国产西尼地平治疗轻中度高血压有效性及安全性研究

目的 评价国产西尼地平治疗轻度至中度高血压的临床疗效及安全性。方法 以国产马来酸氨氯地平为对照药，在轻度至中度高血压病人中进行多中心、随机、双盲、平行、活性对照的临床试验。结果 西尼地平组平均坐位收缩压下降17．48mmHg(2．33kPa)(-11．58％)，舒张压下降14.46mmHg(1．93kPa)(-14．6l％)。有69例(65．09％)患者在治疗结束时达到方案规定的治疗显效标准，15例(14．15％)患者达到有效标准，总有效率为79．24。在安全性/耐受性方面，西尼地平组内出现12例次考虑与治疗相关的不良事件，主要为心悸、头晕和面色潮红。没有出现有临床意义的生化及心电图改变。结论 国产西尼地平片疗效肯定，耐受性好，副作用少。

Efficacy and safety of a novel calcium antagonist cilnidipine in treatment of essential hypertension

Objective To evaluat the antihypertensive effects and tolerance of a novel dihydropyridine calcium antagonist. Methods The multicenter, double-blind, random samples, active-controlled study has been processed in the mild to moderate hypertensive patients, and maleic acid amlodipine as the controll drug. Results Compared with the control, cilnidipine lowered sitting-blood pressure to 17.48 mmHg(2.33 kPa)( - 11.58%)of systolic presure and 14.46 mmHg(1.93 kPa) ( - 14.61%) of diastolic presure after 8 weeks treatment. At the end of the treatment peroid, the total effective rate of cilnidipine is 79.24%. For the safety/tolerance, there are 12 incidences of adverse events regarded relatively with cilnidipine. Most of them are palpitation, dizziness, and face flushing. There are not effective changes in blood markers of liver and kidney functions, and electrocardiogram. Conclusion Cilnidipine (5 - 10 mg) well tolerated and reduces blood pressure in patients with mild to moderate hypertension.