CONTROLLED TRIAL OF ANTIMYCOBACTERIAL THERAPY IN CROHNS-DISEASE - CLOFAZIMINE VERSUS PLACEBO
CONTROLLED TRIAL OF ANTIMYCOBACTERIAL THERAPY IN CROHNS-DISEASE - CLOFAZIMINE VERSUS PLACEBO
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DOI：
10.1007/bf01298873
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发表时间：
1991-04-01
影响因子：
3.1
通讯作者：
ODONOGHUE, DP
中科院分区：
文献类型：
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作者：
AFDHAL, NH;LONG, A;ODONOGHUE, DP
为了研究氯法齐明，一种强大的抗分枝杆菌和抗真菌剂的效果，49例活动性克罗恩病患者被随机分配到皮质类固醇加氯法齐明100 mg每日（N = 25）或类固醇和匹配的安慰剂（N = 24）。共有28例患者（58%）进入疾病缓解期（氯法齐明16例，安慰剂12例; P = NS），疾病活动评分从10.5 +/- 4.4降至3.3 +/- 3.5。患者再用氯法齐明或安慰剂治疗8个月，28例患者中有18例维持缓解并完成研究（氯法齐明12例，安慰剂6例; P = NS）。副作用轻微，包括皮疹和色素沉着增加。氯法齐明作为一种单独的抗分枝杆菌药物在诱导克罗恩病缓解方面似乎无效，但可能在疾病维持或联合化疗中发挥作用。
In order to study the effect of clofazimine, a powerful antimycobacterial and antiinflammatory agent, 49 patients with active Crohn's disease were randomized to either corticosteroids plus clofazimine 100 mg daily (N = 25) or to steroids and matching placebo (N = 24). A total of 28 patients (58%) went into disease remission (clofazimine 16, placebo 12; P = NS) with a fall in disease activity score from 10.5 +/- 4.4 to 3.3 +/- 3.5. Patients were treated for a further eight months with clofazimine or placebo and 18 of 28 maintained their remission and completed the study (clofazimine 12, placebo 6; P = NS). Side effects were minor and consisted of skin rash and increased pigmentation. Clofazimine as a solitary antimycobacterial agent appears ineffective in inducing remission in Crohn's disease but may have a role in either disease maintenance or combination chemotherapy.