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口服与阴道内使用咪唑类和三唑类抗真菌药物治疗单纯性外阴阴道念珠菌病(鹅口疮)的比较

Oral versus intra-vaginal imidazole and triazole anti-fungal treatment of uncomplicated vulvovaginal candidiasis (thrush).

作者信息

Watson M C, Grimshaw J M, Bond C M, Mollison J, Ludbrook A

机构信息

Department of General Practice and Primary Care, University of Aberdeen, Westburn Road, Aberdeen, Scotland, UK, AB25 2AY.

出版信息

Cochrane Database Syst Rev. 2001(1):CD002845. doi: 10.1002/14651858.CD002845.

Abstract

BACKGROUND

Anti-fungals are available for oral and intra-vaginal treatment of vulvovaginal candidiasis (thrush).

OBJECTIVES

The primary objective of this review was to assess the relative effectiveness of oral versus intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis. The secondary objectives of the review were to assess the cost-effectiveness, safety and patient preference of oral versus intra-vaginal anti-fungals.

SEARCH STRATEGY

The following sources were searched: The Cochrane Library (Issue 4, 1999), MEDLINE (January 1985 to May 2000), EMBASE (January 1980 to January 2000) and the Cochrane Collaboration Sexually Transmitted Disease Group Specialised Register of Controlled Trials. The reference lists of retrieved articles were reviewed manually. The manufacturers of anti-fungals available in the UK were contacted.

SELECTION CRITERIA

BulletRandomised controlled trials published in any language. BulletTrials had to compare at least one oral anti-fungal with one intra-vaginal anti-fungal. BulletWomen (aged 16 years or over) with uncomplicated vulvovaginal candidiasis. BulletThe diagnosis of vulvovaginal candidiasis to be made mycologically (i.e. a positive culture and / or microscopy for yeast). BulletTrials were excluded if they solely involved subjects who were HIV positive, immunocompromised, pregnant, breastfeeding or diabetic. BulletThe primary outcome measure was clinical cure.

DATA COLLECTION AND ANALYSIS

Duplicate scrutiny was performed of the titles and abstracts of the electronic search results. Full article formats of all selected abstracts were retrieved and independently assessed by two reviewers. Independent duplicate abstraction was performed by four reviewers. Disagreements regarding trial inclusion or data abstraction were resolved by discussion between the reviewers. Odds ratios were pooled using the random effects model. Chi-squared tests with a p-value of less than 0.1 indicated heterogeneity in the results.

MAIN RESULTS

Seventeen trials are included in the review, reporting 19 oral versus intra-vaginal anti-fungal comparisons. No statistically significant differences were shown between oral and intra-vaginal anti-fungal treatment for clinical cure at short term (OR 1.00 (95% CI, 0.72 to 1.40)) and long term (OR 1.03 (95% CI, 0.72 to 1.49)) follow-up. No statistically significant differences for mycological cure were observed between oral and intra-vaginal treatment at short term (OR 1.20(95% CI, 0.87 to 1.65)) or long term follow-up (OR 1.30 (95% CI, 0.99 to 1.71)). Two trials each reported one withdrawal from treatment due to an adverse reaction. Treatment preference data were poorly reported.

REVIEWER'S CONCLUSIONS: No differences exist in terms of the relative effectiveness (measured as clinical and mycological cure) of anti-fungals administered by the oral and intra-vaginal routes for the treatment of uncomplicated vaginal candidiasis. No definitive conclusion can be made regarding the relative safety of oral and intra-vaginal anti-fungals for uncomplicated vaginal candidiasis. The oral route of administration is the preferred route for anti-fungals for the treatment of vulvovaginal candidiasis. The decision to prescribe or recommend the purchase of an anti-fungal for oral or intra-vaginal administration should take into consideration: safety, cost and treatment preference. Unless there is a previous history of adverse reaction to one route of administration or contraindications: if women are purchasing their own treatment, they should be given full information about the characteristics and costs of treatment to make their own decision. If health services are paying the treatment cost, decision-makers should consider whether the higher cost of oral anti-fungal administration is worth the gain in convenience, if this is the patient's preference.

摘要

背景

抗真菌药物可用于外阴阴道念珠菌病(鹅口疮)的口服和阴道内治疗。

目的

本综述的主要目的是评估口服与阴道内抗真菌药物治疗单纯性外阴阴道念珠菌病的相对有效性。综述的次要目的是评估口服与阴道内抗真菌药物的成本效益、安全性及患者偏好。

检索策略

检索了以下来源:Cochrane图书馆(1999年第4期)、MEDLINE(1985年1月至2000年5月)、EMBASE(1980年1月至2000年1月)以及Cochrane协作网性传播疾病组对照试验专门注册库。人工查阅了检索到文章的参考文献列表。联系了英国可用抗真菌药物的制造商。

选择标准

  • 以任何语言发表的随机对照试验。

  • 试验必须比较至少一种口服抗真菌药物与一种阴道内抗真菌药物。

  • 患有单纯性外阴阴道念珠菌病的16岁及以上女性。

  • 外阴阴道念珠菌病的诊断需通过真菌学方法(即酵母培养阳性和/或显微镜检查阳性)。

  • 仅涉及HIV阳性、免疫功能低下、怀孕、哺乳期或糖尿病患者的试验被排除。

  • 主要结局指标为临床治愈。

数据收集与分析

对电子检索结果的标题和摘要进行了重复筛选。检索了所有选定摘要的全文格式,并由两名审阅者独立评估。由四名审阅者进行独立的重复提取。关于试验纳入或数据提取的分歧通过审阅者之间的讨论解决。使用随机效应模型汇总比值比。p值小于0.1的卡方检验表明结果存在异质性。

主要结果

本综述纳入了17项试验,报告了19项口服与阴道内抗真菌药物的比较。口服和阴道内抗真菌治疗在短期(OR 1.00(95%CI,0.72至1.40))和长期(OR 1.03(95%CI,0.72至1.49))随访时的临床治愈方面无统计学显著差异。口服和阴道内治疗在短期(OR 1.20(95%CI,0.87至1.65))或长期随访(OR 1.30(95%CI,0.99至1.71))时的真菌学治愈方面未观察到统计学显著差异。两项试验各报告有1例因不良反应退出治疗。治疗偏好数据报告较少。

审阅者结论

口服和阴道内途径给药的抗真菌药物在治疗单纯性阴道念珠菌病方面(以临床和真菌学治愈衡量)相对有效性无差异。对于单纯性阴道念珠菌病,口服和阴道内抗真菌药物的相对安全性无法得出明确结论。口服给药途径是治疗外阴阴道念珠菌病抗真菌药物的首选途径。开具或推荐购买口服或阴道内抗真菌药物的决定应考虑安全性、成本和治疗偏好。除非既往有对一种给药途径的不良反应史或禁忌证:如果女性自行购买治疗药物,应向她们提供有关治疗特性和成本的全部信息,以便她们自己做决定。如果医疗服务机构支付治疗费用,决策者应考虑如果这是患者的偏好,口服抗真菌药物给药的较高成本是否值得便利性的提高。

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