Hemsell D L, Wendel G D, Hemsell P G, Heard M L, Nobles B J
Department of Obstetrics and Gynecology University of Texas Southwestern Medical Center at Dallas and Parkland Memorial Hospital, Dallas, TX 75235-9032, USA.
Infect Dis Obstet Gynecol. 1993;1(3):123-9. doi: 10.1155/S1064744993000286.
Ampicillin plus sulbactam, an irreversible beta-lactamase inhibitor, was compared to cefoxitin in the treatment of women with acute pelvic inflammatory disease (PID) with and without inflammatory mass(es).
Participation in an open, prospective, randomized clinical trial was offered to all women given the clinical diagnosis of acute PID who required inpatient therapy. Neisseria gonorrhoeae and Chlamydia trachomatis were sought in cervical and endometrial samples and aerobic and anaerobic species were sought in endometrial samples prior to treatment initiation. Treatment was given on at least 4 days and until women were afebrile for at least 48 h. Daily examinations were performed to assess response to therapy and safety. Only women in whom C. trachomatis was identified were discharged from the hospital on oral doxycycline to be taken for 10-14 days.
One hundred twenty-four women were evaluated for safety; 117 (94%) were evaluated for efficacy. Demographic characteristics were similar for women in each treatment group. N. gonorrhoeae was recovered from 59% and C. trachomatis was recovered from 42% of study subjects. Inflammatory masses were identified in 35/76 (46%) women given ampicillin/sulbactam and 17/41 (41%) women given cefoxitin. Ampicillin/sulbactam cured 75 ,of 76 women (98.7%) [95% confidence interval (CI) 92.9-100.0%] and cefoxitin cured 37 of,41,omen (90.2%) (95% CI 76.9-97.3%) in that treatment regimen.
Overall ampicillin/sulbactam was more effective (P = 0.05) than cefoxitin, due to superior efficacy in infection complicated by inflammatory mass(es).35/35 vs. 12/17 cured; P = 0.007).
将氨苄西林加舒巴坦(一种不可逆的β-内酰胺酶抑制剂)与头孢西丁用于治疗伴有或不伴有炎性包块的急性盆腔炎(PID)女性患者,并进行比较。
所有临床诊断为急性PID且需要住院治疗的女性均可参与一项开放、前瞻性、随机临床试验。在开始治疗前,采集宫颈和子宫内膜样本检测淋病奈瑟菌和沙眼衣原体,采集子宫内膜样本检测需氧菌和厌氧菌。治疗至少持续4天,直至女性体温正常至少48小时。每天进行检查以评估治疗反应和安全性。仅对确诊沙眼衣原体感染的女性出院时给予口服多西环素,疗程为10 - 14天。
对124名女性进行了安全性评估;对117名(94%)女性进行了疗效评估。各治疗组女性的人口统计学特征相似。59%的研究对象检出淋病奈瑟菌,42%的研究对象检出沙眼衣原体。接受氨苄西林/舒巴坦治疗的76名女性中有35名(46%)发现炎性包块,接受头孢西丁治疗的41名女性中有17名(41%)发现炎性包块。在该治疗方案中,氨苄西林/舒巴坦治愈了76名女性中的75名(98.7%)[95%置信区间(CI)92.9 - 100.0%],头孢西丁治愈了41名女性中的37名(90.2%)(95% CI 76.9 - 97.3%)。
总体而言,氨苄西林/舒巴坦比头孢西丁更有效(P = 0.05),这是因为其在伴有炎性包块的感染中疗效更优(35/35例治愈 vs. 12/17例治愈;P = 0.007)。