Clinical Study And Local Immune Research On Xianglian Suppositories Treatment For Recurrent Vulvovaginal Candidiasis

Introduct ionVaginal candidiasis is seen predominantly in women of childbearin g age, and frequently in the absence of obvious predisposing factors. Recurrent vulvovaginal candidiasis (RVVC) is defined as at least four discrete episodes of symptomatic infection occurring in a year. It i s estimated that 5% of all women who have a single episode of vaginal candidiasis will experience chronic or recurrent infection.Scholars have gradually realized although candida is the pathogen, but vaginal local immune function disorder are closely related with repeated attacks from patients. Th1/Th2 cell polarization in vaginal is one of the most important reason for unbalance of local immune fun ction. Type 1 immune response is protective, while IL-12 is the repre sentative cytokine. IL-23 is a newly identified member in the family of IL-12, which is structurally related to IL-12. The ability of IL-2 3 to stimulate CD4+T cells to produce IL-17 plays a dominant role in the development and persistence of autoimmunity. Type 2 immune respo nse is suppressive, while IL-4 and IL-10 are the representative cytok ines. IL-25 is a newly identified member in the family of IL-17. All of them are found to induce the proliferation of eosnophilis and prom ote inflammatory response.Although vaginal candidiasis may be regarded ans a minor conditio n in that it is transitory and its physical effects are not seriously damaging, many authors report that recurrent vaginal candidiasis can result in "significant morbidity",serious social consequences and profoundly distressing deterioration in quality of life, including em otional relationships and sexual functioning. This may lead to excess ive demands on healthcare system and if the women's perception of th e illness is not appreciated by the medical practitioner this can add a further frustrating dimension to the clinical problem.Traditional Chinese medicine has its unique advantages on treatme nt of dermal mucous fungal disease. According to the previous researc h, Xiang Lian outside lotion is a Chinese traditional medicine. It ha s a significant effect on vaginal candidiasis and other dermal mucous fungal disease. There is a need for novel antifungal drugs, as some of the currently available antimycotics are frequently toxic at thera peutic dosage, and there have been several reports of the isolation o f strains of important fungal pathogens which are resistant to antifu ngals. On the other hand, dysfunction of immunity in vaginal may be t he main reason for recurrent vulvovaginal candidiasis. Traditional Ch inese medicine antifungal lacks host toxicity, it has extensive sourc es and rarely resistance. It's suitable for long and preventive appl ication. Compound Chinese herbs can play synergistic effect of antifu ngal activity and regulating the immunity function.ObjectiveFirst, to evaluate the clinical effectiveness of Xiang Lian suppositories for recurrent vulvovaginal candidiasis. Secondly, to evaluate quality of life (QOL) of recurrent vulvovaginal candidiasis patients. Finally, to explore whether Xiang Lian suppositories play a regulatory role in local vaginal immune function of the patients.MethodIn this study, block random, double-bland, donble dummy and contrast clinical research methods were applied.60 cases of reccurent valvaginal candidiasis were divided randomly into two groups including 30 cases in trial group and 20 cases in contral group. The patients of trial group were given the Xiang Lian suppositories and Miconazole Nitrate simulating agents, while those in control groups were given Miconazole Nitrate suppositories and Xiang Lian simulating agents. All of the patients are prescribed 2 suppositories in the night and 2 simulating agents during the day. The intensive treatment lasts for 6 days, and consolidate 3 days of medication treatment. Symptoms, signs, etiology quality of live, etiology and vaginal local immune factors are main evaluating index for clinical effects.16 cases of health control group were included by negeative leucorrhea routine test. Quality of live and vaginal local immune factors are main evaluating index for comparing with reccurrent vulvovaginal patients.Result60 patients and 16 healthy controls have no significant differences between ages. Trial groups and control groups were compared between age sections, the differences are not statistical significant.Quality of life evaluation results show that patients were suffering from recurrent vulvovaginal candidaisis. The negative influences are remarkable in six dimensions. Psychological pressure is the most obvious factor for patients, Average score can reach 3.12 points. The mental pressure includes lack of confidence (1.25 points), dress affecting (0.98 points), shopping (0.88 points), etc. The influence of social activities for patients is 1.72 scored, including social leisure (0.88 points), and exercise (0.87 points). Though the disease may influence patients'daily life and work, but wouldn't cause patients unable to do, and the average score is 1.10 points. Influence on family life is 2.65 points, which is second only to mental pressure. Among the family life, limit for family care and sexual function respectively score 1.18 and 1.47 points. Influence for treatment is only 1.00 points, and it's the least negative factors.28 control patients had improved their some living quality after 6 days'intensive therapy. First, subjective symptoms (vulva vaginal prutitus and pain) have been improved, and average score fell to 1.0714 from 1.607 significantly. Secondly, quality of family life also has been improved from 2.3571 score dropped significantly to 1.7500. However, there were no significant differences between psychological, social, work and treatment effect.29 trial patients also had improved their qualities of symptoms and family life after 6 days'intensive therapy. The score of Vulvar vaginal consciously itch and pain fall to 1.3000 from 1.6667. Average score of family life dropped significantly from 2.8667 to 2.4000. However, patients have not significant differences between paychological, social, work and treatment effect.After the intensive treatment phase, efficient rate of Xiang Lian suppositories is 26.67%(n=8), while Miconazole Nitrate suppositories therapy is 43.33%(n=13). The difference between two groups is not significant, but efficiency of trail group is lower than the control group. After subsequent consolidate treatment, both of two treatment groups have efficiency of 53.33% (n=16).There were higher contents of immunological factors (total protein, IL-4 and IL-10) in vaginal fluide of Recurrent vulvovaginal candidiasis patients before treatment, compared with the healthy controls. However, contents of IL-23 and IL-12 were significantly lower than the healthy group. Besides, contents of IL-25 had no significant difference between two groups. There were not significant differences of immunological factors between trial groups and control groups. After the intensive treatment phase, contents of total protein had been reduced significantly from 0.23479095 to 0.15410034, and other factors had no significant differences. Contents of total protein and IL-25 is higher than healthy groups, but differences were not significant. However, other factors had significant differences. Meanwhile, trial groups reduced content of total protein significantly from 0.22934641 to 0.16027714 after intensive therapy, and other factor's content had no significant differences. Then compared with healthy groups, contents of total protein and IL-25 is higher than healthy groups, but differences were not significant. However, other factors had significant differences. Contents of IL-10 of trail group is significant lower than control groups'. After 3 days' consolidating treatment, contents of total protein and IL-23 reduced in control groups, while other factors had no significant differences, meanwhile, total protein of trial groups had reduced significantly, and other factors had no significant differences. After intensive and consequent consolidating treatment, control groups had a lower contents of IL-23 and higher contents of IL-4 and IL-10 than healthy groups', while other factors had no significant differences. Trail groups had lower contents of IL-12 and IL-23 but higher contents of IL-10 than healthy groups after intensive and consequent consolidating treatment, while other factors had no significant differences. Compared two treatment groups, trial groups had higher content of IL-4 and lower content of IL-10 than control groups significantly, and other factors had no significant differences.ConelusionEffective rates of the Xiang Lian suppositories and Miconazole Nitrate suppositories'are similar. Recurrent vulvovaginal candidiasis patients suffered negative effects from the disease in six dimensions of the living quality. Symptoms and family life among living quality can be improved after therapy in both treatment groups. Xiang Lian suppositories may played a part in regulating vaginal local immune factors.