Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.
Central Clinical School, Monash University, Melbourne, VIC, Australia.
Sci Rep. 2020 Nov 9;10(1):19386. doi: 10.1038/s41598-020-76184-1.
New treatments for oropharyngeal gonorrhoea are required to address rising antimicrobial resistance. We aimed to examine the efficacy of a 14-day course of mouthwash twice daily compared to standard treatment (antibiotic) for the treatment of oropharyngeal gonorrhoea. The OMEGA2 trial was a parallel-group and open-labelled randomised controlled trial among men with untreated oropharyngeal gonorrhoea that was conducted between September 2018 and February 2020 at Melbourne Sexual Health Centre in Australia. Men were randomised to the intervention (rinsing, gargling and spraying mouthwash twice daily for 14 days) or control (standard treatment) arm and followed for 28 days. Participants in both arms were advised to abstain from sex and kissing with anyone for 14 days after enrolment. Oropharyngeal swabs were collected at baseline, Day 14 and Day 28 and tested for Neisseria gonorrhoeae by nucleic acid amplification test (NAAT) and culture. The primary outcome was the detection of oropharyngeal N. gonorrhoeae by NAAT at Day 14 after treatment. This trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12618001380280). This trial stopped early due to a high failure rate in the mouthwash arm. Twelve men were randomly assigned to either mouthwash (n = 6) or standard treatment (n = 6). Of the 11 men who returned at Day 14, the cure rate for oropharyngeal gonorrhoea in the mouthwash arm was 20% (95% CI 1-72%; 1/5) and in the standard treatment arm was 100% (95% CI 54-100%; 6/6). A 14-day course of mouthwash failed to cure a high proportion of oropharyngeal gonorrhoea cases.
需要新的治疗方法来治疗口咽淋病，以应对不断上升的抗生素耐药性。我们旨在研究每天两次使用漱口水 14 天的疗程与标准治疗（抗生素）相比，对治疗口咽淋病的疗效。OMEGA2 试验是一项在澳大利亚墨尔本性健康中心进行的、针对未经治疗的口咽淋病男性的平行组、开放性标签、随机对照试验，于 2018 年 9 月至 2020 年 2 月进行。男性被随机分配到干预组（每天两次漱口、含漱和喷洒漱口水 14 天）或对照组（标准治疗），并随访 28 天。两组参与者均被建议在入组后 14 天内避免与任何人发生性行为和接吻。在基线、第 14 天和第 28 天采集口咽拭子，通过核酸扩增试验（NAAT）和培养检测淋病奈瑟菌。主要结局是治疗后第 14 天通过 NAAT 检测口咽奈瑟菌。该试验在澳大利亚和新西兰临床试验注册中心（ACTRN12618001380280）注册。由于漱口水组的失败率很高，该试验提前停止。12 名男性被随机分配到漱口水组（n=6）或标准治疗组（n=6）。在第 14 天返回的 11 名男性中，漱口水组的口咽淋病治愈率为 20%（95%CI 1-72%；1/5），标准治疗组为 100%（95%CI 54-100%；6/6）。14 天的漱口水疗程未能治愈很大比例的口咽淋病病例。
