Nhóm 10.348 Người Dùng Acid Folic đã Chứng Minh Tác Dụng Dự Phòng đột Quỵ Não Tiên Phát ở Người Tăng Huyết Áp

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Hiệu Quả Của Liệu Pháp Acid Folic Trong Dự Phòng Đột Quỵ Não Tiên Phát Ở Người Bị Tăng Huyết Áp

TS.BS. Nguyễn Văn Tuấn – Học Viện Quân y tham khảo và dịch lược

Tóm tắt nghiên cứu:

Một thử nghiệm lâm sàng ngẫu nhiên lớn ở Trung Quốc với 20.720 người lớn bị tăng huyết áp, tiền sử chưa bị đột quỵ não hoặc nhồi máu cơ tim. Nghiên cứu tiến hành từ 19/5/2008, theo dõi đến 24/8/2013 ở trên 32 cộng đồng dân cư người Trung Quốc. Thử nghiệm lâm sàng được chia thành hai nhóm: nhóm 1 gồm 10.348 bệnh nhân bị tăng huyết áp, điều trị uống 1 viên Enalapril 10 mg (thuốc hạ huyết áp nhóm ức chế men chuyển), kết hợp với acid folic 0,8 mg; nhóm 2 gồm 10.354 người lớn bị tăng huyết áp, chỉ uống Enalapril 10 mg.

Mục đích của nghiên cứu là theo dõi sự xuất hiện đột quỵ não tiên phát (lần đầu), kết hợp theo dõi bệnh mạch vành và tỷ lệ tử vong nói chung. Thời gian theo dõi trung bình của nghiên cứu là 4,5 năm.

Kết quả nghiên cứu cho thấy: nhóm 1 uống phối hợp Enalapril 10mg với acid folic 0,8 mg hàng ngày, tỷ lệ mắc đột quỵ là 2,7%, thấp hơn nhiều so với nhóm chỉ dùng thuốc huyết áp đơn độc (enalapril) là 3,4% với HA = 0,79. Nhóm dùng phối hợp tỷ lệ các biến cố tim mạch gây tử vong là 3,1%, thấp hơn so với nhóm chỉ dùng thuốc huyết áp (3,9%) với HR = 0,8.

Kết luận của nghiên cứu khẳng định, với người lớn có tăng huyết áp, khi điều trị kết hợp thuốc huyết áp (Enalapril 10mg) với acid folic 0,8 mg là giảm nguy cơ đột quỵ não tiên phát có ý nghĩa thống kê.

April 7, 2015

Efficacy of Folic Acid Therapy in Primary Prevention of Stroke Among Adults With Hypertension in ChinaThe CSPPT Randomized Clinical Trial

Yong Huo, MD¹; Jianping Li, MD, PhD¹; Xianhui Qin, PhD^2,3; et alYining Huang, MD⁴; Xiaobin Wang, MD, ScD⁵; Rebecca F. Gottesman, MD, PhD^6,7; Genfu Tang, MD^3,8; Binyan Wang, MD, PhD^2,3; 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, MD^27,28; Fan Fan Hou, MD, PhD²; for the CSPPT Investigators

Audio Interview(05:09)

Folic Acid for Stroke Prevention in Hypertension

Video Interview(5:30)

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

JAMA Report Video(1:59)

Efficacy of Folic Acid Therapy in Primary Prevention of Stroke Among Adults With Hypertension in China

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