贝尼地平治疗轻中度原发性高血压的多中心随机双盲临床研究

Efficacy and Safety of Benidipine in Patients with Mild-to-Moderate Hypertension,a Multicenter Doubleblind Randomized Controlled Clinical Trial

目的评价贝尼地平治疗国人轻中度原发性高血压的疗效与安全性。方法采用多中心、随机、双盲的研究方法,201名轻、中度原发性高血压患者服用安慰剂2周后随机接受贝尼地平或拉西地平治疗,贝尼地平组(99例)起始剂量为2 mg,1次·d-1,拉西地平组(102例)起始剂量为4 mg,1次·d-1,4周后如果血压未达标,将剂量增加至贝尼地平4 mg·d-1,或拉西地平8 mg·d-1。总治疗期间为8周,每2周随访1次,观察降压疗效和不良反应。结果服药4周后贝尼地平组SBP由(152.22±13.77)mmHg降至(137.37±15.96)mmHg,8周时降至(136.72±16.49)mmHg(P<0.01)。4周时DBP由(98.45±3.21)mmHg降至(85.34±9.49)mmHg,8周后DBP为(86.55±9.95)mmHg(P<0.01),降压总有效率74.7%。拉西地平组治疗4周后SBP由(153.59±12.87)mmHg降至(138.94±14.4)mmHg,8周时降至(134.33±13.90)mmHg(P<0.01)。4周时DBP由(98.48±3.63)mmHg降至(85.81±9.30)mmHg,8周后DBP为(85.01±7.79)mmHg(P<0.01),总有效率为78.4%,两组降压疗效比较无显著性差异(P>0.05)。结论贝尼地平与拉西地平比较降压疗效相当,是一种安全有效的降压药,并具有起效缓慢、作用持久、平稳降压的特点,且不良反应轻微。

OBJECTIVE To study effect and safety of benidipine in treatment of Chinese patients with mild to moderate hypertension. METHODS With random and double-blinded method in multicenters, 201 eligible patients aged from 18 to 75 years with mild to moderate hypertension were derided into two groups after received placebo for 2 weeks, 99 patients in experimental group received benidipine 2 mg once a day, 102 patients in control group were given lacidipine 4 rag, once a day for 4 weeks. The dose is adjusted after 4 weeks in the patients not reaching the blood pressure target of DBP or SBP. The whole treatment was continued for 8 weeks, patients must finish one visit every 2 weeks for observing efficacy and adverse events. RESULTS The SBP of the patients in experimen tal group decreased from （ 152. 22 ± 13.77） to （ 137.37± 15.96） mmHg and the DBP from （98.45 ± 3.21 ） to （85.34 ± 9.49） mm Hg after 4 weeks, and DBP was （86. 55 ± 9. 95） mmHg after 8 weeks, the response rate was 74. 7%. In control group, SBP from （ 153.59 ± 12. 87） to （ 138.94± 14.4） mmHg and DBP decreased from （98. 48±3.63 ） to （ 85.81 ± 9. 30） mmHg after 4 weeks, and DBP was （85.01 ±7.79） mmHg after 8 weeks, the response rate was 78, 4%, No significant difference is found between two groups （ P 〉 0. 05 ）. CONCLUSION Benidipine and lacidipine have same efficacy to treat hypertension, benidipine is a kind of safe and effective drug to treat hypertension, the action of this drug is stable, persistent and smooth, adverse events are mild.