School of Clinical Medicine, Tsinghua University, Beijing, China.
Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.
Front Cell Infect Microbiol. 2022 May 13;12:883798. doi: 10.3389/fcimb.2022.883798. eCollection 2022.
The diagnosis and treatment of mixed vaginitis are more complicated than single pathogenic infections, and there may be adverse reactions and several contraindications to conventional antibiotic therapy. Therefore, this study aimed to evaluate the preliminary effects of Fufang Furong Effervescent Suppository for the management of aerobic vaginitis (AV) mixed with bacterial vaginosis (BV) using Accurate 16S absolute quantification sequencing (Accu16S).
In the present randomized, blind, multi-center clinical trial, women (20 to 55 years) who had received a diagnosis of AV+BV were randomly assigned into clindamycin positive control (n = 41) and Fufang Furong Effervescent Suppository (n = 39) groups. The follow-up occurred in three time periods (V1: -2~0 days; V2: 15-17 days; V3: 40 ± 3 days). At each visit, two vaginal swabs, one for clinical evaluation and one for laboratory examination, were taken from each patient. The Nugent score, Donders' score, drug-related complications, recurrence rates, and microecological changes of vaginal swabs were assessed in the time three periods.
At baseline, the two groups were similar in frequency of presentation with vaginal burning, odor, abnormal discharge, and itching. No meaningful differences in Nugent and Donders' scores were detected between the two groups at stage V2 (Nugent: = 0.67; Donders': 0.85) and V3 (Nugent: = 0.97; Donders: = 0.55). The Furong group presented fewer complications compared to the Clindamycin group. However, this difference was not statistically significant ( = 0.15). Additionally, Accu16S indicated that the total abundance of bacteria in both groups sharply decreased in stage V2, but slightly increased in V3. In stage V3, the absolute abundance of in the Furong group was considerably higher compared to untreated samples ( < 0.05). On the other hand, no momentous increase was detected in the Clindamycin group ( > 0.05).
Fufang Furong Effervescent Suppository can be as effective as clindamycin cream in the management of AV+BV while may restore the vagina microecosystem better.
混合性阴道炎的诊断和治疗比单一病原体感染更为复杂,常规抗生素治疗可能会出现不良反应和多种禁忌证。因此,本研究旨在使用 Accu16S 绝对定量测序(Accu16S)评估复方芙蓉泡腾栓治疗需氧性阴道炎(AV)合并细菌性阴道病(BV)的初步效果。
在这项随机、盲法、多中心临床试验中,诊断为 AV+BV 的女性(20 至 55 岁)被随机分配至克林霉素阳性对照组(n=41)和复方芙蓉泡腾栓组(n=39)。随访分为三个时间点(V1:-2~0 天;V2:15-17 天;V3:40±3 天)。每次就诊时,从每位患者中采集两个阴道拭子,一个用于临床评估,一个用于实验室检查。在三个时间点评估阴道拭子的 Nugent 评分、Donders 评分、药物相关并发症、复发率和微生态变化。
基线时,两组患者阴道烧灼感、异味、异常分泌物和瘙痒的发生率相似。在 V2 期(Nugent: = 0.67;Donders': 0.85)和 V3 期(Nugent: = 0.97;Donders: = 0.55),两组的 Nugent 和 Donders 评分无显著差异。与克林霉素组相比,芙蓉组的并发症较少,但差异无统计学意义( = 0.15)。此外,Accu16S 表明,两组细菌总丰度在 V2 期急剧下降,但在 V3 期略有增加。在 V3 期,芙蓉组的丰度明显高于未经治疗的样本( < 0.05)。另一方面,克林霉素组未检测到明显增加( > 0.05)。
复方芙蓉泡腾栓在治疗 AV+BV 方面与克林霉素乳膏同样有效,且可能更好地恢复阴道微生态系统。