西尼地平胶囊治疗轻中度原发性高血压的有效性和安全性临床研究

A clinical trial comparing the efficacy and safety of Cilnidipine capsules versus Cilnidipine tablets in patients with mild and moderate primary hypertension

目的:评价国产西尼地平胶囊在治疗轻、中度高血压患者的临床有效性及安全性。方法:在3个临床试验中心招募病人,采用多中心随机、双盲双模拟、平行阳性对照试验设计,符合入选标准的轻-中度原发性高血压患者经2周模拟剂洗脱期后,240例患者按1∶1的比例随机分为西尼地平胶囊组和西尼地平片组;分别给予西尼地平胶囊或西尼地平片治疗8周观察其疗效和安全性。结果:在治疗8周末,两组的坐位收缩压和舒张压均下降。西尼地平胶囊组和片剂组平均坐位收缩压分别下降11.5mmHg和11.3mmHg(1mmHg=0.133kPa,P=0.82),坐位舒张压分别下降14.1mmHg和16.1mmHg(P=0.50)。经8周治疗,西尼地平胶囊组和片剂组总有效率分别为77.2%和77.9%(P=0.90)。西尼地平胶囊组和片剂组分别出现22和20例次考虑与治疗相关的不良事件,主要为心悸和头晕。服用药物后,两组心率较基线变化有统计学差异(P=0.0009,P=0.0043)。结论:国产西尼地平胶囊对轻中度高血压患者疗效肯定,不良反应少。

AIM：To assess the comparative efficacy and safety of the Cilnidipine capsules versus Cilnidipine tablets in patients with mild and moderate primary hypertension. METHODS：240 patients were enrolled from 3 Chinese study centers for a randomized,double-blind,parallel-group,active-controlled,8-week clinical trial. Patients were randomly assigned to receive daily dose of Cilnidipine capsules or Cilnidipine tablets 5 after two weeks wash out periods.The efficacy and safety were assessed. RESULTS：The study demonstrated similar reductions at week 8 in both DBP and SBP for both groups. For the primary efficacy analysis of sitting diastolic pressure,there was a mean reduction from baseline of 11.5 mm Hg and 11.3 mm Hg for the Cilnidipine capsules and Cilnidipine tablets groups,respectively （P=0.82）. The mean reduction from baseline in sitting systolic presure was 14.1 mm Hg and 16.1 mm Hg for the Cilnidipine capsules and Cilnidipine tablets groups,respectively （P=0.50）. At the end of the treatment peroid,the total effective rate of Cilnidipine capsules and Cilnidipine tablets groups was 77.2% and 77.9% respectively （P=0.90）. For the safety/tolerance,there were 22 and 20 incidences of adverse events regarded relatively with cilnidipine capsules and tables respectively.Most of them were palpitation and dizziness.No statistical difference existed between the two groups with respect to adverse events. Both the two treatment groups were associated with a significantly decrease of heart rate （P=0.0009,P=0.0043）. CONCLUSION：Cilnidipine capsules are an effective and well-tolerated antihypertensive for patients with mild to moderate hypertension.