The Study Of Clinical Efficacy And Safety Of Secnidazole Suppository On Treatment Of Bacterial Vaginosis

Background and ObjectiveBacterial vaginosis (BV) is a clinical infectious disease characterized by polymicrobial anaerobic overgrowth of the vaginal epithelium without vaginal mucosal inflammation. Secnidazole is a5-nitroimidazole product with a broad spectrum of activity against gram-positive anaerobic bacterium, Gram-negative anaerobic bacteria and protozoan, which was researched and developed, and then marked by Rhone Poulenc Rorer in1980. Its chemical structure and physiological activity are similar to metronidazole and tinidazole. In clinic, it is applied to treat infections caused by above-mentioned pathogenic microorganisms. The disadvantages of secnidazole in peroral dosage form marked in our country are its too large dosage resulting in high toxic side effect and low blood concentration reached in pathogenic location. Secnidazole suppository is a new dosage form, and can be placed in vagina directly to contact pathogenic bacteria. As a result, the new dosage form can improve the disadvantages of secnidazole in peroral dosage form. By now, there have been no clinical reports on secnidazole suppository. It is necessary to conduct a research to evaluate clinical efficacy and safety and dose-effect relationship of secnidazole suppository on treatment of bacterial vaginosis, so as to provide a scientific basis for phase Ⅲ clinical trial.Methods1. This research intended to include144patients diagnosed as bacterial vaginosis. According to the order of visit, they were randomly divided into two groups (secnidazole suppository group and metronidazole suppository group). And each group had72cases. The included patients had to complete three follow-up.2. Before treatment (visit1), it was necessary to fill in the general data, to collect anamnesis and to evaluate gynecological gynecological symptoms and signs of patients.3. The patients were told to come back to do gynecological examination and laboratory examination separately when the3-7days after finishing treatment (visit2) and the first3-7days after the end of menstruation (visit3).4. During the three follow-up, it was necessary to inquire and record adverse events (AE), and truthfully complete the adverse event record. If there were adverse events, we should make a corresponding treatment according to the severity of adverse events, and then, we should record the treatment in detail.5. After completing the study, we compared their clinical and pathogenic efficacy, and observed the occurrence of adverse drug events and laboratory abnormalities.Results1. Comparison of clinical efficacy:In the3-7days after finishing treatment and the first3-7days after the end of menstruation, given in the full analysis set (FAS), the comparison result of effective rate and cure rate was that the two groups had no significant difference (P>0.05). And given in the per protocol set (PPS), the comparison result also showed no significant difference (P>0.05).2. Comparison of pathogenic efficacy:Before and after treatment, there were no significant differences (P>0.05) when compared vaginal smears (including cleanliness, cleanliness change, pH, pH change, KOH whiff test, vaginal discharge and other abnormalities) and bacterial pathogens (including etiology, pathogenic changes, total score of etiology and total score change of etiology).3. Comparison of gynecologic symptoms and physical signs:There were no significant differences (P>0.05) between two groups when comparing gynecological symptoms and signs except for vulva congestion. Before treatment, when compared vulva congestion, it was no significant difference (P=0.5371). which indicated that two groups could be compared. After3-7days when finishing treatment, the positive rate of secnidazole suppository group was0%, however, it was8.70%in metronidazole suppository group. When compared, it came up a significant difference between the two groups (P=0.0133). After3-7days when finishing treatment, the disappearance rate of vulva congestion was separately100.00%and62.50%in secnidazole suppository group and in metronidazole suppository group, there was a significant difference (P=0.0205).4. Comparison of laboratory examination:It was not related to the study medication that the abnormal data appeared in laboratory examination after the judgement of the researchers.5. Comparison of adverse events:In terms of the patients who were included into full analysis set, when compared the incidence rate of adverse events, two groups had no significant difference (P>0.05), coupled with that it was14.29%and4.35%separately in secnidazole suppository group and in metronidazole suppository group.ConclusionsSecnidazole suppository and metronidazole suppository on treatment of bacterial vaginosis both have achieved significant clinical efficacy and safety, with no significant differences between the two groups.