环孢素治疗系统性硬化症。10例患者的48周开放性安全性研究结果。
Cyclosporine in systemic sclerosis. Results of a forty-eight-week open safety study in ten patients.
作者信息
Clements P J, Lachenbruch P A, Sterz M, Danovitch G, Hawkins R, Ippoliti A, Paulus H E
机构信息
Department of Medicine, University of California, Los Angeles School of Medicine 90024.
出版信息
Arthritis Rheum. 1993 Jan;36(1):75-83. doi: 10.1002/art.1780360113.
OBJECTIVE
To evaluate safety and efficacy of cyclosporin A (CSA) treatment in systemic sclerosis (SSc).
METHODS
Ten patients with < or = 60 months of SSc were entered into a 48-week open study of CSA. Patients with hypertension or azotemia were excluded. Concurrent use of nonsteroidal antiinflammatory agents or diuretics was not permitted. The extent of cutaneous and visceral involvement at 48 weeks and at study entry were compared.
RESULTS
Adverse reactions (especially nephrotoxicity) were frequent, usually transient, often dose-limiting, and usually associated with CSA doses > or = 3-4 mg/kg/day. Skin thickening decreased significantly (P < 0.001), while pulmonary and cardiac involvement remained unchanged.
CONCLUSION
CSA should undergo blinded controlled study in patients with SSc.
目的
评估环孢素A（CSA）治疗系统性硬化症（SSc）的安全性和有效性。
方法
10例病程≤60个月的SSc患者进入一项为期48周的CSA开放研究。排除高血压或氮质血症患者。不允许同时使用非甾体抗炎药或利尿剂。比较48周时和研究开始时皮肤和内脏受累的程度。
结果
不良反应（尤其是肾毒性）频繁出现，通常为短暂性，常限制剂量，且通常与CSA剂量≥3 - 4mg/kg/天相关。皮肤增厚明显减轻（P < 0.001），而肺部和心脏受累情况未变。
结论
CSA应用于SSc患者应进行盲法对照研究。
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