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氢氯噻嗪、阿替洛尔、尼群地平和依那普利在抗高血压治疗中的随机、双盲、多中心比较:HANE研究结果。HANE试验研究组

Randomised, double blind, multicentre comparison of hydrochlorothiazide, atenolol, nitrendipine, and enalapril in antihypertensive treatment: results of the HANE study. HANE Trial Research Group.

作者信息

Philipp T, Anlauf M, Distler A, Holzgreve H, Michaelis J, Wellek S

机构信息

Zentrum für Innere Medizin, Universitätsklinikum Essen, Germany.

出版信息

BMJ. 1997 Jul 19;315(7101):154-9. doi: 10.1136/bmj.315.7101.154.

Abstract

OBJECTIVE

To compare the effectiveness and tolerability of hydrochlorothiazide, atenolol, nitrendipine, and enalapril in patients with mild to moderate hypertension.

DESIGN

Randomised multicentre trial over 48 weeks with double blind comparison of treatments.

SETTING

48 centres in four countries.

PATIENTS

868 patients with essential hypertension (diastolic blood pressure 95-120 mm Hg)

INTERVENTIONS

Initial treatment (step 1) consisted of 12.5 mg hydrochlorothiazide (n = 215), 25 mg atenolol (n = 215), 10 mg nitrendipine (n = 218), or 5 mg enalapril (n = 220) once daily. If diastolic blood pressure was not reduced to < 90 mm Hg within four weeks, doses were increased to 25 mg, 50 mg, 20 mg, 10 mg, respectively, once daily (step 2) and after two more weeks to twice daily (step 3). The eight week titration phase was followed by an additional 40 weeks for patients who had reached the target diastolic pressure.

MAIN OUTCOME MEASURES

Blood pressure by means of an automatic device with repeated measurements.

RESULTS

After eight weeks the response rate for atenolol (63.7%) was significantly higher than for enalapril (50.0%), hydrochlorothiazide (44.7%), or nitrendipine (44.5%). After one year atenolol was still more effective (48.0%) than hydrochlorothiazide (35.4%) and nitrendipine (32.9%), but not significantly better than enalapril (42.7%). The treatment related dropout rate was higher (P < 0.001) in the nitrendipine group (n = 28).

CONCLUSIONS

There is no evidence of superiority for antihypertensive effectiveness or tolerability of the "new" classes of antihypertensives (calcium channel blockers and angiotensin converting enzyme inhibitors). As these drugs are now widely used as treatment of first choice, our results further emphasise the need for studies confirming that they also reduce morbidity and mortality, as has been shown for diuretics and beta blockers.

摘要

目的

比较氢氯噻嗪、阿替洛尔、尼群地平和依那普利治疗轻至中度高血压患者的有效性和耐受性。

设计

为期48周的随机多中心试验,对各治疗组进行双盲比较。

地点

四个国家的48个中心。

患者

868例原发性高血压患者(舒张压95 - 120 mmHg)

干预措施

初始治疗(第1步)为每日一次服用12.5 mg氢氯噻嗪(n = 215)、25 mg阿替洛尔(n = 215)、10 mg尼群地平(n = 218)或5 mg依那普利(n = 220)。如果四周内舒张压未降至<90 mmHg,则剂量分别增至每日一次25 mg、50 mg、20 mg、10 mg(第2步),再过两周后增至每日两次(第3步)。对于达到目标舒张压的患者,在为期8周的滴定阶段后再进行40周治疗。

主要观察指标

使用自动装置重复测量血压。

结果

8周后,阿替洛尔的有效率(63.7%)显著高于依那普利(50.0%)、氢氯噻嗪(44.7%)或尼群地平(44.5%)。1年后,阿替洛尔仍然比氢氯噻嗪(35.4%)和尼群地平(32.9%)更有效,但不比依那普利(42.7%)显著更好。尼群地平组的治疗相关退出率更高(P < 0.001)(n = 28)。

结论

没有证据表明“新型”抗高血压药物(钙通道阻滞剂和血管紧张素转换酶抑制剂)在抗高血压有效性或耐受性方面具有优越性。由于这些药物现在广泛用作首选治疗药物,我们的结果进一步强调需要进行研究以证实它们也能降低发病率和死亡率,就像利尿剂和β受体阻滞剂已被证明的那样。

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