西尼地平胶囊治疗轻中度原发性高血压的多中心临床研究  

A multicenter clinical trial for evaluation of cilnidipine in patients with mild to moderate essential hypertension

作　　者：漆泓[1] 杨天伦[1] 吴声滨[1] 刘朝中[2] 陶新智[3] 荆施展[1] 

机构地区：[1]中南大学湘雅医院心内科,长沙410008 [2]中国人民解放军空军总医院心内科,北京100036 [3]广西医科大学第一附属医院心内科,南宁530021

出　　处：《中国新药杂志》2006年第22期1958-1961,共4页Chinese Journal of New Drugs

摘　　要：目的:评价西尼地平胶囊治疗轻中度原发性高血压的临床疗效和安全性。方法:采用随机、双盲、平行对照的多中心研究。227例轻中度原发性高血压患者经2周安慰剂洗脱后,随机分入试验组(n=114)或对照组(n=113),分别服用西尼地平胶囊或西尼地平片5mg·d^(-1),治疗2周末坐位舒张压≥90 mmHg者剂量加倍至10 mg·d^(-1)治疗至8周末。于安慰剂洗脱末及治疗2,4,6,8周末测量诊室血压、心率、体征及记录不良反应,试验开始前及结束时进行实验室及心电图检查。结果:203例完成试验,其中西尼地平胶囊组101例,西尼地平片组102例。服药8周后试验组和对照组总有效率分别为78．22%和80．39%,组间比较无统计学差异(P＞0．05)。两组服药后2,4,6,8周坐位收缩压和舒张压与服药前比较均有统计学意义的明显降低(P＜0．05);服药后血压下降幅度组间比较无统计学差异(P＞0．05)。两组血压达标率及剂量加倍情况无统计学差异。两组不良反应轻微,组间比较无显著差异。结论:西尼地平胶囊5～10mg每日一次治疗轻、中度原发性高血压安全有效。Objective：To evaluate the efficacy and safety of cilnidipine in patients with mild to moderate essential hypertension. Methods：A multicenter, randomized, double blind and parallel control clinical trial recruited 227 patients with mild to moderate essential hypertensive patients, who were randomized to one of two treatment groups： cilnidipine capsules （5 mg, n = 114） or cilnidipine tablets （5 mg, n = 113） , once daily for 2 weeks. After 2-week washout period, the patients started oral administration of study drugs. The patients with seated DBP ≥90 mmHg at the end of 2 weeks were titrated the dose to 10 mg once daily for additional 6 weeks. The patients were monitored on blood pressure, heart rates, physical symptoms and signs as well as incidence of adverse events at the end of washout and 2,4, 6 and 8 weeks after the therapy. Laboratory examinations and electrocardiogram were performed at baseline and the end of the trial. Results：Of 203 patients who completed the trial, 101 were in the capsules group and 102 in tablets group. At the end of 8 weeks, the response rate of the cilnidipine capsules and tablets groups was 78.22% vs. 80.39% （P 〉 0.05）. At the end of 2, 4, 6 and 8 weeks, seated systolic blood pressure （SBP） and diastolic blood pressure （DBP） were significantly lowered compared with those at baseline. No significant differences were found in the reduction of blood pressure and the patients＇ number who needed double dosing at the end of the first 2-week therapy between two groups. The incidence of adverse events experienced by patients between two groups showed no statistical difference. Conclusion： Cilnidipine capsules are effective and safe in patients with mild to moderate essential hypertension.

关 键 词：高血压 西尼地平 Ⅱ期临床研究 

分 类 号：R969.4[医药卫生—药理学] R972.4[医药卫生—药学]