Houang E T, Watson C, Howell R, Chapman M
J Antimicrob Chemother. 1984 Nov;14(5):529-35. doi: 10.1093/jac/14.5.529.
A double-blind, placebo-controlled and randomized trial involving a total of 295 patients was carried out to define the role of chemoprophylaxis in major gynaecological surgery in our hospital. Perioperative administration of a single dose of ampicillin (500 mg) plus sulbactam (500 mg) (regimen A), or ampicillin (500 mg) plus metronidazole (1 g suppository) (regimen B), gave similar results. After abdominal hysterectomy, the rates of post-operative wound infection and febrile morbidity were significantly reduced from 24% (12/49) and 20% (10/49) in the placebo group to 3-4% (A = 2/51, B = 3/58) and 2% (A = 1/51, B = 1/58) respectively. After vaginal hysterectomy, pelvic/vaginal infection or febrile morbidity was found in 30% (3/10) of patients in the placebo group but none in either treatment group (A = 10, B = 8). After other types of operation, the rates of infectious complications were reduced, but not statistically significantly, from 11% (4/38) to 4% (A + B 2/71). However, the rates of post-operative urinary tract infection remained similar in the placebo and treatment groups (12-16%).
一项涉及295名患者的双盲、安慰剂对照随机试验在我院开展，以确定化学预防在重大妇科手术中的作用。围手术期给予单剂量氨苄西林（500毫克）加舒巴坦（500毫克）（方案A）或氨苄西林（500毫克）加甲硝唑（1克栓剂）（方案B），结果相似。腹式子宫切除术后，安慰剂组的术后伤口感染率和发热发病率分别从24%（12/49）和20%（10/49）显著降至3-4%（A组=2/51，B组=3/58）和2%（A组=1/51，B组=1/58）。阴式子宫切除术后，安慰剂组30%（3/10）的患者出现盆腔/阴道感染或发热，但治疗组（A组=10例，B组=8例）均未出现。在其他类型的手术后，感染并发症的发生率从11%（4/38）降至4%（A+B组2/71），但差异无统计学意义。然而，安慰剂组和治疗组的术后尿路感染发生率仍相似（12-16%）。
