RANDOMIZED DOUBLE-BLIND, MULTICENTER STUDY OF PROSTAGLANDIN-E1 IN PATIENTS WITH THE ADULT RESPIRATORY-DISTRESS SYNDROME

RANDOMIZED DOUBLE-BLIND, MULTICENTER STUDY OF PROSTAGLANDIN-E1 IN PATIENTS WITH THE ADULT RESPIRATORY-DISTRESS SYNDROME
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DOI:
10.1378/chest.96.1.114
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发表时间:
1989-07-01
期刊:
影响因子:
9.6
通讯作者:
URSPRUNG, JJ
URSPRUNG, JJ
中科院分区:
医学1区
文献类型:
--
作者:
BONE, RC;SLOTMAN, G;URSPRUNG, JJ

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在一项100例患者(50例PGE1,50例安慰剂)的随机、双盲临床试验中,将前列腺素E1(PGE1)与安慰剂进行比较,以确定PGE1治疗是否能提高成人呼吸窘迫综合征(ARDS)患者的生存率。在输注后30天,30名PGE 1和24名安慰剂患者死亡。在6个月时,PGE1组和安慰剂组被判定为与该综合征相关的死亡总数分别为32例和28例。我们的结论是,前列腺素E1并没有提高患者的生存与建立ARDS。PGE1通过降低全身和肺血管阻力增强了这些患者的高动力循环,从而导致血压降低和每搏输出量、心输出量和心率增加。观察到PGE1治疗可改善氧利用率和氧消耗。PGE1与腹泻发生率增加相关(PGE1组6例患者vs安慰剂组1例患者,p < 0.05)。其他不良反应包括低血压(PGE 1组10例患者vs安慰剂组7例患者)、发热(PGE 1组6例患者vs安慰剂组3例患者)和非致命性心律失常(PGE 1组10例患者vs安慰剂组5例患者)。
Prostaglandin E1 (PGE1) was compared to placebo in a 100-patient (50 PGE1, 50 placebo) randomized, double-blind, clinical trial to determine whether PGE1 therapy enhances survival of patients with adult respiratory distress syndrome (ARDS) when infused through a central line at 30 ng/kg/min continuously for seven days. At 30 days postinfusion, 30 PGE1 and 24 placebo patients had died. Total deaths judged to be related to the syndrome were 32 and 28 in the PGE1 and placebo groups respectively at six months. We conclude that PGE1 did not enhance survival in patients with established ARDS. PGE1 augmented the hyperdynamic circulation of these patients by reducing systemic and pulmonary vascular resistance, which resulted in a reduction of blood pressures and increased stroke volume, cardiac output, and heart rate. An improvement in oxygen availability and oxygen consumption was observed with PGE1 therapy. PGE1 was associated with an increased incidence of diarrhea (six patients in the PGE1 group vs one in the placebo group, p < 0.05). Other adverse effects included hypotension (ten patients in the PGE1 group vs seven in the placebo group), fever (six patients in the PGE1 group vs three in the placebo group), and non-fatal dysrhythmias (ten in the PGE1 group vs five in the placebo group).