Tacrolimus 0.03% ointment treatment in exfoliative cheilitis: A randomised controlled clinical trial and monitoring blood concentration
Tacrolimus 0.03% ointment treatment in exfoliative cheilitis: A randomised controlled clinical trial and monitoring blood concentration
复制标题
他克莫司%200.03%%20软膏%20治疗%20in%20剥脱性%20唇炎：%20a%20随机%20对照%20临床%20试验%20和%20监测%20血液%20浓度。
DOI：
10.1111/jop.13142
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发表时间：
2020-12-23
影响因子：
3.3
通讯作者：
Zhou, Hongmei
中科院分区：
文献类型：
--
作者：
Liu, Junjiang;Shi, Liran;Zhou, Hongmei
背景
他克莫司已被用于治疗各种炎症性皮肤病，但其在口腔粘膜局部应用的安全性尚不清楚。剥脱性唇炎(EC)是一种慢性唇部炎症性疾病，其特征是反复结垢，很难治疗。本研究的目的是评价0.03%他克莫司软膏外用治疗食管炎的疗效和安全性。
方法
在这项随机对照临床试验中，40例EC患者被随机分成两组，分别接受0.03%他克莫司软膏(实验组，n=20)和0.1%曲安奈德乳膏(对照组，n=20)治疗3周。分别在第1、2、3周每天给药3、2、1次。对完全愈合的患者进行3个月的随访。测量临床结果，包括每次就诊时的体征(鳞片、干燥、出血和肿胀)和症状(粗糙、干燥、疼痛、瘙痒和烧灼感)的评分。测定他克莫司的血药浓度。
结果
治疗3周后，试验组和对照组鳞片愈合率分别为65%和10%(P=0.018)。试验组所有体征和两种症状(粗糙、瘙痒)的改善明显(P<；0.05)。对照组3个月复发率较高(P=0.029)。他克莫司血药浓度在安全范围内(~lt；5 ng/mL)。
结论
外用0.03%他克莫司软膏治疗EC近期疗效好，安全性好。
BACKGROUND
Tacrolimus has been used to treat various inflammatory skin diseases, but its safety for topical application on the oral mucosa is unknown. Exfoliative cheilitis (EC) is a chronic inflammatory disorder of the lips characterised by repeated scaling; it is difficult to manage. The aim of this study was to assess the efficacy and safety of tacrolimus 0.03% ointment as a topical treatment in patients with EC.
METHODS
In this randomised controlled clinical trial, 40 patients with EC were randomly assigned to receive either tacrolimus 0.03% ointment (experimental group, n = 20) or triamcinolone acetonide 0.1% cream (control group, n = 20) treatment for a 3-week period. Medication was administered in 3, 2, and 1 daily doses during the first, second, and third weeks, respectively. The patients with complete healing were followed up for 3 months. The clinical outcomes were measured, including the scores regarding signs (scale, dryness, rhagades, and swelling) and symptoms (rough, dry, pain, pruritus, and burning sensation) at every visit. Blood concentrations of tacrolimus were assessed.
RESULTS
After the 3-week treatment, healing rates of scale in the experimental and control groups were 65% and 10%, respectively (P = 0.018). Improvement in all signs and two symptoms (rough, pruritus) was much greater in the experimental group (P < 0.05). The 3-month recurrence rate was higher in the control group (P = 0.029). Tacrolimus blood concentrations were in the safe range (< 5 ng/mL).
CONCLUSION
Topical tacrolimus 0.03% ointment has good short-term efficacy and safety for treating EC.