Systematic Evaluation and Trial Sequential Analysis of Kushen Gel Combined with Fluconazole in the Treatment of Mycotic Vaginitis
Objective:To systematically evaluate the effectiveness and safety of Sophora flavescens gel combined with fluconazole in the treatment of fungal vaginitis.Methods:A computer search was performed on The Cochrane Li-brary and other databases to collect relevant randomized controlled trials(RCTs).The search time limit was from the establishment of the database to June 2023.After two researchers independently screened the literature and extracted data,the risk of bias of the included RCTs was assessed,and meta-analysis and trial sequential analysis(TSA)were performed.Results:A total of 25 RCTs were included.Meta-analysis results showed that compared with fluconazole alone,Sophora flavescens gel combined with fluconazole can improve the overall effective rate in the treatment of fungal vaginitis[RR=1.21,95％CI(1.17,1.25),P＜0.00001],and reduce the remission/disappearance time of clinical symp-toms:vulvar pruritus[MD=-3.23,95％CI(-3.41,-3.05),P＜0.00001],vaginal mucosal congestion[MD=-3.49,95％CI(-3.91,-3.08),P＜0.00001],reduce the recurrence rate[RR=0.26,95％CI(0.17,0.41),P＜0.00001],the incidence of adverse reactions in the 2 groups[RR=0.86,95％CI(0.29,2.49),P=0.78]There was no significant difference.TSA re-sults show that there is reliable evidence that Sophora flavescens gel combined with fluconazole can improve the overall effective rate of treatment.Conclusion:Existing evidence shows that Sophora flavescens gel combined with fluconazole is effective and safe in the treatment of fungal vaginitis.Due to the quality and methodological limitations of the includ-ed studies,this conclusion needs to be verified by more high-quality RCTs.
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