Points to consider in renal involvement in systemic sclerosis
Points to consider in renal involvement in systemic sclerosis
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DOI：
10.1093/rheumatology/kex201
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发表时间：
2017-09-01
期刊：
影响因子：
5.5
通讯作者：
Matucci-Cerinic, Marco
中科院分区：
文献类型：
--
作者：
Galluccio, Felice;Mueller-Ladner, Ulf;Matucci-Cerinic, Marco
本文讨论了当进行临床试验以测试SSc肾脏受累的治疗时应考虑的要点，不包括硬皮病肾危象。应强烈考虑双盲、随机对照试验与安慰剂或标准背景疗法的对比。纳入标准应考虑预先指定的肾功能范围或肾功能分层。性别和年龄的限制可能没有必要。同时用药包括血管扩张剂、免疫抑制剂和内皮素受体拮抗剂以及糖尿病、肾结石、高血压和心力衰竭等混杂疾病需要考虑。应强烈考虑肾功能指标，同时也可考虑透析时间、死亡率、硬皮病、肾危象和肾脏疾病进展的预防，尽管这些指标仍有待验证。应大力考虑详细的、预先计划好的分析，并应包括对缺失数据的解释。
This article discusses points to consider when undertaking a clinical trial to test therapy for renal involvement in SSc, not including scleroderma renal crisis. Double-blind, randomized controlled trials vs placebo or standard background therapy should be strongly considered. Inclusion criteria should consider a pre-specified range of renal functions or stratification of renal function. Gender and age limitations are probably not necessary. Concomitant medications including vasodilators, immunosuppressants and endothelin receptor antagonists and confounding illnesses such as diabetes, kidney stones, hypertension and heart failure need to be considered. A measure of renal function should be strongly considered, while time to dialysis, mortality, prevention of scleroderma renal crisis and progression of renal disease can also be considered, although they remain to be validated. Detailed, pre-planned analysis should be strongly considered and should include accounting for missing data.