盐酸贝尼地平片治疗轻、中度原发性高血压的长期、开放性临床研究

Long-action antihypertensive efficacy of Benidipine in patients with mild to moderate hypertension:an open-label,ambulatory blood pressure monitoring and long-term study

目的：应用动态血压监测进行轻、中度原发性高血压患者每日口服盐酸贝尼地平2-4mg的持续性降压疗效研究。方法：20例轻、中度原发性高血压患者经安慰剂1片，d洗脱2周，若诊室舒张压95-109mmHg且24h平均舒张压≥85mmHg，患者接受贝尼地平2m州治疗，如舒张压90mmHg或下降〉20mmHg，则维持原剂量不变．否则递增剂量至4mg／d，治疗8周后进行动态血压监测。另选36例治疗8周且降压有效的患者继续维持原剂量治疗24周。结果：20例患者贝尼地平2-4mg／d治疗后动态血压监测表明，24h动态收缩压／舒张压均值由135．67±6．52／87．30±5．81mmHg降至126．24±7．34／83．35±5．59mmHg，24h、日间和夜间治疗前后差异显著（P〈0．01和P〈0．05）。36例患者治疗24周，诊室收缩压／舒张压由153．06±13．09／98．89±3．65mmHg降低至133．27±12．70／83．69±6．0mmHg（P〈0．01）．降压总有效率为88．9％。贝尼地平片主要不良反应有轻度头痛、心慌、浮肿、瘙痒等。结论：每日口服贝尼地平2-4mg可持久、平稳地降低轻、中度原发性高血压患者的血压水平。

Objective：To investigate antihypertensive efficacy and long-action of L/T/N-type Ca^2± channels blocker Benidipine in Chinese patients with mild to moderate hypertension in an ambulatory blood pressure monitoring （ABPM）and long-term study.Methods：In this open-label ABPM clinical trial,20 eligible patients with sitting systolic blood pressure （BP）〈180mmHg and diastolic BP 95-109mmHg as well as 24h diastolic BP≥85mmHg after placebo 2-week run-in entered an 8-week study.All patients initially received Benidipin 2mg/d for 4 weeks,followed by same close or increase to Benidipin 4mg/d to achieve the target BP（diastolic BP 90mmHg or decreased〉20mmHg） for another 4 weeks.Another group of 36 eligible patients achieving the target BP with 2-4mg/d at the end of 8 weeks completed 24-week study.Results：After treatment with Benidipin 2-4mg/d for 8 weeks,the 24h mean ambulatory BP reduced significantly from 135.67±6.52/87.30± 5.81mmHg to 126.24±7.34/83.35±5.59mmHg.24-hour,daytime and nocturnal BP deceased from the baseline（P〈 0.01）.In 36 patients completing treatment for 24 weeks,the clinical systolic and diastolic BP changed from 153.06±13.09/98.89±3.65mmHg to 133.27±12.70/83.69±6.0mmHg （P〈0.01）.The efficacy was 88.9%.The major adverse reaction including mild headache,palpitation,edema and pruritus happened within 8 weeks and disappeared in the long-term study.Conclusion：Benidipine provides long-action and long-term antihypertensive effects with a favorable tolerability profile suggesting dosage of 2-4mg once a day in Chinese patients with mild to moderate hypertension.