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霉酚酸酯与环孢素治疗中重度慢性斑块状银屑病的序贯研究

Sequential study on the treatment of moderate-to-severe chronic plaque psoriasis with mycophenolate mofetil and cyclosporin.

作者信息

Pedraz J, Daudén E, Delgado-Jiménez Y, García-Río I, García-Díez A

机构信息

Department of Dermatology, Hospital Universitario de la Princesa, Madrid, Spain.

出版信息

J Eur Acad Dermatol Venereol. 2006 Jul;20(6):702-6. doi: 10.1111/j.1468-3083.2006.01577.x.

Abstract

BACKGROUND

There are numerous studies that individually evaluate the efficacy/effectiveness and toxicity of drugs in the systemic treatment of psoriasis. On the contrary, we can hardly find studies that compare each other.

OBJECTIVE

To evaluate and compare the effectiveness and toxicity of mycophenolate mofetil and cyclosporin in chronic plaque psoriasis through a prospective, sequential, cross-over, non-randomized, two-phase, open-label study.

PATIENTS/METHODS: Eight patients (five women and three men; mean age 57, range 35-78) with moderate-to-severe chronic plaque psoriasis were included in the study. They were treated with oral mycophenolate mofetil (30 mg/kg/day) over a period of 16 weeks. Following a variable washout period and after a new outbreak of the disease, oral cyclosporin was introduced at a dose of 4 mg/kg/day. During both treatment regimens, follow-up visits were performed at 3, 8 and 16 weeks.

RESULTS

In both groups, the PASI started to decrease once treatment was begun. Cyclosporin was faster and statistically a lot more effective than mycophenolate mofetil, reaching a higher number of complete remissions and better percentages of PASI improvement from baseline (45.7%, 60.2% and 60.5% at 3, 8 and 16 weeks respectively for mycophenolate mofetil, and 89.7%, 95.3% and 95.3% respectively at the same intervals for cyclosporin). Cyclosporin was also more predictable in its action as the percentage of improvement along the follow-up visits had a much wider range for mycophenolate mofetil. Overall, the tolerability of both drugs was good. None of the patients had to discontinue treatment because of an adverse event. Two patients treated with cyclosporin showed increased plasma levels of creatinine.

CONCLUSIONS

Cyclosporin is more effective, fast, and predictable in its effect than mycophenolate mofetil to control moderate-to-severe chronic plaque psoriasis. Both drugs are well tolerated in short courses of treatment.

摘要

背景

有众多研究分别评估了药物在银屑病系统治疗中的疗效/有效性和毒性。相反,我们很难找到相互比较的研究。

目的

通过一项前瞻性、序贯、交叉、非随机、两阶段、开放标签研究,评估并比较霉酚酸酯和环孢素在慢性斑块状银屑病中的有效性和毒性。

患者/方法:8例中度至重度慢性斑块状银屑病患者(5名女性和3名男性;平均年龄57岁,范围35 - 78岁)纳入研究。他们接受口服霉酚酸酯(30mg/kg/天)治疗16周。经过可变的洗脱期且疾病再次发作后,引入口服环孢素,剂量为4mg/kg/天。在两种治疗方案期间,分别在第3、8和16周进行随访。

结果

两组中,治疗开始后银屑病面积和严重程度指数(PASI)均开始下降。环孢素起效更快且在统计学上比霉酚酸酯更有效,达到完全缓解的病例数更多,PASI从基线改善的百分比更高(霉酚酸酯在第3、8和16周分别为45.7%、60.2%和60.5%,环孢素在相同时间间隔分别为89.7%、95.3%和95.3%)。环孢素的作用也更可预测,因为霉酚酸酯在随访期间改善百分比的范围更广。总体而言,两种药物的耐受性都良好。没有患者因不良事件而不得不停止治疗。两名接受环孢素治疗的患者肌酐血浆水平升高。

结论

在控制中度至重度慢性斑块状银屑病方面,环孢素比霉酚酸酯更有效、起效更快且效果更可预测。两种药物在短期治疗中耐受性良好。

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