Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.
J Infect Chemother. 2011 Feb;17(1):80-6. doi: 10.1007/s10156-010-0092-2. Epub 2010 Aug 7.
Fosfomycin calcium is a fosfomycin antimicrobial agent with a characteristic structure. After oral administration, the drug is absorbed and excreted via the kidneys in the unchanged form, without being metabolized in the body. It is, therefore, indicated for the treatment of urinary tract diseases, including cystitis and pyelonephritis. In the present study, the clinical usefulness of fosfomycin calcium (FOSMICIN® TABLETS 500) administered orally at the dosage of 1 g (two tablets) three times daily for 2 days was examined in female patients, who were at least 20 years of age, with acute uncomplicated cystitis of bacterial origin. Of the 48 patients enrolled between February 2008 and August 2008, 39 were evaluable for efficacy and safety. Overall evaluation of the cure revealed that microbiological eradication rate (microbiological outcome) and clinical efficacy rate (clinical outcome) at 5-9 days after drug administration (visit 2) were 94.9%. Determination of the microbiological and clinical outcomes for the evaluation of recurrence at 4-6 weeks after drug administration (visit 3) were 75.8 and 85.7%, respectively. Of the 48 patients, 40 (83.3%) returned to the clinic at visit 3. The causative bacterial species for cystitis was Escherichia coli in 31 (79.5%) of the 39 patients evaluable for efficacy and safety. Adverse drug reactions observed during the administration and follow-up periods included mild diarrhea and loose stools in 1 patient each, neither requiring any specific treatment. Evaluation of cure at visit 2 in patients in whom the causative bacterial species for the infection was E. coli revealed a microbiological outcome of 93.5%, and clinical outcome was 96.8%. Furthermore, evaluation for recurrence at visit 3 revealed a microbiological outcome of 74.1% and clinical outcome of 82.1%. When the patients were divided by age into an under 60 years of age group and an over 60 years of age group, the microbiological and clinical outcomes determined for evaluation of cure at visit 2 were 96.4 and 92.9%, respectively, and the corresponding rates determined for the evaluation of recurrence at visit 3 were 87.0 and 96.0%, respectively, in the under 60 years of age group. In the over 60 years of age group, the corresponding microbiological outcome and clinical outcome rates evaluated for cure were 90.9 and 100%, respectively, and those evaluated for recurrence were 50.0 and 60.0%, respectively. These results indicate the usefulness of fosfomycin calcium administered at 1 g three times daily for 2 days for acute uncomplicated cystitis.
磷霉素钙是一种具有特征结构的磷霉素类抗菌药物。口服给药后，药物以原形经肾脏吸收和排泄，体内不代谢。因此，它适用于治疗尿路感染疾病，包括膀胱炎和肾盂肾炎。在本研究中，对 48 名年龄在 20 岁以上的患有细菌性急性单纯性膀胱炎的女性患者，以 1 克（两片）每天三次口服给药，连续 2 天的磷霉素钙（FOSMICIN® TABLETS 500）的临床疗效进行了评估。在 2008 年 2 月至 2008 年 8 月之间入组的 48 名患者中，有 39 名可用于疗效和安全性评估。在给药后 5-9 天（就诊 2）的总体疗效评估中，微生物学清除率（微生物学结果）和临床疗效（临床结果）为 94.9%。在给药后 4-6 周（就诊 3）评估复发时，微生物学和临床结果分别为 75.8%和 85.7%。48 名患者中有 40 名（83.3%）在就诊 3 时回到诊所。39 名可评估疗效和安全性的患者中，膀胱炎的致病细菌为大肠埃希菌的有 31 名（79.5%）。在治疗期间和随访期间观察到的药物不良反应包括 1 例轻度腹泻和 1 例稀便，均无需特殊治疗。在感染的致病细菌为大肠埃希菌的患者中，就诊 2 时的治愈评估显示微生物学结果为 93.5%，临床结果为 96.8%。此外，就诊 3 时的复发评估显示微生物学结果为 74.1%，临床结果为 82.1%。当患者按年龄分为 60 岁以下组和 60 岁以上组时，就诊 2 时评估治愈的微生物学和临床结果分别为 96.4%和 92.9%，就诊 3 时评估复发的相应结果分别为 87.0%和 96.0%，在 60 岁以下组中。在 60 岁以上组中，就诊 2 时评估治愈的微生物学和临床结果分别为 90.9%和 100%，就诊 3 时评估复发的相应结果分别为 50.0%和 60.0%。这些结果表明，对于急性单纯性膀胱炎，每天口服磷霉素钙 1 克，连续 2 天是有用的。
