一项多国非劣效性簇随机试验，采用负荷剂量涂片显微镜检查诊断肺结核。
A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis.
机构信息
Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
出版信息
PLoS Med. 2011 Jul;8(7):e1000443. doi: 10.1371/journal.pmed.1000443. Epub 2011 Jul 12.
BACKGROUND
More than 50 million people around the world are investigated for tuberculosis using sputum smear microscopy annually. This process requires repeated visits and patients often drop out.
METHODS AND FINDINGS
This clinical trial of adults with cough ≥2 wk duration (in Ethiopia, Nepal, Nigeria, and Yemen) compared the sensitivity/specificity of two sputum samples collected "on the spot" during the first visit plus one sputum sample collected the following morning (spot-spot-morning [SSM]) versus the standard spot-morning-spot (SMS) scheme. Analyses were per protocol analysis (PPA) and intention to treat (ITT). A sub-analysis compared just the first two smears of each scheme, spot-spot and spot-morning. In total, 6,627 patients (3,052 SSM/3,575 SMS) were enrolled; 6,466 had culture and 1,526 were culture-positive. The sensitivity of SSM (ITT, 70.2%, 95% CI 66.5%-73.9%) was non-inferior to the sensitivity of SMS (PPA, 65.9%, 95% CI 62.3%-69.5%). Similarly, the specificity of SSM (ITT, 96.9%, 95% CI 93.2%-99.9%) was non-inferior to the specificity of SMS (ITT, 97.6%, 95% CI 94.0%-99.9%). The sensitivity of spot-spot (ITT, 63.6%, 95% CI 59.7%-67.5%) was also non-inferior to spot-morning (ITT, 64.8%, 95% CI 61.3%-68.3%), as the difference was within the selected -5% non-inferiority limit (difference ITT = 1.4%, 95% CI -3.7% to 6.6%). Patients screened using the SSM scheme were more likely to provide the first two specimens than patients screened with the SMS scheme (98% versus 94.2%, p<0.01). The PPA and ITT analysis resulted in similar results.
CONCLUSIONS
The sensitivity and specificity of SSM are non-inferior to those of SMS, with a higher proportion of patients submitting specimens. The scheme identifies most smear-positive patients on the first day of consultation.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN53339491. Please see later in the article for the Editors' Summary.
背景
每年，全世界有超过 5000 万人使用痰涂片显微镜检查来诊断结核病。这个过程需要反复就诊，并且患者经常会中途退出。
方法和发现
本项针对咳嗽持续时间≥2 周的成年人（在埃塞俄比亚、尼泊尔、尼日利亚和也门）的临床试验比较了两种方案的敏感性/特异性，即首次就诊时采集的两份即时痰样本加次日清晨采集的一份痰样本（即时-即时-清晨[SSM]）与标准的清晨-即时-清晨（SMS）方案。分析采用按方案分析（PPA）和意向治疗（ITT）。亚分析比较了每种方案的前两份即时痰样本，即时-即时和清晨-即时。共有 6627 例患者（SSM 3052 例，SMS 3575 例）入组；6466 例患者进行了培养，其中 1526 例培养阳性。SSM 的敏感性（ITT，70.2%，95%CI 66.5%-73.9%）不劣于 SMS 的敏感性（PPA，65.9%，95%CI 62.3%-69.5%）。同样，SSM 的特异性（ITT，96.9%，95%CI 93.2%-99.9%）不劣于 SMS 的特异性（ITT，97.6%，95%CI 94.0%-99.9%）。即时-即时（ITT，63.6%，95%CI 59.7%-67.5%）的敏感性也不劣于清晨-即时（ITT，64.8%，95%CI 61.3%-68.3%），因为差异在选定的-5%非劣效性界限内（差异 ITT=1.4%，95%CI -3.7%至 6.6%）。使用 SSM 方案筛查的患者比使用 SMS 方案筛查的患者更有可能提供前两份标本（98% 比 94.2%，p<0.01）。PPA 和 ITT 分析得出的结果相似。
结论
SSM 的敏感性和特异性不劣于 SMS，并且提交标本的患者比例更高。该方案可在首次就诊当天确定大多数涂片阳性的患者。
试验注册
当前对照试验 ISRCTN53339491。请稍后在文章中查看编辑摘要。
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