【摘要】 目的:比较依那普利加叶酸(自由联合)与依那普利叶酸片(固定复方)降低同型半胱氨酸(Hcy)疗效的差异,为中国H型高血压人群高Hcy的控制提供可选用的更有效的治疗方案。方法:对原发性高血压患者采用依那普利和叶酸联合方式治疗8周,根据联合方式的不同分为自由联合和固定复方的2种方案。自由联合方案中共入选241例原发性高血压患者,其中79例进入依那普利10 mg加叶酸0.4 mg组(叶酸低剂量组),82例进入依那普利10 mg加叶酸0.8 mg组(叶酸高剂量组),80例进入依那普利10 mg单药组。固定复方联合方案中,共入选了456例原发性高血压患者,其中151例进入依那普利10 mg叶/酸0.4mg组(叶酸低剂量),152例进入依那普利10 mg叶/酸0.8 mg(叶酸高剂量),153例进入依那普利10 mg单药组。所有患者治疗前、后均采用高效液相色谱法测定Hcy。结果:自由联合用药方案中,叶酸高剂量组在降低Hcy、降压或降Hcy方面疗效均低于叶酸低剂量组,未体现出合理的量效关系,提示患者服用多片叶酸的治疗依从性较差;在固定复方用药方案中,叶酸高剂量组降低Hcy、降压或降Hcy方面疗效均高于于叶酸低剂量组,呈现明显的剂量反应关系。固定复方方案中叶酸高剂量组较自由联合方案中叶酸高剂量组降低Hcy相对有效率提高10%,降压或降Hcy相对有效率提高22%。结论:固定复方制剂依那普利叶酸片具有更好的控制H型高血压患者Hcy的疗效。更多还原

【Abstract】 Objective:H-type hypertension,defined as having both elevated plasma homocysteine level and hypertension,constitutes about 70% of the Chinese hypertensive patients.This study was to compare therapeutic efficacy of lowering plasma total homocystein(tHcy) using a fixed combination vs.a free combination of enalapril and folic acid tablets in hypertensive patients.Methods:This report included two trials in China.The first had a total of 241 hypertensive patients,randomly assigned to ① Enalapril(10mg,control);② Enalapril(10mg) pill and folic acid 0.4mg pill(low FA);and ③ Enalapril(10mg) pill and folic acid 0.8mg pill(high FA),once daily for 8 weeks.The second had a total of 456 hypertensive patients,randomly assigned to ① Enalapril(10mg,control);② a single pill containing Enalapril(10mg) + folic acid 0.4mg;and ③ a single pill containing Enalapril(10mg) + folic acid 0.8mg,once daily for 8 weeks.Plasma homocysteine(Hcy) levels were measured for each patient at baseline,4th and 8th week of the trial.Results:Dose-response effect was only observed in fixed combination regime of enalapril and folic acid,that means the low compliance in free combination regime.Comparing with the enalapril/low-dose folic acid group,the enalapril/high-dose folic acid group in the fixed combination regime had a moderately higher hcy lowering rate and hcy or hypertension lowering rate,by 10% and 22% respectively than in the free combination regime with the enalapril/high-dose-folic acid.Conclusion:The fixed combination regime with the enalapril/high-dose folic acid appeared to have a better efficacy in controlling H-type hypertension than the the free combination regime.更多还原