Kawai Takashi, Kawakami Kohei, Kudo Taku, Ogiahara Shoji, Handa Yutaka, Moriyasu Fuminori
Fourth Department of Internal Medicine, Tokyo Medical University.
Intern Med. 2002 Oct;41(10):780-3. doi: 10.2169/internalmedicine.41.780.
Serological antibody test have been widely performed to detect the presence of H. pylori, but they have not been used to evaluate the status of H. pylori after eradication. In this study we evaluated the diagnostic accuracy of a new serological test kit (E-plate) after eradication.
Eradication of H. pylori was performed in 100 patients by proton pump inhibitor (PPI)+amoxicillin (AMPC)+clarithromycin (CAM) or PPI+AMPC therapy. Evaluation of H. pylori was done by culture, histology and rapid urease test before, and 8 weeks after, the treatment. Serological tests were also performed before and after treatment using the E plate. Cure was defined as no evidence of H. pylori at 8 weeks after the treatment. Receiver operating characteristic (ROC) analysis was performed to determine the ideal cut-off value for percentage change in the serological test.
Success was obtained in 73 patients, failure in 20 patients and there were 7 dropouts. Serological test value was significantly decreased after treatment (44.3 +/- 29.6 U/ ml) compared to before treatment (94.8 +/- 73.2 U/ml) in the successful cases. In contrast, those with no significant change after treatment (62.7 +/- 31.3 U/ml) compared to before treatment (72.9 +/- 47.7 U/ml) were considered as failure cases. ROC analysis revealed that cut-off values of a 20%, 30%, and 40% decrease on E plate result yielded a sensitivity of 95.5%, 92.4%, 71.2% and a specificity of 73.3%, 84.2%, 94.7%, respectively.
The new E plate serological test kit for H. pylori was useful for distinguishing success from failure 8 weeks after completion of eradication therapy for H. pylori.
血清学抗体检测已被广泛用于检测幽门螺杆菌的存在，但尚未用于评估根除幽门螺杆菌后的状态。在本研究中，我们评估了一种新型血清学检测试剂盒（E板）在根除幽门螺杆菌后的诊断准确性。
对100例患者采用质子泵抑制剂（PPI）+阿莫西林（AMPC）+克拉霉素（CAM）或PPI+AMPC疗法根除幽门螺杆菌。在治疗前和治疗后8周，通过培养、组织学和快速尿素酶试验评估幽门螺杆菌。治疗前后还使用E板进行血清学检测。治愈定义为治疗后8周无幽门螺杆菌感染证据。进行受试者操作特征（ROC）分析以确定血清学检测百分比变化的理想临界值。
73例患者治疗成功，20例失败，7例退出研究。成功病例治疗后血清学检测值（44.3±29.6 U/ml）与治疗前（94.8±73.2 U/ml）相比显著降低。相比之下，治疗后与治疗前相比无显著变化（62.7±31.3 U/ml）与（72.9±47.7 U/ml）的患者被视为失败病例。ROC分析显示，E板结果下降20%、30%和40%的临界值分别产生95.5%、92.4%、71.2%的敏感性和73.3%、84.2%、94.7%的特异性。
新型幽门螺杆菌E板血清学检测试剂盒有助于在幽门螺杆菌根除治疗完成8周后区分治疗成功与失败。
