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[山楂叶标准提取物WS 1442用于纽约心脏协会II级心力衰竭:一项安慰剂对照的随机双盲研究]

[Crataegus Special Extract WS 1442 in NYHA II heart failure. A placebo controlled randomized double-blind study].

作者信息

Leuchtgens H

出版信息

Fortschr Med. 1993 Jul 20;111(20-21):352-4.

PMID:8375791
Abstract

In 30 patients with stage NYHA II cardiac insufficiency, a placebo-controlled randomized double-blind study was carried out to determine the efficacy of the Crataegus special extract WS 1442. Treatment duration was 8 weeks, and the substance was administered at a dose of 1 capsule taken twice a day. The main target parameters were alteration in the pressure-x-rate product (PRP) under standardised loading on a bicycle ergometer, and a score of subjective improvement of complaints elicited by a questionnaire. Secondary parameters were exercise tolerance and the change in heart rate and arterial blood pressure. The active substance group showed a statistically significant advantage over placebo in terms of changes in PRP (at a load of 50 W) and the score, but also in the secondary parameter heart rate. In both groups, systolic and diastolic blood pressure was mildly reduced. No adverse reactions occurred.

摘要

对30例纽约心脏协会(NYHA)II级心功能不全患者进行了一项安慰剂对照的随机双盲研究,以确定山楂特殊提取物WS 1442的疗效。治疗持续时间为8周,该物质的给药剂量为每日两次,每次1粒胶囊。主要目标参数是在自行车测力计标准化负荷下压力-心率乘积(PRP)的变化,以及通过问卷调查得出的主观症状改善评分。次要参数是运动耐量以及心率和动脉血压的变化。活性物质组在PRP变化(负荷为50W时)、评分方面以及次要参数心率方面均显示出比安慰剂具有统计学意义的优势。两组的收缩压和舒张压均略有降低。未发生不良反应。

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