微量胶囊^14C-尿素呼气诊断胃内幽门螺杆菌的临床价值

胃内幽门螺杆菌(简称Hp)感染与消化疾病密切相关,故诊断Hp感染显得尤为重要。目前诊断Kp的方法很,多为侵人性(包括快速尿素酶、病理染色、细菌培养等),对患具有一定创伤和痛苦;血清Hp-IgG抗体测定为非侵人性,但根除Hp后血清Hp抗体需长时间才能转阴,不宜疗效考核。无创伤性呼气试验可作为根除Hp前后诊断的金标准。我院于1998年5月至1999年5月,采用微量^14C-尿素呼气法(简称^14C-UBT)诊断Hp感染,同时予快速尿素酶法(RUT)、病理染色(W-S染色)对照,及追踪根除Hp后疗效检测。旨在观察^14C-UBT法在诊断胃内Hp感染的临床价值。现报告如下。     

几种幽门螺杆菌检测方法的比较和评价

目的检测幽门螺杆菌(Helicobacterpylori,Hp)感染的方法很多.本研究对检测Hp的病理组织学、血清学、13C呼气试验(13C-UBT)以及快速尿素酶(HpUT)试验进行比较分析和评价方法151例因各种消化道症状就诊的患者均行内镜检查,同时应用病理组织学,血清学,13C呼气试验(13CUBT)以及快速尿素酶(HpUT)等四种方法检测幽门螺杆菌.其中两项阳性被认为Hp感染存在.结果①151例患者中Hp阳性者127例,总感染率84.1%.②病理组织学、血清学、13C呼气试验、快速尿素酶检测的敏感度分别为88.1%,78.7%,88.2%,71.6%;特异度分别为100%,70.3%,95.0%,63.8%.③四种方法检测的符合率@HpUT与病理组织染色检测的符合率是77.9%.bHpUT与13C-UBT的符合率为70.6%.cHpUT与血清抗体检测的符合率为82%.d病理组织染色与13C-UBT的符合率为74.2%.⑤病理组织染色与血清抗体检测的符合率为63%.⑥13C-UBT与血清抗体检测的符合率为66.7%结论四种检测方法中病理组织染色与13C-UBT的敏感性和特异性都比较高.这两种检查能比较准确地反映体内Hp感染的真实情况.13C-UBT更能准确反映全胃Hp感染的实际情况.快速尿素酶试验和血清抗体检测的结果也较好,其操作方便,费用低,也可作为临床常用的检测手段.两种检查方法的联合为诊断Hp感染较好的选择.以13C呼气试验与HpUT联合;病理组织学W-S染色与HpUT联合的阳性率、敏感度、特异性以及诊断符合率、阳性预测值、阴性预测值同时较高     

老年人幽门螺杆菌粪便抗原检测的价值

目的 评价一种新的酶联免疫法检测老年人粪便中幽门螺杆菌（helicobacter pylori,Hp）特异抗原的可靠性和临床应用价值。方法 因上消化道症状行胃镜检查的老年患者共199例，其中既往无胃手术史者151例，胃大部切除术后者48例。均行胃粘膜活检，作快速尿素酶试验（RUT）和组织学检查（W－S染色），以RUT和W－S染色为金标准，两项均阳性（或阴性）诊断为Hp阳性（或阴性）。所有患者均检查幽门螺杆菌粪便抗原（HpSA）和^13C－尿素呼气试验（^13C-UBT），分别与金标准比较，计算其敏感性和特异性。结果 经金标准诊断，无胃手术史患者中Hp阳性81例，阴性70例。HpSA检测的敏感性和特异性分别为96.3%和90.0%，^13C-UBT为92.6%和92.9%，两种方法的敏感性和特异性差异无显著性。胃大部切除术后患者中Hp阳性23例，阴性25例，HpSA检测的敏感性和特异性分别为91.3%和88.0%，^13C-UBT为65.2%和92.0%，两种方法敏感性差异有显著性（P＜0.05）。结论 HpSA在诊断老年人Hp感染方面准确、快速、简便，值得推广。对于胃大部切除术后的老年患者，其诊断Hp的敏感性明显优于^13C-UBT。     

现症感染条带检测对儿童幽门螺杆菌感染的诊断价值

目的评价现症感染条带（CIM）检测诊断儿童幽门螺杆菌（Hp）感染的价值。方法对102例有上消化道症状的患儿行胃镜检查并取胃窦黏膜活检,分别经快速尿素酶试验（RUT）及免疫组化染色检测Hp;在胃镜检查前分别行13C-尿素呼气试验（13C-UBT）和CIM血清学检测Hp。以13C-UBT为金标准,评价CIM诊断Hp感染的敏感性、特异性和准确性。结果 CIM诊断Hp感染的敏感率高于RUT及免疫组化染色（P均〈0.05）,特异率高于RUT（P〈0.05）。结论 CIM可作为诊断儿童Hp现症感染的有效检测手段。     

胃大部切除术后患者幽门螺杆菌感染诊断方法的评估

目的：评估胃大部切除术后患者中幽门螺杆菌(Hp）感染状态和两种常用诊断方法（^14C-尿素呼气试验、快速尿素酶试验）的准确性，方法：用培养、组织学、^14C-尿素呼气试验（^14C-UBT)和 快速尿素酶试验（RUT）四种方法同时对胃大部切除术后患者进行Hp感染的诊断，以培养和组织学联合诊断作为“金标准”，评估^14C-UBT和RUT的准确性，以非手术者作对照，评估胃大部切除术患者的Hp感染率。结果：37例胃大部切除术后患者（Billroth Ⅰ或17例和BillrothⅡ式20例）的Hp总阳性率为29．7％，BillrothⅠ式（29．4％）和Ⅱ式（30．0％）患者间Hp阳性率差异无显著性（P＞0．05）。RUT敏感性为72．7％，特异性为57．7％，准确性为62．2％，^14C-UBT敏感性为63．6％，特异性为100．0％，阴性预示值86．7％，。对照组Hp阳性率为71．4％。结论：胃大部切除术后患者Hp感染率低，RUT特异性低，^14C-UBT敏感性低，因此均不适用于胃大部切除术后患者Hp感染的诊断。     

^13C—尿素呼气试验诊断幽门螺杆菌感染的研究

目的评估13C-尿素呼气试验（13C-UBT）幽门螺杆菌（Hp）感染的可靠性。方法对82例因胃病而行胃镜检查的患者，于胃窦和胃体取多个活检标本作组织学、粘膜涂片和快速尿素酶试验，以决定是否感染Hp，并作13C-UBT。结果13C-UBT的敏感性、特异性、阳性预测值、阴性预测值是与组织学和尿素酶方法检测Hp的检测结果比较而计算得到。13C-尿素呼气试验的敏感性97．92％、特异性100％、阳性预测值100％、阴性预测值97．14％、准确性98．78％。结论13C-尿素呼气试验有高度敏感性和特异性，对确定患者的Hp感染状态是一非常可靠而又无创伤的诊断方法。     

14C-UBT和RUT诊断慢性胃炎Hp感染11O例分析

幽门螺杆菌(Helicobacter Pyloft简称Hp)是一微需氧的革兰氏阴性杆菌.自1993年Warren和Mashall从慢性胃炎病人的胃粘膜中分离及培养出Hp以来的十多年间,在Hp的诊断治疗方面取得了巨大的进展.Hp显著的生物学特征之一是具有分泌尿素酶的功能,尿素酶可迅速降解尿素成为二氧化碳和氨.医学界在Hp的诊断方面相继出现了胃粘膜尿素酶试验(RUT)和同位素13C和14C尿素酶呼气试验(即13C和14CUBT).现就我院消化科从1988年以来开展RUT检测Hp感染十年多的基础上自1998年2月2日开展了14C-UBT法检测Hp,并对慢性胃炎、消化性溃疡、胃粘膜相关淋巴瘤(MALT)等胃部疾病用14C-UBT和RUT两种方法共检测660余例次,本文就此两种方法检测慢性胃炎病例Hp感染110例的资科的结果对比和统计分析如下.     

~(14)C-呼气试验检测幽门螺杆菌感染

本文应用国产~(14)C-呼气试验(~(14)C-UBT)试剂检测幽门螺杆菌(Hp)。同时应用病理组织染色、尿素酶试验、细菌培养和血清 ELISA 技术等方法与之进行比较。117例病人中 Hp 阳性率为47.9%(56/117),~(14)C-UBT的敏感性与特异性分别为94.6%和93.4%。~(14)C-UBT 由于相对于胃镜依赖的方法而言创伤性大大降低,是目前检测 Hp 感染,尤其是药物治疗后复查时的首选方法。     

14C-尿素呼气试验对幽门螺杆菌感染的诊断价值

目的：评估^14C-尿素呼气试验（^14C-UBT）对幽门螺杆菌（HP）感染的诊断价值。方法：对2000例1月内未曾使用可能影响HP检测结果的药物者同步完成快速尿酶试验（RUT）、病理、^14C-UBT检测，以病理（HE染色）、RUT均阳性为诊断HP感染的标准，评价^14C-UBT对HP感染的诊断价值。结果：^14C-UBT的敏感性89.7％，特异性98.4％，阳性预测值98.4％，准确性93.4％，阴性预测值88.1％。结论：^14C-UBT是HP感染无创伤、敏感而特异的诊断方法。     

评价幽门螺杆菌根除治疗效果的检查方法和时机选择

幽门螺杆菌(Hp)根除治疗后,因细菌数量减少和尿素酶活性受抑制或其他产尿素酶的细菌过度生长,常导致多种Hp 检测方法出现假阴性或假阳性,影响对Hp根除治疗效果的评价.本文对根除治疗后Hp检查方法和时机的选择加以综述,Hp根除治疗后6mo,尿素酶依赖性试验(RUT或13C-UBT)评价根除治疗效果准确性高,粪便Hp抗原(Hp SA)试验在根除治疗后6 mo仍有一定的假阳性,准确性不如尿素酶依赖性试验.     

The clinical utility of string-PCR test in diagnosing Helicobacter pylori infection

BACKGROUND/AIMS: Non-invasive string test has been reported as being convenient and capable of yielding bacteria by means of gastric juice sampling in the diagnosis of Helicobacter pylori infection. Molecular methods, such as polymerase chain reaction for the amplification of DNA, are desirable for the detection of minute quantities of H. pylori. We planned to evaluate the diagnostic efficiency of the combination of the string test and polymerase chain reaction and determine whether the string polymerase chain reaction test could obtain more information in conditions where the bacterial load is so low that other diagnostic tests fail to confirm the presence of H. pylori. METHODOLOGY: We enrolled 48 dyspeptic patients, including 29 males and 19 females, with a mean age of 52.5 years. Each patient received endoscopy and biopsy-based tests, including RUT (rapid urease test), cultures, and histology, followed by 13C-UBT (13Carbon urea breath test). We used the string test, (Entero-Test H. pylori, HDC Corporation, CA, US), for gastric juice sampling. The specimen was further analyzed by polymerase chain reaction for the presence of H. pylori with the primer for cagA gene, which is highly prevalent in Taiwan. H. pylori infection was considered as positive when either culture yield was positive, or when two of the other three tests, including RUT, histology, and 13C-UBT, were positive. RESULTS: Of the total 48 patients, 34 patients were H. pylori-positive, and 14 were H. pylori-negative. A fragment of 349 bp of polymerase chain reaction products was detected by agarose gel electrophoresis in 32 out of 34 patients who was classified as H. pylori-positive. The sensitivity, specificity, positive predictive value, and negative predictive value of the string polymerase chain reaction test were 94.12%, 96.97%, 92.86%, and 86.67%, respectively. These results are comparable to 13C-UBT and RUT, and better than histology and culture. One subject, who tested as H. pylori-negative according to the diagnostic criteria, had positive 13C-UBT and string polymerase chain reaction test results. Further sequencing of the DNA obtained from the results of polymerase chain reaction product was performed and it showed 98% identities with the known sequence of cagA strain H. pylori (GenBank accession number: AF249275). CONCLUSIONS: The string polymerase chain reaction test is non-invasive and provides direct bacterial yields. Its diagnostic efficiency is comparable with 13C-UBT and RUT in detecting H. pylori infection. Also, with the assistance of polymerase chain reaction and DNA sequencing, we can diagnose H. pylori infection even when the bacterial load is low. Further application of string polymerase chain reaction test in the genetic analysis of virulent and resistant strains seems promising.     

Evaluation of 13C-urea breath test to confirm eradication of Helicobacter pylori]

This study aimed to evaluate the effectiveness of the 13C-urea breath test (UBT) for assessment of Helicobacter pylori eradication after treatment. One hundred twenty six patients were enrolled with 85 receiving proton pomp inhibitor based triple therapy. They were underwent upper gastrointestinal endoscopy with biopsies for diagnosis and assessment of H. pylori infection using culture, histology, rapid urease test (RUT) and 13C-UBT. Assessment of eradication needs to be performed 4 weeks or more after completion of treatment. Breath samples were taken 15 minutes after the ingestion of 100 mg 13C-urea. Breath samples were analyzed on a mass spectrometer system. The gold standard for H. pylori infection was a positive culture or positive histology + positive RUT; negative for infection was defined as negative results of all three biopsy tests. Based on ROC curves, the most appropriate cut-off value for diagnosis of H. pylori infection was identified as 2.5/1000, which provided 96.2% sensitivity, 100% specificity, and 96.8% accuracy as judged by the gold standard. However, when confirming the eradication of H. pylori, it was 3.5/1000, which provides for 100%, 95.8%, and 96.5%, respectively. Ten patients (11.8%) had delta13C values that were 2.5-5.0/1000 4-12 weeks after therapy. Eight patients were considered cured of H. pylori infection, and 2 were considered to still have H. pylori infection following 13C-UBT, serology, and H. pylori specific antigen test. The false-positive rate of 13C-UBT was 9.4% (8/85). When the grey zone of 13C-UBT was set at a level of 2.5 to 5.0/1000 (2.5 > : negative, 5.0 < or = : positive) after eradication therapy, the sensitivity and specificity of 13C-UBT was 100% and 98.4% compared to the gold standard. It was concluded that to avoid false-positive results of 13C-UBT, the grey zone of 13C-UBT needs to be set at a level of 2.5 to 5.0/1000; thus improving the accuracy of test for the assessment of eradication of H. pylori infection.     

两种13C-尿素呼气试验试剂诊断幽门螺杆菌感染临床可靠性比较

^13C-尿素呼气试验快捷、无创伤，敏感性和特异性高。在临床上被广泛应用于幽门螺杆菌(H.pylori)感染的检测。从加拿大进口的^13C-尿素试剂已获得国家食品药品监督管理局许可并应用于临床。目的：与加拿大进口的^13C-尿素试剂进行比较，评估美国Isotec公司生产的^13C-尿素试剂用于诊断H.pylori感染的临床可靠性。方法：114例因上消化道症状接受胃镜检查者随机分为A、B两组。取胃窦活检标本分别作快速尿素酶试验、组织学检查和H．pylori培养．三项中有两项或以上阳性，或H．pylori培养单项阳性判为H．pylori感染，否则判为无H．pylori感染。以此作为诊断H．pylori感染的金标准。A组使用加拿大进口的^13C尿-素试剂，B组使用美国Isotec公司生产的^13C-尿素试剂，分别进行^13C-尿素呼气试验。根据金标准分别计算和比较两组^13C-尿素呼气试验的准确性、敏感性、特异性和阳性预测值、阴性预测值。结果：A组^13C-尿素呼气试验诊断H．pylori感染的准确性为92．8％，敏感性为94．1％，特异性为90．9％，阳性预测值为94．1％，阴性预测值为90．9％；B组准确性为98．3％。敏感性为96．9％，特异性为100％，阳性预测值为100％，阴性预测值为96.3％。两组上述各项指标均无显著差异。结论：A组和B组^13C-尿素呼气试验诊断H．pylori感染的准确性、敏感性、特异性和阳性预测值、阴性预测值均较高．美国Isotec公司生产的^13C-尿素试剂用于临床诊断H．pylori感染结果可靠。     

Evaluation of urine ELISA test for detecting Helicobacter pylori infection in Taiwan： A prospective study

AIM: To evaluate the diagnostic accuracy and clinical utility of a new ELISA (URINELISA) test for detecting Helicobacter pylori(H pylori) antibody in the urine of Taiwanese population. METHODS: In this prospective study, 317 consecutive dyspeptic patients (171 men, 146 women; mean age, 51.0 years) were included. They underwent gastroendoscopy for evaluation. Invasive tests, including culture, histology, and rapid urease test (RUT), and non-invasive ~(13)C-urea breath test were preformed. At the same time, urine specimens were collected for URINELISA. The status of H pylori infection was considered as positive when either culture was positive, or when two of the other, RUT, histology or 13C-UBT, were positive. RESULTS: The sensitivity, specificity, positive predictive value, and negative predictive value of URINELISA are 91.7% (211/230), 90.8% (79/87), 96.3% (211/219), and 80.6% (79/98) respectively. CONCLUSION: This URINELISA test is reliable, inexpensive and easy-to-use. The high diagnostic accuracy warrants the use of URINELISA as a first-line screening tool for diagnosis of H pylori infection in untreated patients.     

~(13)C-尿素呼气试验诊断幽门螺杆菌感染的研究

本研究旨在评估~(13)C,尿素呼气试验检测幽门螺杆菌感染的可靠性。方法:我们在82例因胃病而行胃镜检查的患者胃窦和胃体取多个活检标本,作组织学、牯膜涂片和快速尿素酶试验,以决定是否感染幽门螺杆菌,并作~(13)C-尿素呼气试验。~(13)C-尿素呼气试验的敏感性、特异性、阳性预测值、阴性预测值是与组织学和尿素酶方法检测幽门螺杆菌的结果比较而计算得到。结果:~(13)C-尿素呼气试验的敏感性97.92％,特异性100％,阳性预测值100％,阴性预测值97.14％,准确性98.78％。结论:~(13)C-尿素呼气试验有高度敏感性和特异性,对确定患者的幽门螺杆菌感染状态是一可靠的无创伤的诊断方法。     

Breath test is very reliable for diagnosis of Helicobacter pylori infection in real clinical practice

AIMS: To determine the accuracy of the most common available tests for the diagnosis of Helicobacter pylori infection in an unselected and untreated population of patients. PATIENTS AND METHODS: Prospective study including 314 unselected patients from a population of 814 patients referred for upper endoscopy at one hospital. H. pylori infection was diagnosed by rapid urease test (RUT), histology, culture and 13C-urea-breath test (UBT) and serum IgG (EIA). H. pylori infection was defined as positive if culture or at least two of the other tests were positive. RESULTS: The prevalence of H. pylori infection in this population was 72%. The diagnostic test with the greatest combination of sensitivity (97%) and specificity (100%) was the UBT. EIA had a good sensitivity (96%), but it was the test with the least specificity (71%). RUT, histology and culture showed a high specificity (>98%) but a sensitivity lower than 90%. In elderly patients (>65 years old, n=120), UBT was also the test with the greatest combination of sensitivity (94%) and specificity (100%). CONCLUSIONS: In conditions of real clinical practice the 13C-urea-breath test is a reliable test for H. pylori diagnosis, both in young and elderly patients.     

14C-urea breath test for assessment of gastric Helicobacter pylori colonization and eradication.

BACKGROUND AND OBJECTIVE: Urea breath test (UBT) is a reliable noninvasive technique for detecting gastric Helicobacter pylori colonization. 14C isotope-based test requires simple equipment and is inexpensive. We studied the utility of 14C-UBT in diagnosis of gastric H. pylori infection. METHODS: Presence of H. pylori was studied using antral histology and culture in patients with rapid urease test (RUT)-positive peptic ulcer. 14C-UBT was performed using a 185-kBq dose. Radioactivity in 15-min breath samples was measured using a beta-scintillation counter and result expressed as % dose recovered/mmol CO2. H. pylori was considered positive when any two tests were positive. All tests were repeated one month after completion of H. pylori eradication therapy. RESULTS: Among 41 patients (duodenal ulcer 36, gastric ulcer 5), H. pylori was detected by histology in 23 (56%) and by culture in 27 (66%). Overall, H. pylori was detected in 28 (68%) patients. Follow-up assessment was possible in 28 patients: 26 cleared the infection (all three tests negative). Mean 14C recovery values at 15 minutes associated with H. pylori-positive status were significantly higher (12.3 [SD 6.8] x 10(-3); n=30; p<0.001) than those associated with H. pylori-negative status (2.1 [0.9] x 10(-3); n=26). Using receiver-operating-characteristic analysis of 15-minute 14C recovery values, a cut-off of 6.5x10(-3) gave the best separation of H. pylori-positive and -negative cases. 14C-UBT had 93% sensitivity, 96% specificity and 95% accuracy. CONCLUSION: 14C-UBT appears to be a reliable noninvasive test for diagnosis of H. pylori infection.     

红外能谱仪检测~(13)C-尿素呼气试验诊断幽门螺杆菌感染

目的：验证红外能谱仪检测１３Ｃ－尿素呼气试验（ＵＢＴ）诊断幽门螺杆菌（Ｈ．ｐｙｌｏｒｉ）感染的可靠性,并与气体质谱仪检测结果作一比较。方法：对７６例患者以红外能谱仪进行１３Ｃ－ＵＢＴ检测Ｈ． ｐｙｌｏｒｉ感染,Ｈ． ｐｙｌｏｒｉ感染状态由快速尿素酶试验、组织学检查以及细菌培养确定。其中１７例患者的呼气样本分别用红外能谱仪与气体质谱仪进行检测。结果：７６例患者中Ｈ． ｐｙｌｏｒｉ阳性者４３例（５６．６％）,红外能谱仪进行１３Ｃ－ＵＢＴ的测定结果为４１例（５３．９％）,其敏感性和特异性分别达到９３．０％和９７．０％。气体质谱仪与红外能谱仪的检测数值相差无几。结论：以红外能谱仪进行１３Ｃ－ＵＢＴ检测可靠、准确地诊断Ｈ．ｐｙｌｏｒｉ感染,并具有简单、实用的特点。红外能谱仪与气体质谱仪一样可被广泛应用于Ｈ．ｐｙｌｏｒｉ检测。     

Comparison of serum and urine ELISA methods for the diagnosis of Helicobacter pylori--a prospective pilot study

BACKGROUND/AIMS: Helicobacter pylori infection has a close relationship with many upper digestive tract diseases, but a gold standard for identifying this infection has not yet been well established, especially in clinical application. There is an increasing interest in non-invasive diagnostic tests. In this study, we will compare two non-invasive tests (ELISA method of urine and serum) in clinical use. METHODOLOGY: 170 patients (82 women, 88 men; mean age 52.4 yr) were included in this study and all underwent gastroendoscopy. None of the patients had received any H. pylori eradication therapy. The H. pylori infection status was evaluated by histology, culture, CLO test, and 13C-UBT. We also collected urine and serum for the ELISA method. H. pylori infection was defined as positive if the culture was positive or if two of the other three tests (histology, CLO test and 13C-UBT) were positive. If all four tests were negative or only one of the other three tests was positive, the result would be interpreted as negative. RESULTS: Of these 170 patients, 107 (62.94%) were H. pylori infected and 63 (37.06%) were uninfected. The sensitivity, specificity, positive predictive value and negative predictive value of serum ELISA were 96.26%, 74.60%, 86.55%, and 92.16% respectively; while those of urine ELISA were 93.46%, 92.06%, 95.24% and 89.23% respectively. There was no significant difference between these two tests in sensitivity, but urine ELISA has better specificity than serum ELISA significantly. CONCLUSIONS: Urine ELISA is a better non-invasive test for H. pylori infection than serum ELISA in clinical practice, because no blood need be drawn, it is safer, easier, and more convenient for sampling and has better specificity. Therefore it would be suitable in epidemiological screening of H. pylori infection, especially in young children, older patients and those who cannot cooperate.