| ObjectiveTo evaluate the efficacy and safety of Ku E Jie Yin gel in treating bacterial vaginosis with hot and humid betting certificate, compared with compound metronidazole suppository as positive control medicine.MethodsThis is a a randomized, blinded, placebo and positive drug parallel controlled study. Choose40patients with bacterial vaginosis, TCM leukorrhagia, and in accordance with hot and humid betting certificate, who see a doctor in gynecology outpatient department of Dongzhimen hospital affiliated to Beijing university of Chinese medicine between January to march2013.40patients were randomly divided into experimental group, the placebo group, and the positive control group, according to the ratio of3:1:1.The three groups of patients were respectively24cases,8cases,8cases. To formulate the TCM Syndrome Scale of TCM leukorrhagia hot and humid betting certificate and score the40patients. Distribute drugs by blind method, to give medicine between3days after menstrual clean and the10days prior start of the next menstrual to arrival,1time/day,7days of continuous use. During the medication, sexual life and hip bath are prohibited. Antibacterial drugs, other vaginal drug use, and tampons are banned to use. Check in3to5days after the drug was stopped. Observed BV elimination rate, the comprehensive curative effect and the change of TCM syndrome score, at the same time, observe the changes of laboratory examination and adverse reactions. All data was analysed by SPSS17.0statistical software, measurement data was analysed by single factor analysis of variance or t test or rank and inspection, the rate of count data compared by chi-square test, when P<0.05was considered statistically significant.results1. The differences in age(year)(34.28±7.52,30.83±6.24,36.83±6.65), course of the disease(day)(20.00±22.45,20.00±22.45,21.50±23.12) and TCM syndrome score(11.94±2.39,11.13±0.84,13.17±3.19) before treatment of the experimental group, placebo group and positive control group had no statistical significance (P>0.05).2. The BV eliminating rate of experimental group, placebo group and positive control group are79.17%,25.00%and87.50%respectively. BV eliminate rate in experimental group and positive control group were higher than that in the placebo group (P<0.05). The difference of BV eliminate rate between experimental group and positive control group is not significant (P>0.05).3. The efficiency of comprehensive curative effect of the experimental group, placebo group and positive control group were79.17%,25.00%and87.50%respectively. The efficiency in experimental group and positive control group were higher than that in the placebo group(P<0.05). The efficiency in experimental group and positive control group showed no statistically significant difference (P>0.05).4. The TCM symptoms scores of the experimental group, the placebo group and positive control group were decreased after treatment (11.94±2.39vs3.50±3.01,11.13±0.84vs6.00±2.62,13.17±3.19vs4.33±3.07). The falling range of experimental group and positive control group were higher than that in the placebo group (P<0.05). Experimental group and positive control group has no statistically significant difference (P>0.05). 5. The efficiency of TCM symptoms of the experimental group, placebo group and positive control group were54.17%,12.5%and62.5%respectively. The efficiency in experimental group and positive control group were higher than that in the placebo group(P<0.05). The efficiency in experimental group and positive control group showed no statistically significant difference (P>0.05).6. Security:It was not observed in the experimental group that the drugs have abnormal effects on liver and kidney function, blood system and so on, and no adverse reactions occurred.Conclusions1. Ku E Jie Yin gel is effective to treat bacterial vaginosis with hot and humid betting certificate.It is obviously better than placebo in BV elimination rate,and the comprehensive curative effect.2. Ku E Jie Yin gel is effective to treat bacterial vaginosis with hot and humid betting certificate. It is significantly superior to placebo in curative effect of TCM certificate.3. Ku E Jie Yin gel have no obvious differences in BV eliminate rate, comprehensive curative effect and to treat bacterial vaginosis with hot and humid betting certificate, compared with compound metronidazole suppository.4. No adverse reactions occurred in the process of research. Laboratory examinations showed no evidence of damage to liver and kidney function, blood system and so on. Ku E Jie Yin gel is safe and reliable, and it is worth popularization and application. |
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