马来酸依那普利叶酸片降压、降同型半胱氨酸的疗效和安全性

Efficacy and safety of Enalapril-Folate acid tablets in lowering blood pressure and plasma homocysteine

目的:评价马来酸依那普利叶酸片用于轻、中度高血压患者降压和降低同型半胱氨酸(homocysteine,Hcy)的疗效及安全性。方法:在6个研究中心选择轻、中度原发性高血压患者,随机分配到3个治疗组中,分别接受依那普利10.0mg、依那普利叶酸片10.0mg/0.4mg和10.0mg/0.8mg,每日1次,连续双盲治疗8周。于给药前及治疗第2、4、6、8周末进行随访,测量坐位血压、心率并记录不良反应,在给药前、治疗第4周及试验结束时测定Hcy。结果:共480例轻、中度原发性高血压患者进入随机试验。采用意向性分析。主要疗效指标:依那普利10.0mg组、依那普利叶酸片10.0mg/0.4mg组和10.0mg/0.8mg组降压和降Hcy同时有效率分别为4.6%、13.2%和17.1%,两种配比依那普利叶酸片组均显著优于依那普利组;依那普利10.0mg组、依那普利叶酸片10.0mg/0.4mg组和10.0mg/0.8mg组降压或降Hcy有效率分别为45.8%、59.6%和65.1%,两个依那普利叶酸片组均显著优于依那普利组。次要疗效指标:两个依那普利叶酸片组降Hcy疗效均显著优于依那普利组,3组降压疗效差异无统计学意义。依那普利叶酸片各种不良事件发生率与依那普利类似。结论:依那普利叶酸片用于轻、中度原发性高血压患者降压、降低同型半胱氨酸安全、有效。

Objective： To investigate the efficacy and safety of Enalapril-Folic acid tablets in lowering blood pressure and plasma homocysteine （Hcy） level. Methods： A randomized, double blind, multicenter clinical trial was performed. Subjects with mild-moderate hypertension were randomly assigned to the following three groups ： group 1, Enalapril 10.0 mg/d ; group 2, Enalapril 10.0 mg ＋ Folic acid 0.4 mg/d ; group 3, Enalapril 10.0 mg ＋ Folic acid were examined every two weeks, for a total period of 8 enrolled. All analyses were performed according to the tients. Compared to group 1, both group 2 and group 0.8 mg/d. Blood pressure and plasma Hcy level weeks. Results： A total of 480 hypertensives were intention to treat and included all randomized patients. Compared to group 1, both group 2 and group 3 had significantly higher effectiveness in lowering both blood pressure and plasma Hcy level, or in lowering either blood pressure or plasma Hcy level. The proportions of subjects showing obvious reduction in both blood pressure and plasma homocysteine level in group 1, group 2, group 3, were 4.6%, 13.2%, 17. 1%, respectively; the proportions of subjects showing obvious reduction in either blood pressure or plasma homocysteine level in group 1, group 2, group 3, were 45.8%, 59.6%, and 65.1%, respectively; Effects on blood pressure, as well as the safety profile were not significantly different among the three regimens. Conclusion： Enalapril-Folic acid tablets could be used to reduce both blood pressure and plasma Hcy level in mild to moderate hypertensive subjects.