Univ, Dept Populat Family & Reprod Hlth, Bloomberg Sch Publ Hlth, Baltimore, MD USA
9.Johns Hopkins Univ, Sch Med, Dept Neurol, Baltimore, MD 21205 USA
10.Johns Hopkins Univ, Dept Epidemiol, Bloomberg Sch Publ Hlth, Baltimore, MD USA
11.Peking Univ, Hlth Sci Ctr, Dept Epidemiol & Biostat, Sch Publ Hlth, Beijing 100871, Peoples R China
12.Anhui Med Univ, Affiliated Hosp 1, Dept Neurol, Hefei, Peoples R China
13.Guangdong Prov Hosp Chinese Med, Dept Neurol, Guangzhou, Guangdong, Peoples R China
14.Peking Univ, Hosp 1, Dept Cardiol, Beijing 100034, Peoples R China
15.Peoples Liberat Army, Gen Hosp, Dept Geriatr Cardiol, Beijing, Peoples R China
16.Nanchang Univ, Affiliated Hosp 2, Dept Cardiol, Nanchang, Peoples R China
17.Zhejiang Univ, Sch Med, Affiliated Hosp 2, Dept Cardiol, Hangzhou 310003, Zhejiang, Peoples R China
18.Capital Med Univ, Beijing Chaoyang Hosp, Dept Cardiol, Beijing, Peoples R China
19.Cent S Univ, Dept Cardiol, Xiangya Hosp, Changsha, Hunan, Peoples R China
20.Shanxi Med Univ, Hosp 1, Dept Cardiol, Taiyuan, Peoples R China
21.Fourth Mil Med Univ, Dept Neurol, Xijing Hosp, Xian 710032, Peoples R China
22.Fudan Univ, Huashan Hosp, Dept Neurol, Shanghai 200433, Peoples R China
23.Shanghai Jiao Tong Univ, State Key Lab Med Genom, Shanghai Key Lab Hypertens, Ruijin Hosp, Shanghai 200030, Peoples R China
24.Peking Univ, Dept Physiol & Pathophysiol, Sch Basic Med Sci, Beijing 100034, Peoples R China
25.Fudan Univ, Zhongshan Hosp, Dept Cardiol, Shanghai Inst Cardiovasc Dis, Shanghai 200433, Peoples R China
26.Fourth Mil Med Univ, Dept Cardiol, Tangdu Hosp, Xian 710032, Peoples R China
27.Fu Wai Hosp, Div Hypertens, Beijing, Peoples R China
28.Beijing Hypertens League Inst, Beijing, Peoples R China

Recommended Citation:
Huo, Yong,Li, Jianping,Qin, Xianhui,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.
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