| Objective:Aerobic vaginitis(AV)is a new type vaginal infection characterized by absence or lack of Lactobacilli species,overgrowth of aerobic bacteria and an increasing vaginal p H.Up to now,no standard treatment regiments was accessible for AV.This clinical study was aimed to investigate the efficacy and safety of cefuroxime axetil combined with vaginal probiotics for AV to provide new insight for AV treatment.Methods:One hundred and five women diagnosed AV at Tianjin Medical University General Hospital general gynecology clinic from Mar.2018 to Dec.2019 were recruited in this prospective,randomized controlled study.Three treatment regiments for AV includes single drug group(cefuroxime axetil administrated orally 0.25 g,twice daily for 7 days),concomitant group(cefuroxime axetil administrated orally0.25 g,twice a day for 7 days,meanwhile topically used 1 capsule of vaginal probiotics every night for 10 days,and period of interval medication ≥4 hours),and sequence group(cefuroxime axetil administrated orally 0.25 g,twice a day for 7 days,and then topically used 1 capsule of vaginal probiotics every night from next day,for10 days).Vaginal probiotics was not topically used during menstruation and restarted to use it at 3 days after menstruation.Microbiology and clinical efficacy of each protocol were evaluated at 7±3 days and 30±3 days after one course treatment.Comparison of normal distributed data was performed by univariate analysis,and comparison of non-normal distributed data was used by Kruskal-wallis rank sum test.Additionally,Chi-square test or Fisher exact probability method was used to compare qualitative data.Results:1.7±3 days after treatment,the microbiological cure rate of single drug group,concomitant group and sequence group was 48.57%(17/35),44.44%(16/36),58.82%(20/34),respectively.There was no significant difference in microbiological cure rate among three groups(P>0.05).The microbiological response rate of single drug group,concomitant group and sequence group was 57.14%(20/35),55.56%(20/36),61.77%(21/34),respectively.There was no significant difference in microbiological response rate among three groups(P>0.05).2.Compared with the situations before treatment,each of single drug group,concomitant group and sequence group could significantly decrease AV Donders score and improve vaginal microflora of patients with AV(P<0.05).Compared with before treatment,the proportion of patients with vaginal p H less than 4.5 at concomitant group(5.88% vs.26.54%,P=0.021)and at sequence group(6.25% vs.40.63%,P=0.001)increased significantly after treatment,especially the sequence group.Compared with before treatment,the number of leukocytes more than 10/HPF at single group(74.19% vs.45.16%,P=0.020)and at sequence group(87.50% vs.56.25%,P=0.005)decreased significantly after treatment,especially the sequence group.3.7±3 days after treatment,the clinical symptom was completely relieved in 29.52%(31/105)and improved in 43.81%(46/105).The clinical cure rate of single drug group,concomitant group and sequence group was 37.14%(13/35)、30.56%(11/36)、20.59%(7/34),respectively.There was no significant difference among above three groups(P=0.246).The clinical cure and significant rate of single drug group,concomitant group and sequence group was 45.71%(16/35)、47.22%(17/36)、38.24%(13/34),respectively.No difference among above three groups was significant(P=0.602).4.7±3 days after treatment,compared with the situations before treatment,each of single drug group,concomitant group and sequence group could significantly decrease the clinical symptomatic score(P<0.05).Compared with before treatment,the congested vaginal mucosa was significantly improved in 41.94%(13/31)of patients at single group and 34.38%(11/32)of patients at sequence group,and there was significant difference in both groups(P < 0.05).Vulvovaginal itching was significantly reduced in 32.35%(11/34)of patients at concomitant group and 25.00%(8/32)of patients at sequence group,and there was significant difference in both groups(P<0.05).Increased vaginal discharge was significantly reduced in 23.53%(8/34)of patients at concomitant group and 37.50%(12/32)of patients at sequence group,and the significant difference was presented in both groups(P<0.05).5.30±3 days after treatment,the overall recurrence rate of patients with AV was7.55%(4/53).The recurrence rate of single drug group,concomitant group and sequence group was 5.88%(1/17)、0.00%(0/17)、15.79%(3/19),respectively.And there was no significant difference among three group(P>0.05).Conclusion:Cefuroxime axetil subsequently combined with vaginal probiotics can treat AV patients effectively.The regiment not only plays a bactericidal role,but also is conductive to the colonization of vaginal flora,which could be beneficial to promote the recovery of vaginal microecological balance and provides a new idea for the treatment of AV.However,the follow-up time in the further study is needed to be extended to observe the long-term efficacy of vaginal probiotics. |
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