美国当地时间3月15日上午11：20左右，霍勇教授在美国心脏病学会年会(ACC2015)上，首次正式对外公布CSPPT研究结果。该研究是世界上首次针对高血压患者补充叶酸预防卒中的大规模、随机、对照研究。在对2万余例中国高血压患者平均4.5年的随访中显示，在降压治疗同时补充叶酸，可以显著降低首次卒中的风险。该研究结果已于美国当地时间11时左右在《美国医学会杂志》（简称JAMA）在线发表。

原文摘要：Original Investigation | March 15, 2015

Efficacy of Folic Acid Therapy in Primary Prevention of Stroke Among Adults With Hypertension in China
The CSPPT Randomized Clinical Trial FREE ONLINE FIRST

Yong Huo, MD1; Jianping Li, MD, PhD1; Xianhui Qin, PhD2,3; Yining Huang, MD4; Xiaobin Wang, MD, ScD5; Rebecca F. Gottesman, MD, PhD6,7; Genfu Tang, MD3,8; Binyan Wang, MD, PhD2,3; Dafang Chen, PhD9; Mingli He, MD10; Jia Fu, MD11; Yefeng Cai, MD12; Xiuli Shi, MD11; Yan Zhang, MD, PhD1; Yimin Cui, MD, PhD13; Ningling Sun, MD14; Xiaoying Li, MD15; Xiaoshu Cheng, MD16; Jian’an Wang, MD17; Xinchun Yang, MD18; Tianlun Yang, MD19; Chuanshi Xiao, MD20; Gang Zhao, MD21; Qiang Dong, MD22; Dingliang Zhu, MD23; Xian Wang, MD, PhD24; Junbo Ge, MD25; Lianyou Zhao, MD26; Dayi Hu, MD14; Lisheng Liu, MD27,28; Fan Fan Hou, MD, PhD2 ; for the CSPPT Investigators

JAMA. Published online March 15, 2015. doi:10.1001/jama.2015.2274 Text Size: A A A

ABSTRACT

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% 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.

Trial Registration  clinicaltrials.gov Identifier: NCT00794885

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The CSPPT Randomized Clinical Trial