氨氯地平与非洛地平缓释剂治疗原发性轻、中度高血压的随机、双盲平行对照研究

The Antihypertensive Effects of Amlodipine and Felodipine ER in Hypertensive Patients

目的:对比氨氯地平与非洛地平缓释剂治疗轻中度原发性高血压的疗效和安全性;每日1次服药对24小时动态血压的影响;并对比药物漏服对血压控制的影响。方法:76例轻、中度高血压患者被随机、双盲分成两组,分别每日口服1次氨氯地平5～10mg(Ⅰ组)或非洛地平缓释剂5～10mg(Ⅱ组),治疗12周,并用24小时动态血压监测评价用药前后24小时血压变化情况及漏服48小时的血压变化。结果:氨氯地平治疗组舒张压降低15.1mmHg(治疗末为84.8mmHg),非洛地平缓释剂治疗组舒张压降低15.3mmHg(治疗末为85.0mmHg)。总有效率Ⅰ组病人为83.8％,Ⅱ组为87.9％(P=NS)。在药物的初始剂量下即能达到有效血压控制的病人数Ⅰ组为76％,Ⅱ组为52％(P<0.01)。药物漏服24和48h后,Ⅰ组临床血压仍低于140/90mmHg,24小时动态血压与漏服前相比无显著性差异,而Ⅱ组的临床血压高于140/90mmHg,临床血压和24小时动态血压与漏服前相比具有显著性差异。两治疗组的副作用发生率均较低。结论:氨氯地平与非洛地平缓释剂均能有效降低轻、中度高血压病人的血压,安全、疗效可靠,病人耐受性好,但漏服试验表明漏服24与48h氨氯地平仍能较好的控制血压。Ⅰ组的血压波动明显低于Ⅱ组。

Objectives: To compare the antihypertensive effect and safety of amlodipine and felodipine ER. Both drugs were given once daily and 24 - hour ambulatory blood pressure (ABP) was monitored. The effect of missed doses was also evaluated. Methods: Seventy - six patients with mild to moderate hypertension were randomized to two groups in double -blind manner. One group was treated with amlodipine 5. 0 - 10. 0 mg/day (group I), the other group with felodipine ER 5. 0 - 10. 0 mg/day (group Ⅱ), for 12 weeks. Twenty -four hour ABP monitoring at baseline and post - treatment was used to evaluate the drug efficacy and blood pressure (BP) changes during drug holiday (48 hours) . Results: Diastolic blood pressure was reduced in the amlodipine group by 15.1mmHg(to a final BP of 84. 8mmHg) and in the felodipine ER group by 15. 3mmHg(to a final BP of 85, 0mmHg). Efficacy was achieved in 83. 8% of patients in group I and in 87. 9% of patients in group Ⅱ (P = NS). The BP was controlled at the starting dose in 76% for patients in group I and 52% in groupⅡ (P < 0.01) . In group I BP remained below 140/90mmHg 24 - 48 hours after missed dose and 24 - hour ABP was not significantly different from that before the missed doses. In group Ⅱ BP was above 140/90 mmHg after missed dose, and both BP and 24 - hour ABP was statistically higher than those before the missed doses. Adverse reactions were infrequent in both groups. Conclusions: Both Amlodipine and felodipine ER are effective, safe, reliable and well - tolerated in the treatment of mild and moderate essential hypertension. BP was well controlled in group I 24 - 48 hours after missed dose. The fluctuation of BP in group I was significantly leas than that in group Ⅱ.