动态血压监测评价国产坎地沙坦酯对高血压的疗效及安全性  

Efficacy and safety of candesartan monotherapy in patients with hypertension by 24 hour ambulatory blood pressure monitor

作　　者：汪芳[1] 华潞[1] 王莉[1] 龚培[1] 成小如[1] 贾宣[1] 李一石[1] 

机构地区：[1]中国医学科学院阜外心血管病医院临床药理中心卫生部心血管药物临床研究重点实验室,北京100037

出　　处：《临床心血管病杂志》2004年第12期722-724,共3页Journal of Clinical Cardiology

摘　　要：目的 :观察国产坎地沙坦酯对原发性高血压 (EH)患者治疗的有效性、安全性及耐受性。方法 :EH患者 37例 ,整个研究过程包括 2周停药观察期和 8周治疗期。口服坎地沙坦酯 8mg ,qd ,在治疗 1、2、4、6和 8周末各随访 1次。服药 4周后若患者坐位舒张压 (DBP)≥ 90mmHg(1mmHg =0 .133kPa)则增加剂量至 16mg。在治疗开始时以及治疗期的第 8周进行 2 4h动态血压监测。结果 :①服药后 2 4h和白昼、夜间收缩压 (SBP)和DBP较服药前明显下降 ,分别为 (7.5 4± 12 .2 9) / (5 .19± 8.2 8) ,(6 .99± 14 .0 5 ) / (4 .6 2± 9.5 0 ) ,(8.4 8± 13.4 0 /(6 .0 2± 9.5 0 )mmHg ,均 P <0 .0 1。② 2 4h动态血压监测示服药后 2 4h各时点DBP和SBP均较服药前下降 ,大部分时点P <0 .0 5。③DBP、SBP的谷峰比率分别为 0 .70、0 .6 4。④平滑指数 (SI) :SBP、DBPSI分别为 3.99、3.10。⑤轻微不良反应发生率为 8.1% (3/ 37例 )。结论 :患者每日一次口服国产坎地沙坦酯 8～ 16mg治疗EH能持续 2 4h安全。Objective: To evaluate the effect, safety and tolerance of candesartan cilexitil made in our country by 24 h ambulatory blood pressure monitor (ABPM). Method:After 2 weeks wash-out, a total of 37 patients with seated diastolic blood pressure (SiDBP) 95～115 mmHg and ambulatory diastolic blood pressure(ADBP) ≥85 mmHg were investigated by 8 weeks of treatment with candesartan 8 mg, qd, possibly titrated to 16 mg QD;. At 4 weeks, the regimens of patients not reaching a goal SiDBP <90 mm Hg were titrated as described, whereas patients achieving this goal continued with low-dose monotherapy. Both ABPM and laboratory test were performed over 24-hour period after wash-out and at the end of 8 weeks. Results: At 8 weeks, changes in SiDBP/sitting systolic blood pressure (SiSBP) from baseline in 24 h, day-time(6:00～22:00),night-time(22:00～6:00) were -( 7.54± 12.29)/ ( 5.19± 8.28),-( 6.99± 14.05)/( 4.62± 9.50),-( 8.48± 13.40)/( 6.02± 9.50) mm Hg (P< 0.01) Trough : Peak ratios were 70% for DBP and 64% for SBP. Smooth Index were 3.99 and 3.10 in DBP and SBP separately. All treatments were well tolerated, with few patients experiencing slight adverse events( 8.1%)。Conclusion:Candesartan cilexitil 8-16 mg given once daily appears to be a well-tolerated, safe and effective antihypertensive treatment.

关 键 词：高血压 坎地沙坦酯 动态血压监测 

分 类 号：R544.1[医药卫生—心血管疾病]