Iraji Fariba, Asilian Ali, Saeidi Ahmad, Siadat Amir Hossein, Saeidi Ali Reza, Hassanzadeh Akbar
Department of Dermatology, Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Science, Isfahan, Iran.
Adv Biomed Res. 2013 Jul 30;2:76. doi: 10.4103/2277-9175.115798. eCollection 2013.
The aim of this study was to evaluate and compare the therapeutic efficacy of subcutaneous enoxaparin versus oral prednisone (as a standard treatment) in patients with disseminated lichen planus.
In this parallel randomized clinical trial study, overall 48 patients completed the study. 25 patients were treated with subcutaneous enoxaparin 5 mg weekly and 23 patients with 0.5 mg/kg prednisone orally daily until complete remission or a maximum of 8 weeks. The results of itching severity, extent of active lesions and drug side effects were compared. In remission, patients were followed for 6 months for recurrent lesions.
In enoxaparin group, 8 patients (32%) had complete remission and 10 patients (40%) had partial improvement. In the oral prednisone group, 16 patients (69.6%) had complete remission and 6 patients (26.1%) had partial improvement (P = 0.005). Average size of active lesions in both groups decreased significantly after treatment, but analysis of covariance showed that the mean lesion size after treatment in the oral prednisone group was significantly lower than the enoxaparin group (P = 0.005). The relapse rate from improved patients in the enoxaparin group was 6 (33%) and in oral prednisone group was 9 (40.9%, P = 0.083). In the enoxaparin group no serious complications was seen. But 22% in the oral prednisone group show side effect, the most common complications were dyspepsia.
Low dose enoxaparin on lichen Planus have therapeutic effect and is important for the least side effects but not as much as oral prednisone. But it could be accepted as an alternative treatment.
本研究旨在评估和比较皮下注射依诺肝素与口服泼尼松(作为标准治疗)对播散性扁平苔藓患者的治疗效果。
在这项平行随机临床试验研究中,共有48例患者完成了研究。25例患者每周皮下注射5毫克依诺肝素,23例患者每天口服0.5毫克/千克泼尼松,直至完全缓解或最长治疗8周。比较两组患者瘙痒严重程度、活动性皮损范围及药物副作用的结果。缓解后,对患者随访6个月以观察皮损复发情况。
依诺肝素组中,8例患者(32%)完全缓解,10例患者(40%)部分改善。口服泼尼松组中,16例患者(69.6%)完全缓解,6例患者(26.1%)部分改善(P = 0.005)。两组治疗后活动性皮损的平均大小均显著减小,但协方差分析显示,口服泼尼松组治疗后的平均皮损大小显著低于依诺肝素组(P = 0.005)。依诺肝素组病情改善患者的复发率为6例(33%),口服泼尼松组为9例(40.9%,P = 0.083)。依诺肝素组未见严重并发症。但口服泼尼松组有22%出现副作用,最常见的并发症是消化不良。
低剂量依诺肝素对扁平苔藓有治疗作用,且副作用最小,但效果不如口服泼尼松。不过它可作为一种替代治疗方法。