坎地沙坦、缬沙坦对轻中度原发性高血压降压疗效及心脏重构与舒张功能影响的对比研究

Comparison of antihypertensive efficacy of Candesartan and Valsartan and their influence on cardiac remodeling and diastolic function in patients with mild to moderate essential hypertension

目的评价坎地沙坦治疗轻中度原发性高血压的疗效和安全性,以及对心脏重构与左室舒张功能的影响。方法采用随机、双盲、缬沙坦对照方法。72例患者随机服用坎地沙坦或缬沙坦各1粒,1次/d,4周后如血压未达标,则增加1倍剂量1次,总疗程8周。结果 8周末,两组患者坐位平均收缩压和舒张压较治疗前下降(P<0.05),缬沙坦组血压下降幅度为(18.44±4.67)/(12.00±3.57)mm Hg;坎地沙坦组血压下降幅度为(21.00±4.18)/(13.21±3.36)mm H(g P<0.01),主要降幅均在前2周。两组的降压总有效率分别为78.8%和79.4%(P>0.05)。动态血压资料显示,治疗8周后,24 h、白天和夜间血压负荷均较治疗前下降。其中坎地沙坦组夜间血压负荷低于缬沙坦组(P<0.05);两组谷峰比值差异无统计学意义。治疗8周后,两组左心房容积指数(LAVI)治疗后较治疗前下降[坎地沙坦组:治疗8周后(14.2±2.72)vs治疗前(20.0±3.51),缬沙坦组:治疗8周后(16.7±3.24)vs治疗前(20.5±2.32)]。N末端脑钠肽原(NT-pro BNP)浓度较治疗前下降[坎地沙坦组:治疗8周后(48.2±14.3)vs治疗前(80.5±15.2)(pg/ml);缬沙坦组:治疗8周后(55.6±12.1)vs治疗前(81.3±13.2)(pg/ml)];治疗8周后坎地沙坦组LAVI和NT-pro BNP低于缬沙坦组(P<0.05)。左心室质量指数(LVMI)与治疗前比较[坎地沙坦组(84.5±10.7)vs(88.2±10.1)g/m^2;缬沙坦组(85.5±9.8)vs(89.1±11.2)g/m^2],差异无统计学意义(P>0.05)。两组均无不良事件发生,血液生化等实验室指标除血总胆固醇呈下降趋势外,其余无异常改变。结论国产坎地沙坦酯胶囊治疗轻中度原发性高血压效果优于缬沙坦,可改善24 h非杓型曲线,剂量小,同时可早期改善心脏重构,逆转舒张功能不全,较缬沙坦有一定的优势,不良反应少,适用于长期治疗。

Objective To evaluate the efficacy and safety of domestically-produced Candesartan cilexetil in patients with mild to moderate essential hypertension, and the effect on cardiac remodeling and left ventricular diastolic function. Methods Sixty-seven patients were randomly assigned to receive Candesartan cilexetil 4-8 mg/d or Valsartan 80-160 mg/d for 8 weeks. The dosage was doubled once if BP was not controlled to standard level in 4 weeks. Ambulatory blood pressure monitoring and echocardiography were measured before and after treatment. Results At the end of the 8th week, systolic blood pressure （SBP） and diastolic blood pressure （DBP） significantly decreased by （18.44 ± 4.67） and （12.00 ± 3.57）mmHg in the Valsartan group and （21.00 ±4.18） and （13.21 ± 3.36）mmHg in the Candesartan group respectively （P〈 0.05）; the major decline appeared in the first two weeks. The total effective rate was 78.8% in the Candesartan group and 79.4% in the Valsartan group （P〉 0.05）. Compared with the Valsartan group, the blood pressure decreased to a significantly lower level in the Candesartan group. Compared with those before treatment, 24-h, daytime and night SBP loads and DBP loads were significantly lower after 8-week treatment in both groups, the differences were statistically significant （P 〈 0.05）. nSBP and nDBP in the Candesartan group were significantly improved compared to those in the Valsartan group （P 〈 0.05）. Trough/peak ratios （T/P） of SBP and DBP were 64% and 65% in the Candesartan group and 57% and 59% in the Valsartan group, there were no significant differences between both groups. After 8-week treatment, the improvement in the left atrial volume index （LAVI） and NT-proBNP of the Candesartan group was more obvious than that of the Valsartan group, the difference was statistically signifi- cant （P 〈 0.05）. Left ventrical mass index （LVMI） of both groups decreased after treatment, but the differences were not significant （P 〉 0.05）. There were no adverse events in either group, there were no changes of blood biochemical or other laboratory indexes except for slight decrease in total cholesterol （P〉 0.05）. Conclusions Domestically-produced Candesartan can reduce blood pressure load, improve 24-h non-dipper curve, reverse cardiac remodeling in early stage, and improve left ventricular diastolic function and prognosis in patients with essential hvoertension. Adverse reactions are few. It is worthy of clinical oromotion.