高血压人群基线同型半胱氨酸水平对依那普利叶酸片降压及降同型半胱氨酸疗效的分析

The effect of baseline homocysteine level on the efficacy of enalapril maleate and folic acid tablet in lowering blood pressure and plasma homocysteine

目的评价高血压人群基线同型半胱氨酸（Hcy）水平对马来酸依那普利叶酸片（依叶片）降压、降同型半胱氨酸的疗效。方法在7个研究中心入选456例Ⅰ、Ⅱ级原发性高血压患者，随机分配到3个治疗组中，分别接受依那普利（10mg）、依叶片10／0．4（依那普利10mg／叶酸0．4mg）和依叶片10／0．8（依那普利10mg／叶酸0．8mg），每日1次，连续双盲治疗8周。结果本组原发性高血压人群高同型半胱氨酸血症的发生率达75％。3组治疗均可显著降低血压（均P〈0．01）。降压疗效在3组间以及各组内不同Hcy水平者之间差异均无统计学意义。依叶片（10／0．4和10／0．8）对于高Hcy患者降压或降低Hcy水平均显著优于依那普利组[OR（95％凹）：3．0（1．7～5．5），P=0．000和3．3（1．8～5．9），P：0．000]，对于低Hcy患者依叶片（10／0．4和10／0．8）与依那普利比较疗效差异均无统计学意义[OR（95％CI）：1．0（0．3—2．9），P=0．997和1．7（0．5—5．2），P=0．372]；同时依叶片（10／0．4和10／0．8）在高Hcy患者组降压或降低Hcy疗效均显著优于低Hcy患者组[OR（95％CI）：7．5（2．6～21．2），P=0．000和3．5（1．4—8．7），P=0．0071。依叶片（10／0．4和10／0．8）对于高Hcy患者降低血压及Hcy疗效均显著优于单用依那普利（均P〈0．01），对于低Hcy患者依叶片（10／0．8）降Hcy疗效仍显著优于单用依那普利（P=0．016）。结论中国高血压患者高Hcy血症发生率较高，依叶片对Hcy升高的高血压患者可有效控制血压和降低Hcy。在Hcy较低患者，依叶片总体疗效和依那普利片无显著区别，但在控制Hcy方面仍优于依那普利。

Objective To investigate the effect of baseline homocysteine （Hey） level on the efficacy of enalapril maleate and folic acid tablet in lowering blood pressure and plasma Hey in patients with mild or moderate essential hypertension. Methods 456 patients with mild or moderate essential hypertension were from 7 hospitals in Southern and Northern China, 196 males and 260 females, aged 18 - 75, were randomly assigned to one of the 3 groups ： Group 1 treated with enalapril 10 mg （ n = 153 ） ; Group 2 treated with enalapril maleate and folic acid tablet at the ratio of 10/0.4 （n = 151 ） ; and Group 3 treated with nalapril maleate and folie acid tablet at the ratio of 10/0.8 （n = 152）. Blood pressure was measureded every 2 weeks and plasma Hey level was measured before the experiment, 4 weeks after the beginning of experiment, and by the end of experiment. Results Compared with the baseline levels, the blood pressures of the 3 groups were all well controlled （ all P 〈 0.01 ）. There was no significant difference among the 3 groups in the efficacy in lowering blood pressure, even after stratification by the baseline Hey level. 75% of all the subjects had elevated plasma Hey level （≥ 10 μmol/L）. The blood pressure and Hey lowering rates of the subjects with hyperhomocysteinemia in Groups 2 and 3 were 70.9% and 67.0% respectively, both significantly higher than that of Group 1 [45.6 %, 0R（95% CI） ：3.0 （ 1.7-5.5 ）, P = 0. 000 and OR = 3.3 （1.8-5.9）, P=0.000] , and in lowering Hcy [0R（95%CI）： 7.5（2.6-21.2）, P =0.000 and 3.5 （ 1.4-8.7 ）, P = 0. 007 ] subjects with hyperhomocy steinemia. The Hcy lowering efficacy in the patients without hyperhomocysteinemia of Group 3 was significantly higher than that of Group 1 （ P = 0. 016 ）. Conclusion Hyperhomocysteinemia is s extremely common in Chinese hypertensive patients. Enalapril maleate combine with folic acid tablet shows better efficacy in lowering either blood pressure or Hcy in hypertensive patients with hyperhomocysteinemia.