Rademaker M, Cooke E D, Almond N E, Beacham J A, Smith R E, Mant T G, Kirby J D
Department of Dermatology, St Bartholomew's Hospital, London.
BMJ. 1989 Mar 4;298(6673):561-4. doi: 10.1136/bmj.298.6673.561.
To compare the long term effects of short term intravenous infusions of iloprost with those of oral nifedipine in patients with Raynaud's phenomenon associated with systemic sclerosis.
Double blind, placebo controlled, randomised group comparison.
Dermatology outpatient clinic.
Twenty three patients with Raynaud's phenomenon associated with well documented systemic sclerosis (American Rheumatism Association criteria) and with typical abnormalities in fingernail folds on capillaroscopy.
Twelve patients were randomised to receive intravenous infusions of iloprost starting at 0.5 ng/kg/min and increased by 0.5 ng/kg/min every 15 minutes to a maximum of 2.0 ng/kg/min for eight hours on three consecutive days with a further single infusion at week 8. Placebo capsules were given concurrently. Eleven patients were randomised to receive nifedipine, starting at 30 mg daily and increased to 60 mg daily after four weeks for another 12 weeks. Infusions of placebo were given in the same manner as the infusions of iloprost. One patient from each group withdrew because of social reasons and three patients receiving nifedipine withdrew because of side effects.
Reduction in number, duration, and severity of attacks of Raynaud's phenomenon, reduction in number of digital lesions, increase in digital blood flow.
Measurements were taken at 0, 4, 8, 12, and 16 weeks. Both regimens produced a reduction in the number, duration, and severity of attacks of Raynaud's phenomenon. The mean (SE) number of digital lesions was reduced with iloprost (from 3.5 (1.6) to 0.6 (0.3] and with nifedipine (from 4.3 (0.8) to 1.4 (0.5] after 16 weeks. Hand temperature and digital and microcirculatory blood flow were increased with iloprost but not with nifedipine.
Both iloprost and nifedipine are beneficial in the treatment of Raynaud's phenomenon. With nifedipine, however, side effects are common. Short term infusions of iloprost provide longlasting relief of symptoms, and side effects occur only during the infusions and are dose dependent.
比较短期静脉输注伊洛前列素与口服硝苯地平对系统性硬化症相关雷诺现象患者的长期影响。
双盲、安慰剂对照、随机分组比较。
皮肤科门诊。
23例系统性硬化症（符合美国风湿病协会标准）相关雷诺现象患者，且甲襞毛细血管镜检查有典型异常。
12例患者随机接受伊洛前列素静脉输注，起始剂量为0.5 ng/kg/min，每15分钟增加0.5 ng/kg/min，最大剂量为2.0 ng/kg/min，连续3天，每天8小时，第8周再进行一次单次输注。同时给予安慰剂胶囊。11例患者随机接受硝苯地平治疗，起始剂量为每日30 mg，4周后增至每日60 mg，持续12周。安慰剂输注方式与伊洛前列素输注相同。每组各有1例患者因社会原因退出，3例接受硝苯地平治疗的患者因副作用退出。
雷诺现象发作次数、持续时间和严重程度的减少，指端病变数量的减少，指端血流增加。
在0、4、8、12和16周进行测量。两种治疗方案均使雷诺现象发作次数、持续时间和严重程度减少。16周后，伊洛前列素组指端病变的平均（标准误）数量减少（从3.5（1.6）降至0.6（0.3）），硝苯地平组也减少（从4.3（0.8）降至1.4（0.5））。伊洛前列素使手部温度、指端和微循环血流增加，而硝苯地平未使其增加。
伊洛前列素和硝苯地平对雷诺现象的治疗均有益。然而，硝苯地平副作用常见。短期输注伊洛前列素可长期缓解症状，且副作用仅在输注期间出现，且与剂量相关。
