| Objective: To observe the clinical effect of Jia Jian Wan Dai Decoction on the consolidation stage of recurrent vulvovaginal candidiasis(RVVC)with spleen deficiency and dampness,in order to find a safe and effective method for consolidation treatment of recurrent vulvovaginal candidiasis,and summarize the clinical experience of the instructor.Methods: A randomized controlled study was conducted.70 patients who met the criteria of negative mycology after intensive treatment were enrolled in consolidation therapy.They were randomly divided into treatment group and control group with 35 cases in each group.The treatment group was treated with Jia Jian Wan Dai Decoction and the control group was treated with fluconazole.Both groups were treated for 3 months.During the treatment,health education and psychological counseling were given to the two groups.Fill in the clinical curative effect observation form,observe the clinical symptoms,changes of TCM syndrome integral,leucorrhea routine,blood,urine,feces routine,liver and kidney function,electrocardiogram and other safety indicators before and after treatment,and follow up the recurrence after drug withdrawal,make statistical analysis,compare the clinical efficacy of different methods.Result:1.A total of 70 patients were enrolled in this study.65 of them completed the clinical observation.In the treatment group,2 cases fell off,and in the control group,3 cases fell off.The falling off rate was 7.14%.2.Comparison of clinical efficacy: the total effective rate of the treatment group was 97.0%,and that of the control group was 90.6%.There was significant difference in clinical efficacy between the treatment group and the control group(P < 0.05);the clinical efficacy of the treatment group was better than that of the control group.3.Comparisons of TCM syndromes: The effective rate of the treatment group was 93.9%,and that of the control group was 84.4%.There was significant difference between the treatment group and the control group in TCM syndromes(P < 0.05);the curative effect of TCM syndromes in the treatment group was better than that in the control group.4.Comparisons of TCM syndromes integral: There was significant difference between the two groups in TCM syndromes total integral and TCM single syndromes before and after treatment;there was no significant difference between the two groups in the improvement of quantity,color,quality,taste and local symptoms(P > 0.05).The two groups had the same effect in the improvement of quantity,color,quality,taste and local symptoms under the band;while in the improvement of systemic symptoms such as pallor,intolerance.There were significant differences in fewer stools,abdominal distension between the two groups(P < 0.05),and the treatment group was better than the control group.5.Comparisons of leucorrhea pus: There was significant difference between the two groups before and after treatment,and there was significant difference between the two groups(P < 0.05).Both groups could effectively improve the situation of leucorrhea pus.The treatment group was better than the control group in improving the situation of leucorrhea pus.6.Comparison of TCM syndromes after discontinuation: There was no significant difference in TCM syndromes score between the treatment group and the treatment group after 3 months of discontinuation(P > 0.05),but there was difference in TCM syndromes score between the control group and the treatment group after 3 months of discontinuation(P < 0.05).There was significant difference between the two groups(P < 0.05),and the TCM syndromes in the treatment group were more stable after withdrawal.7.Comparison of recurrence rate: 3 months after withdrawal,the total recurrence rate of the treatment group was 12.1%,significantly lower than that of the control group,34.4%.There was a difference between the two groups(P < 0.05),and the recurrence rate of the treatment group was lower than that of the control group.8.In the course of treatment,there were no adverse events in the treatment group,and some patients in the control group had adverse reactions such as nausea,diarrhea and dizziness to varying degrees,but they could insist on taking medicine.9.Safety analysis: During the period of medication,blood,urine and feces,liver and kidney function and electrocardiogram were all in normal range,and the treatment methods of both groups were safe.Conclusion: Jia Jian Wan Dai Decoction consolidation treatment of recurrent vulvovaginal candidiasis of spleen deficiency and dampness excess type can significantly improve the clinical symptoms,improve the situation of leucorrhea pus,reduce the recurrence rate effectively,with no obvious adverse reactions,ensuring the safety and effectiveness in clinic. |
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