摘要
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。
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.
出处
《中日友好医院学报》
2006年第6期323-326,329,共5页
Journal of China-Japan Friendship Hospital
关键词
缬沙坦
氢氯噻嗪
高血压
临床试验
valsartan
hydrochlorothiazide
hypertension
clinical trial
