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目的评价国产贝尼地平的降压效应及安全性。方法本试验为多中心、随机、双盲、对照研究。201例原发性高血压病人随机分配到贝尼地平组(n=99)和拉西地平组(n=102),第1周口服贝尼地平2mg或拉西地平4mg,4周后舒张压>85mmHg者,贝尼地平增加到4mg、拉西地平增加到8mg,8周为一疗程。结果贝尼地平组服药8周后SBP和DBP下降(15.51±17.19)和(11.82±9.84)mmHg(P<0.01),拉西地平组SBP和DBP下降(19.26±15.85)和(13.51±7.26)mmHg(P<0.01);试验组和对照组总有效率分别为74.7%和78.4%(P>0.05)。服药8周有效的36例患者继续服药到24周,仍维持88.9%的总有效率。对12例服贝尼地平患者作动态血压资料分析,24h、白天和夜间平均收缩压/舒张压均显著下降,收缩压和舒张压的谷峰比值分别为78%和80%。2药的不良反应轻微,发生率分别为10.80%、11.5%(P>0.05)。结论贝尼地平是一种安全有效的抗高血压药。
Objective To evaluate the antihypertensive effect and safety of domestic benidipine. Methods This trial was a multicenter, randomized, double-blind, controlled study. 201 patients with essential hypertension were randomized to receive either benidipine (n = 99) or lacidipine (n = 102), 2 mg of benidipine 2 mg or lacidipine orally at week 1, 4 weeks after diazepam > 85mmHg, benidipine increased to 4mg, lacidipine increased to 8mg, 8 weeks for a course of treatment. Results SBP and DBP decreased (15.51 ± 17.19) and (11.82 ± 9.84) mmHg (P <0.01) in the benidipine group and decreased in the lacidipide group (19.26 ± 15.85 and 13.51 ± 7.26) mmHg (P <0.01). The total effective rate was 74.7% in the test group and 78.4% in the control group (P> 0.05). Thirty-six patients who took the drug for 8 weeks remained on medication until 24 weeks, still maintaining a total effective rate of 88.9%. In 12 patients with benidipine, the mean systolic blood pressure / diastolic blood pressure decreased significantly at 24h, daytime and nighttime, and the peak-to-peak systolic and diastolic blood pressure values were 78% and 80% respectively. Adverse reactions of 2 drugs were mild, the incidence rates were 10.80%, 11.5% (P> 0.05). Conclusion Benidipine is a safe and effective antihypertensive drug.