Goormans E, Bergstein N A, Loendersloot E W, Branolte J H
Chemotherapy. 1982;28 Suppl 1:106-9. doi: 10.1159/000238162.
90 female patients suffering from Candida vaginitis were included in an open, mycologically controlled study, carried out at three gynaecological clinics, to investigate the efficacy and tolerance of one single vaginal tablet containing 500 mg clotrimazole (Canesten 1). In 40% of the patients the infection was considered to be mild and in 60% severe. In order to confirm the diagnosis and to evaluate the therapeutic effect (before application and 1 as well as 4 weeks after therapy), the following criteria were considered: (1) identification of Candida species on direct microscopic examination (wet film) and also by culture on a Nickerson medium, and (2) influence on the clinical symptoms, such as itching, burning, pathological changes of the vaginal mucosa, thrush. The principle criterion was the cultural mycological finding. In 79 patients (88%) the culture was negative 1 week after therapy and in 81 (90%) 4 weeks after therapy; 9 patients (10%) were treatment failures with positive cultural findings at the last control. The clinical symptoms improved parallel to the mycological findings. At the controls they had disappeared in the majority (up to 90%) of the affected patients. The favourable impression achieved at consideration of the cultural findings could be confirmed at the overall assessment by the clinicians: 88% of the patients were cured 1 week after application and 90% 4 weeks after application. By means of different criteria the state of disease did not have any influence on the therapeutic success. The 500-mg clotrimazole vaginal tablet was very well tolerated by all patients.
90例念珠菌性阴道炎女性患者纳入了一项开放性、真菌学对照研究,该研究在三家妇科诊所进行,以调查一片含500毫克克霉唑的阴道片(凯妮汀1)的疗效和耐受性。40%的患者感染被认为是轻度的,60%是重度的。为了确诊并评估治疗效果(用药前、用药后1周和4周),考虑了以下标准:(1)通过直接显微镜检查(湿片)以及在尼克森培养基上培养来鉴定念珠菌种类,(2)对临床症状的影响,如瘙痒、灼痛、阴道黏膜病理变化、鹅口疮。主要标准是真菌学培养结果。79例患者(88%)在治疗1周后培养结果为阴性,81例(90%)在治疗4周后培养结果为阴性;9例患者(10%)治疗失败,在最后一次检查时培养结果为阳性。临床症状的改善与真菌学检查结果平行。在检查时,大多数(高达90%)受影响患者的症状已经消失。考虑真菌学检查结果时获得的良好印象在临床医生的总体评估中得到了证实:88%的患者在用药1周后治愈,90%在用药4周后治愈。通过不同标准,疾病状态对治疗成功没有任何影响。所有患者对500毫克克霉唑阴道片的耐受性都非常好。