国产和进口赖诺普利在高血压治疗中的临床比较

目的　评价国产与进口赖诺普利在原发性高血压治疗中降压疗效及安全性的临床等效性。方法　本研究采用多中心随机、单盲、平行对照的方法。 18～ 70岁不拘性别的原发性高血压患者 ,坐位血压 <180 /90～ 10 9mmHg ,不伴有严重靶器官损害。符合入选条件者经两周的安慰剂清洗期后随机分为国产或进口赖诺普利组 ,两组分别服国产或进口赖诺普利10mg/d一次两周 ,两周后坐位舒张压仍≥ 90mmHg者 ,加量至 2 0mg到试验结束。总计服药时间为 6周。服国产赖诺普利者完成 2 4h动态血压监测 2 0例。结果　完成 6周观察者 192例 ,其中赖诺普利组 94例 ,总有效率 5 0 0 %。进口赖诺普利 (捷赐瑞 )组 98例 ,总有效率为 5 4 1%。两组总有效率无显著差异。两组服药 4周后的血压与用药前比较均有显著性差异 ,无严重不良反应。咳嗽的发生率为赖诺普利组 2 8 7% ( 2 7/94) ,捷赐瑞组 2 6 5 % ( 2 6/98)。两组无统计学差异。赖诺普利组共完成 2 4h动态血压监测 2 0例。赖诺普利的降压谷 /峰比值大于 5 0 %。结论　国产与进口赖诺普利相比 ,两者具有相同的疗效 ,主要不良反应咳嗽的发生率相似 ,国产赖诺普利同样可以作为长效制剂用于原发性高血压治疗

Antihypertensive Effects of Domestic Produced and Imported Lisinopril

Objective To compare the antihypertensive effects and safety of domestic produced lisinopril and imported lisinopril. Methods One hundred ninety two patients with hypertension aged 18-70 years old with seated BP<180/90-109 mmHg were recruited. Patients with severe target organ dysfunction were excluded. After 2 weeks of washout period, patients were randomly assigned to receive domestic or imported lisinopril (10 mg/d). If the goal BP were not reached after 2 weeks of treatment, the doses were titrated to a maximum of 20 mg/d for another 2 weeks. ABPM was carried out in 20 patients in the domestic lisinopril group. Results One hundred ninety two patients completed the 6 weeks treatment(94 in domestic and 98 in imported group). No significant differences in the total response rate between the two groups(50% vs 54%, P>0.05) was shown with no difference in the side effects. The incidence of cough was 28.7% in domestic vs 26.5% in the imported group (P>0.05). The trough/peak ratio of SBP and DBP of domestic lisinopril was 50% and 54.5%. Conclusion The antihypertensive effects of domestic and imported lisinopril are comparable and the incidence of side effects of cough are also similar.