Yu Fanya, Zhang Lina, Zhang Xudong, Zhang Juwen, Yu Junhong, Tang Chuwei, Xiong Ling, Liu Xia, Li Yun, Chen Wei
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Shanghai Haitian Medical Technology Co., Ltd, Shanghai, China.
J Ethnopharmacol. 2025 Feb 10;338(Pt 3):119107. doi: 10.1016/j.jep.2024.119107. Epub 2024 Nov 16.
Vulvovaginal candidiasis (VVC) represents the most prevalent form of candidal infections, imposing a significant societal burden. Kushen gel, a chinese patent medicine, has demonstrated favorable outcomes in the treatment of VVC. In clinical practice, Kushen gel is often used in conjunction with antifungal drugs. However, the clinical evidence supporting the combined use of Kushen gel with antifungal drugs for the treatment of VVC is currently limited.
This study aimed to evaluate the effectiveness and safety of Kushen gel combined with antifungal drugs in the treatment of vulvovaginal candidiasis (VVC).
Databases namely CNKI, Wanfang Database, VIP Database, CBM, PubMed, Cochrane Library, and Embase were searched from their inception to January 2024. Randomized controlled trials (RCTs) applying Kushen gel combined with antifungal drugs for the treatment of VVC were included. Methodological quality assessment was performed using the Cochrane risk of bias assessment tool (RoB 1.0). A Meta-analysis was performed using RevMan 5.4 software. The primary outcomes were total efficacy rate, recurrence rate, secondary outcomes included adverse events and time to clinical symptom resolution.
A Meta-analysis of 42 RCTs, encompassing a total of 4259 VVC patients was conducted. The results indicated that compared to antifungal drugs alone, Kushen gel combined with antifungal drugs increased the effectiveness (RR = 1.20, 95%CI [1.17, 1.23], P < 0.00001) and reduced the recurrence rate (RR = 0.21, 95%CI [0.13, 0.34], P < 0.00001), with no significant difference in safety (RR = 0.56, 95%CI [0.30, 1.03], P = 0.11).
Based on the available results, it appears that the combination of Kushen gel with antifungal drugs may increase the effectiveness and reduce the recurrence rate. However, due to the poor methodological quality of the included studies, more high-quality evidence from large-sample and well-designed research is needed in the future.
外阴阴道念珠菌病(VVC)是念珠菌感染最常见的形式,给社会带来了沉重负担。苦参凝胶是一种中成药,在治疗VVC方面已显示出良好效果。在临床实践中,苦参凝胶常与抗真菌药物联合使用。然而,目前支持苦参凝胶与抗真菌药物联合用于治疗VVC的临床证据有限。
本研究旨在评估苦参凝胶联合抗真菌药物治疗外阴阴道念珠菌病(VVC)的有效性和安全性。
检索中国知网、万方数据库、维普数据库、中国生物医学文献数据库、PubMed、Cochrane图书馆和Embase数据库,检索时间从建库至2024年1月。纳入应用苦参凝胶联合抗真菌药物治疗VVC的随机对照试验(RCT)。采用Cochrane偏倚风险评估工具(RoB 1.0)进行方法学质量评估。使用RevMan 5.4软件进行Meta分析。主要结局指标为总有效率、复发率,次要结局指标包括不良事件和临床症状缓解时间。
对42项RCT进行了Meta分析,共纳入4259例VVC患者。结果表明,与单独使用抗真菌药物相比,苦参凝胶联合抗真菌药物提高了有效性(RR = 1.20,95%CI [1.17, 1.23],P < 0.00001),降低了复发率(RR = 0.21,95%CI [0.13, 0.34],P < 0.00001),安全性方面无显著差异(RR = 0.56,95%CI [0.30, 1.03],P = 0.11)。
根据现有结果,苦参凝胶与抗真菌药物联合使用可能提高有效性并降低复发率。然而,由于纳入研究的方法学质量较差,未来需要更多来自大样本、设计良好研究的高质量证据。