Investigation on the clinical efficacy and safety of 0.1% tacrolimus ointment (Protopic) in canine atopic dermatitis: a randomized, double-blinded, placebo-controlled, cross-over study.
Investigation on the clinical efficacy and safety of 0.1% tacrolimus ointment (Protopic) in canine atopic dermatitis: a randomized, double-blinded, placebo-controlled, cross-over study.
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研究%20on%20the%20临床%20疗效%20和%20安全性%20of%200.1%%20他克莫司%20软膏%20（Protopic）%20in%20犬%20特应性%20皮炎：%20a%20随机，%20双盲，%20安慰剂对照
DOI：
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发表时间：
2004
期刊：
影响因子：
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通讯作者：
Jennifer Lopez
中科院分区：
文献类型：
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作者：
R. Marsella;C. Nicklin;S. Saglio;Jennifer Lopez
局部他克莫司已成功用于特应性皮炎患者。在患有特应性皮炎的犬中使用他克莫司复方洗剂的初步研究表明，根据研究者的报告，他克莫司可显著降低红斑和瘙痒，但犬主人未报告显著改善。本研究旨在评价市售0.1%他克莫司软膏（Protopic）在特应性皮炎犬中的临床疗效和安全性。本研究设计为双盲、安慰剂对照、交叉研究。将选定的犬分配至他克莫司或安慰剂组，持续4周。4周后，有2周的洗脱期，并转换治疗。12只犬完成了研究。对临床体征进行评分。在每次治疗的第0周和第4周采集血液样本，用于全血细胞计数、化学检查和他克莫司水平。在试验结束时，他克莫司软膏显著降低了主人和研究者的症状严重程度。当相同的犬接受安慰剂时，第0周和第4周评分之间没有差异。局部疾病的狗比全身性疾病的狗反应更好。在接受活性成分的动物血液中检测到他克莫司。水平低于毒性水平，在任何犬中均未报告不良反应。未检测到组间或组内全血细胞计数和化学参数的变化。总之，他克莫司似乎是一种安全的替代治疗犬异位性皮炎，特别是在那些局部疾病。
Topical tacrolimus is successfully used in people with atopic dermatitis. Preliminary studies in dogs with atopic dermatitis using tacrolimus in a compounded lotion formulation indicated that tacrolimus significantly decreased erythema and pruritus according to investigator, but no significant improvement was reported by the dog owners. The objectives of this study were to evaluate the clinical efficacy and safety of the commercially available 0.1% tacrolimus ointment (Protopic) in dogs with atopic dermatitis. The study was designed as a double-blinded, placebo-controlled, cross-over study. Selected dogs were allocated to either tacrolimus or placebo for 4 weeks. After 4 weeks there was a wash-out period of 2 weeks and treatments were switched. Twelve dogs completed the study. Clinical signs were scored. Blood samples were collected for complete blood count, chemistry panels and tacrolimus levels at week 0 and 4 of each treatment. Tacrolimus ointment significantly decreased severity of symptoms for both owners and investigators at the end of the trial. When the same dogs received the placebo, there were no differences between week 0 and week 4 scores. Dogs with localized disease responded better than dogs with generalized disease. Tacrolimus was detected in the blood of animals receiving the active ingredient. Levels were below the level of toxicity and no adverse effects were reported in any of the dogs. No changes in complete blood count and chemistry parameters were detected between groups or within groups. In conclusion, tacrolimus appears to be a safe alternative treatment in dogs with atopic dermatitis, especially in those with localized disease.