苯磺酸左氨氯地平/富马酸比索洛尔固定复方治疗轻中度原发性高血压的剂量探索:一项多中心、随机、双盲、Ⅱ期临床试验OA

Objective To evaluate the efficacy and safety of different dose combinations of levamlodipine besilate tablets and bisoprolol fumarate tablets compared with placebo and control.Methods A multicenter,randomized,double-blind,double-dummy,placebo-positive drug-controlled dose-finding study in which patients with grade 1-2 essential hypertension were randomly divided into 5 groups after 14 days of placebo,namely:group A(placebo group),group B(levamlodipine besilate 2.5 mg/placebo),group C(bisoprolol 5 mg/placebo),group D(levamlodipine besilate 2.5 mg/bisoprolol fumarate 2.5 mg group)and E group(levamlodipine besilate 2.5 mg/bisoprolol fumarate 5 mg group),treated for 56 days.14 days,28 days,and 56 days after treatment,the main indicators-diastolic blood pressure,and the secondary indicators-systolic blood pressure,were analyzed,and the efficacy and safety were analyzed.Results After 56 days of treatment,the decrease in diastolic blood pressure was 3.26±8.09 mmHg in group A,8.89±6.97 mmHg in group B,7.89±6.48 mmHg in group C,12.64±6.49 mmHg in group D,and 13.46±7.80 mmHg in group E.Compared with group A,groups B,C,D,and E,P＜0.001;the reduction of blood pressure between groups D and E(combination treatment group)and group B and C(monotherapy group)was significantly lower than that of group A P＜0.01,and P＞0.05 between combination treatment groups(D and E)and monotherapy groups(B and C groups).In terms of reducing systolic blood pressure,group B(decrease of 13.39±11.48 mmHg),group D(decrease of 17.55±10.31 mmHg)and group E(decrease of 20.60±13.06 mmHg)and group A(decrease of 5.55±13.19 mmHg)were P＜0.001;group E compared with group B and C,P＜0.001;compared between group D and C,P＜0.01;and P＞0.05 between groups D and E of the two combination treatment groups.Conclusion The 2.5 mg levamlodipine besilatee tablets combined with 2.5 mg bisoprolol fumarate tablets and 2.5 mg levamlodipine besilate tablets combined with 5 mg bisoprolol fumarate tablets have good efficacy and are better than the single agent levamlodipine besilate or bisoprolol fumarate in reducing diastolic blood pressure,and are well tolerated.