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长期美托洛尔治疗对窦性心律二尖瓣狭窄患者心脏血流动力学的有益作用——一项随机临床试验。

Beneficial effects of long-term metoprolol therapy on cardiac haemodynamics in patients with mitral stenosis in sinus rhythm--a randomised clinical trial.

作者信息

Kumar R, Saran R K, Dwivedi S K, Narain V S, Puri V K, Hasan M, Chandra N, Agrawal A, Sinha N, Ahuja R C

机构信息

Department of Cardiology & Medicine, K.G's Medical College, Lucknow.

出版信息

Indian Heart J. 1994 Nov-Dec;46(6):297-301.

PMID:7797214
Abstract

We conducted a placebo controlled randomised clinical trial to evaluate the effects of 6 months therapy with metoprolol on resting and exercise haemodynamics in 31 patients with isolated mitral stenosis in sinus rhythm. Twenty six of them (placebo n = 13, metoprolol n = 13) completed the study protocol. Their mean age was 23.1 +/- 7.9 years and the mean mitral valve area was 0.93 +/- 0.25 cm2. The dose of metoprolol ranged between 50-100 mg per day. The primary outcome variables for the study were the resting and exercise mean pulmonary capillary wedge pressure (PCWP) and cardiac index (CI) and the secondary outcome variables consisted of resting and exercise heart rate, mean pulmonary artery pressure (PAP), mean pulmonary vascular resistance (PVR) and clinical improvement on visual analog scale. These outcome variables were assessed blindly. The resting and exercise mean PCWP (mmHg) increased by 9.1 +/- 3.1 and 16.4 +/- 6.4 on placebo and 2.5 +/- 2.1 and -4.6 +/- 2.3 on metoprolol after 6 months therapy. These differences were statistically significant (p < 0.01). The resting and exercise CI (liters/min/m2) decreased by 0.2 +/- 0.1 and 0.1 +/- 0.1 on placebo and 0.3 +/- 0.5 and 0.3 +/- 1.0 on metoprolol. These haemodynamic effects were accompanied with much better symptomatic improvement in patients treated with metoprolol. The differences in change in mean PAP and PVR in two groups were statistically not significant. Our results suggest that the symptomatic patients with MS, waiting for definitive intervention for 6 months or less, would benefit if given beta blockers during this period.

摘要

我们进行了一项安慰剂对照随机临床试验,以评估美托洛尔6个月治疗对31例窦性心律的单纯二尖瓣狭窄患者静息和运动血流动力学的影响。其中26例(安慰剂组n = 13,美托洛尔组n = 13)完成了研究方案。他们的平均年龄为23.1±7.9岁,平均二尖瓣面积为0.93±0.25平方厘米。美托洛尔的剂量为每日50 - 100毫克。该研究的主要结局变量为静息和运动时的平均肺毛细血管楔压(PCWP)和心脏指数(CI),次要结局变量包括静息和运动时的心率、平均肺动脉压(PAP)、平均肺血管阻力(PVR)以及视觉模拟量表上的临床改善情况。这些结局变量通过盲法评估。6个月治疗后,安慰剂组静息和运动时的平均PCWP(mmHg)分别升高9.1±3.1和16.4±6.4,美托洛尔组分别升高2.5±2.1和降低 - 4.6±2.3。这些差异具有统计学意义(p < 0.01)。安慰剂组静息和运动时的CI(升/分钟/平方米)分别降低0.2±0.1和0.1±0.1,美托洛尔组分别降低0.3±0.5和0.3±1.0。这些血流动力学效应伴随着美托洛尔治疗患者更好的症状改善。两组平均PAP和PVR变化的差异无统计学意义。我们的结果表明,对于等待确定性干预6个月或更短时间的有症状二尖瓣狭窄患者,在此期间给予β受体阻滞剂会有益处。

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