Abstract:
Bacterial vaginosis (BV) is the most common vaginal infection affecting women of childbearing age, and is associated with a substantial burden on women\'s physical, emotional, sexual and social lives, as well as being linked to a number of gynaecological and obstetrical complications and adverse pregnancy outcomes. Antibiotics, such as metronidazole or clindamycin, are recommended as first-line treatment for BV, but may be associated with antibiotic resistance, high rates of recurrence and poor patient treatment satisfaction. Astodrimer sodium gel is a novel, non-antibiotic treatment for BV that is not systemically absorbed. It prevents pathogenic bacteria from adhering to the vaginal wall, and disrupts and inhibits the formation of pathogenic bacterial biofilms. Clinical cure rates of 50-57% were observed in patients with BV treated with astodrimer sodium compared with 17-21% treated with placebo (p < 0.001) in Phase 3 trials. In a separate Phase 3 trial, recurrence of BV occurred in 44% of patients treated with astodrimer sodium compared with 54% of patients who received placebo (p = 0.015). Astodrimer sodium is well tolerated, with vulvovaginal candidosis being the only treatment-related adverse event reported to occur more often than with placebo. The availability of astodrimer sodium, a well-tolerated, convenient, non-antibiotic treatment for BV, represents significant progress in the treatment of this burdensome condition.
摘要:
细菌性阴道病(BV)是影响育龄妇女的最常见阴道感染,并且与女性身体的沉重负担有关,情感,性生活和社交生活,以及与许多妇科和产科并发症和不良妊娠结局有关。抗生素,如甲硝唑或克林霉素,建议作为BV的一线治疗,但可能与抗生素耐药性有关,复发率高,患者治疗满意度差。Astodrimer钠凝胶是一种新颖的,非抗生素治疗BV,不被系统吸收。它可以防止致病菌粘附在阴道壁上,并破坏和抑制致病性细菌生物膜的形成。在3期试验中,用阿托瑞尔钠治疗的BV患者的临床治愈率为50-57%,而安慰剂治疗的治愈率为17-21%(p<0.001)。在一个单独的第三阶段试验中,在接受阿托瑞尔钠治疗的患者中,44%的患者发生BV复发,而接受安慰剂治疗的患者为54%(p=0.015).稳定钠耐受性良好,外阴阴道念珠菌病是唯一报告的与治疗相关的不良事件,其发生频率高于安慰剂组.钠的可用性,一个很好的耐受性,方便,BV的非抗生素治疗,代表了在治疗这种繁重的疾病方面的重大进展。