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目的评价坎地沙坦加氢氯噻嗪(复方坎地沙坦酯片)对原发性高血压的降压疗效和安全性。方法对原发性高血压患者经过2周清洗期后,进入坎地沙坦酯片8 mg单药治疗期,对4周后血压未达标者(达标血压为<140/90 mm Hg),以随机、双盲双模拟、平行对照、多中心试验方法,分别服复方坎地沙坦酯片(坎地沙坦酯16.0 mg/氢氯噻嗪12.5 mg)或坎地沙坦酯片16 mg单药治疗8周。结果经过2周清洗期,共有392例进入单药治疗期,坎地沙坦酯8 mg单药治疗(n=353)2周后,血压下降值(10.2±0.6)/(6.5±5.7)mm Hg;4周的下降值为(10.8±10.9)/(6.6±6.1)mm Hg,4周血压达标率为15.3%(54/353例),组内比较,差异有非常显著意义(P<0.01)。在以后8周随机双盲对照期,复方坎地沙坦酯组(134例)与坎地沙坦酯单药组(142例)4周时的血压分别下降为(9.3±11.7)/(8.7±6.2)和(5.4±10.8)/(5.4±6.1)mm Hg;8周时为(11.1±11.2)/(10.7±6.6)和(7.8±11.1)/(7.8±6.3)mm Hg(组内及组间比较P<0.01)。随机期4周时联合治疗组血压达标率分别为64.9%(87/ 134),单药组为39.4%(56/142),8周时分别为79.9%(107/134)和51.4%(73/142)(组间比较P<0.01)。不良反应事件,在单药治疗期为6.2%(22/353),复方坎地沙坦组为2.9%(4/134),坎地沙坦酯组2.8%(4/142),组间比较差异无统计学意义(P>0.05)。结论复方坎地沙坦酯片较之单用坎地沙坦对原发性高血压患者有较好的降压效果和耐受性。
Objective To evaluate the antihypertensive effect and safety of candesartan plus hydrochlorothiazide (compound candesartan cilexetil) on essential hypertension. Methods Patients with essential hypertension were treated with candesartan 8 mg monotherapy after 2 weeks of washout. After 4 weeks, blood pressure was less than 140/90 mm Hg A randomized, double-blind, double-dummy, parallel-controlled, multicenter trial was performed with candesartan cilexetil (candesartan cilexetil 16.0 mg / hydrochlorothiazide 12.5 mg) or candesartan cilexetil 16 mg week. Results After 2 weeks of cleaning, a total of 392 patients entered the monotherapy period. After 2 weeks of candesartan 8 mg monotherapy (n = 353), the blood pressure decreased by (10.2 ± 0.6) / (6.5 ± 5.7) mm (P <0.01), and the descending value at 4 weeks was (10.8 ± 10.9) / (6.6 ± 6.1) mm Hg. The blood pressure compliance rate at 4 weeks was 15.3% (54/353). There was significant difference ). During the next 8 weeks of randomized double-blind control, the blood pressure decreased to (9.3 ± 11.7) / (8.7) at 4 weeks after treatment with candesartan cilexetil (134 cases) and candesartan cilexetil (142 cases) (11.1 ± 11.2) / (10.7 ± 6.6) and (7.8 ± 11.1) / (7.8 ± 6.3) mm Hg at 8 weeks And between groups P <0.01). At 4 weeks of randomization, the blood pressure compliance rates in the combination group were 64.9% (87/134) and 39.4% (56/142) respectively in the combination group, 79.9% (107/134) and 51.4% / 142) (P <0.01 for comparison between groups). The incidence of adverse reactions was 6.2% (22/353) in the monotherapy period, 2.9% (4/134) in the candesartan group, and 2.8% (4/142) in the candesartan cilexetil group The difference was not statistically significant (P> 0.05). Conclusion The combination of candesartan cilexetil has better antihypertensive efficacy and tolerability than candesartan in patients with essential hypertension.