Almangour Thamer A, Kaye Keith S, Alessa Mohammed, Eljaaly Khalid, Sfouq Aleanizy Fadilah, Alsharidi Aynaa, Al Majid Fahad M, Alotaibi Naif H, Alzeer Abdullah A, Alnezary Faris S, Alhifany Abdullah A
Department of Clinical Pharmacy, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
Director of Clinical Research, Division of Infectious Diseases, University of Michigan Medical School, 5510A MSRB I, SPC 5680, 1150 W. Medical Center Drive, Ann Arbor, MI 48109-5680, United States.
Saudi Pharm J. 2021 Apr;29(4):315-323. doi: 10.1016/j.jsps.2021.03.003. Epub 2021 Mar 24.
To assess the efficacy and safety of topical application of clotrimazole versus others in the treatment of oropharyngeal candidiasis (OPC).
Four electronic databases, registries of ongoing trials, and manual search were used to identify randomized controlled trials (RCTs) that compared the efficacy of clotrimazole to other antifungal agents in patients who were clinically diagnosed with oral candidiasis up to November 1st, 2019. Primary outcomes were clinical response and mycological cure rates. Secondary outcomes include relapse rate, incidence of systemic infections, and compliance. Adverse effects were also evaluated.
Sixteen RCTs with a total of 1685 patients were included. Half of the eligible studies were considered at high risk of performance bias and more than a third, at high risk of reporting bias. Our analysis showed no significant difference in clinical response between clotrimazole and all other antifungal agents. However, clotrimazole was less effective in terms of mycologic cure and relapse rate. Sensitivity analysis comparing clotrimazole to other topical antifungal agents only showed no differences in clinical response, microbiologic cure or relapse. Further sensitivity analysis showed significant efficacy of fluconazole over clotrimazole.
This meta-analysis indicated that clotrimazole is less effective than fluconazole but as effective as other topical therapies in treating OPC. Well-designed high-quality RCT is needed to validate these findings.
评估克霉唑局部应用与其他药物相比治疗口腔念珠菌病(OPC)的疗效和安全性。
使用四个电子数据库、正在进行的试验注册库并进行手工检索,以识别在2019年11月1日前临床诊断为口腔念珠菌病的患者中比较克霉唑与其他抗真菌药物疗效的随机对照试验(RCT)。主要结局为临床反应和真菌学治愈率。次要结局包括复发率、全身感染发生率和依从性。还评估了不良反应。
纳入了16项RCT,共1685例患者。一半的合格研究被认为存在高实施偏倚风险,超过三分之一存在高报告偏倚风险。我们的分析表明,克霉唑与所有其他抗真菌药物在临床反应上无显著差异。然而,克霉唑在真菌学治愈和复发率方面效果较差。将克霉唑与其他局部抗真菌药物进行比较的敏感性分析仅显示临床反应、微生物学治愈或复发方面无差异。进一步的敏感性分析显示氟康唑比克霉唑疗效显著。
这项荟萃分析表明,克霉唑在治疗OPC方面比氟康唑效果差,但与其他局部治疗方法效果相当。需要设计良好的高质量RCT来验证这些发现。