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干扰素α-2b、秋水仙碱和苄星青霉素与秋水仙碱和苄星青霉素治疗白塞病的疗效比较:一项随机试验

Interferon alfa-2b, colchicine, and benzathine penicillin versus colchicine and benzathine penicillin in Behçet's disease: a randomised trial.

作者信息

Demiroglu H, Ozcebe O I, Barista I, Dündar S, Eldem B

机构信息

Department of Internal Medicine, Hacettepe University of Medical School, Ankara, Turkey.

出版信息

Lancet. 2000 Feb 19;355(9204):605-9. doi: 10.1016/S0140-6736(99)05131-4.

DOI:10.1016/S0140-6736(99)05131-4
PMID:10696980
Abstract

BACKGROUND

Sight-threatening eye involvement is a serious complication of Behçet's disease. Extraocular complications such as arthritis, vascular occlusive disorders, mucocutaneous lesions, and central-nervous-system disease may lead to morbidity and even death. We designed a prospective study in newly diagnosed patients without previous eye disease to assess whether prevention of eye involvement and extraocular manifestations, and preservation of visual acuity are possible with combination treatments with and without interferon alfa-2b.

METHODS

Patients were randomly assigned 3 million units interferon alfa-2b subcutaneously every other day for the first 6 months plus 1.5 mg colchicine orally daily and 1.2 million units benzathine penicillin intramuscularly every 3 weeks (n=67), or colchicine and benzathine penicillin alone (n=68). The primary endpoint was visual-acuity loss. Analysis was by intention to treat.

FINDINGS

Significantly fewer patients who were treated with interferon had eye involvement than did patients who did not receive interferon (eight vs 27, relative risk 0.21 [95% CI 0.09-0.50], p<0.001). Ocular attack rate was 0.2 (SD 0.62) per year with interferon therapy and 1.02 (1.13) without interferon therapy (p=0.0001). Visual-acuity loss was significantly lower among patients treated with interferon than in those without interferon (two vs 13, relative risk 0.13 [95% CI 0.03-0.60], p=0.003). Arthritis episodes, vascular events, and mucocutaneous lesions were also less frequent in patients treated with interferon than in those not receiving interferon. No serious side-effects were reported.

INTERPRETATION

Therapy with interferon alfa-2b, colchicine, and benzathine penicillin seems to be an effective regimen in Behçet's disease for the prevention of recurrent eye attacks and extraocular complications, and for the protection of vision.

摘要

背景

威胁视力的眼部病变是白塞病的一种严重并发症。关节炎、血管闭塞性疾病、黏膜皮肤病变和中枢神经系统疾病等眼外并发症可能导致发病甚至死亡。我们针对既往无眼部疾病的新诊断患者开展了一项前瞻性研究,以评估联合使用或不使用干扰素α-2b进行治疗是否能够预防眼部病变和眼外表现,并保留视力。

方法

患者被随机分为两组,一组在前6个月每隔一天皮下注射300万单位干扰素α-2b,同时每天口服1.5毫克秋水仙碱,并每3周肌肉注射120万单位苄星青霉素(n = 67);另一组仅使用秋水仙碱和苄星青霉素(n = 68)。主要终点是视力丧失。分析采用意向性治疗。

结果

接受干扰素治疗的患者发生眼部病变的人数显著少于未接受干扰素治疗的患者(8例对27例,相对风险0.21 [95%可信区间0.09 - 0.50],p < 0.001)。接受干扰素治疗的患者眼部发作率为每年0.2(标准差0.62),未接受干扰素治疗的患者为1.02(1.13)(p = 0.0001)。接受干扰素治疗的患者视力丧失显著低于未接受干扰素治疗的患者(2例对13例,相对风险0.13 [95%可信区间0.03 - 0.60],p = 0.003)。接受干扰素治疗的患者关节炎发作、血管事件和黏膜皮肤病变也比未接受干扰素治疗的患者更少。未报告严重副作用。

解读

干扰素α-2b、秋水仙碱和苄星青霉素联合治疗似乎是白塞病预防复发性眼部发作和眼外并发症以及保护视力的有效方案。

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