Long-term safety of cyclosporine in the treatment of psoriasis
Long-term safety of cyclosporine in the treatment of psoriasis
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DOI：
10.1001/archderm.132.6.623
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发表时间：
1996-06-01
影响因子：
--
通讯作者：
Dubertret, L
中科院分区：
文献类型：
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作者：
Grossman, RM;Chevret, S;Dubertret, L
背景和设计：环孢素已被证明在治疗牛皮癣方面非常有效。然而，环孢菌素具有潜在毒性。副作用包括肾毒性作用、高血压和恶性肿瘤风险增加。环孢素的毒性与剂量相关，但安全治疗持续时间尚未确定。我们研究了 1987 年 1 月 1 日至 1993 年 12 月 31 日期间在法国巴黎圣路易斯医院接受环孢素治疗的所有银屑病患者的医院记录。总共评估了 122 名接受治疗 3 至 76 个月的患者。结果：由于副作用而停止治疗的患者百分比从 12 个月时的平均值+/-SD 14%+/-2.4%上升到48 个月时为 41%+/-6.7%。中位治疗时间 23 个月后，53 名患者的血清肌酐水平升高至基线值以上 30% 以上。中位治疗时间为 53 个月后，29 名患者出现高血压。三个初始患者特征——年龄超过 50 岁 (P=.04)、初始舒张压高于 75 mm Hg (P=.05) 和血清肌酐水平超过 100 μmol/L (1.1 mg/dL)（P=.02，对数秩检验）——预测因副作用而停用环孢素。结论：环孢素引起的毒性反应的风险随着使用剂量的增加而增加。患者的年龄以及先前存在的高血压或高血清肌酐水平。数据表明，副作用的发生率随着时间的推移而增加。因此，环孢菌素不是银屑病可接受的长期单一疗法。
Background and Design: Cyclosporine has proved to be highly effective in the treatment of psoriasis. However, cyclosporine is potentially toxic. Side effects include renal toxic effects, hypertension, and an increased risk of malignant neoplasm. The toxicity of cyclosporine is dose-related, yet the safe duration of treatment is undefined. We studied the hospital records of all patients with psoriasis treated with cyclosporine at Saint Louis Hospital, Paris, France, between January 1, 1987, and December 31, 1993. In total, 122 patients treated for 3 to 76 months were evaluated.Results: The percentage of patients who discontinued treatment because of side effects rose from a mean+/-SD of 14%+/-2.4% at 12 months to 41%+/-6.7% at 48 months. An increase in serum creatinine levels to more than 30% above the baseline value occurred in 53 patients after a median treatment time of 23 months. Hypertension developed in 29 patients after a median treatment time of 53 months. Three initial patient characteristics-age older than 50 years (P=.04), initial diastolic pressure higher than 75 mm Hg (P=.05),and serum creatinine levels more than 100 mu mol/L (1.1 mg/dL) (P=.02, log rank test)-predicted discontinuation of cyclosporine because of side effects.Conclusions: The risk of cyclosporine-induced toxic effects increases with age of the patient and with preexisting hypertension or high serum creatinine levels. The data suggest that the incidence of side effects increases with time. Thus, cyclosporine is not an acceptable long-term monotherapy for psoriasis.