国产苯磺酸氨氯地平和络活喜治疗慢性肾功能不全合并高血压的对比研究

目的评价苯磺酸氨氯地平(压氏达)和络活喜对慢性肾功能不全合并高血压的患者的治疗效果和安全性。方法慢性肾功能不全(血清肌酐值265~442μmol.L-1)合并高血压患者(坐位DBP 90~105mmHg和/或坐位SBP≤170mmHg)63例被随机分为两组,分别服用压氏达或络活喜5mg每日1次,治疗4周末坐位DBP<80mmHg,且SBP<130mmHg者继续原剂量治疗至8周末;坐位DBP≥80mmHg或SBP≥130mmHg者剂量分别加倍至10mg每日1次治疗至8周末。分别观察患者服药前后血压、心率和肝肾功能等生化指标变化及其不良反应。结果 63例病人均完成8周的临床试验。与试验前比较,用药第4周起,两组患者的收缩压和舒张压均有显著性下降(P<0.01),降压总有效率压氏达组达87%,络活喜组达90%,若以血压为130/80mmHg为靶目标值则:压氏达组8周后12例(37.5%)达标;络活喜组10例(32.3%)达标。两组不良反应轻,试验结束时主要实验室检查指标与试验前比较无统计学差异。结论压氏达5~10mg每日1次是治疗慢性肾功能不全合并高血压的有效药物之一,且安全性好。

Comparative study of Yashida and Norvasc in chronic renal insufficiency with hypertension

OBJECTIVE To evaluate the antihypertensive effect and safety of Yashida and Norvase in the treatment of chronic renal insufficiency patients with hypertension. METHODS Sixty-three patients with chronic renal insufficiency（Scr： 265- 442μmol · L^- 1, seated DBP 90 - 105mmHg and seated SBP≤170mmHg） were enrolled in this study. Patients were randomly assigned to receive Yashida 5rag or Novasc 5mg once daily for 4 weeks. Doses were titrating to 10mg· d^-1 for another 4 weeks in patients having seated DBP≥80mmHg or SBP≥130mmHg at the end of 4 weeks. Blood pressure, heart rate, laboratory examinations were performed at baseline and the end of the trial, and side effects were assessed pre and post Yashida or Novasc treatment. RESULTS Yashida group and Novasc group finished a 8 week clinical trial. At the end of 4, 8 weeks, seated SBP and DBP were significantly lowered compared with those at baseline（P〈 0.01）. There was no significant difference in the reduction of seated DBP or SBP between the two groups at the end of 4, 8 weeks（P 〉0.05） .At the end of 8 weeks, the response rate was 88 % in Yashida group and 90 % in Novase group. If the target value of blood pressure is below 130/80mmHg, the response rate was 37.5 % in Yashida group and 32.2% in Novasc group.At the end of 8 weeks, no difference was found in laboratory findings compared with those at baseline in the two groups （P 〉 0.05）. Side effects were comparable during the period of treatment. CONCLUSION Yashida 5mg or 10mg daily is as effective and safe as Novase in chronic renal insufficiency patients with hypertension.