盐酸马尼地平治疗轻中度高血压的有效性和安全性

Evaluation of efficacy and safety of manidipine hydrochloride among patients with mild or moderate essential hypertension: a multicenter,randomized,doubleblind study

目的评价盐酸马尼地平治疗原发性轻、中度高血压的有效性和安全性。方法采用随机、双盲、多中心、阳性药物平行对照研究的临床方法，将240例原发性轻、中度高血压患者分为观察组（120例）和对照组（120例），经过1～2周安慰剂清洗期后进入双盲治疗期，分别给予观察组（盐酸马尼地平片10～20mg／d）和对照组（苯磺酸氨氯地平片5～10m∥d）药物治疗8周后，比较两组用药前后血压值、耐受性和不良事件发生率。结果入组轻、中度高血压患者观察组完成103例，对照组完成103例。两组患者用药的依从性良好。对照组和观察组患者之间的年龄、性别比例、体质量指数、基础血压和心率等基线指标，差异无统计学意义（P〉0．05）。双盲治疗期末，两组间收缩压、舒张压下降值，心率及坐位舒张压正常化率比较，差异无统计学意义（P〉0．05）。两组间不良反应发生率差异无统计学意义（P〉0．05）。结论盐酸马尼地平治疗原发性轻、中度高血压降压疗效与苯磺酸氨氯地平相当，安全性及耐受性良好。

Objective To evaluate the efficacy and safety of manidipine hydrochloride among patients with essential mild or moderate hypertension. Methods Two hundred and forty subjects with mild or moderate hypertension were en- rolled in the study and assigned to two groups （the study group and the control group） equally by a randomized, doub- le-blind, multicenter and positive controlled study. After a one to two-week placebo run-in period, patients with essen- tial mild or moderate hypertension were distributed randomly into two groups to receive study drug （manidipine hydro- chloride 10 -20 mg per day） or positive controlled drug （ amlodipine besylate 5 - 10 mg per day） respectively for 8 weeks. BP change, tolerance and adverse events between the two groups were evaluated. Results One hundred and three patients completed trial in the study group and 103 patients in the control group. Subjects who completed the study were with good compliance, except those dropped off or were excluded. There was no significant difference for baselinecharacteristics between the two groups （ P 〉 0.05 ） including age, sex, body mass index, baseline systolic and diastolic BP, and heart rate. The reduction of diastolic and systolic BP, heart rate and seat diastolic blood pressure normalized rate between the two groups had no significant difference at the end of treatment （ P 〉 0.05 ）. The incidence of adverse events also had no significant difference between the two groups （ P 〉 0.05 ）. Conclusion The antihypertensive effica- cy of manidipine hydrochloride is equal to amlodipine besylate among patients with mild or moderate hypertension. Manidipine hydrochloride is safe and can be well tolerated.