甲硝维参阴道膨胀栓治疗细菌性阴道病的Ⅲ期临床研究

PhaseⅢclinical study of metronidazole vaginal swelling suppository in the treatment of bacterial vaginosis

目的评价甲硝维参膨胀栓治疗细菌性阴道病的临床疗效与安全性。方法采用前瞻性、双盲、随机、平行对照方法,入选4个中心480例细菌性阴道炎患者,随机分为A、B、C、D组,A组患者给予替硝唑栓,B组给予硝呋太尔制霉素栓,C组患者给予甲硝唑栓,D组给予甲硝维参膨胀栓。主要评估四组的转阴率、复发率、不良反应。结果四组转阴率分别为68.3%、64.2%、67.5%、74.2%,D组与A、C组转阴率相似(P>0.05),但高于B组(P<0.05)。四组复发率分别为15.0%、23.3%、17.5%、6.7%。A、B、C组与D组比较差异具有统计学意义(χ^(2)=5.38,P=0.030)。硝呋太尔制霉素不良反应发生率为20.0%,发生率显著高于其他三组(χ^(2)=9.12,P=0.0001)。结论甲硝维参膨胀栓治疗细菌性阴道病与甲硝唑、替硝唑转阴率相似,高于硝呋太尔制霉素,甲硝维参膨胀栓复发率明显更低。

Objective To evaluate the clinical efficacy and safety of metronidazole ginseng expansion in the treatment of bacterial vaginosis.Methods A prospective,double-blind,randomized,parallel-controlled method was used to enroll 480 patients with bacterial vaginitis in 4 centers,and they were randomly divided into groups A,B,C,and D.Patients in group A were given tinidazole suppositories,and group B nifuratel nystatin suppository was given,patients in group C were given metronidazole suppository,and patients in group D were given metronidazole swelling suppository.The negative conversion rate,recurrence rate and adverse reactions of the four groups were evaluated.Results The negative conversion rates of the four groups were 68.3%,64.2%,67.5%,and 74.2%,respectively.The negative conversion rates of group D and group A and C were similar(P>0.05),but higher than group B(P<0.05).The recurrence rates of the four groups were 15.0%,23.3%,17.5%,and 6.7%,respectively.There were statistical differences between group A,B,C and group D(χ^(2)=5.38,P=0.030).The adverse reaction rate of nifuratel nystatin was 20.0%,which was significantly higher than the other three groups(χ^(2)=9.12,P=0.0001).Conclusion Metronidazole expansive suppository treatment of bacterial vaginosis is similar to that of metronidazole and tinidazole,which is higher than nifuratel statomycin,and the recurrence rate of metronidazole is significantly lower.