叶酸在中国成人高血压患者卒中一级预防中的作用:CSPPT随机临床试验

Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: The CSPPT randomized clinical trial
2015-09-15 12:00发表评论
作者:Huo Y., Li J., Qin X., Huang Y., Wang X., Gottesman R.F., Tang G., Wang B., Chen D., He M., Fu J., Cai Y., Shi X., Zhang Y., Cui Y., Sun N., Li X., Cheng X., Wang J., Yang X.C., Yang T., Xiao C., Zhao G., Dong Q., Zhu D., Wang X., Ge J., Zhao L., Hu D., Liu L., Hou F.F., Cao K., Chen L., Gao P., Gao R., Ji X., Li N., Ma C., Wang W., Yang X., Dai X., Fan F., Gao X., Hui R., Jiang H., Jiang J., Jiang X., Kong W., Liu B., Sun G., Sun L., Wang B., Yin D., Yang W., Zhang H., Zhang C., Zhao L., Wang L., Chen Y., Huang A., Li Y., Wang J., Xie R., Yao C., Zhao D., Zhao Z., Wei L.-J., Chen F., Dong J., Gu J., Guo J., Shen L., Zhang W., Zhang Z., Wang Z., Li X., Wan Y.L., Hu G., Tan J., Dong S., Tong
机构: 北京大学第一医院心内科
期刊: JAMA2015年4月13期313卷

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.

 

通讯机构:Department of Cardiology, Peking University First Hospital, No. 8 Xishiku St, Xicheng District, Beijing, China
学科代码:内科学   关键词:叶酸 中国成人高血压患者 卒中 ,中国作者重要发表 爱思唯尔医学网, Elseviermed
来源: Scopus
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