缬沙坦与氢氯噻嗪复方制剂治疗轻中度原发性高血压临床疗效观察

目的：观察缬沙坦与氢氯噻嗪复方制剂（复方缬沙坦胶囊、片）治疗轻、中度原发性高血压的疗效和安全性。方法：随机、双盲、平行对照、多中心试验，符合条件的216例轻、中度原发性高血压患者随机分为3组，复方缬沙坦胶囊（A）组72例、复方缬沙坦片剂（B）组72例及缬沙坦胶囊（C）组72例。每日服药1次，每2周随访1次，4周后达到有效标准者继续按原剂量治疗4周，未达到有效标准者剂量加倍治疗4周。结果：（1）治疗8周后，A、B组收缩压及舒张压降压幅度均大于C组（P〈0．05）。（2）治疗4周后，A、B组因舒张压未达90mmHg而需加量的人数明显少于C组（P〈0．05），治疗8周后。A、B组显效率明显高于C组（P〈0．05）。（3）3组均未发生严重不良事件。3组在不良事件的发生率、心电图及实验室指标的变化方面均无明显差别（P〉0．05）。结论：复方缬沙坦胶囊和复方缬沙坦片治疗轻、中度高血压安全有效。复方制剂降压疗效优于同剂量单药制剂。

Effects of compound valsartan in patients with mild to moderate essential hypertension

Objective:To observe the efficacy and safety of compound valsartan in treating essential hypertension.Methods:Two hundred and sixteen eligible mild and moderate essential hypertension patients were divided randomly into 3 groups,of which 72 received compound valsartan capsules(1 capsule Qd,group A),72 received compound valsartan tablets(1 tablet,Qd group B),and 72 received valsartan capsules(1 capsule Qd,group C).The doses were doubled,if DBP>90mmHg still remained after 4 weeks' treatment.The trial continued for 8 weeks and patients were followed-up every 2 weeks.Results:(1)After 8 weeks,SBP and DBP decreased more in group A and B than in C(P<0.05).(2)After 4 weeks,There were more patients in group C who needed to double their dosage(P<0.05),at the same time,higher significant effective rates were observed in group A and B after 8 weeks(P<0.05).(3)No serious adverse events happened.There was no significant difference in the rate of adverse events between the 3 groups.Conclusion:Compound valsartan is effective and safe in treating mild to moderate essential hypertension,and is superior to Valsartan capsules.