复方伊贝沙坦治疗轻中度高血压的疗效和安全性

Effect and Safety of Irbesartan/Hydrochlorothiazide Combination Therapy on Mild to Moderate Essential Hypertension

目的 :评价伊贝沙坦与氢氯噻嗪 (复方伊贝沙坦 )降压疗效和安全性。 方法 :①采用多中心、随机、双盲、平行对照试验 (简称对照试验 ) ,选择轻中度高血压患者 2 48例 ,随机入伊贝沙坦 15 0～ 3 0 0mg与氢氯噻嗪 12 5mgQd或伊贝沙坦 15 0～ 3 0 0mgQd治疗 ,共 8周。治疗前、治疗后 4周和治疗后 8周进行降压疗效及安全性分析。②采用开放试验 ,选择轻中度高血压患者 2 8例 ,日服伊贝沙坦 15 0mg与氢氯噻嗪 12 5mgQd ,共 8周 ,治疗前后行 2 4h动态血压监测并计算降压有效患者的收缩压、舒张压谷 /峰值。 结果 :对照试验降压疗效 :治疗 4周末复方伊贝沙坦组和伊贝沙坦组的坐位舒张压 (SeDBP)及坐位收缩压 (SeSBP)较治疗前下降幅度明显 (P =0 0 2 3 2 ,P =0 0 0 45 )。治疗 8周末两组的SeDBP及SeSBP仍明显下降 ,但复方伊贝沙坦组下降更明显 (P =0 0 118,P =0 0 2 0 1) ;治疗 8周末复方伊贝沙坦组较伊贝沙坦组的SeDBP及SeSBP降压幅度均明显 (P <0 0 5 )。复方伊贝沙坦组降压总有效率 76 47% ,高于伊贝沙坦组的 61 16% (P =0 0 10 )。开放试验部分 :收缩压及舒张压谷 /峰值分别为 5 6 1%、 5 5 3 %。 结论 :复方伊贝沙坦降压安全有效、作用强于伊贝沙坦 ,可 2 4h平稳降压。

Objective : To assess the efficacy and safety of irbesartan/hydrochlorothiazide combination in patients with mild to moderate hypertension. JP Methods:①A multicenter, randomized , double blind, actively controlled clinical trial was conducted. All 248 patients were randomized to irbesartan/hydrochlorothiazide combination group or irbesartan group. Irbesartan 150 mg/ hydrochlorothiazide 12 5 mg Qd or irbesartan 150 mg Qd was respectively given. After 4 weeks of treatment,if DBP was still >85 mmHg ,we titrated dosage to irbesartan 300 mg/ hydrochlorothiazide 12 5 mg Qd or irbesartan 300 mg Qd. ②An opened clinical treal was also conducted.Twenty eight patients took irbesartan 150 mg/hydrochlorothiazide 12 5 mg once daily for 8 weeks. Ambulatory blood pressure monitoring was done before and after treatment respectively. Results:①After 8 weeks of treatment, the sitting blood pre ure (BP) was significantly reduced in both groups.Dia tolic blood pre ure (DBP) and y tolic blood pre ure (SBP) were more decreased in the combination group than in the irbesartan group (12 4 mmHg vs 10 0 mmHg, p =0 0118;16 6 mmHg vs 12 9 mmHg, p =0 0201) .②The response rate in the combination group was higher than in the irbesartan group (76 47% for and 61 16%, p =0 010) . ③Adverse events between groups were comparable ( p =0 241) Q . ④Trough/peak ratios of DBP and SBP were 55 3% and 56 1%. Conclusion: Irbesartan/hydrochlorothiazide combination is effective and safe for patients with mild to moderate hypertension.The BP reduction is more significant than that induced by irbesartan and it could control the reduced BP throughout 24 hours.