Wigley F M, Wise R A, Seibold J R, McCloskey D A, Kujala G, Medsger T A, Steen V D, Varga J, Jimenez S, Mayes M, Clements P J, Weiner S R, Porter J, Ellman M, Wise C, Kaufman L D, Williams J, Dole W
Johns Hopkins University, Division of Molecular and Clinical Rheumatology, Baltimore, MD 21205.
Ann Intern Med. 1994 Feb 1;120(3):199-206. doi: 10.7326/0003-4819-120-3-199402010-00004.
To evaluate the efficacy and safety of iloprost, a prostacyclin analog, administered intravenously in patients with Raynaud phenomenon secondary to systemic sclerosis.
Multicenter, randomized, parallel placebo-controlled, double-blind study.
University medical centers.
131 patients with systemic sclerosis (101 women, 30 men) ages 20 to 79 years.
Patients were randomly assigned to receive one of two parallel treatments of five daily sequential, 6-hour intravenous infusions of iloprost (0.5 to 2.0 ng/kg per min) or to receive a similar volume of placebo.
Frequency of Raynaud attacks, Raynaud severity score, physician's overall rating of treatment effect, and digital cutaneous lesion healing.
Of the 131 patients enrolled, 126 completed the 5-day infusion and 114 (87%) completed at least 6 weeks of follow-up. Sixty-four patients were randomly assigned to receive iloprost and 67 patients, to receive placebo. The mean weekly number of Raynaud attacks decreased 39.1% with iloprost and 22.2% with placebo (P = 0.005). In addition, the mean percentage of improvement in a global Raynaud severity score during the entire 9-week follow-up was greater in patients given iloprost (34.8%) than in those receiving placebo (19.7%) (P = 0.011). The physician's overall rating of treatment effect showed greater improvement with iloprost than with placebo at week 6 (52.4% compared with 27.4%; P = 0.008) and week 9 (60.9% compared with 26.9%; P < 0.001). At week 3, 14.6% more patients receiving iloprost had 50% or more lesions heal compared with those given placebo (95% CI, 0.9% to 30%). During the infusion, 59 (92%) of the patients receiving iloprost had one or more side effects compared with 38 (57%) of the patients receiving placebo.
Iloprost is effective for the short-term palliation of severe Raynaud phenomenon in patients with systemic sclerosis.
评估前列环素类似物伊洛前列素静脉给药治疗系统性硬化症继发雷诺现象患者的疗效和安全性。
多中心、随机、平行安慰剂对照、双盲研究。
大学医学中心。
131例系统性硬化症患者（101例女性，30例男性），年龄20至79岁。
患者被随机分配接受两种平行治疗之一，即每天进行5次连续6小时的伊洛前列素静脉输注（0.5至2.0 ng/kg每分钟），或接受相同体积的安慰剂。
雷诺发作频率、雷诺严重程度评分、医生对治疗效果的总体评价以及指端皮肤病变愈合情况。
131例入组患者中，126例完成了为期5天的输注，114例（87%）完成了至少6周的随访。64例患者被随机分配接受伊洛前列素治疗，67例患者接受安慰剂治疗。接受伊洛前列素治疗的患者雷诺发作平均每周次数减少39.1%，接受安慰剂治疗的患者减少22.2%（P = 0.005）。此外，在整个9周的随访期间，接受伊洛前列素治疗的患者雷诺严重程度总分的平均改善百分比（34.8%）高于接受安慰剂治疗的患者（19.7%）（P = 0.011）。在第6周（52.4% 对比 27.4%；P = 0.008）和第9周（60.9% 对比 26.9%；P < 0.001），医生对治疗效果的总体评价显示，伊洛前列素组比安慰剂组改善更明显。在第3周，接受伊洛前列素治疗的患者中，病变愈合50%或更多的患者比接受安慰剂治疗的患者多14.6%（95%可信区间，0.9%至30%）。在输注期间，接受伊洛前列素治疗的患者中有59例（92%）出现一种或多种副作用，而接受安慰剂治疗的患者中有38例（57%）出现副作用。
伊洛前列素对系统性硬化症患者严重雷诺现象的短期缓解有效。
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