盐酸巴尼地平治疗肾性高血压的前瞻性对照研究

A prospective controlled study of barnidipine hydrochloride in the therapy for renal hypertension

目的观察钙拮抗剂盐酸巴尼地平缓释胶囊治疗肾性高血压的有效性和安全性。方法采用开放、随机、对照试验。84例肾性高血压患者随机分为盐酸巴尼地平组和盐酸贝那普利组,治疗4周,观察血压、心率、服药状况及不良反应,并检测血常规、尿常规、血液生化、心电图及胸部X线。结果(1)盐酸巴尼地平组与盐酸贝那普利组的显效率、有效率和总有效率分别为:73.81%(31/42)比85.71%(36/42),16.67%(7/42)比7.14%(3/42),90.48%(38/42)比92.86%(39/42),2组间无显著性差异。(2)治疗4周后,盐酸巴尼地平组与盐酸贝那普利组的收缩压、舒张压分别下降(16.45±11.94)比(17.19±10.49)mmHg,(13.55±6.84)比(15.05±8.87)mmHg,2组间无显著性差异。(3)试验期间盐酸巴尼地平组与盐酸贝那普利组总不良反应发生率为11.63%比28.57%(P>0.05);但咳嗽的发生率,盐酸贝那普利组(14.29%)明显高于盐酸巴尼地平组(0.00%)。结论盐酸巴尼地平缓释胶囊10mg或15mg,每日1次口服治疗肾性高血压安全、有效。

Objective To investigate the efficacy and safety in the therapy for renal hypertension with a calcium antagonist—barnidipine hydrochloride slow release capsule. Methods An open randomized controlled clinical trial was performed. Eighty four patients with renal hypertension were randomly allocated into two groups to be treated for 4 weeks with either barnidipine hydrochloride or benazepril hydrochloride. The blood pressure, heart rate, administration status and adverse reactions of the patients were investigated. At the same time, blood routine, urine routine, blood biochemistry, electrocardiagram and chest X ray of the patients were examined.Results (1) After 4 weeks of treatment, the markedly effective rate, effective rates and the total effective rate in barnidipine hydrochloride group and benazepril hydrochloride group were 73 81%(31/42)vs. 85 71%(36/42), 16 67%(7/42)vs. 7 14%(3/42)and 90 48%(38/42)vs. 92 86%(39/42)respectively.(2)The systolic and diastolic pressures in barnidipine hydrochloride group and benazepril hydrochloride group were reduced by (16 45±11 94) vs. (17 19±10 49)mmHg and (13 55±6 84) vs. (15 05±8 87)mmHg respectively(P >0 05),which were not significant.(3) The total adverse event incidences in barnidipine hydrochloride group and benazepril hydrochloride group were 11 63%and 28 57%respectively(P >0 05). However, the cough incidence in benazepril hydrochloride group(14 29%)was significantly higher than that in barnidipine hydrochloride group(0 00%)(P=0 0120). Conclusion Barnidipine hydrochloride (10mg,15mg) per day is effective and safe in the therapy for renal hypertension.