Oral Antimycobacterial Therapy in Chronic Cutaneous Sarcoidosis A Randomized, Single-Masked, Placebo-Controlled Study
Oral Antimycobacterial Therapy in Chronic Cutaneous Sarcoidosis A Randomized, Single-Masked, Placebo-Controlled Study
复制标题
DOI：
10.1001/jamadermatol.2013.4646
复制
发表时间：
2013-09-01
期刊：
影响因子：
10.9
通讯作者：
King, Lloyd E.
中科院分区：
文献类型：
--
作者：
Drake, Wonder P.;Oswald-Richter, Kyra;King, Lloyd E.
重要性 结节病是一种慢性肉芽肿性疾病，治疗选择有限。这是第一项随机、安慰剂对照研究，证明抗分枝杆菌治疗可减少慢性皮肤结节病患者的病灶直径和疾病严重程度。 目的 评估每日一次抗分枝杆菌治疗对缓解慢性皮肤结节病病灶的安全性和有效性。 设计和参与者 对 30 名被认为需要治疗干预的有症状的慢性皮肤结节病病变患者进行单盲试验。地点位于田纳西州纳什维尔的三级转诊皮肤科中心。干预措施参与者被随机分配接受口服左氧氟沙星、乙胺丁醇、阿奇霉素和利福平 (CLEAR) 方案或比较安慰剂方案 8 周，随访 180 天。 主要结果和措施 治疗完成后，监测参与者病变直径的绝对变化和肉芽肿负荷的减少（如果存在）。 观察结果 在意向治疗分析中，CLEAR 治疗组的病变直径平均 (SD) 减少了 -8.4 (14.0) mm，而增加了 0.07 (3.2) mm。 在安慰剂治疗组中（P=.05）。 CLEAR 组肉芽肿负担显着减少，病变严重程度平均 (SD) 下降 -2.9 (2.5) mm，而安慰剂组下降 -0.6 (2.1) mm (P=.02)。 结论和相关性 与安慰剂相比，抗分枝杆菌治疗可能导致慢性皮肤结节病病变直径显着减小。这些观察到的减少与临床上症状的显着改善相关，在 180 天的随访期间出现。结节病 CD4+ T 细胞的转录组分析揭示了与疾病严重程度相关的通路的逆转以及 T 细胞受体刺激后 T 细胞功能的增强。
IMPORTANCE Sarcoidosis is a chronic granulomatous disease for which there are limited therapeutic options. This is the first randomized, placebo-controlled study to demonstrate that antimycobacterial therapy reduces lesion diameter and disease severity among patients with chronic cutaneous sarcoidosis.OBJECTIVE To evaluate the safety and efficacy of once-daily antimycobacterial therapy on the resolution of chronic cutaneous sarcoidosis lesions.DESIGN AND PARTICIPANTS A randomized, placebo-controlled, single-masked trial on 30 patients with symptomatic chronic cutaneous sarcoidosis lesions deemed to require therapeutic intervention.SETTING A tertiary referral dermatology center in Nashville, Tennessee.INTERVENTIONS Participants were randomized to receive either the oral concomitant levofloxacin, ethambutol, azithromycin, and rifampin (CLEAR) regimen or a comparative placebo regimen for 8 weeks with a 180-day follow-up.MAIN OUTCOMES AND MEASURES Participants were monitored for absolute change in lesion diameter and decrease in granuloma burden, if present, on completion of therapy.OBSERVATIONS In the intention-to-treat analysis, the CLEAR-treated group had a mean (SD) decrease in lesion diameter of -8.4 (14.0) mm compared with an increase of 0.07 (3.2) mm in the placebo-treated group (P=.05). The CLEAR group had a significant reduction in granuloma burden and experienced a mean (SD) decline of -2.9 (2.5) mm in lesion severity compared with a decline of -0.6 (2.1) mmin the placebo group (P=.02).CONCLUSIONS AND RELEVANCE Antimycobacterial therapy may result in significant reductions in chronic cutaneous sarcoidosis lesion diameter compared with placebo. These observed reductions, associated with a clinically significant improvement in symptoms, were present at the 180-day follow-up period. Transcriptome analysis of sarcoidosis CD4+ T cells revealed reversal of pathways associated with disease severity and enhanced T-cell function following T-cell receptor stimulation.