国产氨氯地平治疗慢性肾功能不全并高血压的临床观察

目的 评价国产氨氯地平(兰迪)治疗慢性肾功能不全合并轻中度高血压的降压疗效和安全性.方法 慢性肾功能不全(血清肌酐值265-442 μmol/L)合并高血压患者61例,随机分为两组:兰迪组(31例)、氨氯地平组(络活喜组,30例),分别服用兰迪或络活喜5 mg每日1次,治疗4周末坐位DBP＜80 mm Hg且SBP＜130 mm Hg者继续原剂量治疗至8周末;坐位DBP≥80 mm Hg或SBP≥130 mm Hg者剂量分别加倍至10 mg 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 61例患者均完成8周的临床试验.降压总有效率兰迪组达87%,络活喜组达90%,若以血压为130/80 mm Hg为靶目标值则:兰迪组8周后11例(36%)达标;络活喜组9例(30%)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差异无统计学意义.结论 国产氨氯地平(兰迪)5～10 mg,每日1次是治疗慢性肾功能不全合并轻中度肾性高血压有效药物之一,且安全性好.

Clinical efficacy and safety of domestic produced amlodipine in the treatment of chronic renal insufficiency with hypertension

Objective To evaluate the antihypertensive effect and safety of domestic produced amlodipine(Lan Di) in the treatment of chronic renal insufficiency with mild-mnderate hypertension and to compare with the effect of imported amledipine.Methods Sixty-onc patients with chronic renal insufficiency(Scr:265～442 μmol/L,seated DBP 90 ～105mmHg and seated SBP≤170mmHg) were enrolled in this study.Patients were randomly assigned to receive Lan Di 5mg or novasc 5mg once daily for 4 weeks.Doses were titrating to 10mg/d for another 4 weeks in patients hating 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 Lan Di or novasc treatment.Results Lan Di group(31 cases) and novasc group(30 cases) 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 87% in Lan Di group and 90% in novasc group.If the target value of blood pressure is below 130/80mmHg,the response rate was 36% in Lan Di group and 30% in novasc group.At the end of 8 weeks,no difference was found in laboratory findings compared with those at baseline in two groups(P＞0.05).Side effects were comparable during the period of treatment.Condusion Domestic produced amlodipine 5mg or 10mg daily is as effective and safe as imported amolodipine in chronic renal insufficiency patients with mild to moderate hypertension.