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随机对照试验筛查沙眼衣原体以预防盆腔炎:POPI(预防盆腔感染)试验。

Randomised controlled trial of screening for Chlamydia trachomatis to prevent pelvic inflammatory disease: the POPI (prevention of pelvic infection) trial.

机构信息

Division of Community Health Sciences, St George's, University of London SW17 0RE.

出版信息

BMJ. 2010 Apr 8;340:c1642. doi: 10.1136/bmj.c1642.

Abstract

OBJECTIVE

To determine whether screening and treating women for chlamydial infection reduces the incidence of pelvic inflammatory disease over the subsequent 12 months.

DESIGN

Randomised controlled trial.

SETTING

Common rooms, lecture theatres, and student bars at universities and further education colleges in London.

PARTICIPANTS

2529 sexually active female students, mean age 21 years (range 16-27).

INTERVENTION

Participants completed a questionnaire and provided self taken vaginal swabs, with follow-up after one year. Samples were randomly allocated to immediate testing and treatment for chlamydial infection, or storage and analysis after a year (deferred screening controls).

MAIN OUTCOME MEASURE

Incidence of clinical pelvic inflammatory disease over 12 months.

RESULTS

Baseline prevalence of chlamydia was 5.4% (68/1254) in screened women and 5.9% (75/1265) in controls. 94% (2377/2529) of women were followed up after 12 months. The incidence of pelvic inflammatory disease was 1.3% (15/1191) in screened women compared with 1.9% (23/1186) in controls (relative risk 0.65, 95% confidence interval 0.34 to 1.22). Seven of 74 control women (9.5%, 95% confidence interval 4.7% to 18.3%) who tested positive for chlamydial infection at baseline developed pelvic inflammatory disease over 12 months compared with one of 63 (1.6%) screened women (relative risk 0.17, 0.03 to 1.01). However, most episodes of pelvic inflammatory disease occurred in women who tested negative for chlamydia at baseline (79%, 30/38). 22% (527/2377) of women reported being tested independently for chlamydia during the trial.

CONCLUSION

Although some evidence suggests that screening for chlamydia reduces rates of pelvic inflammatory disease, especially in women with chlamydial infection at baseline, the effectiveness of a single chlamydia test in preventing pelvic inflammatory disease over 12 months may have been overestimated. Trial registration ClinicalTrials.gov NCT00115388.

摘要

目的

确定筛查和治疗衣原体感染女性是否能降低随后 12 个月内盆腔炎的发病率。

设计

随机对照试验。

地点

伦敦大学和继续教育学院的公共休息室、演讲厅和学生酒吧。

参与者

2529 名有性行为的活跃女学生,平均年龄 21 岁(16-27 岁)。

干预措施

参与者完成了一份问卷,并提供了自己的阴道拭子,一年后进行随访。样本被随机分配到立即进行衣原体感染检测和治疗,或储存一年后进行分析(延迟筛查对照)。

主要观察指标

12 个月内临床盆腔炎的发病率。

结果

筛查组中衣原体的基线患病率为 5.4%(68/1254),对照组为 5.9%(75/1265)。94%(2377/2529)的女性在 12 个月后进行了随访。筛查组盆腔炎的发病率为 1.3%(15/1191),对照组为 1.9%(23/1186)(相对风险 0.65,95%置信区间 0.34-1.22)。基线时检测出衣原体感染的 74 名对照组女性(9.5%,95%置信区间 4.7%-18.3%)中有 7 人在 12 个月内发展为盆腔炎,而 63 名筛查组女性(1.6%)中有 1 人(相对风险 0.17,0.03-1.01)。然而,大多数盆腔炎病例发生在基线时衣原体检测阴性的女性(79%,30/38)。在试验期间,22%(527/2377)的女性独立接受了衣原体检测。

结论

尽管有证据表明筛查衣原体可以降低盆腔炎的发病率,尤其是在基线时感染衣原体的女性,但单次衣原体检测在 12 个月内预防盆腔炎的有效性可能被高估了。

试验注册

ClinicalTrials.gov NCT00115388。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7fb/4787650/f1c7824238db/oakp723007.f1_default.jpg

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