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一项针对108例缺血性外周血管疾病患者的静脉注射前列环素(PGI2)双盲安慰剂对照试验。

A double blind placebo controlled trial of intravenous prostacyclin (PGI2) in 108 patients with ischaemic peripheral vascular disease.

作者信息

Virgolini I, Fitscha P, Linet O I, O'Grady J, Sinzinger H

机构信息

2nd Department of Internal Medicine, Policlinic, Vienna, Austria.

出版信息

Prostaglandins. 1990 Jun;39(6):657-64. doi: 10.1016/0090-6980(90)90025-q.

Abstract

108 patients with ischemic peripheral vascular disease were randomly allocated to receive infusion of either PGI2 (6 ng/kg/min over 8 hours daily for 5 consecutive days) or placebo in a double-blind manner. All patients had Stage II disease (Fontaine classification). One month after infusion the absolute and relative walking times were significantly (p less than 0.05) longer in the PGI2- than in the placebo-treated group. Patients were further classified as treatment responders or non-responders on the basis of increase of absolute and relative walking times. After one month 44% (24 out of 54) of the PGI2- and 15% (8 out of 54) of the placebo-treated patients were positive treatment-responders (p less than 0.01).

摘要

108例缺血性周围血管疾病患者被随机分配,以双盲方式接受前列环素(PGI2)输注(每天8小时,6 ng/kg/分钟,连续5天)或安慰剂。所有患者均为II期疾病(Fontaine分级)。输注1个月后,PGI2治疗组的绝对和相对步行时间显著长于安慰剂治疗组(p<0.05)。根据绝对和相对步行时间的增加,将患者进一步分为治疗反应者或无反应者。1个月后,PGI2治疗组44%(54例中的24例)和安慰剂治疗组15%(54例中的8例)为阳性治疗反应者(p<0.01)。

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