Points to consider-Raynaud's phenomenon in systemic sclerosis
Points to consider-Raynaud's phenomenon in systemic sclerosis
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DOI：
10.1093/rheumatology/kex199
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发表时间：
2017-09-01
期刊：
影响因子：
5.5
通讯作者：
Herrick, Ariane L.
中科院分区：
文献类型：
--
作者：
Cutolo, Maurizio;Smith, Vanessa;Herrick, Ariane L.
RP 是对寒冷或情绪的过度血管痉挛反应。应主要考虑随机、双盲、安慰剂对照试验以及平行组或交叉试验。交叉设计有利于立即或非常短期结果的早期试验，对于像 RP 这样异质性的情况非常重要：应始终包括治疗组之间的清除期，以尽量减少周期（残留）效应的可能性。 RP 试验的持续时间通常受到在单个季节（通常是天气较冷的冬季）内完成这些试验的需要的限制。对于交叉试验，每个治疗组的时间通常为 4 周或更短。攻击的频率和持续时间以及雷诺状况评分是广泛使用的结果衡量标准。人们对生理实验室终点越来越感兴趣，例如至少在早期试验中的激光多普勒成像。
RP is an exaggerated vasospastic response to cold or emotion. Randomized, double-blind, placebo-controlled trials with either parallel group or cross-over trials should be mainly considered. Cross-over design, which is good for early phase trials of immediate or very short-term outcomes, is important in a condition as heterogeneous as RP: a wash-out period between treatment arms should always be included to minimize the possibility of a period (carry-over) effect. Duration of RP trials is usually constrained by the need to complete these over a single season, usually winter when the weather is colder. For cross-over trials, each treatment arm tends to be 4 weeks or less. Frequency and duration of attacks, and the Raynaud's Condition Score are widely used outcome measures. There is increasing interest in physiological laboratory endpoints, for example laser Doppler imaging at least for early phase trials.