Belch J J, Capell H A, Cooke E D, Kirby J D, Lau C S, Madhok R, Murphy E, Steinberg M
University Department of Medicine, Ninewells Hospital and Medical School, Dundee, United Kingdom.
Ann Rheum Dis. 1995 Mar;54(3):197-200. doi: 10.1136/ard.54.3.197.
To compare the efficacy, tolerance and safety of 50-150 micrograms orally administered iloprost given twice a day versus placebo in patients with Raynaud's syndrome.
The study was multicentre (n = 3), double blind and placebo controlled. Sixty three patients who had eight or more vasospastic attacks per week were enrolled. After a one week run-in period, all patients received either iloprost or placebo treatment to a maximum tolerated dose of 150 micrograms twice a day for 10 days. Diary cards assessed the duration and severity of the vasospastic attacks. Side effects were monitored by direct questioning. A global assessment of treatment efficacy was made by the patient at the end of treatment and two weeks later.
Patient opinion tended to favour iloprost at the end of the 10 day treatment phase (p = 0.09) and this was significant at day 24 (the follow up visit) (p = 0.011). Although the duration and severity of attacks tended to decrease in the iloprost treated group, these results tended not to reach statistical significance (for severity p = 0.06 at end of treatment, p = 0.09 on day 24).
Iloprost administered intravenously has been shown to be of benefit in the treatment of the Raynaud's syndrome associated with systemic sclerosis, but this route of administration is inconvenient. This study evaluated the use of iloprost administered orally to patients with Raynaud's syndrome. Patient documented improvement was significantly improved by iloprost. Diary card analysis showed a trend in favour of iloprost, but these results did not reach statistical significance.
比较每日两次口服50 - 150微克伊洛前列素与安慰剂治疗雷诺综合征患者的疗效、耐受性和安全性。
本研究为多中心研究（n = 3），双盲且采用安慰剂对照。纳入了每周有8次或更多血管痉挛发作的63例患者。经过1周的导入期后，所有患者接受伊洛前列素或安慰剂治疗，最大耐受剂量为每日两次150微克，持续10天。日记卡评估血管痉挛发作的持续时间和严重程度。通过直接询问监测副作用。患者在治疗结束时和两周后对治疗效果进行整体评估。
在10天治疗阶段结束时，患者意见倾向于支持伊洛前列素（p = 0.09），在第24天（随访就诊）这一差异具有统计学意义（p = 0.011）。尽管伊洛前列素治疗组发作的持续时间和严重程度有下降趋势，但这些结果未达到统计学显著性（治疗结束时严重程度p = 0.06，第24天p = 0.09）。
静脉注射伊洛前列素已被证明对治疗与系统性硬化症相关的雷诺综合征有益，但这种给药途径不方便。本研究评估了口服伊洛前列素用于雷诺综合征患者的情况。伊洛前列素使患者记录的改善情况有显著改善。日记卡分析显示有支持伊洛前列素的趋势，但这些结果未达到统计学显著性。
