氨苄西林舒巴坦与头孢西丁及多西环素或克林霉素与庆大霉素治疗盆腔炎或子宫内膜炎的随机对照比较

Randomized comparison of ampicillin-sulbactam to cefoxitin and doxycycline or clindamycin and gentamicin in the treatment of pelvic inflammatory disease or endometritis.

作者信息

McGregor J A, Crombleholme W R, Newton E, Sweet R L, Tuomala R, Gibbs R S

机构信息

Department of Obstetrics and Gynecology, University of Colorado, Denver.

出版信息

Obstet Gynecol. 1994 Jun;83(6):998-1004. doi: 10.1097/00006250-199406000-00020.

DOI:10.1097/00006250-199406000-00020

PMID:8190448

Abstract

OBJECTIVE

To evaluate the efficacy and safety of ampicillin-sulbactam (3 g every 6 hours) in patients with pelvic inflammatory disease or postpartum endometritis using a randomized, comparative, multicenter study of parallel design.

METHODS

Eligible patients with pelvic inflammatory disease were randomized to receive either ampicillin-sulbactam or cefoxitin (2 g every 6 hours) plus doxycycline (100 mg every 12 hours). Those with endometritis were randomized to ampicillin-sulbactam or clindamycin (900 mg every 8 hours) plus gentamicin (1.5 mg/kg every 8 hours). In the ampicillin-sulbactam group, chlamydia-positive patients also received oral doxycycline.

RESULTS

For pelvic inflammatory disease, the clinical response rates (cure or improvement) were 85.5% (47 of 55) and 89.6% (43 of 48) in the ampicillin-sulbactam and cefoxitin and doxycycline groups, respectively (chi 2 = 0.10, P = .76). For endometritis, the clinical response rates were 88.7% (141 of 159) and 90.8% (139 of 153) in the ampicillin-sulbactam and clindamycin and gentamicin groups, respectively (chi 2 = 0.15, P = .70). The percentages of patients with pelvic inflammatory disease who had adverse experiences were not significantly different in the cefoxitin and doxycycline group (47% [29 of 62]) than in those receiving ampicillin-sulbactam (33% [22 of 66]) (P = .12). These adverse effects were mostly mild or moderate. In the endometritis subjects, the incidence of adverse experiences in the ampicillin-sulbactam group (11% [20 of 179]) was comparable to that during treatment with clindamycin and gentamicin (12% [22 of 180]). These adverse experiences were also mostly mild to moderate.

CONCLUSION

Ampicillin-sulbactam is as effective and well tolerated as combination regimens using cefoxitin plus doxycycline and clindamycin plus-gentamicin for the treatment of pelvic inflammatory disease or endometritis, respectively.

摘要

目的

采用随机、对照、多中心平行设计研究，评估氨苄西林舒巴坦（每6小时3克）治疗盆腔炎或产后子宫内膜炎患者的疗效和安全性。

方法

符合条件的盆腔炎患者被随机分为两组，分别接受氨苄西林舒巴坦或头孢西丁（每6小时2克）加多西环素（每12小时100毫克）治疗。子宫内膜炎患者被随机分为接受氨苄西林舒巴坦或克林霉素（每8小时900毫克）加庆大霉素（每8小时1.5毫克/千克）治疗。在氨苄西林舒巴坦组中，衣原体阳性患者还接受口服多西环素治疗。

结果

对于盆腔炎，氨苄西林舒巴坦组和头孢西丁加多西环素组的临床缓解率（治愈或改善）分别为85.5%（55例中的47例）和89.6%（48例中的43例）（χ² = 0.10，P = 0.76）。对于子宫内膜炎，氨苄西林舒巴坦组和克林霉素加庆大霉素组的临床缓解率分别为88.7%（159例中的141例）和90.8%（153例中的139例）（χ² = 0.15，P = 0.70）。盆腔炎患者中，头孢西丁加多西环素组（47%[62例中的29例]）出现不良事件的患者百分比与接受氨苄西林舒巴坦治疗的患者（33%[66例中的22例]）相比，差异无统计学意义（P = 0.12）。这些不良反应大多为轻度或中度。在子宫内膜炎患者中，氨苄西林舒巴坦组不良事件的发生率（11%[179例中的20例]）与克林霉素加庆大霉素治疗期间的发生率（12%[180例中的22例]）相当。这些不良事件也大多为轻度至中度。