基层医疗中幽门螺杆菌酶联免疫吸附测定的验证及价值
Validation and value of an enzyme-linked immunosorbent assay for Helicobacter pylori in primary care.
作者信息
Lewin-van den Broek N T, Numans M E, Buskens E, de Wit N J, Smout A J, Verheij T J
机构信息
Dept. of General Practice, and Julius Center for Patient Oriented Research, Faculty of Medicine, University of Utrecht, University Hospital, The Netherlands.
出版信息
Scand J Gastroenterol. 1999 Apr;34(4):391-5. doi: 10.1080/003655299750026407.
BACKGROUND
Helicobacter pylori infection is related to gastric ulcer and carcinoma. In this study we validated the Pyloriset EIA-G New (a quantitative enzyme-linked immunosorbent assay) in a general practice population. The implications of eradication in case of a positive result were assessed.
METHODS
One hundred and fifteen subsequent patients, enrolled in a randomized clinical trial evaluating the optimal strategy for treatment of dyspeptic patients in primary care, were included. Using biopsy as gold standard, we calculated the sensitivity and specificity of the test.
RESULTS
The sensitivity and specificity of the test were 91% (95% confidence interval (CI) = 86% to 97%) and 78% (95% CI = 75% to 82%), respectively. Eradication of H. pylori would be indicated in 8 of 57 positive patients, since these actually had a peptic ulcer. In the other 49 patients eradication therapy would be unnecessary.
CONCLUSION
The Pyloriset EIA-G New is a reliable test in primary care. However, a serologic test-and-treat strategy in all dyspeptic patients cannot be recommended.
背景
幽门螺杆菌感染与胃溃疡和胃癌有关。在本研究中，我们在普通人群中验证了新型幽门螺杆菌酶联免疫吸附测定法（Pyloriset EIA - G New，一种定量酶联免疫吸附测定法）。评估了检测结果呈阳性时根除幽门螺杆菌的意义。
方法
纳入了115例后续患者，这些患者参与了一项评估初级保健中消化不良患者最佳治疗策略的随机临床试验。以活检作为金标准，我们计算了该检测的敏感性和特异性。
结果
该检测的敏感性和特异性分别为91%（95%置信区间（CI）= 86%至97%）和78%（95% CI = 75%至82%）。57例阳性患者中有8例因实际患有消化性溃疡而需根除幽门螺杆菌。在其他49例患者中，根除治疗则无必要。
结论
新型幽门螺杆菌酶联免疫吸附测定法在初级保健中是一种可靠的检测方法。然而，不建议对所有消化不良患者采用血清学检测并治疗的策略。
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