Objective: To evaluate the efficacy and safety of Valsartan/ hydrochlorothiazide 80/12.5mg in mild to moderate essential hypertensive patients who did not reach goal with Valsartan medoxomil 80mg monotherapy.Methods:After 2 weeks of wash-out period,162 patients with mild to moderate essential hypertension were administered with valsartan 80mg for 4 weeks.At the end of this period,patients who had diastolic blood pressure,90mmHg were treated with Valsartan/hydrochlorothiazide 80/12.5mg or valsartan 160mg daily.Results:Compared with baseline,the decrease of mean systolic blood pressure(MSBP) and MDBP of valsartan 80mg/hydr ochlorothiazide group(13.8/11.3mmHg ) were significantly more than monotherapy group (9.0/9.2mmHg,P < 0.01).The total efficacy rate of valsartan 80mg/hydrochlorothiazide group (91.3%) were significantly higher than valsartan 80mg (80.4%) at 8 weeks (P < 0.01). The rate of drug related adverse event was similar between two groups(P > 0.05).Conclusion:Valsartan/hydrochlorothiazide single pill combination therapy showed more potent antihypertension effect and higher efficacy rate than valsartan up titrated in patients who did not well respond to valsartan 80mg monotherapy.%目的:观察复方缬沙坦氢氯噻片剂用于治疗缬沙坦单药口服后未达标的原发性轻中度高血压患者的疗效、安全性.方法:选择我们两院轻、中度原发性高血压的患者162例,经2周安慰剂洗脱期后,缬沙坦治疗4周,4周末单药治疗无效的92例患者随机分别接受缬沙坦80mg/氢氯噻嗪12.5mg(复方片剂组)和缬沙坦160mg/d(单药组)治疗.在洗脱期末(0周)、缬沙坦单药治疗末(4周末)和缬沙坦氢氯噻嗪治疗末(12周末)进行诊室血压、心电图、24h动态血压监测、离子、血肌酐等检测.结果:治疗12周末,复方片剂组诊室血压收缩压/舒张压较基线降低13.8/11.3mmHg,下降幅度大于单药组(9.0/9.2mmHg,P<0.01).复方片剂组的血压治疗有效率达91.3%,显著高于单药组的80.4%(P<0.01).两组间与试验药物有关的不良事件发生率无差异(P>0.05).结论:对于缬沙坦单药治疗控制欠佳的高血压患者,使用缬沙坦/氢氯噻嗪复方片剂,较之缬沙坦单药剂量加倍的用法,降压作用更强,具有良好的安全性.
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