Abstract：
OBJECTIVE: To investigate the non-inferiority of efficacy and tolerability of Lactobacillus plantarum P 17630 soft vaginal capsules compared to the antifungal therapy with miconazole nitrate 400 mg soft vaginal capsules in patients with symptomatic vulvovaginal infection due to Candida.
METHODS: Adult women with vulvovaginal candidiasis were randomized to either L. plantarum P17630 100,000,000 CFU soft vaginal capsules by vaginal route each day for 3 or 6 consecutive days or miconazole nitrate 400 mg soft vaginal capsule. Visual Analog Scale (VAS) scores for vaginitis symptoms were used, and vaginal fluid interleukin 6 (IL6) was dosed. The study was registered in EudraCT database (code LPP17630-C-018; number: 2018-003095-12).
RESULTS: 200 patients were included in the study. The mean VAS scores for vaginitis symptoms were progressively reduced in both treatment groups at each visit, without significant difference between groups (p>0.05 for each symptom, at each time point). The efficacy of L. plantarum and the reference medicinal product was maintained at follow-up (day 21). The mean concentration of IL-6 decreased from visit 1 to visit 3 in both groups without a significant difference (p>0.05). No adverse events were reported.
CONCLUSIONS: L. plantarum P17630 100,000,000 CFU soft vaginal capsules are effective and safe for treating vaginal candidiasis without the concomitant use of an antifungal product, which rules out the risk of antimicrobic resistance. The long-term effect on vaginal microflora may add the possibility of reducing the risk of recurrences.
METHODS: Adult women with vulvovaginal candidiasis were randomized to either L. plantarum P17630 100,000,000 CFU soft vaginal capsules by vaginal route each day for 3 or 6 consecutive days or miconazole nitrate 400 mg soft vaginal capsule. Visual Analog Scale (VAS) scores for vaginitis symptoms were used, and vaginal fluid interleukin 6 (IL6) was dosed. The study was registered in EudraCT database (code LPP17630-C-018; number: 2018-003095-12).
RESULTS: 200 patients were included in the study. The mean VAS scores for vaginitis symptoms were progressively reduced in both treatment groups at each visit, without significant difference between groups (p>0.05 for each symptom, at each time point). The efficacy of L. plantarum and the reference medicinal product was maintained at follow-up (day 21). The mean concentration of IL-6 decreased from visit 1 to visit 3 in both groups without a significant difference (p>0.05). No adverse events were reported.
CONCLUSIONS: L. plantarum P17630 100,000,000 CFU soft vaginal capsules are effective and safe for treating vaginal candidiasis without the concomitant use of an antifungal product, which rules out the risk of antimicrobic resistance. The long-term effect on vaginal microflora may add the possibility of reducing the risk of recurrences.
摘要：
目的：探讨植物乳杆菌P17630阴道软胶囊与硝酸咪康唑400mg阴道软胶囊抗真菌治疗念珠菌外阴感染患者的疗效和耐受性的非劣效性。
方法：将患有外阴阴道念珠菌病的成年女性随机分为连续3或6天，每天通过阴道途径接受植物乳杆菌P17630100,000,000CFU软阴道胶囊或硝酸咪康唑400mg软阴道胶囊。使用阴道炎症状的视觉模拟量表（VAS）评分，和阴道液白细胞介素6（IL6）的剂量。该研究已在EudraCT数据库中注册（代码LPP17630-C-018；编号：2018-003095-12）。
结果：200名患者被纳入研究。每次就诊时，两个治疗组的阴道炎症状的平均VAS评分均逐渐降低，组间无显著差异(每种症状p>0.05，在每个时间点)。植物乳杆菌和参考药物产品的功效在随访时(第21天)得以维持。两组中IL-6的平均浓度从第1次到第3次均降低，差异无统计学意义（p>0.05）。未报告不良事件。
结论：L.足底P17630100,000,000CFU软阴道胶囊可有效且安全地治疗阴道念珠菌病，而无需同时使用抗真菌产品，排除了抗微生物药物耐药性的风险。对阴道微生物群的长期影响可能增加降低复发风险的可能性。
方法：将患有外阴阴道念珠菌病的成年女性随机分为连续3或6天，每天通过阴道途径接受植物乳杆菌P17630100,000,000CFU软阴道胶囊或硝酸咪康唑400mg软阴道胶囊。使用阴道炎症状的视觉模拟量表（VAS）评分，和阴道液白细胞介素6（IL6）的剂量。该研究已在EudraCT数据库中注册（代码LPP17630-C-018；编号：2018-003095-12）。
结果：200名患者被纳入研究。每次就诊时，两个治疗组的阴道炎症状的平均VAS评分均逐渐降低，组间无显著差异(每种症状p>0.05，在每个时间点)。植物乳杆菌和参考药物产品的功效在随访时(第21天)得以维持。两组中IL-6的平均浓度从第1次到第3次均降低，差异无统计学意义（p>0.05）。未报告不良事件。
结论：L.足底P17630100,000,000CFU软阴道胶囊可有效且安全地治疗阴道念珠菌病，而无需同时使用抗真菌产品，排除了抗微生物药物耐药性的风险。对阴道微生物群的长期影响可能增加降低复发风险的可能性。
