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

AbstractOBJECTIVE:
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.
AuthorsJ A McGregor, W R Crombleholme, E Newton, R L Sweet, R Tuomala, R S Gibbs
JournalObstetrics and gynecology (Obstet Gynecol) Vol. 83 Issue 6 Pg. 998-1004 (Jun 1994) ISSN: 0029-7844 [Print] United States
PMID8190448 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Gentamicins
  • Clindamycin
  • sultamicillin
  • Cefoxitin
  • Ampicillin
  • Doxycycline
  • Sulbactam
Topics
  • Adult
  • Ampicillin (adverse effects, therapeutic use)
  • Cefoxitin (adverse effects, therapeutic use)
  • Clindamycin (adverse effects, therapeutic use)
  • Doxycycline (adverse effects, therapeutic use)
  • Drug Therapy, Combination (therapeutic use)
  • Endometritis (drug therapy)
  • Female
  • Gentamicins (adverse effects, therapeutic use)
  • Humans
  • Pelvic Inflammatory Disease (drug therapy)
  • Puerperal Infection (drug therapy)
  • Sulbactam (adverse effects, therapeutic use)

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