依那普利-氢氯噻嗪治疗原发性高血压的临床疗效

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。

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

AIM: To study the efficacy, safety, and toleration of combination of enalapril/hydrochlorothiazide in Chinese patients with primary hypertension. METHODS: A randomized, double blind, parallel-group, 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 8 wk were (15±4) mmHg from (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) mmHg and the 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 incidence rate of 3 groups. CONCLUSION: The efficacy of combination of enalapril/hydrochlorothiazide is better than single use of enalapril in the treatment of mild and moderate primary hypertension. The efficacy of enalapril/hydrochloro-thiazide (10 mg : 6.25 mg) and enalapril/ hydrochlorothiazide (10 mg : 12.5 mg) are similar. Combination of enalapril/hydrochlorothiazide has the same safety and toleration as single use of enalapril.