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男性直肠标本中用于诊断性病淋巴肉芽肿的沙眼衣原体基因研究:成本效益分析。

Genotypic study of Chlamydia trachomatis for lymphogranuloma venereum diagnosis in rectal specimens from men who have sex with men: a cost-effectiveness analysis.

机构信息

Microbiology Service, Hospital Clínico Universitario, INCLIVA Research institute, Valencia, Spain.

Department of Microbiology, School of Medicine, University of Valencia, Valencia, Spain.

出版信息

BMC Infect Dis. 2024 Mar 7;24(1):298. doi: 10.1186/s12879-024-09185-4.

Abstract

PURPOSE

The significant proportion of asymptomatic patients and the scarcity of genotypic analysis of lymphogranuloma venereum (LGV), mainly among men who have sex with men (MSM), triggers a high incidence of underdiagnosed patients, highlighting the importance of determining the most appropriate strategy for LGV diagnosis, at both clinical and economical levels.

MATERIALS AND METHODS

We conducted L1-L3 serovar detection by molecular biology in stored Chlamydia trachomatis-positive samples from MSM patients with HIV, another STI or belonging to a Pre-exposure prophylaxis program, to make a cost effectiveness study of four diagnostic strategies with a clinical, molecular, or mixed approach.

RESULTS

A total of 85 exudates were analyzed: 35urethral (31 symptomatic/4 positive) and 50 rectal (22 symptomatic/25 positive), 70/85 belonging to MSM with associated risk factors. The average cost per patient was €77.09 and €159.55 for clinical (Strategy I) and molecular (Strategy IV) strategies respectively. For molecular diagnosis by genotyping of all rectal exudate samples previously positive for CT (Strategy II), the cost was €123.84. For molecular diagnosis by genotyping of rectal and/or urethral exudate samples from all symptomatic patients (proctitis or urethritis) with a previous positive result for CT (Strategy III), the cost was €129.39. The effectiveness ratios were 0.80, 0.95, 0.91, and 1.00 for each strategy respectively. The smallest ICER was €311.67 for Strategy II compared to Strategy I.

CONCLUSIONS

With 30% asymptomatic patients, the most cost-effective strategy was based on genotyping all rectal exudates. With less restrictive selection criteria, thus increasing the number of patients with negative results, the most sensitive strategies tend to be the most cost-effective, but with a high incremental cost-effectiveness ratio.

摘要

目的

无症状患者比例较高,且淋球菌肉芽肿病(LGV)的基因分析稀缺,主要发生在男男性行为者(MSM)中,这导致大量患者漏诊,因此明确 LGV 诊断的最佳策略至关重要,这不仅在临床层面,也在经济层面上具有重要意义。

材料与方法

我们对 HIV 阳性、患有其他性传播感染(STI)或参与暴露前预防计划的 MSM 患者的储存沙眼衣原体阳性样本进行 L1-L3 血清型检测,以对四种具有临床、分子或混合方法的诊断策略进行成本效益研究。

结果

共分析了 85 份渗出物样本:35 份尿道(31 例有症状/4 例阳性)和 50 份直肠(22 例有症状/25 例阳性),85 份样本中有 70 份来自 MSM,且存在相关风险因素。每位患者的平均成本分别为 77.09 欧元和 159.55 欧元,用于临床(策略 I)和分子(策略 IV)策略。对于通过对所有先前 CT 阳性的直肠渗出物样本进行基因分型的分子诊断(策略 II),成本为 123.84 欧元。对于对所有有 CT 先前阳性结果的症状性患者(直肠炎或尿道炎)的直肠和/或尿道渗出物样本进行分子诊断(策略 III),成本为 129.39 欧元。每个策略的有效性比分别为 0.80、0.95、0.91 和 1.00。与策略 I 相比,策略 II 的最小增量成本效益比为 311.67 欧元。

结论

对于 30%的无症状患者,最具成本效益的策略是对所有直肠渗出物进行基因分型。通过放宽选择标准,从而增加阴性结果患者的数量,最敏感的策略往往最具成本效益,但增量成本效益比较高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c092/10918947/159bc8c0470a/12879_2024_9185_Fig1_HTML.jpg

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