摘要
目的 评价一种新的酶免疫法———幽门螺杆菌 (Hp)粪便抗原 (HpSA)试验检测Hp感染和监测Hp根除治疗的可靠性。方法 未接受过抗Hp治疗的患者分为 2组,A组 331例,无胃部手术史;B组 65例,胃大部切除术后。2组患者因上消化道症状而接受胃镜检查,以胃黏膜活检标本快速尿素酶试验(RUT)和组织学检查 (W S染色 )联合检测Hp作为“金标准”,对HpSA试验的准确性进行评价,并与另一非侵入性的13C 尿素呼气试验(13C-UBT)加以比较。此外,A组中Hp阳性的 56例患者 (C组)给予三联根除治疗 1周,分别于停药后第 1、7、14、21、28天收集粪便标本进行HpSA测定。于停药后第 28天测定13C UBT,并以此为标准,评价HpSA试验的准确性。结果 A组患者经“金标准”诊断Hp阳性 175例,阴性 156例。HpSA试验的敏感性为95. 4%,特异性为 91. 0%,与 13C UBT比较差异无统计学意义。B组患者中,经“金标准”诊断Hp阳性 30例,阴性 35例。HpSA试验敏感性为 90. 0%, 13C UBT的敏感性为 66. 7%。HpSA试验的敏感性明显优于13C UBT(P<0. 05)。C组患者于停药后第 28天经 13C UBT诊断Hp阳性 16例,阴性 40例。HpSA于停药后第 1天 54例阴性,此后随时间推移,未成功根除病例陆续转为阳性,而成功根除病例仍大部分保持在阴性范围,仅少数病例出现假阳性。停药?
Objective The aim of this study was to assess the reliability of a newly developed enzymeimmumoassay, the Helicobacter pylori (H. pylori) stool antigen (HpSA) test, for the detection of H.pylori infection before and after eradication. Methods The H.pylori infected patients referred to our department were included. They were divided into two groups. The 331 patients in group A had intact stomach, and 65 patients in group B had history of subtotal gastrectomy. All patients underwent gastroscopy with biopsies for rapid urease test (RUT) and histology, which was viewed as “gold standard”. H.pylori status was defined as positive or negative with both RUT and histology presenting concordant positive or negative results. The results of these reference tests were compared with those obtained by HpSA test and ()^(13)C-urea breath test (()^(13)C-UBT). In addition, Fifty-six-positive patients in group A, constituting group C, were treated with 1-week triple therapy. At the 28 th day after the end of therapy, the patients underwent another ()^(13)C-UBT which was also defined as “gold standard”. The stool specimens were collected on days 1, 7, 14, 21, and 28 after completion of therapy and were used to detect the antigen of H.pylori by HpSA. Results In group A, 175 patients were defined as H.pylori-positive and 156 as negative by the “gold standard”. The sensitivity and specificity of the HpSA test was (95.4%) and 91.0%, respectively. There was no significant difference between HpSA test and ()^(13)C-UBT. In group B, 30 patients were defined as H.pylori-positive and 35 as negative by the “gold standard”. The sensitivity of the HpSA test and ()^(13)C-UBT was 90.0% and 66.7%, respectively (P<0.05). In group C, 16 patients were defined as H. pylori-positive and 40 as negative by ()^(13)C-UBT on day 28 after antimicrobial therapy. HpSA tests became negative immediately after the end of treatment in 54 patients. During the 4-week follow-up period, HpSA gradually changed to positive in patients without successful eradication and remained negative in patients with successful eradication except for several cases. The accuracy of the HpSA test was excellent on day 28 after treatment (92.9%). Conclusions HpSA test is a reliable non-invasive method for the diagnosis of H. pylori infection before and after treatment. It is also accurate for the detection of H.pylori infection in the patients with subtotal gastrectomy.
出处
《中华消化杂志》
CAS
CSCD
北大核心
2005年第1期15-18,共4页
Chinese Journal of Digestion
