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阿司多明钠与细菌性阴道病:小型综述。

Astodrimer sodium and bacterial vaginosis: a mini review.

机构信息

German Centre for Infections in Gynecology and Obstetrics at Landesfrauenklinik, Helios University Hospital Wuppertal, Heusnerstrasse 40, 42283, Wuppertal, Germany.

Wolfgang Holzgreve, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.

出版信息

Arch Gynecol Obstet. 2022 Jul;306(1):101-108. doi: 10.1007/s00404-022-06429-z. Epub 2022 Mar 4.

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)是最常见的阴道感染,影响育龄妇女,对女性的身体、情绪、性和社交生活造成重大负担,并且与许多妇科和产科并发症及不良妊娠结局有关。抗生素,如甲硝唑或克林霉素,被推荐为 BV 的一线治疗药物,但可能与抗生素耐药性、高复发率和较差的患者治疗满意度有关。阿司多明钠凝胶是一种新型的非抗生素治疗 BV 的药物,不会被全身吸收。它可防止病原菌黏附于阴道壁,并破坏和抑制病原菌生物膜的形成。在 3 期临床试验中,与安慰剂相比,接受阿司多明钠治疗的 BV 患者的临床治愈率为 50-57%,而接受安慰剂治疗的患者为 17-21%(p<0.001)。在一项单独的 3 期临床试验中,接受阿司多明钠治疗的患者中,BV 复发率为 44%,而接受安慰剂治疗的患者为 54%(p=0.015)。阿司多明钠具有良好的耐受性,仅报告治疗相关的外阴阴道念珠菌病比安慰剂更常见。阿司多明钠的出现,作为一种耐受性良好、方便的、非抗生素治疗 BV 的药物,代表了治疗这种负担沉重疾病的重大进展。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fd0/9300565/7493e99958c5/404_2022_6429_Fig1_HTML.jpg

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