Wigley F M, Korn J H, Csuka M E, Medsger T A, Rothfield N F, Ellman M, Martin R, Collier D H, Weinstein A, Furst D E, Jimenez S A, Mayes M D, Merkel P A, Gruber B, Kaufman L, Varga J, Bell P, Kern J, Marrott P, White B, Simms R W, Phillips A C, Seibold J R
The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Arthritis Rheum. 1998 Apr;41(4):670-7. doi: 10.1002/1529-0131(199804)41:4<670::AID-ART14>3.0.CO;2-I.
To evaluate the efficacy and tolerability of an oral preparation of iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon (RP) secondary to systemic sclerosis (scleroderma).
A multicenter, randomized, parallel-group, placebo-controlled double-blind study was performed at university and community-based medical centers. Patients were randomly assigned to receive either 50 microg of iloprost orally twice daily or an identical gelatin-coated capsule containing placebo for 6 weeks. Outcome measures included average total daily duration of RP attacks, average number of RP attacks, and RP condition scored via a standardized daily diary.
Three hundred eight patients with scleroderma (272 women, 36 men, mean age 49 years [range 18-80]) were enrolled. One hundred fifty seven were assigned to receive iloprost and 151 to receive placebo. One hundred forty-three patients in the iloprost group (91.1%) and 144 in the placebo group (95.4%) completed the 6-week treatment phase. Fifteen of these treated patients (8 iloprost, 7 placebo) failed to complete all of the followup visits. The mean reduction in the average duration of attacks from baseline to week 5-6 was 24.32 minutes in the iloprost group and 34.34 minutes in the placebo group (P = 0.569). Likewise, the mean reduction from baseline to week 5-6 in the daily frequency of attacks was 1.02 in the iloprost group and 0.83 in the placebo group (P = 0.459). The Raynaud's condition score, a patient-completed assessment of the severity of RP attacks, was reduced by 1.32 in the iloprost group and 1.00 in the placebo group (P = 0.323). The lack of significant difference between treatment groups did not change when a variety of factors, including use of other vasodilators, duration of disease, classification of scleroderma (limited versus diffuse), or number of baseline digital ulcers were taken into account. Premature withdrawal from the study due to adverse events occurred in 10 patients (6.4%) in the iloprost group and 3 (2.0%) in the placebo group (P = 0.058).
Oral iloprost at a dosage of 50 microg twice daily is no better than placebo for management of RP secondary to scleroderma, either during 6 weeks of treatment or during 6 weeks of posttreatment followup.
评估前列环素类似物伊洛前列素口服制剂对系统性硬化症（硬皮病）继发雷诺现象（RP）患者的疗效和耐受性。
在大学及社区医疗中心进行了一项多中心、随机、平行组、安慰剂对照的双盲研究。患者被随机分配，每日两次口服50微克伊洛前列素或服用含安慰剂的相同明胶胶囊，为期6周。观察指标包括RP发作的平均每日总时长、RP发作的平均次数，以及通过标准化每日日志对RP状况进行评分。
共纳入308例硬皮病患者（272例女性，36例男性，平均年龄49岁[范围18 - 80岁]）。157例被分配接受伊洛前列素治疗，151例接受安慰剂治疗。伊洛前列素组143例患者（91.1%）和安慰剂组144例患者（95.4%）完成了6周的治疗阶段。这些接受治疗的患者中有15例（8例伊洛前列素组，7例安慰剂组）未完成所有随访。从基线至第5 - 6周，伊洛前列素组发作平均时长的平均减少量为24.32分钟，安慰剂组为34.34分钟（P = 0.569）。同样，从基线至第5 - 6周，伊洛前列素组发作的每日平均次数减少量为1.02次，安慰剂组为0.83次（P = 0.459）。伊洛前列素组患者完成的RP发作严重程度评估指标——雷诺状况评分降低了1.32分，安慰剂组降低了1.00分（P = 0.323）。当考虑多种因素，包括是否使用其他血管扩张剂、病程、硬皮病分类（局限性与弥漫性）或基线指端溃疡数量时，治疗组之间缺乏显著差异的情况并未改变。伊洛前列素组有10例患者（6.4%）因不良事件提前退出研究，安慰剂组有3例患者（2.0%）提前退出（P = 0.058）。
每日两次口服50微克伊洛前列素在治疗6周期间或治疗后6周的随访期间，对于硬皮病继发RP的治疗效果并不优于安慰剂。
