| Objective:To investigate the treatment effectiveness and safety of Butoconazole Nitrate on the Vulvovaginal Candidasis (VVC).Method:48cases patients with simple of WC of medical records are randomly divided into two groups, The experimental group and control group,24for each group.The experimental group are given Butoconazole Nitrate Cream2g, and the positive control group are given Miconazole Nitrate Vaginal Soft Sapsules, both deep into the vagina before going to bed each night, for3days. Follow-up the patients before drug use and7-14days and28-35days after the end of drug use. During the observation of drug use, vaginal irrigation and sexual life should be avoid, or using a condom. The use of other Chinese and Western medicine and therapy should be ban, Which affects the evaluation of experimental drugs. Follow-up each time,observation of vital signs, examinations of Gynecology, score of VVC symptoms and signs, routine examinations of leucorrhea, and testing of vaginal secretion PH value should be done. Vaginal fungus should be cultured after the end of drug use. Electrocardiogram examination,Urine routine examination, blood test, liver (ALT,AST)and renal (BUN, Cr)function test also should be detected before drug use and follow-up for the first time. Please record adverse events at any time.Results:Both effects of the Butoconazole nitrate cream and the miconazole nitrate vaginal soft capsules are obvious in the treatment of Vulvovaginal Candida. The scores of WC symptoms and signs in patients are significantly lower. Leucorrhea routine shown that the number of white cells is reduce and cleanliness is Significantly improved. Patients with increased vaginal discharge and vaginal itching symptom relief time, compared with the control group the differences were statistically significant, to test drugs rapid onset of action, can quickly relieve the discomfort of patients symptoms.Experimental group compared with the positive control group: The Clinical efficacy is equal. There are20in Experimental group and22in positive control group are effective.The difference was not statistically significant (P>0.05). But the pathogenic effect of Experimental group is lower than that of positive control group. There are18in Experimental group and22in positive control group are effective.The clearance rates of VVC of Experimental group is lower than that of positive control group. The difference was statistically significant (P<0.05).The integrated effect is equal to. There are20in Experimental group and22in positive control group are effective.The difference was also not statistically significant (P>0.05).(The Comprehensive comparison is the same as Clinical efficacy.) Compare with positive control group, the rate of recurrence is higher. There are6cases in Experimental group and3cases in positive control relapse.The differences has statistics significance (P<0.05). Compare with positive control group, the adverse reactions is lower. There are2cases in Experimental group and9cases in positive group. Vaginal burning pain discomfort symptoms, occurrence rate of4.17%, lower than that of control group37.5%,The differences has statistics significance (P<0.05).Both of the group have stable vital signs, with no symptoms such as dizziness, skin rashes and vaginal laceration and infection. Electrocardiogram is not markedly abnormal. Urine routine examination, blood test, liver (ALT, AST)and renal (BUN, Cr)function test of Patients are all abnormal before and after drug use.Conclusion:Both effects of the Butoconazole nitrate cream and the miconazole nitrate vaginal soft capsules are obvious in the treatment of Vulvovaginal Candida. Compare with positive control group, The Clinical efficacy is equal, so as Comprehensive comparison.However, the pathogenic effect and Adverse reactions are lower. It not only has the advantages of rapid onset, and can quickly relieve the discomfort of patients symptoms.Butoconazole Nitrate Vaginal Cream as antifungal drugs medication safety, Patients with high compliance. we can attempt a broad clinical application. |
