Khan M S, Begg H B, Frampton J, Hughes T B
Scand J Infect Dis Suppl. 1981;26:115-7.
A double-blind placebo controlled trial was embarked upon to study the prophylactic effect of intravenous metronidazole in the prevention of septic complications following gynaecological surgery. Comparison was made between the effect of a single dose only, given during the operation and that of a single dose given during the operation with an additional dose given 12 h later. 270 patients took part in the trial. These patients were admitted for elective hysterectomy, abdominal or vaginal, or for repair of uterovaginal prolapse. They were randomly allocated to one of three treatment groups. In group I, each patient received 500 mg/100 ml of metronidazole i.v. given over a 20 min period at the beginning of the operation followed by a second dose of 500 mg/100 ml of metronidazole i.v. 12 h later. In group II, the procedures were the same but the second dose was 100 ml of normal saline (placebo). In group III, both doses were 100 ml of normal saline. Out of 90 patients in group I, 2 patients (2.2%) developed postoperative sepsis. 8 patients (9.0%) out of 89 in group II developed sepsis. In the placebo group (group III) 19 patients (20.9%) developed sepsis. The results clearly indicate that a two-dose i.v. metronidazole regimen is highly effective in the prevention of post-operative sepsis in gynaecological surgery.
开展了一项双盲安慰剂对照试验,以研究静脉注射甲硝唑在预防妇科手术后感染性并发症方面的预防效果。对仅在手术期间给予单剂量的效果与在手术期间给予单剂量并在12小时后追加一剂的效果进行了比较。270名患者参与了该试验。这些患者因择期子宫切除术(腹部或阴道)或子宫阴道脱垂修复入院。他们被随机分配到三个治疗组之一。在第一组中,每位患者在手术开始时20分钟内静脉注射500mg/100ml甲硝唑,12小时后再静脉注射第二剂500mg/100ml甲硝唑。在第二组中,操作相同,但第二剂为100ml生理盐水(安慰剂)。在第三组中,两剂均为100ml生理盐水。第一组的90名患者中,2名患者(2.2%)发生了术后败血症。第二组的89名患者中有8名患者(9.0%)发生了败血症。在安慰剂组(第三组)中,19名患者(20.9%)发生了败血症。结果清楚地表明,两剂静脉注射甲硝唑方案在预防妇科手术后败血症方面非常有效。