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0.4%局部用氟化亚锡制剂(MedEquine凝胶)治疗马细菌性皮肤感染的临床疗效和耐受性研究:一项前瞻性、随机、双盲、安慰剂对照临床试验。

Investigation on the clinical efficacy and tolerability of a 0.4% topical stannous fluoride preparation (MedEquine Gel) for the treatment of bacterial skin infections in horses: a prospective, randomized, double-blinded, placebo-controlled clinical trial.

作者信息

Marsella Rosanna, Akucewich Lisa

机构信息

Blanche Saunders Dermatology Laboratory, College of Veterinary Medicine, University of Florida, Gainesville, FL 32610, USA.

出版信息

Vet Dermatol. 2007 Dec;18(6):444-50. doi: 10.1111/j.1365-3164.2007.00623.x.

Abstract

The purpose of this prospective, double-blinded, placebo-controlled clinical trial was to investigate the efficacy and tolerability of a novel gel containing 0.4% stannous fluoride (MedEquine) for the treatment of cutaneous bacterial infections in horses. Twenty privately owned horses diagnosed with bacterial skin infections based on physical findings and cytology results were enrolled and randomly assigned to either a placebo or an active ingredient treatment group. The product was applied on affected areas daily for 4 weeks. Cytology and clinical evaluations were done by the same investigator at the beginning and at the end of the treatment. Owners scored pruritus weekly. Both owners and investigators were blinded to the allocation to the groups. At the end of the study, stannous fluoride gel treatment significantly decreased the investigator's clinical scores and owners' pruritus scores while no significant changes were detected in the vehicle treatment group. At the end of the trial, none of the horses in the stannous fluoride group required additional therapy while four of ten horses in the vehicle group required systemic therapy to resolve the infection. No adverse effects were detected in any of the groups. The gel formulation made compliance easier for owners compared to the traditional bathing regimen and allowed spot treatment, which was particularly helpful in animals with localized infections. These favourable aspects of the treatment were highlighted by the owners of the horses enrolled in the study. In conclusion, 0.4% stannous fluoride gel (MedEquine) was an effective and safe therapy for the topical management of bacterial skin infections in the horses included in the study.

摘要

这项前瞻性、双盲、安慰剂对照临床试验的目的是研究一种含0.4%氟化亚锡的新型凝胶(MedEquine)治疗马皮肤细菌感染的疗效和耐受性。根据体格检查结果和细胞学结果,20匹被诊断为细菌性皮肤感染的私人饲养马匹被纳入研究,并随机分为安慰剂组或活性成分治疗组。该产品每天在受影响区域涂抹,持续4周。在治疗开始和结束时,由同一名研究人员进行细胞学和临床评估。主人每周对瘙痒程度进行评分。主人和研究人员均对分组情况不知情。研究结束时,氟化亚锡凝胶治疗显著降低了研究人员的临床评分和主人的瘙痒评分,而赋形剂治疗组未检测到显著变化。试验结束时,氟化亚锡组的马匹均无需额外治疗,而赋形剂组的10匹马中有4匹需要全身治疗以解决感染问题。所有组均未检测到不良反应。与传统洗浴方案相比,凝胶制剂使主人更容易配合治疗,且允许进行局部治疗,这对局部感染的动物尤其有帮助。参与研究的马匹主人强调了该治疗方法的这些有利方面。总之,0.4%氟化亚锡凝胶(MedEquine)是本研究中马匹细菌性皮肤感染局部治疗的一种有效且安全的疗法。

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