甲硝维参栓剂治疗细菌性阴道炎有效性和安全性的前瞻性、随机、阳性药物对照临床研究

A prospective,randomized,positive drug-controlled clinical study of the efficacy and safety of metronivitol suppositories in the treatment of bacterial vaginosis

目的探讨甲硝维参栓剂与甲硝唑栓和甲硝唑阴道泡腾片治疗细菌性阴道炎的临床价值。方法选取270例细菌性阴道炎患者,根据随机数字表法将患者分为A组、B组和C组,每组90例。其中A组患者采用甲硝维参栓剂治疗,B组患者采用甲硝唑栓治疗,C组患者采用甲硝唑阴道泡腾片治疗。比较三组的临床效果。结果A组、B组和C组的转阴率分别为81.11%、70.00%、72.22%,比较差异有统计学意义(P<0.05)。治疗前,三组白日瘙痒评分比较,差异无统计学意义(P>0.05);治疗后,三组白日瘙痒评分低于治疗前,A组患者低于B组和C组,差异有统计学意义(P<0.05)。治疗后A组患者Ⅰ度阴道清洁度占比明显高于B组和C组,差异有统计学意义(P<0.05)。随访3个月,A组、B组、C组复发率分别为4.44%、16.67%和10.00%;随访6个月,A组、B组、C组复发率分别为7.78%、21.11%和15.56%,比较差异有统计学意义(P<0.05)。A组、B组和C组患者依从率分别为97.78%、83.33%和86.67%,比较差异有统计学意义(P<0.05)。三组不良反应发生率比较,差异有统计学意义(P<0.05)。结论甲硝维参栓剂治疗细菌性阴道炎具有较好的临床疗效,同时还可以减少复发情况及不良反应发生情况,有效性与安全性均优于甲硝唑栓和甲硝唑阴道泡腾片。

Objective To investigate the clinical value of metronidoxin suppository,metronidazole suppository and metronidazole vaginal effervescent tablets in the treatment of bacterial vaginosis.Methods 270 patients with bacterial vaginitis were selected and divided into group A,group B and group C according to random number table method,with 90 cases in each group.Among them,group A was treated with methonitrogen suppository,group B was treated with metronidazole suppository and group C was treated with metronidazole vaginal effervescent tablet.The clinical effects of the three groups were compared.Results The negative conversion rates in groups A,B and C were 81.11%,70.00%and 72.22%,respectively,and the difference was statistically significant(P<0.05).Before treatment,there was no significant difference in daytime pruritus score among the three groups(P>0.05).After treatment,the daytime pruritus score in the three groups was lower than before treatment,and that in group A was lower than that in group B and C,the difference was statistically significant(P<0.05).After treatment,the proportion ofⅠdegree vaginal cleanliness in group A was significantly higher than that in group B and group C,and the difference was statistically significant(P<0.05).After 3 months of follow-up,the recurrence rates of group A,B and C were 4.44%,16.67%and 10.00%,respectively.After 6 months of follow-up,the recurrence rates of group A,group B and group C were 7.78%,21.11%and 15.56%,respectively,and the difference was statistically significant(P<0.05).The compliance rates of group A,B and C were 97.78%,83.33%and 86.67%,respectively,and the difference was statistically significant(P<0.05).There was statistical significance in the incidence of adverse reactions among the three groups(P<0.05).Conclusion Metronidazole suppository has good clinical efficacy in the treatment of bacterial vaginosis,and can also reduce recurrence and adverse reactions,and the efficacy and safety are better than metronidazole suppository and metronidazole vaginal effervescent tablets.