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自然流产不全后的手术前预防性使用抗生素的随机试验
A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery


David Lissauer ... 妇产科和儿科 • 2019.03.14
相关阅读
• 自然流产不全后的手术前使用抗生素可否降低感染风险

摘要


背景

一些自然流产病例需要通过外科手术清除残留的妊娠产物。预防性使用抗生素可降低盆腔感染风险,而盆腔感染是该手术的重要并发症,尤其是在缺乏医疗资源的国家。

 

方法

我们开展了一项双盲、安慰剂对照、随机试验,研究在缺乏医疗资源的国家中发生自然流产的妇女和青少年在为了完成流产而实施手术前预防性使用抗生素可否减少盆腔感染。我们将患者随机分组,术前分别接受400 mg口服多西环素联合400 mg口服甲硝唑单剂给药或外观相同的安慰剂单剂给药。主要结局为术后14日内的盆腔感染。盆腔感染的定义为有四种临床表现(阴道脓性分泌物、发热、子宫压痛和白细胞增多)中的两种或两种以上,或者有其中一种表现并且临床上认为需要给予抗生素治疗。数据揭盲前曾对盆腔感染定义做出修改;最初的严格定义为有两种或两种以上临床表现,而不考虑是否给予抗生素治疗。

 

结果

我们在马拉维、巴基斯坦、坦桑尼亚和乌干达纳入了3,412例患者。共有1,705例患者被分配接受抗生素治疗,1,707例患者被分配接受安慰剂治疗。在抗生素组和安慰剂组中,盆腔感染风险分别为4.1%(1,676例妊娠中的68例)和5.3%(1,684例感染中的90例)(风险比,0.77;95%置信区间[CI],0.56~1.04;P=0.09)。根据最初的严格标准,盆腔感染的诊断率分别为1.5%(1,700例妊娠中的26例)和2.6%(1,704例妊娠中的44例)(风险比,0.60;95% CI,0.37~0.96)。不良事件无显著组间差异。

 

结论

根据实用性广义标准中的定义,与安慰剂相比,自然流产后的手术前预防性使用抗生素未显著降低盆腔感染风险(由英国医学研究委员会[Medical Research Council]等资助;AIMS在Current Controlled Trials注册号为ISRCTN97143849)。





作者信息

David Lissauer, M.B., Ch.B., Ph.D., Amie Wilson, Ph.D., Catherine A. Hewitt, M.Sc., Lee Middleton, M.Sc., Jonathan R.B. Bishop, Ph.D., Jane Daniels, Ph.D., Abi Merriel, Ph.D., Andrew Weeks, M.D., Chisale Mhango, M.B., Ch.B., Ronald Mataya, M.D., Frank Taulo, F.R.C.O.G., Theresa Ngalawesa, B.Sc., Agatha Chirwa, B.Sc., Colleta Mphasa, N.M.Dip., Tayamika Tambala, N.M.Cert., Grace Chiudzu, M.B., B.S., Caroline Mwalwanda, M.Med., Agnes Mboma, N.M.Cert., Rahat Qureshi, F.R.C.O.G., Iffat Ahmed, M.B., B.S., Humera Ismail, M.Sc., Olufemi T. Oladapo, M.P.H., Godfrey Mbaruku, Ph.D., Jerome Chibwana, M.Med., Grace Watts, M.B., B.S., Beatus Simon, B.Sc., James Ditai, M.P.H., Charles Otim Tom, M.Med., JaneFrances Acam, B.Sc., John Ekunait, M.Med., Hellen Unzia, N.M.Dip., Margaret Iyaku, N.Dip., Joshua J. Makiika, M.B., Ch.B., Javier Zamora, Ph.D., Tracy Roberts, Ph.D., Ilias Goranitis, Ph.D., Sarah Bar-Zeev, Ph.D., Nicola Desmond, Ph.D., Sabaratnam Arulkumaran, M.D., Zulfiqar A. Bhutta, Ph.D., Ahmet M. Gulmezoglu, Ph.D., and Arri Coomarasamy, M.D.
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.). Address reprint requests to Dr. Lissauer at the Institute of Metabolism and Systems Research, University of Birmingham, Birmingham Women’s Hospital, Mindelsohn Way, Birmingham B15 2TG, United Kingdom, or at d.m.lissauer@bham.ac.uk. Godfrey Mbaruku, Ph.D., is deceased.

 

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