| Objective:The objective of this study was to identify the risk factors associated with severity of vulvovaginal candidiasis(VVC),and to explore the association between interleukin-17(IL-17),immunoglobulin E(Ig E)and severity of VVC,so as to recommend preventive measures of severe VVC and better understand its pathogenesis.In addition,the efficacy of four potential therapeutic regimens in the treatment of severe VVC was evaluated,so as to provide the basis for rational treatment of severe VVC.Methods:In the first part of this study,a prospective case-control study was implemented from August 2011 to December 2014.A total of 223 women with severe VVC were enrolled as study participants.Controls were 390 women with moderate VVC.All participants were asked to complete a standardized questionnaire,which covered sociodemographic factors,menstrual history,obstetric history,contraceptive methods,history of genital tract infections and sexually transmitted disease,sexual behaviors,medical health,personal hygiene habits and health behaviors.Univariate and multivariate logistic regression analysis were used for statistical evaluation.The strength of associations of these factors was analyzed using the odds ratio(OR)with95%confidence interval(CI).A P-value less than 0.05 was considered statistically significant.The second part of this study was implemented from July 2013 to July 2014.Participants included 41 women with severe VVC,46 women with moderate VVC,and 42 healthy women.5 ml normal saline was used for vaginal rinsing.The vaginal rinsing samples were centrifuged and the supernatants were measured for IL-17 and Ig E by enzyme linked immunosobert assay.IL-17 and Ig E levels among the groups were compared with one-way ANOVA.The third part of this study was a prospective,randomized controlled clinical trial,which was implemented from December 2011 to July 2013.158 women with severe VVC were enrolled and randomized for treatment.Therapeutic regimens included oral fluconazole(Group A,150mg quaque day,for the first and forth day),topical clotrimazole(Group B,500mg quaque day,for the first and forth day),combined treatment(Group C,oral fluconazole 150mg quaque day,and topical clotrimazole 500mg quaque day,for the first day),and repeated combined treatment(Group D,oral fluconazole 150mg quaque day,and topical clotrimazole 500mg quaque day,for the first and forth day).The participants were asked to check up at7±3 and 30±5 days after the end of treatment.The number of women who had checked up on time was 34 in Group A,38 in Group B,30 in Group C and 39 in Group D.VVC scores were compared with the situation at the initial visit with the use of Wilcoxon rank sum test.The microbiological efficacy and clinical efficacy at7±3 days after the end of treatment,as well as recurrence rates at 30±5 days after the end of treatment were compared among the groups with?~2and Fisher's test.Time to total relief of symptoms was analyzed using Kaplan-Meier estimates.Adverse events were recorded.Results:In the first part of this study,according to univariate analysis,unmarried status,infected by Candida albicans,oral sex and allergy to drugs,foods or flowers were risk factors for severe VVC.On the contrary,age of more than 29 years old,history of pregnancy,history of delivery,history of natural labor and use of natural family planning method for contraception were protective factors for severe VVC.In the multivariate analysis,infected by Candida albicans(OR 4.590,95%CI 1.447-14.560,P=0.010)and allergy to drugs,foods or flowers(OR=2.706,95%CI 1.028-7.120,P=0.044)were independent risk factors for severe VVC.In the second part,vaginal concentration of IL-17 was higher in women with VVC compared with healthy women(P<0.001).In multiple comparison,IL-17 level was raised in women with severe VVC compared with healthy women(P<0.001),and IL-17 level was higher in women with moderate VVC comparted with healthy women(P<0.001).Vaginal concentration of Ig E was higher in women with VVC compared with healthy women(P<0.001).In multiple comparison,Ig E level was raised in women with severe VVC compared with healthy women(P<0.001)and women with moderate VVC(P=0.010).In the third part,we observed that VVC scores of all the groups reduced significantly both at 7±3 and 30±5 days after the end of treatment(P<0.001).At 7±3days after the end of treatment,85.3%of women in Group A were microbiologically cured,and 85.3%of women were clinically cured.86.8%of women in Group B were microbiologically cured,and 84.2%of women were clinically cured.90.0%of women in Group C were microbiologically cured,and 83.3%of women were clinically cured.97.4%of women in Group D were microbiologically cured,and92.3%of women were clinically cured.Therapeutic efficacy and recurrence rate of Group D were not significantly different from the other groups.Short-term microbiological and clinical efficacy were not significantly different among Group A,B and C.At 30±5 days after the end of treatment,the recurrence rate of Group A was significantly lower than Group B(P=0.006).There were significant differences among the four groups with respect to time to total relief of symptoms(P=0.028).The median time to total relief of symptoms occurred at one day for women in Group A and D,two days for women in Group B,and three days for women in Group C.In this study,3 women reported adverse events,including rash and diarrhea.Conclusions:(1)Infection of Candida albicans and allergy to drugs,foods or flowers are independent risk factors for severe VVC.(2)IL-17 and Ig E play important roles in the pathogenesis of VVC.The vaginal concentration of Ig E was significantly higher in women with severe VVC compared with women with moderate VVC.(3)The four therapeutic regimens were all effective in the treatment of severe VVC.Women with oral fluconazole recurred less and achieved total relief of symptoms sooner. |
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