背景:阴道念珠菌病(VC)通常影响孕妇。传统上,克霉唑阴道片(CLO)一直是管理的基石。然而,舍他康唑胚珠(SER)提供了一种新颖的局部抗真菌剂选择。这个双盲,随机试验评估了单剂量SER和CLO治疗妊娠期急性VC的疗效.
方法:从2020年6月至2021年5月,这项试验招募了年龄≥18岁的孕妇,这些孕妇具有经显微镜检查证实的VC症状(阴道分泌物异常和/或外阴/阴道瘙痒)。前一年有≥4次VC发作的参与者,免疫受损状态,或咪唑禁忌症和在2周随访时缺席的患者被排除.参与者随机接受300mgSER或500mgCLO。初始用药后2周的评估包括临床治愈(所有症状的自我报告解决),显微治疗(假菌丝缺失),患者满意度,副作用,和临床治愈的时间。持续性VC的参与者每周接受SER剂量直至分娩。对复发和妊娠结局进行评估。
结果:分析包括96名参与者(每组48名,平均年龄27.4±7.4岁,诊断时的胎龄22.9±6.4周)。没有统计学意义,SER取得了较高的临床治愈率(62.5%vs50%,p=0.217;平均差为12.5%,95CI:-17.5%至42.5%;比率为1.25,95CI:0.71至2.23)和较低的微观固化(47.9%与62.5%,p=0.151;平均差为-14.6%,95CI:-44.3%至15.1%;比率为0.77,95CI:0.43至1.37)。两组的临床治愈时间相当(SER:3.1±1.8天,CLO:3.4±2.7天;p=0.848)和实质性满意率(SER:66.7%,CLO:60.4%;p=0.753)。没有副作用的报道。在Siriraj医院分娩的60名参与者中,妊娠结局无显著差异.反复SER给药根除症状并提高显微治愈率。在1-2个月内,四名SER和两名CLO参与者观察到复发。
结论:在妊娠期急性VC的治疗中,300mgSER和500mgCLO在临床和微观治愈率方面表现出可比的疗效,满意,副作用,临床治愈的时间,复发率,和妊娠结局。
背景:TCTR20190308004(注册日期2019年3月8日)。
BACKGROUND: Vaginal candidiasis (VC) commonly affects pregnant women. Traditionally,
clotrimazole vaginal tablets (CLO) have been the cornerstone of management. However, sertaconazole ovules (SER) offer a novel topical antimycotic option. This double-blinded, randomized trial evaluated the efficacy of single-dose SER and CLO in treating acute VC during pregnancy.
METHODS: From June 2020 to May 2021, this trial recruited pregnant women aged ≥ 18 years with VC symptoms (abnormal vaginal discharge and/or vulvar/vaginal itching) confirmed by microscopy. Participants with ≥ 4 VC episodes in the prior year, immunocompromised status, or imidazole contraindications and those who were absent at the 2-week follow-up were excluded. Participants were randomized to receive either 300 mg SER or 500 mg CLO. Evaluations 2 weeks after the initial medication administration included clinical cure (self-reported resolution of all symptoms), microscopic cure (pseudohyphal absence), patient satisfaction, side effects, and time to clinical cure. Participants with persistent VC received weekly SER doses until delivery. Assessments of recurrence and pregnancy outcomes were done.
RESULTS: The analysis included 96 participants (48 per group, mean age 27.4 ± 7.4 years, gestational age at diagnosis 22.9 ± 6.4 weeks). Without statistical significance, SER achieved a higher clinical cure rate (62.5% vs 50%, p = 0.217; a mean difference of 12.5%, 95%CI: -17.5% to 42.5%; and a rate ratio of 1.25, 95%CI: 0.71 to 2.23) and a lower microscopic cure (47.9% vs. 62.5%, p = 0.151; a mean difference of -14.6%, 95%CI: -44.3% to 15.1%; and a rate ratio of 0.77, 95%CI: 0.43 to 1.37). The two groups had comparable times to clinical cure (SER: 3.1 ± 1.8 days, CLO: 3.4 ± 2.7 days; p = 0.848) and substantial satisfaction rates (SER: 66.7%, CLO: 60.4%; p = 0.753). No side effects were reported. Of 60 participants who gave birth at Siriraj Hospital, there were no significant differences in pregnancy outcomes. Repeated SER dosing eradicated symptoms and enhanced the microscopic cure rate. Recurrence was observed in four SER and two CLO participants within 1-2 months.
CONCLUSIONS: In the treatment of acute VC during pregnancy, 300 mg SER and 500 mg CLO exhibited comparable efficacy in terms of clinical and microscopic cure rates, satisfaction, side effects, time to clinical cure, recurrence rates, and pregnancy outcomes.
BACKGROUND: TCTR20190308004 (registration date March 8, 2019).