Quartero A O, Numans M E, de Melker R A, de Wit N J
Department of General Practice, Utrecht University, The Netherlands.
Br J Gen Pract. 2000 Jan;50(450):13-6.
Approximately 10% of patients presenting with dyspepsia to the general practitioner have peptic ulcers; the large majority of which are related to infection with Helicobactor pylori. Office-based tests for H. pylori detection are generally validated and evaluated in selected patient groups.
To evaluate the clinical effectiveness of a whole-blood serology test for infection with Helicobacter pylori in detecting peptic ulcer disease (PUD) in daily general practice.
A descriptive study of 171 primary care dyspepsia patients selected for open-access endoscopy in primary care and aged between 18 and 75 years, in 92 general practices in central, southern, and eastern parts of the Netherlands. H. pylori status was assessed using the BM-test Helicobacter pylori, which is identical to the Helisal test. Dyspepsia severity score was measured using a validated symptom score. Symptom characteristics and probability of relevant disease were assessed by the general practitioner. Endoscopy was carried out in local hospitals. Diagnostic outcome of both endoscopy and H. pylori reference test was supplied by local specialists. The BM-test was evaluated against endoscopic results.
A high number (61.8%) of false-negative BM-tests resulted in a low sensitivity (95% confidence interval [CI] = 48-75%) for detection of H. pylori infection. Only 12 out of 32 patients with PUD had a positive BM-test, resulting in a positive likelihood ratio (LR) for PUD of 1.41 and a negative LR of 0.85.
This study confirms the relatively poor performance of the BM-test in daily general practice, and shows the limited diagnostic value of H. pylori office-tests for detecting PUD in primary care. The discriminative value of the test result is too small to support either a 'test-and-endoscope' of a 'test-and-treat' strategy in general practice.
因消化不良症状前往全科医生处就诊的患者中，约10%患有消化性溃疡；其中绝大多数与幽门螺杆菌感染有关。基于门诊的幽门螺杆菌检测试验通常是在特定患者群体中进行验证和评估的。
评估全血血清学检测幽门螺杆菌感染在日常全科医疗中诊断消化性溃疡疾病（PUD）的临床有效性。
一项描述性研究，选取了荷兰中部、南部和东部92家全科诊所中171例因消化不良症状选择接受开放式内镜检查的初级保健患者，年龄在18至75岁之间。使用BM-幽门螺杆菌检测评估幽门螺杆菌感染状况，该检测与Helisal检测相同。使用经过验证的症状评分来测量消化不良严重程度评分。症状特征和相关疾病的可能性由全科医生评估。在内科医院进行内镜检查。内镜检查和幽门螺杆菌参考检测的诊断结果由当地专家提供。将BM-检测结果与内镜检查结果进行对照评估。
大量（61.8%）BM-检测出现假阴性，导致检测幽门螺杆菌感染的灵敏度较低（95%置信区间[CI]=
48 - 75%）。在32例PUD患者中，只有12例BM-检测呈阳性，导致PUD的阳性似然比（LR）为1.41，阴性似然比为0.85。
本研究证实了BM-检测在日常全科医疗中的表现相对较差，并表明在初级保健中，幽门螺杆菌门诊检测对检测PUD的诊断价值有限。检测结果的鉴别价值过小，无法支持全科医疗中“检测并内镜检查”或“检测并治疗‘策略。
