预防性抗生素用于流产手术的随机试验。
A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery.
机构信息
From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).
出版信息
N Engl J Med. 2019 Mar 14;380(11):1012-1021. doi: 10.1056/NEJMoa1808817.
BACKGROUND
Surgical intervention is needed in some cases of spontaneous abortion to remove retained products of conception. Antibiotic prophylaxis may reduce the risk of pelvic infection, which is an important complication of this surgery, particularly in low-resource countries.
METHODS
We conducted a double-blind, placebo-controlled, randomized trial investigating whether antibiotic prophylaxis before surgery to complete a spontaneous abortion would reduce pelvic infection among women and adolescents in low-resource countries. We randomly assigned patients to a single preoperative dose of 400 mg of oral doxycycline and 400 mg of oral metronidazole or identical placebos. The primary outcome was pelvic infection within 14 days after surgery. Pelvic infection was defined by the presence of two or more of four clinical features (purulent vaginal discharge, pyrexia, uterine tenderness, and leukocytosis) or by the presence of one of these features and the clinically identified need to administer antibiotics. The definition of pelvic infection was changed before the unblinding of the data; the original strict definition was two or more of the clinical features, without reference to the administration of antibiotics.
RESULTS
We enrolled 3412 patients in Malawi, Pakistan, Tanzania, and Uganda. A total of 1705 patients were assigned to receive antibiotics and 1707 to receive placebo. The risk of pelvic infection was 4.1% (68 of 1676 pregnancies) in the antibiotics group and 5.3% (90 of 1684 pregnancies) in the placebo group (risk ratio, 0.77; 95% confidence interval [CI], 0.56 to 1.04; P = 0.09). Pelvic infection according to original strict criteria was diagnosed in 1.5% (26 of 1700 pregnancies) and 2.6% (44 of 1704 pregnancies), respectively (risk ratio, 0.60; 95% CI, 0.37 to 0.96). There were no significant between-group differences in adverse events.
CONCLUSIONS
Antibiotic prophylaxis before miscarriage surgery did not result in a significantly lower risk of pelvic infection, as defined by pragmatic broad criteria, than placebo. (Funded by the Medical Research Council and others; AIMS Current Controlled Trials number, ISRCTN97143849.).
背景
在某些自然流产的情况下，需要手术干预以清除残留的妊娠产物。抗生素预防可降低盆腔感染的风险，这是该手术的一个重要并发症，尤其是在资源匮乏的国家。
方法
我们进行了一项双盲、安慰剂对照、随机试验，以研究在资源匮乏的国家中，手术前预防性使用抗生素能否降低自然流产后女性和青少年的盆腔感染风险。我们将患者随机分配接受单次术前口服 400mg 强力霉素和 400mg 甲硝唑或相同的安慰剂。主要结局是手术后 14 天内的盆腔感染。盆腔感染的定义为出现以下 4 种临床特征中的 2 种或以上（脓性阴道分泌物、发热、子宫压痛和白细胞增多），或出现其中 1 种特征并伴有临床确定需要使用抗生素。在数据揭盲前，我们改变了盆腔感染的定义；原始的严格定义是出现 2 种或以上临床特征，而不参考使用抗生素的情况。
结果
我们在马拉维、巴基斯坦、坦桑尼亚和乌干达共纳入了 3412 名患者。共有 1705 名患者被分配接受抗生素治疗，1707 名患者接受安慰剂治疗。抗生素组的盆腔感染风险为 4.1%（1676 例妊娠中的 68 例），安慰剂组为 5.3%（1684 例妊娠中的 90 例）（风险比，0.77；95%置信区间 [CI]，0.56 至 1.04；P=0.09）。按照原始严格标准诊断的盆腔感染分别为 1.5%（1700 例妊娠中的 26 例）和 2.6%（1704 例妊娠中的 44 例）（风险比，0.60；95%CI，0.37 至 0.96）。两组间不良事件无显著差异。
结论
与安慰剂相比，流产手术后预防性使用抗生素并不能显著降低根据实用宽泛标准定义的盆腔感染风险。（由医学研究委员会和其他机构资助；AIMS 当前对照试验编号，ISRCTN97143849。）
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