Hooton Thomas M, Scholes Delia, Gupta Kalpana, Stapleton Ann E, Roberts Pacita L, Stamm Walter E
Department of Medicine, School of Medicine, University of Washington, Seattle, USA.
JAMA. 2005 Feb 23;293(8):949-55. doi: 10.1001/jama.293.8.949.
The high prevalence of resistance to trimethoprim-sulfamethoxazole and other antimicrobials among Escherichia coli causing acute cystitis in women has led to increased use of alternative antibiotics. One such antibiotic, amoxicillin-clavulanate, has not been well studied.
To compare the efficacy of a 3-day regimen of amoxicillin-clavulanate to that of a 3-day regimen of ciprofloxacin in the treatment of acute cystitis in women. The primary study hypothesis was that the amoxicillin-clavulanate and ciprofloxacin treatment groups would differ in clinical cure.
DESIGN, SETTING, AND PATIENTS: Randomized, single-blind treatment trial of 370 women, aged 18 to 45 years, with symptoms of acute uncomplicated cystitis and a urine culture with at least 10(2) colony-forming units of uropathogens per milliliter from a university student health center or a health maintenance organization.
Women were randomly assigned to receive amoxicillin-clavulanate (500 mg/125 mg twice daily) or ciprofloxacin (250 mg twice daily) for 3 days and were followed up for 4 months.
The main outcome measure was clinical cure. Secondary study outcomes of interest were microbiological cure and vaginal E coli colonization at the 2-week follow-up visit.
Clinical cure was observed in 93 (58%) of 160 women treated with amoxicillin-clavulanate compared with 124 (77%) of 162 women treated with ciprofloxacin (P<.001). Amoxicillin-clavulanate was not as effective as ciprofloxacin even among women infected with strains susceptible to amoxicillin-clavulanate (65 [60%] of 109 women in the amoxicillin-clavulanate group vs 114 [77%] of 149 women in the ciprofloxacin group; P = .004). The difference in clinical cure rates occurred almost entirely within the first 2 weeks after therapy. Microbiological cure at 2 weeks was observed in 118 (76%) of 156 women treated with amoxicillin-clavulanate compared with 153 (95%) of 161 women treated with ciprofloxacin (P<.001). At this visit, 45% of women in the amoxicillin-clavulanate group compared with 10% in the ciprofloxacin group had vaginal colonization with E coli (P<.001).
A 3-day regimen of amoxicillin-clavulanate is not as effective as ciprofloxacin for the treatment of acute uncomplicated cystitis, even in women infected with susceptible strains. This difference may be due to the inferior ability of amoxicillin-clavulanate to eradicate vaginal E coli, facilitating early reinfection.
在引起女性急性膀胱炎的大肠杆菌中，对甲氧苄啶 - 磺胺甲恶唑及其他抗菌药物的高耐药率导致了替代抗生素使用的增加。其中一种抗生素，阿莫西林 - 克拉维酸，尚未得到充分研究。
比较阿莫西林 - 克拉维酸三日疗法与环丙沙星三日疗法治疗女性急性膀胱炎的疗效。主要研究假设是阿莫西林 - 克拉维酸治疗组和环丙沙星治疗组在临床治愈方面存在差异。
设计、地点和患者：对370名年龄在18至45岁、有急性单纯性膀胱炎症状且尿培养每毫升尿中至少有10²个尿路病原体菌落形成单位的女性进行随机、单盲治疗试验，这些女性来自大学生健康中心或健康维护组织。
女性被随机分配接受阿莫西林 - 克拉维酸（500毫克/125毫克，每日两次）或环丙沙星（250毫克，每日两次）治疗3天，并随访4个月。
主要结局指标是临床治愈。感兴趣的次要研究结局是微生物学治愈以及在2周随访时阴道大肠杆菌定植情况。
接受阿莫西林 - 克拉维酸治疗的160名女性中有93名（58%）实现临床治愈，而接受环丙沙星治疗的162名女性中有124名（77%）实现临床治愈（P<0.001）。即使在感染对阿莫西林 - 克拉维酸敏感菌株的女性中，阿莫西林 - 克拉维酸也不如环丙沙星有效（阿莫西林 - 克拉维酸组109名女性中有65名[60%]，环丙沙星组149名女性中有114名[77%]；P = 0.004）。临床治愈率的差异几乎完全出现在治疗后的前2周内。接受阿莫西林 - 克拉维酸治疗的156名女性中有118名（76%）在2周时实现微生物学治愈，而接受环丙沙星治疗的161名女性中有153名（95%）实现微生物学治愈（P<0.001）。在此次随访时，阿莫西林 - 克拉维酸组45%的女性阴道有大肠杆菌定植，而环丙沙星组为10%（P<0.001）。
即使在感染敏感菌株的女性中，阿莫西林 -克拉维酸三日疗法治疗急性单纯性膀胱炎的效果也不如环丙沙星。这种差异可能是由于阿莫西林 - 克拉维酸根除阴道大肠杆菌的能力较差，从而易于早期再次感染。
