Colchicine versus placebo in Behcet's disease: randomized, double-blind, controlled crossover trial
Colchicine versus placebo in Behcet's disease: randomized, double-blind, controlled crossover trial
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DOI：
10.1007/s10165-009-0200-2
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发表时间：
2009-10-01
影响因子：
2.2
通讯作者：
Chams-Davatchi, Cheyda
中科院分区：
文献类型：
--
作者：
Davatchi, Fereydoun;Abdollahi, Bahar Sadeghi;Chams-Davatchi, Cheyda
秋水仙碱对白塞氏病（BD）患者的疗效进行了评估，并与安慰剂进行了比较。在一项随机、双盲、对照交叉试验中，连续选择169例无主要器官受累的患者。他们符合白塞氏病的国际标准。患者被随机分配使用秋水仙碱或安慰剂。在4个月时，他们被交换（秋水仙碱换成安慰剂，安慰剂换成秋水仙碱）再持续4个月。主要终点是总体疾病活动指数（IBDDAM）。次要结果是个体症状的反应。使用学生配对t检验来评估每组内的结果，并使用方差分析来检查秋水仙碱与安慰剂之间的差异。采用“意向治疗”方法进行分析。安慰剂组IBDDAM从3.17恶化至3.63 （t = 1.750, P = 0.08）。秋水仙碱的IBDDAM从3.35提高到2.75 （t = 4.143, P < 0.0001）。秋水仙碱可显著改善口腔溃疡、生殖器溃疡、假性毛囊炎和结节性红斑，而安慰剂无显著改善。方差分析显示，秋水仙碱组与安慰剂组IBDDAM差异极显著（F = 14.674, P = 0.00016）。男女结果差异无统计学意义（F = 0.181, P = 0.67）。总之，秋水仙碱，而不是安慰剂，显著改善了整体疾病活动指数。秋水仙碱组与安慰剂组的结果差异也有统计学意义。
The effect of colchicine was evaluated in a large cohort of Behcet's disease (BD) patients and compared to placebo. In a randomized, double-blind, controlled crossover trial, 169 patients without major organ involvement were selected consecutively. They fulfilled the International Criteria for Behcet's Disease. Patients were randomly assigned to colchicine or placebo. At 4 months, they were swapped over (colchicine to placebo, placebo to colchicine) for another 4 months. The primary outcome was the overall disease activity index, the IBDDAM. The secondary outcome was the responses of the individual symptoms. A Student's paired t test was used to evaluate results within each group, and an ANOVA to check for differences between colchicine and placebo. Analysis was performed using the "intention to treat'' method. For placebo, IBDDAM worsened from 3.17 to 3.63 (t = 1.750, P = 0.08). For colchicine, IBDDAM improved from 3.35 to 2.75 (t = 4.143, P < 0.0001). Oral aphthosis, genital aphthosis, pseudofolliculitis, and erythema nodosum improved significantly with colchicine but not with placebo. According to the ANOVA, the difference in IBDDAM between colchicine and placebo was highly significant (F = 14.674, P = 0.00016). The difference between the results for males and females was not significant (F = 0.181, P = 0.67). In conclusion, colchicine, but not placebo, significantly improved the overall disease activity index. The difference between the results for colchicine and placebo was also statistically significant.