Sweet R L, Roy S, Faro S, O'Brien W F, Sanfilippo J S, Seidlin M
University of California, San Francisco.
Obstet Gynecol. 1994 Feb;83(2):280-6.
To compare the efficacy and safety of a combination of piperacillin and tazobactam with that of clindamycin and gentamicin in the treatment of hospitalized women with infections of the upper genital tract.
This was a randomized open-label trial in hospitalized women with infections of the upper genital tract. Patients were recruited at 12 hospitals in the United States and two hospitals in Canada and were randomly assigned to one of two regimens in a 2:1 ratio. One group received piperacillin, 3 g every 6 hours, and tazobactam, 375 mg every 6 hours; the other group received clindamycin, 900 mg every 8 hours, and gentamicin, 2.5-5.0 mg/kg/day in three divided doses. Therapy with the assigned regimen was to be administered for a minimum of 3 days. Cultures for aerobic and anaerobic bacteria were obtained from the site of infection before initiation of therapy. Cultures for Chlamydia trachomatis were also obtained from patients with endometritis or pelvic inflammatory disease. Subjects were evaluated for clinical and bacteriologic response at 24-72 hours and 2-4 weeks after completing therapy.
Two hundred ninety-nine patients were enrolled; 196 were in the piperacillin-tazobactam group and 103 were in the clindamycin-gentamicin group. The most common diagnoses were endometritis (146) and pelvic inflammatory disease (115). The most common microorganisms recovered included: Peptostreptococcus sp (99), Prevotella sp (87), black pigmented Bacteroides (29), B fragilis (11), enterococci (64), group B streptococcus (26), Escherichia coli (31), Neisseria gonorrhoeae (49), and C trachomatis (19). A favorable clinical response occurred in 84.7% (166 of 196) of piperacillin-tazobactam patients and 87.3% (90 of 103) of clindamycin-gentamicin patients. Among those evaluable for bacteriologic response, 78% (67 of 86) and 82% (23 of 28), respectively, had a favorable response. Diarrhea occurred significantly more frequently in the piperacillin-tazobactam group (9.7 versus 2.9%; P = .04), but the majority of episodes were mild to moderate. None of the adverse experiences in either treatment group were considered life-threatening and drug-related.
The combination of piperacillin and tazobactam is an effective and well-tolerated antibiotic regimen for the treatment of infections of the upper genital tract in women.
比较哌拉西林-他唑巴坦与克林霉素-庆大霉素联合用药治疗住院上生殖道感染女性的疗效和安全性。
这是一项针对住院上生殖道感染女性的随机开放标签试验。在美国的12家医院和加拿大的2家医院招募患者，并以2:1的比例随机分配至两种治疗方案之一。一组每6小时接受3g哌拉西林和375mg他唑巴坦；另一组每8小时接受900mg克林霉素和每日2.5 - 5.0mg/kg分三次给药的庆大霉素。指定方案的治疗至少持续3天。在开始治疗前从感染部位获取需氧菌和厌氧菌培养物。还从子宫内膜炎或盆腔炎患者中获取沙眼衣原体培养物。在完成治疗后的24 - 72小时和2 - 4周对受试者进行临床和细菌学反应评估。
共纳入299例患者；196例在哌拉西林-他唑巴坦组，103例在克林霉素-庆大霉素组。最常见的诊断为子宫内膜炎（146例）和盆腔炎（115例）。分离出的最常见微生物包括：消化链球菌属（99例）、普雷沃菌属（87例）、产黑色素类杆菌（29例）、脆弱拟杆菌（11例）、肠球菌（64例）、B族链球菌（26例）、大肠埃希菌（31例）、淋病奈瑟菌（49例）和沙眼衣原体（19例）。哌拉西林-他唑巴坦组84.7%（196例中的166例）和克林霉素-庆大霉素组87.3%（103例中的90例）出现良好的临床反应。在可评估细菌学反应的患者中，分别有78%（86例中的67例）和82%（28例中的23例）有良好反应。腹泻在哌拉西林-他唑巴坦组显著更频繁发生（9.7%对2.9%；P = 0.04），但大多数发作轻微至中度。两个治疗组的不良事件均未被认为危及生命且与药物相关。
哌拉西林和他唑巴坦联合用药是治疗女性上生殖道感染的一种有效且耐受性良好抗生素方案。
