TREATMENT OF CROHNS-DISEASE WITH 6-MERCAPTOPURINE - A LONG-TERM, RANDOMIZED, DOUBLE-BLIND-STUDY

TREATMENT OF CROHNS-DISEASE WITH 6-MERCAPTOPURINE - A LONG-TERM, RANDOMIZED, DOUBLE-BLIND-STUDY
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DOI:
10.1056/nejm198005013021801
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发表时间:
1980-01-01
影响因子:
158.5
通讯作者:
PASTERNACK, BS
PASTERNACK, BS
中科院分区:
医学1区
文献类型:
--
作者:
PRESENT, DH;KORELITZ, BI;PASTERNACK, BS

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为了检验6-巯基嘌呤(6-MP)治疗克罗恩病的有效性,83名慢性病患者参加了一项为期2年的双盲研究,比较6-MP和安慰剂。交叉数据显示,6-MP组39个疗程中有26个(67%)与安慰剂组39个疗程中的3个(8%)相比有改善(P < 0.0001)。非交叉数据同样证实了6-MP的优效性。在闭合瘘管(31 vs. 6%)和允许停止或减少类固醇剂量(75 vs. 36%)方面,该药比安慰剂更有效(P < 0.001)。对6-MP的反应通常延迟,32%的患者需要超过3个月。19%的患者需要超过4个月的时间才有反应。6-MP的不良副作用发生在10%的患者中,并且一致可逆。6-MP是治疗克罗恩病的有效药物。
To test the effectiveness of 6-mercaptopurine (6-MP) in the treatment of Crohn''s disease 83 chronically ill patients participated in a 2 yr double-blind study comparing 6-MP with placebo. Crossover data showed that improvement occurred in 26 of 39 courses of 6-MP (67%) as compared with 3 of 39 courses of placebo (8%) (P < 0.0001). Non-crossover data likewise confirmed the superiority of 6-MP. The drug was more effective than placebo in closing fistulas (31 vs. 6%) and in permitting discontinuation or reduction of steroid dosage (75 vs. 36%) (P < 0.001). The onset of response to 6-MP was often delayed, with 32% of patients taking longer than 3 mo. to respond, and 19% taking longer than 4 mo. Adverse side effects to 6-MP occurred in 10% of patients and were uniformly reversible. 6-MP is an effective and useful agent in the management of Crohn''s disease.