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STREET 阶段 1 试验中利福平耐药结核病的放射学特征及其对短程方案中培养物转换时间的影响。

Radiographic characteristics of rifampicin-resistant tuberculosis in the STREAM stage 1 trial and their influence on time to culture conversion in the short regimen.

机构信息

Division of Pulmonary Medicine, Department of Internal Medicine, Wan Fang Hospital, Taipei Medical University, 111 Hsin-Long Road, Section 3, Taipei, 116, Taiwan.

Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, 250, Wuxing St., Xinyi Dist., Taipei, 110, Taiwan.

出版信息

BMC Infect Dis. 2024 Jan 30;24(1):144. doi: 10.1186/s12879-024-09039-z.

Abstract

BACKGROUND

Stage 1 of the STREAM trial demonstrated that the 9 month (Short) regimen developed in Bangladesh was non-inferior to the 20 month (Long) 2011 World Health Organization recommended regimen. We assess the association between HIV infection and radiographic manifestations of tuberculosis and factors associated with time to culture conversion in Stage 1 of the STREAM trial.

METHODS

Reading of chest radiographs was undertaken independently by two clinicians, and films with discordant reading were read by a third reader. Recording of abnormal opacity of the lung parenchyma included location (right upper, right lower, left upper, and left lower) and extent of disease (minimal, moderately-advanced, and far advanced). Time to culture conversion was defined as the number of days from initiation of treatment to the first of two consecutive negative culture results, and compared using the log-rank test, stratified by country. Cox proportional hazards models, stratified by country and adjusted for HIV status, were used to identify factors associated with culture conversion.

RESULTS

Of the 364 participants, all but one had an abnormal chest X-ray: 347 (95%) had opacities over upper lung fields, 318 (87%) had opacities over lower lung fields, 124 (34%) had far advanced pulmonary involvement, and 281 (77%) had cavitation. There was no significant association between HIV and locations of lung parenchymal opacities, extent of opacities, the presence of cavitation, and location of cavitation. Participants infected with HIV were significantly less likely to have the highest positivity grade (3+) of sputum culture (p = 0.035) as compared to participants not infected with HIV. Cavitation was significantly associated with high smear positivity grades (p < 0.001) and high culture positivity grades (p = 0.004) among all participants. Co-infection with HIV was associated with a shorter time to culture conversion (hazard ratio 1.59, 95% CI 1.05-2.40).

CONCLUSIONS

Radiographic manifestations of tuberculosis among the HIV-infected in the era of anti-retroviral therapy may not differ from that among those who were not infected with HIV. Radiographic manifestations were not consistently associated with time to culture conversion, perhaps indicating that the Short regimen is sufficiently powerful in achieving sputum conversion across the spectrum of radiographic pulmonary involvements.

TRIAL REGISTRATION

ISRCTN ISRCTN78372190. Registered 14/10/2010. The date of first registration 10/02/2016.

摘要

背景

STREAM 试验的第 1 阶段表明,在孟加拉国开发的 9 个月(短)方案与 2011 年世界卫生组织推荐的 20 个月(长)方案不劣效。我们评估了在 STREAM 试验第 1 阶段中 HIV 感染与肺结核的影像学表现之间的关联,以及与培养转换时间相关的因素。

方法

由两名临床医生独立进行胸部 X 光片阅读,对阅读结果不一致的胸片由第三位读者进行阅读。肺部实质异常透光性的记录包括位置(右上、右下、左上和左下)和疾病程度(轻度、中度进展和重度进展)。培养转换时间定义为从开始治疗到首次连续两次培养结果均为阴性的天数,采用对数秩检验进行比较,按国家分层。采用 Cox 比例风险模型,按国家和 HIV 状况分层,以确定与培养转换相关的因素。

结果

364 名参与者中,除 1 人外,其余人均有异常胸部 X 光片:347 人(95%)有上肺区透光性改变,318 人(87%)有下肺区透光性改变,124 人(34%)有严重肺部受累,281 人(77%)有空洞。HIV 与肺部实质透光区的位置、透光区的范围、空洞的存在以及空洞的位置之间没有显著关联。与未感染 HIV 的参与者相比,感染 HIV 的参与者痰培养最高阳性等级(3+)的可能性显著降低(p=0.035)。所有参与者中,空洞均与高涂片阳性等级(p<0.001)和高培养阳性等级(p=0.004)显著相关。合并感染 HIV 与培养转换时间更短相关(风险比 1.59,95%CI 1.05-2.40)。

结论

在抗逆转录病毒治疗时代,HIV 感染者的肺结核影像学表现可能与未感染者不同。影像学表现与培养转换时间不一致,这表明短方案在实现各种肺部受累的痰培养转换方面具有足够的疗效。

试验注册

ISRCTN,ISRCTN78372190。于 2010 年 10 月 14 日注册。首次注册日期 2016 年 10 月 2 日。

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