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低剂量环孢素治疗克罗恩病:对临床试验的启示

Low-dose cyclosporin for Crohn's disease: implications for clinical trials.

作者信息

Brynskov J, Binder V, Riis P, Lauritsen K, Schaffalitzky de Muckadell O, Freund L, Fallingborg J, Nørby Rasmussen S, Matzen P, Krag E

机构信息

Department of Internal Medicine, Herlev University Hospital, Denmark.

出版信息

Aliment Pharmacol Ther. 1989 Apr;3(2):135-42. doi: 10.1111/j.1365-2036.1989.tb00199.x.

DOI:10.1111/j.1365-2036.1989.tb00199.x
PMID:2491464
Abstract

Cyclosporin is a potent immunosuppressant, which has gained recent interest as a possible treatment for Crohn's disease. Chronic nephrotoxicity, however, has recently been demonstrated as a result of early treatment with high initial cyclosporin doses. We report the effect of a 3-month treatment with low-dose cyclosporin (5-7.5 mg kg-1 day-1) in 11 chronically active, therapy-resistant Crohn's disease patients. Eight of the 11 patients (72%) improved according to a clinical grading score and the Dutch Activity Index whereas 9/11 (82%) improved according to the Crohn's Disease Activity Index (P less than 0.05) after 1 month. Three patients were withdrawn despite clinical improvement. One developed arterial hypertension, one dropped out and one required surgical treatment due to a small bowel stricture. Five patients (45%) completed the treatment period with improved clinical scores. After tapering-off, two patients (18%) were better at follow-up. No serious side-effects were encountered and it is concluded that low-dose cyclosporin treatment should be further investigated in Crohn's disease.

摘要

环孢素是一种强效免疫抑制剂,最近作为克罗恩病的一种可能治疗方法而受到关注。然而,近期研究表明,早期使用高初始剂量环孢素治疗会导致慢性肾毒性。我们报告了11例慢性活动期、对治疗耐药的克罗恩病患者接受低剂量环孢素(5 - 7.5毫克/千克/天)治疗3个月的效果。11例患者中有8例(72%)根据临床分级评分和荷兰活动指数有所改善,而9/11(82%)根据克罗恩病活动指数在1个月后有所改善(P < 0.05)。尽管临床症状有所改善,但仍有3例患者退出治疗。1例出现动脉高血压,1例退出,1例因小肠狭窄需要手术治疗。5例患者(45%)完成治疗期时临床评分有所改善。减量停药后,2例患者(18%)在随访时情况较好。未出现严重副作用,因此得出结论,低剂量环孢素治疗在克罗恩病中应进一步研究。

相似文献

1
Low-dose cyclosporin for Crohn's disease: implications for clinical trials.低剂量环孢素治疗克罗恩病:对临床试验的启示
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Unsatisfactory effect of cyclosporin A treatment in Crohn's disease: a report of five cases.环孢素A治疗克罗恩病效果欠佳:5例报告
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引用本文的文献

1
Cyclosporine for induction of remission in Crohn's disease.环孢素用于诱导克罗恩病缓解
Cochrane Database Syst Rev. 2005 Apr 18(2):CD000297. doi: 10.1002/14651858.CD000297.pub2.
2
Ulcerative colitis disease activity following treatment of associated primary sclerosing cholangitis with cyclosporin.用环孢素治疗相关原发性硬化性胆管炎后溃疡性结肠炎的疾病活动情况。
Gut. 1993 Feb;34(2):242-6. doi: 10.1136/gut.34.2.242.
3
Effect of oral cyclosporin on renal function in Crohn's disease.
Dig Dis Sci. 1993 Sep;38(9):1624-30. doi: 10.1007/BF01303170.
4
Cyclosporin. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in immunoregulatory disorders.环孢素。对其药效学和药代动力学特性以及在免疫调节紊乱中的治疗应用的综述。
Drugs. 1993 Jun;45(6):953-1040. doi: 10.2165/00003495-199345060-00007.
5
Plasma interleukin-2 and a soluble/shed interleukin-2 receptor in serum of patients with Crohn's disease. Effect of cyclosporin.克罗恩病患者血清中的血浆白细胞介素-2及可溶性/脱落白细胞介素-2受体。环孢素的作用
Gut. 1990 Jul;31(7):795-9. doi: 10.1136/gut.31.7.795.