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[西班牙一项塞利洛尔药物监测研究的结果。塞利洛尔多中心研究组]

[The results of a celiprolol drug surveillance study in Spain. The Celiprolol Multicenter Group].

出版信息

An Med Interna. 1989 Dec;6(12):619-23.

PMID:2535249
Abstract

The aim of this prospective multicenter study is to determine the efficacy and tolerance of a new, highly cardioselective beta-blocking agent with vasodilatation effects, Celiprolol. 185 patients with mild-light blood hypertension, grade 1-2, were admitted. Patient's progress was followed in 21 centers, 15 of them not being evaluated due to study protocol transgression. 82 patients were male and 87 female, with a median age of 50 +/- 11 (18-74). A doses of 200 mq/day of Celiprolol, once a day, during 2 weeks produced a significant statistical decrease of TAS and TAD (165 +/- 18 vs 151 +/- 18 mmHg, P less than 0.01 and 103.9 +/- 7 vs 94 +/- 9, P less than 0.01), with a minimal reduction of CR (78.5 +/- 10 vs 72.9 +/- 8 p min); 72 patients (43%) did not show a decrease in TAD lower than 95 mmHg, this being the reason to increase the celiprolol doses to 400 mg once a day, obtaining a decrease of TAS and TAD (TAS 146 +/- 16, P less than and TAD 90.5 +/- 9, P less than 0.01) with final CR of 71 +/- 8 p min. 18 patients had secondary effects, being mild in 16 cases, moderate in 2 and only one left the study spontaneously. 107 patients obtained a good control of blood hypertension (TAD less than 90) (62.9%), 80 of them with 200 mg doses. Analysing quality of life, 97 patients recognised that they left better (59.9%), 58 (35.8%) no different, and only 7 (4.3%) worse.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

这项前瞻性多中心研究的目的是确定一种新型的、具有血管舒张作用的高心脏选择性β受体阻滞剂塞利洛尔的疗效和耐受性。共纳入185例轻度至中度高血压(1 - 2级)患者。在21个中心对患者的病情进行跟踪,其中15个中心因违反研究方案未进行评估。82例男性,87例女性,中位年龄为50±11岁(18 - 74岁)。每天一次服用200毫克塞利洛尔,持续2周,收缩压(TAS)和舒张压(TAD)显著下降(分别为165±18 mmHg对151±18 mmHg,P<0.01;103.9±7对94±9,P<0.01),心率(CR)仅有轻微降低(78.5±10对72.9±8次/分钟);72例患者(43%)舒张压下降未低于95 mmHg,因此将塞利洛尔剂量增至每日400毫克,收缩压和舒张压再次下降(收缩压146±16,P<0.01;舒张压90.5±9,P<0.01),最终心率为71±8次/分钟。18例出现副作用,16例为轻度,2例为中度,仅1例自行退出研究。107例患者血压得到良好控制(舒张压<90)(62.9%),其中80例使用200毫克剂量。分析生活质量,97例患者感觉情况变好(59.9%),58例(35.8%)无差异,仅7例(4.3%)感觉变差。(摘要截断于250字)

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