乳酸菌阴道胶囊治疗细菌性阴道病的效果评价OA

Objective:To evaluate the efficacy and safety of Lactobacillus vaginal cap-sules in the treatment of bacterial vaginosis(BV)based on metronidazole therapy.Methods:A randomized,open-label,positive-drug parallel-controlled,multicenter clinical study was conduc-ted.A total of 41 patients were enrolled in the experimental group and 40 in the control group.Patients in the experimental group received both metronidazole and Lactobacillus vaginal cap-sules,while the control group received metronidazole alone.Metronidazole was administered for 7 days,and Lactobacillus vaginal capsules were used for 21 days.Comprehensive efficacy,mi-crobiological efficacy,and safety were assessed.Results:In the BV population,the cure rate and total effective rate in the experimental group at 7～9 days after treatment were 31.7%and 100%,respectively,significantly higher than those in the control group(7.5%and 77.5%),with OR values of 6.42(95%CI:1.54～26.85)and 9.49(95%CI:2.39～37.61),respec-tively.After extended treatment to 21～23 days,the cure rate further increased to 45.0%,but there was no significant difference compared to the cure rate at 7～9 days(P=0.23).At 7～9 days after treatment,The microbiological cure rate in the experimental group was 80.5%,signif-icantly higher than that in the control group(47.5%,P=0.002).At 21～23 days after treat-ment,the microbiological cure rate in the experimental group increased to 87.5%.No serious adverse events occurred.Conclusion:Lactobacillus vaginal capsules can effectively improve lo-cal vulvovaginal symptoms and signs of BV and demonstrate efficacy in the short term(7～9 days),and further enhance efficacy with long-term use(21～23 days),with good safety pro-file.