Nurbhai M, Grimshaw J, Watson M, Bond Cm, Mollison J, Ludbrook A
Ottawa Health Research Institute, ASB Box 693, Rm 2-006, 1053 Carling Avenue, Ottawa, Ontario, Canada, K1Y 4 E9.
Cochrane Database Syst Rev. 2007 Oct 17(4):CD002845. doi: 10.1002/14651858.CD002845.pub2.
Anti-fungals are available for oral and intra-vaginal treatment of uncomplicated vulvovaginal candidiasis (thrush).
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.
The following sources were searched for the original review: The Cochrane Library (Issue 4, 1999), MEDLINE (January 1985 to May 2000), EMBASE (January 1980 to January 2000) and the Cochrane Sexually Transmitted Disease (STD) Group Specialised Register of Controlled Trials. The manufacturers of anti-fungals available in the UK were contacted. For the update, CENTRAL (January 2000 to August 2006), PUBMED (January 2000 to August 2006), EMBASE (January 2000 to August 2006) and the Cochrane STD Group Specialised Register were searched in August 2006. The reference lists of retrieved articles were reviewed manually.
Randomised controlled trials published in any language. Trials had to compare at least one oral anti-fungal with one intra-vaginal anti-fungal. Women (aged 16 years or over) with uncomplicated vulvovaginal candidiasis. The diagnosis of vulvovaginal candidiasis to be made mycologically (i.e. a positive culture and / or microscopy for yeast). Trials were excluded if they solely involved subjects who were HIV positive, immunocompromised, pregnant, breast feeding or diabetic. The primary outcome measure was clinical cure.
Two reviewers screened titles and abstracts of the electronic search results and full text of potentially relevant papers. Independent duplicate abstraction was performed by two reviewers. Disagreements regarding trial inclusion or data abstraction were resolved by discussion between the reviewers. Odds ratios were pooled using the fixed effects models (except for two analyses when random effects models were used because of potentially important heterogeneity).
Two new trials reporting three comparisons were found in the update. Nineteen trials are included in the review, reporting 22 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 0.94, 95% CI, 0.75 to 1.17) and long term (OR 1.07, 95% CI, 0.82 to 1.41) follow-up. No statistically significant differences for mycological cure were observed between oral and intra-vaginal treatment at short term (OR 1.15, 95% CI, 0.94 to 1.42). There was a statistically significant difference for long term follow-up (OR 1.29, 95% CI, 1.05 to 1.60) in favour of oral treatment, however the clinical significance of this result is uncertain. Two trials each reported one withdrawal from treatment due to an adverse reaction. Treatment preference data were poorly reported.
AUTHORS' CONCLUSIONS: No statistically significant differences were observed in clinical cure rates 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 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, women who are purchasing their own treatment 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 some oral anti-fungals is worth the gain in convenience, if this is the patient's preference.
抗真菌药物可用于口服和阴道内给药,治疗单纯性外阴阴道念珠菌病(鹅口疮)。
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。该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。
在最初的综述中检索了以下来源:《考科蓝图书馆》(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)以及考科蓝性传播疾病(STD)小组专门的对照试验注册库。还联系了英国市场上抗真菌药物的制造商。在更新时,于2006年8月检索了考科蓝中央对照试验注册库(CENTRAL,2000年1月至2006年8月)、PUBMED(2000年1月至2006年8月)、EMBASE(2000年1月至2006年8月)以及考科蓝性传播疾病小组专门注册库。对检索到的文章的参考文献列表进行了人工查阅。
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女性(年龄16岁及以上)。外阴阴道念珠菌病的诊断需通过真菌学方法做出(即酵母培养阳性和/或显微镜检查阳性)。若试验仅涉及HIV阳性、免疫功能低下、怀孕、哺乳期或糖尿病患者,则排除该试验。主要结局指标为临床治愈。
两名评审员筛选了电子检索结果的标题和摘要以及潜在相关论文的全文。由两名评审员独立进行重复提取。评审员之间通过讨论解决关于试验纳入或数据提取的分歧。使用固定效应模型合并比值比(由于存在潜在的重要异质性,有两项分析使用了随机效应模型)。
在更新中发现了两项新试验,报告了三项比较。本综述纳入了19项试验,报告了22项口服与阴道内抗真菌药物的比较。在短期(比值比0.94,95%可信区间0.75至1.17)和长期(比值比1.07,95%可信区间0.82至1.41)随访中,口服与阴道内抗真菌药物治疗临床治愈方面未显示出统计学显著差异。在短期(比值比1.15,95%可信区间0.94至1.42)口服与阴道内治疗之间未观察到真菌学治愈的统计学显著差异。长期随访存在统计学显著差异(比值比1.29,95%可信区间1.05至1.60),支持口服治疗,然而该结果的临床意义尚不确定。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。
口服和阴道内给药的抗真菌药物治疗单纯性阴道念珠菌病的临床治愈率未观察到统计学显著差异。关于口服与阴道内抗真菌药物治疗单纯性阴道念珠菌病的相对安全性无法得出明确结论。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。除非之前有对一种给药途径的不良反应史或禁忌证,对于自行购买治疗药物的女性,应提供关于治疗特点和成本的确切信息,以便她们自己做出决定。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,某些口服抗真菌药物较高的成本是否值得其在便利性方面的优势。