依那普利-氢氯噻嗪治疗原发性高血压的临床疗效  

Efficacy of combination of enalapril/hydrochlorothiazide in Chinese patients with primary hypertension

作　　者：王晓莉[1] 柯元南[1] 吴文静[1] 周新腾[2] 姜斯博 

机构地区：[1]中日友好医院心内科,北京100029 [2]北京红林制药有限公司,北京101407

出　　处：《中国新药与临床杂志》2006年第10期759-762,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的:研究依那普利-氢氯噻嗪治疗中国人原发性高血压的临床疗效、安全性和耐受性。方法:采用随机、双盲、平行对照临床试验。126例轻、中度原发性高血压[95mmHg≤平均坐位舒张压(DBP)<110mmHg,平均坐位收缩压(SBP)<180mmHg(1mmHg=0.133kPa)],口服安慰剂2wk后, DBP仍在95-110mmHg的病人,随机分为3组,A组口服依那普利-氢氯噻嗪(10mg:6.25mg),qd;B组口服依那普利-氢氯噻嗪(10mg:12.5mg),qd;C组口服依那普利10mg,qd,4wk后如DBP≥90mmHg,各组剂量均加倍,疗程为8wk。安慰剂期末和治疗2,4,6,8wk测量坐位、立位血压和心率,记录不良反应。结果:8wk末,A组DBP由(99±4)mmHg降至(83±6)mmHg,降低(15±4)mmHg, SBP降低(18±14)mmHg;B组DBP由(100±5)mmHg降至(83±6)mmHg,降低(16±7)mmHg, SBP降低(17±16)mmHg;C组DBP由(97.0±2.0)mmHg降至(89±8)mmHg,降低(8±8)mmHg, SBP降低(3±14)mmHg。各组内DBP与治疗前相比均有非常显著差异(P<0.01),A,B两组组间差异无显著意义(P>0.05),A,B两组降压幅度优于C组,组间比较差异显著(P<0.05)。A,B,C组降压总有效率分别为86％,83％及60％,A,B两组比较无显著差异,分别与C组比较差异显著,优于C组(P<0.05)。3组主要不良反应为咳嗽、干咳,组间比较发生率无显著差异。结论:依那普利-氢氯噻嗪治疗轻、中度原发性高血压疗效优于单药制剂,6.25mg与12.5mg氢氯噻嗪的复方制剂降压疗效相似,复方制剂和单药一样安全,且耐受性好。AIM： To study the efficacy, safety, and toleration of combination of enalapril/hydrochlorothiazide in Chinese patients with primary hypertension. METHODS： A randomized, double blind, parallelgroup, and comparative study was conducted among 126 patients with mild and moderate primary （95 mmHg ≤DBP 〈 110 mmHg, SBP 〈 180 mmHg） . Patients with DBP 95 - 110 mmHg after 2 wk of placebo run-in period were randomized into 3 groups： group A （42 patients were treated with enalapril/hydrochlorothiazide （ 10 mg ： 6.25 mg, qd）） ; group B （35 patients were treated with enalapril/hydrochlorothiazide （10 mg ： 12.5 mg qd） ） ; group C （33 patients were treated with enalapril （10 mg, qd）） . If DBP ≥ 90 mmHg after 4 wk, the dosage were doubled till 8 wk treatment. Blood pressure and heart rate were measured and adverse reactions were observed. RESULTS： The reduction of SBP in group A was （18± s 14） mmHg and the mean changes of DBP at the end of 8wkwere （15 ±4） mmHgfrom （99±4） mmHg to （83 ± 6） mmHg. The reduction of SBP of group B was （17± 16） mmHg and the mean changes of DBP at the end of 8 wk were （16± 7） mmHg from （100 ± 5） mmHg to （83 ± 6） mmHg. The reduction of SBP of group C was （3 ± 14） mmHgandthe mean changes of DBP at the end of 8 wk were （8 ± 8） mmHg from （97.0 ± 2.0） mmHg to （89 ± 8） mmHg. There was significant difference of SBP and DBP after treatment in 3 groups （P 〈 0.01 ） . There was no significant difference of SBP and DBP between group A and B （P 〉 0.05）, but there were significant differences between group A, B and C respectively （P 〈 0.05） . The total effective rate were 86 % in group A, 83 % in group B, and 60 % in group C. There was no significant difference between group A and group B （P 〉 0.05）, but compare group A and B with C respectively, there was significant difference （P 〈 0.05 ） . The adverse reaction were cough and dry cough. There was no significant difference in inci

关 键 词：依那普利 氢氯噻嗪 复方合剂 高血压 随机对照试验 双盲法 

分 类 号：R544.1[医药卫生—心血管疾病]