盐酸莫索尼啶治疗高血压病的多中心临床研究

Multicentre Clinical Trial on Moxonidine Hydrochloride for Treatment of Hypertension

目的:评价国产盐酸莫索尼啶对轻、中度高血压病的降压疗效及安全性。方法:本文多中心临床试验以可乐定为对照,采用随机单盲平行试验方法,莫索尼啶组302例(101例与可乐定对照,201例开放试验),可乐定组100例。起始剂量分别为每日0.2mg与0.15mg,2周末若血压≥140/90mmHg,则分别增量至0.4mg与0.3mg,疗程共4周。对莫索尼啶降压有效者继续用至6个月,另19例有效者在治疗前后完成动态血压监测,进行T/P比值分析。结果:两组药物治疗一周血压即开始下降。治疗4周末,莫索尼啶组平均坐位收缩压与舒张压分别下降12.1％～12.6％与12％～13.5％,可乐定组分别下降12.9％与13.4％,两药总有效率分别为82.5％与74％。两组间临床疗效无显著性差异。莫索尼啶治疗延续6个月仍保持降压效果。常见的不良反应为头晕、嗜睡、乏力等,但症状轻,病人耐受性好。实验室检查无异常发现。结论:莫索尼啶对轻、中度高血压患者,降压疗效确切,不良反应轻,病人耐受性好,临床综合评价优于可乐定。

OBJECTIVE: To evaluate the effect and safety of domestic moxonidine hydrochloride on mild to moderate hypertension METHOD: This multicentre clinical trial used clonidine as control, and it was single blind and randomly parellel. There were 302 patients in moxonidine group, (101 of them were compared with clonidine group, the other 201 were set as open treatment group.) and there were 100 patients in clonidine group. The start dose were 0.2 and 0.15mg· d-1, respectively. After two weeks, if the blood pressure was higher than 140/90 mmHg, the doses were added to 0.4 and 0.3mg · d-1, respectively. The total course of treatment was 4 weeks. Patients who were reactive to moxonidine continued to use it for 6 months, and 19 of them were carried out ambulatory blood pressure monitoring before and after treatment, then analysed with T/P ratio. RESULT: Blood pressure began to decline in the first week of treatment. After 4 weeks,the mean systolic and diastolic blood pressure in seat of moxonidine group declined 12.1%-12.6% and 12%-13.5%, respectively. And those of control group declined 12.9% and 13.4%. The total efficacy rates of the two kinds of drug were 82.5% and 74%. There was no remarkable difference between the clinical efficacy rates of the two kinds of drug . Six months treatment with moxonidine could maintain its anti-hypertensive effect. The frequent adverse reaction of moxonidine is dizziness,drowsiness and inertia, et al. But they were all gently, the patients had better tolerance. And moxonidine had no side effect on biochemistry exams. CONCLUSION: Moxonidine has affirmed effect on mild to moderate hypertension, with little side effects, good patients tolerance. Moxonidine is better than clonidine by total clinical evaluation.