用于急诊科女性的沙眼衣原体和淋病奈瑟菌快速诊断可改善临床管理：一项随机临床试验报告。
Use of a Rapid Diagnostic for Chlamydia trachomatis and Neisseria gonorrhoeae for Women in the Emergency Department Can Improve Clinical Management: Report of a Randomized Clinical Trial.
机构信息
Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD; Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD.
Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD.
出版信息
Ann Emerg Med. 2019 Jul;74(1):36-44. doi: 10.1016/j.annemergmed.2018.09.012. Epub 2018 Nov 2.
STUDY OBJECTIVE
In emergency departments (EDs), diagnosis and treatment of Chlamydia trachomatis and Neisseria gonorrhoeae are challenging. We conducted a randomized clinical trial to assess rapid C trachomatis and N gonorrhoeae testing on overtreatment and undertreatment of women evaluated for C trachomatis and N gonorrhoeae.
METHODS
Women undergoing pelvic examinations and C trachomatis and N gonorrhoeae testing (n=254) were randomized to control or rapid test groups. The control group received standard-of-care C trachomatis and N gonorrhoeae nucleic acid amplification tests of endocervical specimens, with 2- to 3-day turnaround times. For the rapid test group, clinicians collected an extra endocervical swab for GeneXpert C trachomatis and N gonorrhoeae rapid testing, in addition to the standard-of-care nucleic acid amplification test swab. Rapid results were immediately provided, and all patients were treated according to providers' clinical judgment.
RESULTS
In the rapid test group, 7.9% of patients had positive test results for C trachomatis; 3.9% had positive test results for N gonorrhoeae. In the control standard-of-care group, 10.2% of patients had positive nucleic acid amplification test results for C trachomatis; 5.5% had positive results for N gonorrhoeae. Undertreatment for both C trachomatis and N gonorrhoeae in the ED was 0% for the rapid test group and 43.8% for the control standard-of-care group. Clinicians overtreated 46.5% of uninfected standard-of-care control patients for C trachomatis compared with 23.1% of uninfected rapid test patients. For patients uninfected with N gonorrhoeae, clinicians overtreated 46.7% of standard-of-care control patients compared with 25.4% of rapid test patients. The length of stay did not differ significantly between groups.
CONCLUSION
Rapid C trachomatis and N gonorrhoeae testing in the ED led to a significant reduction in overtreatment for women without infections compared with the standard-of-care control group. Additionally, in the rapid test group there was significant improvement in appropriate treatment for patients with infections.
研究目的
在急诊科（ED），沙眼衣原体和淋病奈瑟菌的诊断和治疗具有挑战性。我们进行了一项随机临床试验，以评估对接受沙眼衣原体和淋病奈瑟菌检测的女性进行快速沙眼衣原体和淋病奈瑟菌检测是否会过度治疗和治疗不足。
方法
对 254 名接受盆腔检查和沙眼衣原体和淋病奈瑟菌检测的女性进行随机分组，分为对照组和快速检测组。对照组接受标准护理的宫颈拭子沙眼衣原体和淋病奈瑟菌核酸扩增检测，检测周转时间为 2-3 天。对于快速检测组，临床医生除了采集标准护理核酸扩增检测拭子外，还额外采集宫颈拭子进行 GeneXpert 沙眼衣原体和淋病奈瑟菌快速检测。快速检测结果立即提供，所有患者均根据提供者的临床判断进行治疗。
结果
在快速检测组中，7.9%的患者沙眼衣原体检测结果阳性；3.9%的患者淋病奈瑟菌检测结果阳性。在对照组标准护理组中，10.2%的患者沙眼衣原体核酸扩增检测结果阳性；5.5%的患者淋病奈瑟菌检测结果阳性。ED 中沙眼衣原体和淋病奈瑟菌的治疗不足率在快速检测组为 0%，在对照组标准护理组为 43.8%。与未感染快速检测患者相比，未感染的标准护理对照组患者中，临床医生过度治疗了 46.5%的沙眼衣原体患者。对于未感染淋病奈瑟菌的患者，与快速检测患者相比，标准护理对照组患者中有 46.7%被过度治疗。两组患者的住院时间无显著差异。
结论
与标准护理对照组相比，ED 中快速沙眼衣原体和淋病奈瑟菌检测可显著减少未感染女性的过度治疗。此外，在快速检测组中，对感染患者的治疗更加恰当。
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