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目的对稳定性冠心病患者,观察将培哚普利由4mg/d 调整至8mg/d 后的耐受性。方法开放性多中心研究。入组已经服用培哚普利4 mg/d 至少4周的稳定性冠心病患者,采用培哚普利8 mg/d 治疗2个月,观察增量后的安全性与耐受性。观察指标:不良事件和严重不良事件、患者依从性,记录基线状态、第4周和第8周的血压、心率、血钾、钠、肌酐和尿素氮。结果共入选109例符合入选标准的稳定性冠心病患者。其中102例患者能够很好耐受培哚普利8 mg/d 治疗,总耐受率为93.6%。共计18例患者(占16.5%)发生不良事件,无严重不良事件发生。仅1例患者(占0.9%)因不良事件退出。培哚普利增量使基线血压未达标患者的血压由(149.4±7.6)/(84.1±11.0)mm Hg(1 mm Hg=0.133 kPa)下降至(128.8±14.2)/(79.5±8.9)mm Hg(均 P<0.01),而对基线血压达标患者的血压无影响。观察期间患者心率由(72.3±9.4)次/min 下降至(69.8±7.8)次/min(P<0.05),血电介质、肌酐和尿素氮水平无变化。结论中国稳定性冠心病患者对培哚普利8 mg/d 的治疗剂量耐受性良好。
Objective To investigate the tolerability of perindopril in patients with stable coronary artery disease from 4 mg / day to 8 mg / day. Methods Open-label multicenter study. Patients enrolled in the study were enrolled in this study. Patients with stable coronary heart disease who had received perindopril 4 mg / d for at least 4 weeks and perindopril 8 mg / day for 2 months were enrolled. The safety and tolerability of the enteral diet were observed. OUTCOME MEASURES: Adverse events and serious adverse events, patient compliance, baseline status, blood pressure, heart rate, serum potassium, sodium, creatinine and urea nitrogen at weeks 4 and 8. Results A total of 109 patients with stable coronary heart disease were enrolled in the study. 102 patients were well tolerated perindopril 8 mg / d treatment, the total tolerability rate was 93.6%. A total of 18 patients (16.5%) had adverse events without serious adverse events. Only 1 patient (0.9%) quit due to adverse events. The increase of perindopril decreased the blood pressure of patients without baseline blood pressure from (149.4 ± 7.6) / (84.1 ± 11.0) mm Hg (1 mm Hg = 0.133 kPa) to (128.8 ± 14.2) / (79.5 ± 8.9) mm Hg (all P <0.01), but had no effect on the blood pressure of baseline blood pressure patients. During the observation period, the heart rate decreased from (72.3 ± 9.4) times / min to (69.8 ± 7.8) times / min (P <0.05), and there was no change in the blood level of creatinine, creatinine and blood urea nitrogen. Conclusions Patients with stable coronary heart disease in China are well tolerated by perindopril 8 mg / d.