复方尼群洛尔片治疗轻中度原发性高血压的疗效和安全性及剂量配比

目的验证复方尼群洛尔片的有效性和安全性，探讨尼群地平和阿替洛尔的最佳剂量配比。方法2005年2月至7月将上海、南京、苏州7家医院入选275例原发性高血压患者以等比例随机分成3个不同剂量配比的复方尼群洛尔组[每片分别含尼群地平、阿替洛尔：5mg、12．5mg（复方一组），5mg、10mg（复方二组），5mg、7．5mg（复方三组）]、单用尼群地平（10mr,／片）组及阿替洛尔（25mg／片）组共5组，进行为期8周治疗。结果治疗8周后5组舒张压的下降值分别为（17±7）、（18±9）、（17±7）、（13±7）和（12±6）mmHg（1mmHg=0．133kPa）。3种不同剂量组合复方组舒张压下降幅度均大于任一单药组。复方一组、复方二组、复方三组、尼群地平组和阿替洛组收缩压的下降值分别为（21±11）、（24±12）、（23±11）、（19±13）和（18±9）mmHg，组间比较，复方二组收缩压下降大于阿替洛尔组。5组的降压总有效率分别为94．4％、98．1％、88．2％、78．4％和71．4％，不同剂量复方组与阿替洛尔组比较，降压疗效的差异有统计学意义（P〈0．01）。第5周时增加剂量比例的组间比较，复方二组低于其他4组。不良反应多数轻微，无需特殊处理，实验室检查无明显改变。结论复方尼群洛尔片治疗轻、中度原发性高血压安全、有效，耐受性好，剂量组合以尼群地平5mg和阿替洛尔10mg为佳。

Efficacy and safety of fixed combination of nitrendipine and atenolol in treatment for patients with mild to moderate essential hypertension and their optimal dosage matching

Objective To evaluate efficacy and safety of fixed combination of nitrendipine and atenolol in treatment for patients with mild to moderate essential hypertension and their optimal dosage matching.Methods Totally,275 patients with essential hypertension were selcted from seven hospitals in Shanghai,Nanjing and Suzhou,China and randomized into five groups with same proportional probability in a double-blind,double-dummy,parallel active-controlled,multi-center clinical trial,receiving fixed combination of nitrendipine and atenolol at three different dosage matching (nitrendipine/atenolol 5/12.5 mg,5/10 mg,5/7.5 mg for groups 1,2 and 3),and nitrendipine (10 mg for group 4) or atenolol (25 mg for group 5),respectively for eight weeks.Results Mean reduction of diastolic blood pressure (DBP)was (17±7) mm Hg,(18±9) mm Hg and (17±7) mm Hg for groupl,2 and 3,respectively from the baseline,significantly greater than that in groups 4 and 5[(13±7) mm Hg and (12±6) mm Hg,respectively].Mean reduction of systolic blood pressure (SBP) was (21 ±11)mm Hg,(24±12) mm Hg,(23±11) mm Hg,(19±13) mm Hg and (18±9) mm Hg,respectively for the five groups from the baseline,and the reduction in group 2 was significantly greater than that in group 5,with an overall efficacy of 94.4%,98.1% and 88.2% for groups 1,2 and 3,respectively,all statistically higher than that in group 5 (71.4%) with P＜0.01,eight weeks after treatment.The ratio of patients with increased dose of antihypertensive agents in week 5 was lower in group 2 than that in the other four groups,with mild adverse reaction only,no obvious change in laboratory biochemical examinations,and no needs in special management.Conclusions Fixed combination of atenolol and nitrendipine with an optimal doses of 5 mg and 10 mg respepctively was effective and safe for mild and moderate hypertension with good tolerance.