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硝酸咪康唑含皂制剂用于尿布念珠菌病的前瞻性临床试验研究

Prospective trial for the clinical efficacy of anogenital skin care with miconazole nitrate-containing soap for diaper candidiasis.

机构信息

Department of Dermatology, Division of Medicine, Faculty of Medical Sciences, University of Fukui Hospital, Fukui, Japan.

Department of Dermatology, JCHO Fukui Katsuyama General Hospital, Fukui, Japan.

出版信息

J Dermatol. 2020 Apr;47(4):385-389. doi: 10.1111/1346-8138.15257. Epub 2020 Feb 6.

Abstract

Anogenital skin care for the elderly remains an umbrella term concerning protective and non-interventional regimens, particularly for ordinary diaper users. Our recent investigation has demonstrated the preventive effect of daily anogenital washing with miconazole nitrate-containing soap to the development of diaper candidiasis. We extended this work to cover our hypothesis as to whether the miconazole soap has a therapeutic benefit in genital candidiasis. The study outline includes: (i) the enrollment of 21 bedridden inpatients (84 ± 9 years; eight men and 13 women) who were diagnosed clinically and mycologically with genital candidiasis, and who had never received topical and/or systemic antifungal agents; (ii) administration of anogenital washing with 0.75% miconazole-containing soap once daily for 4 weeks; and (iii) assessment of clinical symptoms and detection of Candida materials by culture and microscopic examination. As assessed by clinical symptom scoring for incontinence-associated dermatitis (IAD), the ratio of patients with severe to moderate symptoms dramatically decreased by 2 weeks and 10 of 21 patients became symptom-free at 4 weeks. The IAD clinical severity score was significantly decreased at 4 weeks. Compared with the baseline positivity, both microscopic and cultured Candida-positive rates were significantly decreased at 4 weeks after washing. All culture-detected fungi were Candida albicans. Severe adverse events did not occur in all participants. Individual medical and risk factors had no significant correlation with clinical severity and duration of candidiasis on variance analysis. In conclusion, topical washing with miconazole soap is a safe and reliable non-medical approach for soothing diaper-associated genital candidiasis in bedridden inpatients in whom it is difficult to perform prompt medical examination.

摘要

老年人生殖器和肛周皮肤护理仍然是一个涵盖保护和非干预性方案的术语,特别是对于普通尿布使用者。我们最近的研究表明,每天用含有硝酸咪康唑的肥皂清洗生殖器和肛周皮肤可以预防尿布念珠菌病的发生。我们将这项工作扩展到研究含咪康唑的肥皂是否对生殖器念珠菌病有治疗作用。研究大纲包括:(i)纳入 21 名卧床住院患者(84±9 岁;8 名男性和 13 名女性),他们临床和真菌学诊断为生殖器念珠菌病,且从未接受过局部和/或全身抗真菌药物治疗;(ii)每天用 0.75%含咪康唑的肥皂清洗生殖器和肛周皮肤一次,持续 4 周;(iii)评估临床症状和通过培养和显微镜检查检测念珠菌材料。根据失禁相关性皮炎(IAD)的临床症状评分评估,严重和中度症状的患者比例在 2 周时显著降低,21 名患者中有 10 名在 4 周时症状消失。IAD 临床严重程度评分在 4 周时显著降低。与基线阳性率相比,清洗后 4 周时,显微镜和培养的念珠菌阳性率均显著降低。所有培养出的真菌均为白色念珠菌。在所有参与者中均未发生严重不良事件。方差分析显示,个体医疗和风险因素与念珠菌病的临床严重程度和持续时间无显著相关性。总之,对于难以进行及时医学检查的卧床住院患者,用咪康唑肥皂清洗生殖器和肛周皮肤是一种安全可靠的非药物方法,可以缓解与尿布相关的生殖器念珠菌病。

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