氨氯地平/叶酸复方制剂对高血压且血清同型半胱氨酸浓度≥10 μmol/l（H型高血压）患者的血压及降同型半胱氨酸效应：一项多中心、随机、双盲、平行对照临床试验。
摘要
背景：血浆同型半胱氨酸升高（Hcy ≥10 μmol/l）与高血压并存定义为H型高血压，二者可协同增加心血管疾病风险，尤其是卒中风险。本研究旨在评估氨氯地平-叶酸与单用氨氯地平相比，在降低血压（BP）和血浆Hcy方面的疗效与安全性。方法：符合条件的受试者（299例男性、241例女性）按1:1:1比例随机分配至5 mg氨氯地平组（对照组，A组）、5 mg氨氯地平加0.4 mg叶酸组（B组）或5 mg氨氯地平加0.8 mg叶酸组（C组）。…
正文 待译
BACKGROUND: Elevated plasma homocysteine (Hcy ≥10 μmol/l) and hypertension, defined as H-type hypertension, can synergistically increase the risk of cardiovascular diseases, especially for stroke. We aimed to assess the efficacy and safety of amlodipine-folic acid in lowering both blood pressure (BP) and plasma Hcy, compared with amlodipine alone. METHODS: Eligible participants (299 males and 241 females) were randomly assigned in a 1:1:1 ratio to 5 mg amlodipine (control, group A), 5 mg amlodipine plus 0.4 mg folic acid (group B), or 5 mg amlodipine plus 0.8 mg folic acid (group C). All participants were followed at 2, 4, 6, and 8 weeks. The primary outcome was the efficacy of lowering both BP and Hcy. RESULTS: Among the 540 participants who were randomized, the efficacy of lowering both BP and Hcy was significantly better in groups B and C compared with group A at the end of 4 weeks, and sustained at the end of 8 weeks (group B vs. group A: 31.7% vs. 6.1%, P < 0.001; group C vs. group A: 32.8% vs. 6.1%, P < 0.001). Both groups B and C were more efficacious in lowering Hcy and raising folate levels than amlodipine alone at 8 weeks. There was no significant difference in BP lowering and adverse events among the three treatment groups. CONCLUSIONS: In H-type hypertension patients, amlodipine-folic acid (5 mg/0.4 mg or 5 mg/0.8 mg) had a significantly higher efficacy of lowering both BP and plasma Hcy compared with amlodipine alone. The efficacy of BP lowering and safety profile were comparable among the three treatment groups. This trial was registered in clinicaltrials.gov, identifier: NCT01848873.
English
BACKGROUND: Elevated plasma homocysteine (Hcy ≥10 μmol/l) and hypertension, defined as H-type hypertension, can synergistically increase the risk of cardiovascular diseases, especially for stroke. We aimed to assess the efficacy and safety of amlodipine-folic acid in lowering both blood pressure (BP) and plasma Hcy, compared with amlodipine alone. METHODS: Eligible participants (299 males and 241 females) were randomly assigned in a 1:1:1 ratio to 5 mg amlodipine (control, group A), 5 mg amlodipine plus 0.4 mg folic acid (group B), or 5 mg amlodipine plus 0.8 mg folic acid (group C).…