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环孢素与氯倍他索在萎缩性糜烂性口腔扁平苔藓局部治疗中的比较:一项双盲随机对照试验

Ciclosporin vs. clobetasol in the topical management of atrophic and erosive oral lichen planus: a double-blind, randomized controlled trial.

作者信息

Conrotto D, Carbone M, Carrozzo M, Arduino P, Broccoletti R, Pentenero M, Gandolfo S

机构信息

Department of Biological Sciences and Human Oncology, Oral Medicine Section, University of Turin, C.so Dogliotti 38, 10126 Turin, Italy.

出版信息

Br J Dermatol. 2006 Jan;154(1):139-45. doi: 10.1111/j.1365-2133.2005.06920.x.

DOI:10.1111/j.1365-2133.2005.06920.x
PMID:16403107
Abstract

BACKGROUND

Oral lichen planus (OLP) is a chronic inflammatory disease that can be painful, especially in the atrophic and erosive forms. Several drugs have been used with varying results, but most treatments are empirical, and do not have adequate control groups or correct study designs.

OBJECTIVES

To compare the effectiveness of clobetasol and ciclosporin in the topical management of OLP and to evaluate which is more cost-effective and which gives the longest remission from signs and symptoms.

METHODS

A randomized, comparative, double-blind study was designed. Forty consecutive patients were divided into two groups to receive clobetasol propionate or ciclosporin for 2 months. Both drugs were placed in 4% hydroxyethyl cellulose bioadhesive gel. Antimycotic prophylaxis was also given. After the end of therapy, patients underwent a 2-month follow-up.

RESULTS

Eighteen of 19 clobetasol-treated patients (95%) improved after 2 months of therapy, while 13 of 20 ciclosporin-treated patients (65%) had a clinical response (P = 0.04). Symptomatology improved in 18 clobetasol-treated patients (95%) and in 17 ciclosporin-treated patients (85%) (not statistically significantly different). Two months after the end of therapy, 33% of clobetasol-treated patients and 77% of ciclosporin-treated patients were stable (P = 0.04). Clobetasol produced significantly more side-effects than ciclosporin (P = 0.04). The daily cost of ciclosporin treatment was 1.82 compared with 0.35 for clobetasol therapy.

CONCLUSIONS

Clobetasol is more effective than ciclosporin in inducing clinical improvement, but the two drugs have comparable effects on symptoms. Conversely, clobetasol gives less stable results than ciclosporin when therapy ends and has shown a higher incidence of side-effects. The daily cost of ciclosporin is more than five times higher than clobetasol.

摘要

背景

口腔扁平苔藓(OLP)是一种慢性炎症性疾病,可能会引起疼痛,尤其是萎缩型和糜烂型。已经使用了几种药物,效果各不相同,但大多数治疗都是经验性的,没有足够的对照组或正确的研究设计。

目的

比较氯倍他索和环孢素在OLP局部治疗中的有效性,并评估哪种药物更具成本效益,以及哪种药物能使体征和症状缓解时间最长。

方法

设计了一项随机、对照、双盲研究。40例连续患者被分为两组,分别接受丙酸氯倍他索或环孢素治疗2个月。两种药物均置于4%羟乙基纤维素生物黏附凝胶中。同时给予抗真菌预防治疗。治疗结束后,患者进行2个月的随访。

结果

19例接受氯倍他索治疗的患者中有18例(95%)在治疗2个月后病情改善,而20例接受环孢素治疗的患者中有13例(65%)有临床反应(P = 0.04)。18例接受氯倍他索治疗的患者(95%)和17例接受环孢素治疗的患者(85%)症状改善(无统计学显著差异)。治疗结束2个月后,33%接受氯倍他索治疗的患者和77%接受环孢素治疗的患者病情稳定(P = 0.04)。氯倍他索产生的副作用明显多于环孢素(P = 0.04)。环孢素治疗的每日费用为1.82,而氯倍他索治疗为0.35。

结论

氯倍他索在诱导临床改善方面比环孢素更有效,但两种药物对症状的影响相当。相反,治疗结束时氯倍他索的疗效不如环孢素稳定,且副作用发生率更高。环孢素的每日费用比氯倍他索高出五倍多。

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