(英文原文)Efficacy of Folic Acid Therapy in Primary Prevention of Stroke AmongAdults With Hypertension in China
Importance Uncertainty remains about the efficacy of folic acidtherapy for the primary prevention of stroke because of limited andinconsistent data.
Objective To test the primary hypothesis that therapy with enalapril andfolic acid is more effective in reducing first stroke than enalapril aloneamong Chinese adults with hypertension.
Design,Setting, and Participants The ChinaStroke Primary Prevention Trial, a randomized, double-blind clinical trialconducted from May 19, 2008, to August 24, 2013, in 32 communities in Jiangsuand Anhui provinces in China. A total of 20702 adults with hypertension without history of stroke or myocardialinfarction (MI) participated in the study.
Interventions Eligible participants, stratifiedby MTHFR C677T genotypes (CC, CT, and TT), were randomly assigned toreceive double-blind daily treatment with a single-pill combination containingenalapril, 10 mg, and folic acid, 0.8 mg (n=10348) or a tablet containing enalapril, 10 mg, alone (n=10354).
MainOutcomes and Measures The primaryoutcome was first stroke. Secondary outcomes included first ischemic stroke;first hemorrhagic stroke; MI; a composite of cardiovascular events consistingof 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 asignificant risk reduction in first stroke (2.7% of participants in theenalapril–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% withenalapril–folic acid vs 2.8% with enalapril alone; HR, 0.76; 95% CI,0.64-0.91), and composite cardiovascular events consisting of cardiovasculardeath, MI, and stroke (3.1% with enalapril–folic acid vs 3.9% with enalaprilalone; 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 treatmentgroups. There were no significant differences between the 2 treatment groups inthe frequencies of adverse events.
Conclusionsand Relevance Among adults withhypertension in China without a history of stroke or MI, the combined use ofenalapril and folic acid, compared with enalapril alone, significantly reducedthe risk of first stroke. These findings are consistent with benefits fromfolate use among adults with hypertension and low baseline folate levels.
來源: ACC News Story(March 15,2015)
葉酸+依那普利可降低高血壓患者的初發卒中危險(中文摘要)
近日CSPPT研究顯示,在無卒中或心梗(MI)病史的中國成年高血壓患者中,相比單用依那普利,依那普利和葉酸的複合製劑可顯著降低初發卒中的危險。該結果與葉酸水平低的高血壓患者可獲益於葉酸的結論一致。
由於相關資料有限或結論不一致,至今人們仍不確定葉酸療法一級預防卒中的效果。為了驗證依那普利聯合葉酸在減少初發卒中方面比單用依那普利有效,隨機、雙盲的中國卒中一級預防試驗(CSPPT)於2008年5月19日至2013年8月24日在中國江蘇省和安徽省的32個社區進行。研究將20702名符合入組要求的成年受試者隨機分為兩組:單片複合製劑組(含依那普利10 mg以及葉酸0.8 mg,10348例)和1片依那普利組(10 mg,10354例)。主要轉歸為初發卒中,次要轉歸包括初發缺血性或出血性卒中,MI,包括心血管死亡、MI和卒中的複合轉歸,以及全因死亡。
結果顯示,中位治療4.5年期間,與依那普利單藥組相比,依那普利-葉酸組的初發卒中(3.4%對比2.7%,HR:0.79)、初發缺血性卒中(2.8%對比2.2%,HR:0.76)以及複合心血管轉歸(3.9%對比3.1%,HR:0.80)的發生危險均顯著下降。兩組的出血性卒中(HR:0.93)、MI(HR:1.04)和全因死亡(HR:0.94)危險無顯著差異。此外,兩組的不良事件發生率亦無顯著差異。