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流产后感染预防的随机对照试验:头孢曲松与安慰剂对比

A randomised controlled trial of prophylaxis of post-abortal infection: ceftriaxone versus placebo.

作者信息

Henriques C U, Wilken-Jensen C, Thorsen P, Møller B R

机构信息

Department of Obstetrics and Gynaecology, Rigshospitalet, University of Copenhagen, Denmark.

出版信息

Br J Obstet Gynaecol. 1994 Jul;101(7):610-4. doi: 10.1111/j.1471-0528.1994.tb13652.x.

DOI:10.1111/j.1471-0528.1994.tb13652.x
PMID:8043540
Abstract

OBJECTIVE

To investigate the incidence of post-operative infection after first trimester abortion in women treated with a long-acting cephalosporin (ceftriaxone) compared with low risk patients receiving no treatment and with high risk patients receiving our standard treatment of ampicillin/pivampicillin and metronidazole.

DESIGN

A prospective, randomised controlled trial.

SETTING

Department of Obstetrics and Gynaecology, Rigshospitalet, University of Copenhagen, Denmark.

SUBJECTS

Nine hundred and ninety-six women, admitted on an outpatient basis for legal termination of pregnancy at 12 weeks or less of gestation, were included in the study after giving informed consent. The women were divided into high risk and low risk categories and allocated either to treatment with ceftriaxone or to standard treatment. For high risk patients the standard treatment was initiated by a peroperative injection of ampicillin and metronidazole, followed by oral doses of metronidazole and pivampicillin three times daily for four days. No prophylactic antibiotics were given to the women randomised to standard treatment in the low risk group.

INTERVENTIONS

All women were kept under observation, and, between six and 14 days postoperatively, underwent pelvic examination. Clinical endpoints were noted.

MAIN OUTCOME MEASURES

Post-operative pelvic inflammatory disease in women applying for legal first trimester abortion.

RESULTS

Seven hundred and eighty-six women fulfilled the criteria for evaluation. A tendency toward a prophylactic effect of ceftriaxone was observed in most clinical findings. A significant prophylactic effect of ceftriaxone was found in the low risk group.

CONCLUSIONS

This study demonstrated a significant reduction in post-operative pelvic inflammatory disease in low risk patients, who were applying for legal first trimester abortion, treated peroperatively with ceftriaxone. No significant difference was demonstrated between high risk patients treated with ceftriaxone or ampicillin/pivampicillin and metronidazole.

摘要

目的

研究长效头孢菌素(头孢曲松)治疗的早孕流产女性术后感染的发生率,并与未接受治疗的低风险患者以及接受氨苄西林/匹氨西林和甲硝唑标准治疗的高风险患者进行比较。

设计

一项前瞻性随机对照试验。

地点

丹麦哥本哈根大学 Rigshospitalet 妇产科。

研究对象

996名妊娠12周及以内因合法终止妊娠而门诊入院的女性,在获得知情同意后纳入研究。这些女性被分为高风险和低风险类别,并被分配接受头孢曲松治疗或标准治疗。对于高风险患者,标准治疗是术前注射氨苄西林和甲硝唑,随后口服甲硝唑和匹氨西林,每日三次,共四天。低风险组中被随机分配至标准治疗的女性未给予预防性抗生素。

干预措施

所有女性均接受观察,并在术后6至14天接受盆腔检查。记录临床终点。

主要观察指标

申请合法早孕流产女性的术后盆腔炎。

结果

786名女性符合评估标准。在大多数临床结果中观察到头孢曲松有预防作用的趋势。在低风险组中发现头孢曲松有显著的预防作用。

结论

本研究表明,接受手术时使用头孢曲松治疗的申请合法早孕流产的低风险患者术后盆腔炎显著减少。使用头孢曲松或氨苄西林/匹氨西林和甲硝唑治疗的高风险患者之间未显示出显著差异。

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