苦参凝胶联合氟康唑治疗霉菌性阴道炎的系统评价和试验序贯分析  

Systematic Evaluation and Trial Sequential Analysis of Kushen Gel Combined with Fluconazole in the Treatment of Mycotic Vaginitis

作　　者：李丽 张毛毛 LI Li;ZHANG Maomao(Anhui Lixin County Hospital of Traditional Chinese Medicine,Anhui Lixin 236700,China;Anhui Bozhou Food and Drug Inspection Center,Anhui Bozhou 236800,China)

机构地区：[1]安徽省利辛县中医院,安徽利辛236700 [2]安徽省亳州市食品药品检验中心,安徽亳州236800

出　　处：《中医药临床杂志》2024年第6期1104-1109,共6页Clinical Journal of Traditional Chinese Medicine

摘　　要：目的:系统评价苦参凝胶联合氟康唑治疗霉菌性阴道炎的有效性和安全性。方法:计算机检索The Cochrane Library等数据库,搜集相关随机对照试验(RCT),检索时限从建库至2023年6月。由2位研究员独立筛选文献并提取资料后,评估纳入RCT的偏倚风险,并进行Meta分析和试验序贯分析(TSA)。结果:共纳入25篇RCT,Meta分析结果示:与单用氟康唑相比,苦参凝胶联合氟康唑可提高霉菌性阴道炎治疗的总有效率[RR=1.21,95%CI(1.17,1.25),P<0.00001],减少临床症状缓解/消失时间:外阴瘙痒[MD=-3.23,95%CI(-3.41,-3.05),P<0.00001]、阴道黏膜充血[MD=-3.49,95%CI(-3.91,-3.08),P<0.00001],降低复发率[RR=0.26,95%CI(0.17,0.41),P<0.00001],2组不良反应发生率[RR=0.86,95%CI(0.29,2.49),P=0.78]无显著性差异。TSA结果显示苦参凝胶联合氟康唑提高治疗总有效率的证据可靠。结论:现有证据表明,苦参凝胶联合氟康唑治疗霉菌性阴道炎的有效性和安全性较好。受纳入研究的质量和方法学的局限性,该结论尚需更多高质量RCT进行验证。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.

关 键 词：霉菌性阴道炎 苦参凝胶 氟康唑 META分析 

分 类 号：R271.1[医药卫生—中医妇科学]