Molteni Bruno, D'Antuono Antonietta, Bandini Patrizia, Sintini Giuseppe, Barcellona Eliana, Agnello Antonella, Milani Massimo
Obstetric and Gynecology Department 'Ospedale Civile', Giussano, Italy.
Curr Med Res Opin. 2004 Jun;20(6):849-53. doi: 10.1185/030079904125003692.
We evaluated the efficacy and tolerability of a new chlorhexidine-based bioadhesive vaginal gel (Clomirex) in women with vaginal infections.
A total of 90 nonpregnant women with vaginal infections of both bacterial (bacterial vaginosis: BV) or fungal (vaginal candidiasis VC) origin, were enrolled in the study: a randomised, controlled, 4-week, multicentre trial. Patients were randomly treated with either chlorhexidine 0.5% vaginal gel (CHX-VG), 2.5 g or with metronidazole vaginal tablets 500 mg (M) or clotrimazole (CL) vaginal cream, depending on aetiology of the infection, daily for 7 days (treatment phase) in a 2:1 ratio. A total of 45 women had a diagnosis of BV and 45 a diagnosis of VC. Sixty women were treated with CHX-VG, 15 with M and 15 with CL. All patients were followed for an additional 3 weeks without treatments (follow-up phase). For women with BV,clinical cure rate was defined as the disappearance of the following signs and symptoms: homogenous vaginal discharge; presence of >or= 2 or more clue cells at the wet mount microscopy; a vaginal pH > 4.7 and a positive whiff test. For women with VC, clinical cure rate was defined as a resolution of signs and symptoms plus absence of hyphae, pseudohyphae and blastospores on 10% KOH wet mount microscopy. Clinical cure rate was assessed at the end of the study (week 4) by an investigator unaware of the patient's treatment allocation.
At week 4, in women with BV, 28 out of 30 (93%) women in the CHX-VG group were clinically cured in comparison with 11 out of 15 (74%) in the M group (p = 0.3). In women with VC, 26 out of 30 (86.6%) women in the CHX-VG group were clinically cured in comparison with 13 out of 15 (86%) in the CL group (p = 0.5). Tolerability was good and very good in 90% of the CHX-VG patients. Six women (10%) complained of a mild transient burning sensation after CHX-VG vaginal application. No serious adverse events were observed during the trial in all treated groups. No women presented with vaginal discharge after treatment.
我们评估了一种新型的基于氯己定的生物粘附性阴道凝胶（克霉唑）对患有阴道感染的女性的疗效和耐受性。
共有90名非妊娠女性参与了该研究，她们患有细菌性（细菌性阴道病：BV）或真菌性（阴道念珠菌病VC）阴道感染：这是一项随机、对照、为期4周的多中心试验。根据感染病因，患者被随机给予0.5%氯己定阴道凝胶（CHX-VG）2.5g、甲硝唑阴道片500mg（M）或克霉唑（CL）阴道乳膏，以2:1的比例每日使用7天（治疗阶段）。共有45名女性被诊断为BV，45名被诊断为VC。60名女性接受CHX-VG治疗，15名接受M治疗，15名接受CL治疗。所有患者在不进行治疗的情况下再随访3周（随访阶段）。对于患有BV的女性，临床治愈率定义为以下体征和症状消失：均匀的阴道分泌物；湿片显微镜检查发现≥2个线索细胞；阴道pH值>4.7且胺试验阳性。对于患有VC的女性，临床治愈率定义为体征和症状消失，加上在10%氢氧化钾湿片显微镜检查中未发现菌丝、假菌丝和芽生孢子。在研究结束时（第4周），由不知道患者治疗分配情况的研究者评估临床治愈率。
在第4周时，患有BV的女性中，CHX-VG组中的30名女性中有28名（93%）临床治愈，而M组中的15名女性中有11名（74%）临床治愈（p = 0.3）。患有VC的女性中，CHX-VG组中的30名女性中有26名（86.6%）临床治愈，而CL组中的15名女性中有13名（86%）临床治愈（p = 0.5）。90%的CHX-VG患者耐受性良好或非常好。6名女性（10%）在阴道应用CHX-VG后抱怨有轻微的短暂烧灼感。在试验期间，所有治疗组均未观察到严重不良事件。治疗后没有女性出现阴道分泌物。
