de Vries J, Baarsma G S, Zaal M J, Boen-Tan T N, Rothova A, Buitenhuis H J, Schweitzer C M, de Keizer R J, Kijlstra A
Eye Hospital, Department of Ophthalmology, Erasmus University Rotterdam, The Netherlands.
Br J Ophthalmol. 1990 Jun;74(6):344-9. doi: 10.1136/bjo.74.6.344.
In a randomised double-masked study of 27 patients with a severe chronic idiopathic uveitis we evaluated the efficacy, safety, and tolerability of cyclosporin. All received prednisone in a low dose (0.3 mg/kg/day). In 14 patients this was combined with cyclosporin in a single daily dose of 10 mg/kg/day, while 13 patients received a placebo. The dosages were tapered off in accordance with a protocol, and we compared the number of months of successful therapy before the uveitis relapsed. The efficacy results, as expressed in a Kaplan-Meier curve, were in favour of cyclosporin. Owing to the small sample size, however, this difference did not reach statistical significance. The immunosuppressive effect of cyclosporin was not permanent, and in all but one patient the intraocular inflammation relapsed on reduction of dosage. Rather small cumulative doses of cyclosporin proved to be nephrotoxic, but subjective tolerability for cyclosporin was good.
在一项针对27例严重慢性特发性葡萄膜炎患者的随机双盲研究中,我们评估了环孢素的疗效、安全性和耐受性。所有患者均接受低剂量泼尼松(0.3mg/kg/天)治疗。其中14例患者联合使用环孢素,每日单次剂量为10mg/kg/天,而13例患者接受安慰剂治疗。剂量按照方案逐渐减少,我们比较了葡萄膜炎复发前成功治疗的月数。以Kaplan-Meier曲线表示的疗效结果显示环孢素更具优势。然而,由于样本量小,这种差异未达到统计学显著性。环孢素的免疫抑制作用并非永久性的,除1例患者外,所有患者在剂量减少时眼内炎症均复发。事实证明,相当小的环孢素累积剂量就具有肾毒性,但环孢素的主观耐受性良好。