氢氯噻嗪与螺内酯、卡托普利联合治疗原发性高血压

Antihypertensive Effects of low-dose Hydrochlorothiazide in Combination with Captopril or Sprironolactone

目的评价小剂量氢氯噻嗪(HCTZ)与螺内酯、卡托普利联用的降压疗效和安全性。方法采用多中心、随机、双盲、平行对照试验,选择轻中度高血压患者829例,经2周安慰剂洗脱期、6周HCTZ导入期后随机进入HCTZ12.5mg q.d组HCTZ12·5mg与螺内酯20mg q.d组HCTZ12·5mg q.d与卡托普利25mg b.i.d组治疗,共12个月,随访1次/月。治疗前、治疗6周末和治疗12个月末分别进行血生化检查并评估降压疗效及安全性。结果①治疗6周末,3组的坐位收缩压及舒张压(以下血压值均指坐位血压值)较治疗前明显下降(P<0·01,P<0·01)。治疗12个月末3组的血压值仍明显下降。HCTZ组、螺内酯组和卡托普利组患者的收缩压下降值分别为(10·5±17·3),(13·3±15·8),(14·6±17·4)mmHg,卡托普利组下降幅度较HCTZ组明显(P=0·034)。②HCTZ组、螺内酯组和卡托普利组降压达标率分别为34·9%、44·3%和47·1%,HCTZ组达标率低于其他两组(44·3%vs34·9%P=0·038;47·1%vs34·9%P<0·001),螺内酯和卡托普利2组间无统计学差异。③3组间副反应发生率无统计学差异。结论小剂量HCTZ与螺内酯、卡托普利联用降压安全有效。

Objective To study the antihypertensive effects of low-dose hydrochlorothiazide （HCTZ） in combination with Captopril or Spironolactone in mild or moderate hypertensive patients. Methods A muhicenter, randomized, double blind, actively-controlled clinical trial was conducted. After two weeks＇ washout period and 6 weeks＇ leading period, 829 patients were randomized to receive HCTZ （12.5 mg, q. d）group or HCTZ（12. 5 mg q. d）/Spironolactone（20 mg q.d） group or HCTZ（12. 5 mg q. d）/Captopril （25 mg b. i. d） group for 12 months. Results ①After 6 weeks of treatment, blood pressure （BP） was significantly reduced in all groups （P〈0.01, respectively）. After 12 months of treatment, therapeutic effect was sustained and SBP was decreased more markedly in the HCTZ /Captopril group than that in other groups [（14.6±17.4 vs HCTZ 10.5±17.3, P=0. 027; 14. 6±17.4 vs HCTZ/ Spri 13.3± 15.8）mm Hg, P〉0.05]. ②The response rate in HCTZ/Spironolactone or HCTZ/Captopril group were higher than HCTZ group [44.3% vs 34.9%, P=0.038; 47.1% vs 34.9%, P〈0. 001）. ③ Adverse effects among three groups were comparable （P〉0.05）. Conclusion The low-dose HCTZ in combination with captopril or spironolactone is effective and safe for patients with essential hypertension.