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Abstract：
OBJECTIVE: To assess the efficacy, acceptability, and tolerability of a vaginal cream based on plant extracts for treating signs and symptoms of vulvovaginitis (VV) (Zelesse cream®), either as monotherapy (non-infectious VV) or adjuvant to antimicrobial therapy (infectious VV).
METHODS: This prospective, observational, multicenter study included women who attended outpatient offices for VV. The severity of signs (vaginal discharge, erythema, and edema) and symptoms (pruritus, burning, and dysuria) was assessed before and after 15±5 days of daily treatment with Zelesse cream on a 4-point scale (18-point global score).
RESULTS: The study included 58 women aged 43.0±13.2 years, including 42 who were treated with Zelesse cream only and 16 who used Zelesse cream as adjuvant to antimicrobial therapy. All participants showed significantly reduced scores and absolute prevalence of individual signs and symptoms in both groups. Similarly, the median signs/symptoms decreased by 4.0 and 8.0 points in women using Zelesse only and those using Zelesse plus antimicrobial therapy, respectively. This product was well tolerated and had high acceptability.
CONCLUSIONS: Zelesse cream relieves signs and symptoms of VV, either as monotherapy in non-infectious VV or as adjuvant to antimicrobial therapy in infectious VV. Future randomized, placebo-controlled trials with larger sample sizes are warranted.
METHODS: This prospective, observational, multicenter study included women who attended outpatient offices for VV. The severity of signs (vaginal discharge, erythema, and edema) and symptoms (pruritus, burning, and dysuria) was assessed before and after 15±5 days of daily treatment with Zelesse cream on a 4-point scale (18-point global score).
RESULTS: The study included 58 women aged 43.0±13.2 years, including 42 who were treated with Zelesse cream only and 16 who used Zelesse cream as adjuvant to antimicrobial therapy. All participants showed significantly reduced scores and absolute prevalence of individual signs and symptoms in both groups. Similarly, the median signs/symptoms decreased by 4.0 and 8.0 points in women using Zelesse only and those using Zelesse plus antimicrobial therapy, respectively. This product was well tolerated and had high acceptability.
CONCLUSIONS: Zelesse cream relieves signs and symptoms of VV, either as monotherapy in non-infectious VV or as adjuvant to antimicrobial therapy in infectious VV. Future randomized, placebo-controlled trials with larger sample sizes are warranted.
摘要：
目的：为了评估疗效，可接受性,基于植物提取物的阴道乳膏的耐受性，用于治疗外阴阴道炎（VV）的体征和症状（Zelesse乳膏®），作为单一疗法（非感染性VV）或辅助抗菌治疗（感染性VV）。
方法：这种前瞻性，观察,多中心研究包括在VV门诊就诊的女性。体征的严重程度（阴道分泌物，红斑,和水肿）和症状（瘙痒，燃烧,和排尿困难）在每天用Zelesse乳膏治疗15±5天之前和之后以4分量表（18分整体评分）进行评估。
结果：该研究包括58名年龄为43.0±13.2岁的女性，其中42人只接受Zelesse乳膏治疗，16人使用Zelesse乳膏作为抗菌治疗的辅助治疗。在两组中，所有参与者的得分和个体体征和症状的绝对患病率均显着降低。同样，仅使用Zelesse和使用Zelesse联合抗菌治疗的女性的中位体征/症状减少了4.0和8.0分，分别。该产品耐受性良好，可接受性高。
结论：Zelesse乳膏可缓解VV的体征和症状，作为非感染性VV的单一疗法或作为感染性VV的抗菌治疗的辅助疗法。未来随机，需要更大样本量的安慰剂对照试验.
方法：这种前瞻性，观察,多中心研究包括在VV门诊就诊的女性。体征的严重程度（阴道分泌物，红斑,和水肿）和症状（瘙痒，燃烧,和排尿困难）在每天用Zelesse乳膏治疗15±5天之前和之后以4分量表（18分整体评分）进行评估。
结果：该研究包括58名年龄为43.0±13.2岁的女性，其中42人只接受Zelesse乳膏治疗，16人使用Zelesse乳膏作为抗菌治疗的辅助治疗。在两组中，所有参与者的得分和个体体征和症状的绝对患病率均显着降低。同样，仅使用Zelesse和使用Zelesse联合抗菌治疗的女性的中位体征/症状减少了4.0和8.0分，分别。该产品耐受性良好，可接受性高。
结论：Zelesse乳膏可缓解VV的体征和症状，作为非感染性VV的单一疗法或作为感染性VV的抗菌治疗的辅助疗法。未来随机，需要更大样本量的安慰剂对照试验.
