One week triple therapy for Helicobacter pylori: a multicentre comparative study

Background—Eradication ofHelicobacter pylori cures and prevents the relapse ofduodenal ulceration and also results in histological resolution ofchronic active gastritis.
Aim—To compare four treatment regimenslasting seven days of a proton pump inhibitor and two antibiotics inthe eradication of H pylori.
Patients—Men or women with Hpylori positive duodenal ulceration or gastritis, or both.
Methods—A single blind, prospectively randomised,parallel group, comparative, multicentre study. After a positive CLOtest, patients underwent histology, H pylori culture, anda ¹³C urea breath test to confirm H pyloristatus. Treatment with one of four regimens: LAC, LAM, LCM, or OAM,where L is 30 mg of lansoprazole twice daily, A is 1 g of amoxycillintwice daily, M is 400 mg of metronidazole twice daily, C is 250 mg ofclarithromycin twice daily, and O is 20 mg of omeprazole twice daily,was assigned randomly. A follow up breath test was done at least 28 days after completing treatment.
Results—H pylori eradication(intention to treat) was 104/121 (86.0%) with LAC, 87/131 (66.4%)with LAM, 103/118 (87.3%) with LCM, and 94/126 (74.6%) with OAM.There was a significant difference (p < 0.001) in the proportion ofpatients in whom eradication was successful between LAC and LCM whencompared with LAM, but no significant difference (p = 0.15) between LAMand OAM. Metronidazole resistance before treatment was identified as asignificant prognostic factor with regard to eradication of Hpylori. The regimens which contained metronidazole weresignificantly less effective than those without metronidazole in thepresence of pretreatment resistant H pylori. There was nodifference among the treatment groups with regard to the incidence andseverity of adverse events reported.
Conclusions—All four treatment regimenswere safe and effective in eradicating H pylori in thepatient population studied. LAC was the most efficacious treatment inpatients with pretreatment metronidazole resistant Hpylori, and was significantly better than LAM and OAM in thisgroup of patients.

Keywords:eradication; Helicobacterpylori; lansoprazole; omeprazole; metronidazole resistance

     

唾液幽门螺杆菌IgG测定在胃癌初步筛查中的价值

胃癌的症状常无特异性,大多数患者诊断时己属中晚期,预后较差.但若能得到早期诊断和及时治疗,则预后甚好,5年存活率在80%以上.     

Performance of two immunosorbent assay kits for the detection of serum immunoglobulin G to Helicobacter pylori in untreated greek patients

BACKGROUND: The performance of serological methods used to detect Helicobacter pylori varies with the ethnicity and prevalence of the infection in the community. We have prospectively evaluated the performance of two commercially available serum enzyme immunoassays (EIA) detecting H. pylori immunoglobulin G (IgG) antibodies in the sera of untreated Greek patients. METHODS: One-hundred-and-thirty consecutive untreated dyspeptic patients underwent endoscopy with biopsies from the gastric body (n = 2) and antrum (n = 2). Serum samples were also obtained from each patient. Serum H. pylori IgG antibody titres were determined with two EIA kits (Pyloriset EIA-G and Milenia H. pylori IgG). Sensitivities, specificities and optimal cut-off values of serum EIAs were determined for the population under investigation by using receiver operating characteristic (ROC) curve analysis and histology as gold standard. RESULTS: Ninety-seven patients were defined H. pylori-positive and 33 negative by histology. ROC curve analysis for the Pyloriset kit yielded 86% (95% CI, 78%-92%) sensitivity and 85% (68%-95%) specificity at an optimal cut-off value of >358 units/ml. The respective values for the Milenia kit were 86% (78%-92%) and 82% (65%-93%) at an optimal cut-off value of >51 units/ml. The suggested cut-off values of the manufacturers for Pyloriset and Milenia kits are >300 and >44 EIA units, respectively, which yield 2% and 4% higher sensitivity, but 9% lower specificity for both EIA kits. CONCLUSIONS: Both serum EIA kits performed well in our study. Our data show that EIA cut-off values should be optimized for the population under investigation.     

安速快速检测试剂盒诊断幽门螺杆菌的现症感染

目的:评价安速幽门螺杆菌(H pylori)快速检测卡诊断H pylori现症感染的敏感性及特异性.方法:对154例因上消化道症状进行胃镜检查的患者同时进行快速尿素酶试验及Warthin- Starry银染,同时取指血进行安速快速检测试剂盒检测.以快速尿素酶试验和Warthin-Starry银染同时阳性或阴性作为诊断是否H pylori感染的金标准.结果:和金标准相比较,安速快速检测试剂盒敏感性为92.0%(81/88),特异性为94.0%(47/50).准确率为92.8%(128/138);与RUT相比安速快速检测试剂盒敏感性为89.7%(87/97),特异性为91.2%(52/57),准确性为90.3%(139/154).结论:安速快速检测试剂盒在没有进行根除治疗的患者中能够较好的反应现症感染的情况.临床可用于H pylori现症感染的诊断.     

幽门螺杆菌临床检验方法评价及选择

幽门螺杆菌(H.pylori,简称Hp)是1983年由澳大利亚学者Warren和Marshall首次从胃黏膜中分离出的一种螺杆菌,它的发现使人们对慢性胃炎、消化性溃疡等许多胃肠道疾病的发病机制及其治疗的认识发生了革命性的变化.     

Evaluation of the string test for the detection of Helicobacter pylori

AIM: Helicobacter pylori can be diagnosed by invasive or non-invasive tests but to obtain bacteria for culture and antibiotic susceptibility testing, an upper GI endoscopy is often required. The string test may be a minimally-invasive alternative method of obtaining H. pylori samples. This study evaluates the sensitivity and specificity of the string test in the diagnosis of H. pylori in comparison with endoscopic means of diagnosis. METHODS: This was a prospective open comparative study of patients with dyspepsia with endoscopy-based tests as gold standard (defined as a positive CLO test and antral histology). Fasting patients swallowed the encapsulated-string (Entero-test Hp), which was withdrawn after 1 hour. The gastric juice from the string was plated onto H. pylori-selective media for culture. Helicobacter pylori was identified by typical colony morphology, gram stain and biochemical test results. RESULTS: Thirty dyspeptic patients were recruited of whom 21 (70 %) were positive for H. pylori according to the gold standard. The sensitivity, specificity, positive predictive value, and negative predictive value for the string test were 38 %, 100 %, 100 % and 41 % respectively, and for endoscopic biopsies 81 %, 100 %, 100 %, 69 % respectively (P=0.004). Logistic regression showed that only abundant growth density from endoscopic biopsy cultures to be a predictor of a positive string test (P=0.018). CONCLUSION: The string test is an alternative method to endoscopy in obtaining H. pylori but has a low sensitivity compared to endoscopic biopsies.     

幽门螺杆菌粪便抗原试验检测幽门螺杆菌感染的临床评价

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。月psA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。停药后第28天的准确性最高(92．9％)。结论 HPSA试验是一种可靠的非侵入性检测方法，对于抗HP治疗前、后患者HP感染的诊断均有较高的准确性。对于胃大部切除术后的患者亦有较高的诊断价值。     

Evaluation of the Helicobacter pylori stool antigen test (HpSA) for detection of Helicobacter pylori infection in children

OBJECTIVE: Helicobacter pylori (H. pylori) infection is usually acquired in early childhood. Noninvasive methods for detection of H. pylori infection are required to study its incidence, transmission, and clearance. They should be easy to perform, inexpensive, and have a high diagnostic accuracy, especially in infants and toddlers. Both serology and the 13C-urea breath test (13C-UBT) do not fulfill all these requirements. The aim of this study was to evaluate a new enzyme immunoassay for detection of H. pylori antigen in stool (Premier Platinum HpSA, Meridian Diagnostics, Cincinnati, OH) in a large cohort of children and to compare it to invasive techniques and the 13C-UBT. METHODS: HpSA was performed in 310 stool samples of 274 children divided into three groups. Group A consisted of 145 children and adolescents (0.5-19.8 yr, 66/145 <6 yr) who underwent upper endoscopy for various gastrointestinal symptoms. H. pylori status was defined by histology, culture, and rapid urease test from biopsies of the antrum and corpus. A 13C-UBT was performed in 133 of 145 children. Group B consisted of 22 patients (5.7-16.1 yr) who were retested with both noninvasive tests 8 wk after anti-H. pylori triple therapy. Group C consisted of 129 healthy infants and toddlers (0.9-3.1 yr) who were tested with the 13C-UBT. Children with discrepant or positive test results were retested after 2 and 12 months. Results of the HpSA were read at 450/620 nm by spectrophotometry. An optical density <0.100 was defined as negative, >0.120 as positive, and values between 0.100 and 0.120 were considered as equivocal. RESULTS: In Group A, the HpSA gave false-negative results in five of 45 infected children and false-positive results in four of 100 noninfected children, whereas four patients (2.8%) showed equivocal results. In both infected and noninfected children, no relation between the optical density values and age was found. The 13C-UBT was correct in 132 of 133 children tested. In Group B, there was complete concordance between the HpSA and 13C-UBT: 19 children tested negative and three positive. In Group C, concordant results between the two noninvasive methods were found in 124 of 129 (96%) toddlers (122 negative and two positive). Retesting of five children with discrepant results revealed that, on initial testing, the HpSA was incorrect in two (one false-positive, one false-negative), and the 13C-UBT was incorrect in three (always false-positive). CONCLUSIONS: In symptomatic children, the HpSA revealed a sensitivity of 88.9% (95% CI 77.3-96.3) and a specificity of 94.0% (88.1-97.7) compared to the 13C-UBT, 100% (94.0-100) and 98.9% (94.7-100), respectively. However, in healthy toddlers, the HpSA performed as well as the 13C-UBT with excellent concordance between the two noninvasive tests. There was no age dependency of the stool test results, and changing the cutoff would not have improved accuracy. Thus, the HpSA test seems suitable to monitor the success of anti-H. pylori therapy.     

幽门螺杆菌粪便抗原试验的多中心研究

目的：评估幽门螺杆菌（H.pylori)粪便抗原（HpSA)试验诊断H.pylori感染的准确性。方法：应用酶免疫反应原理进行HpSA试验，在大样本、多中心研究中进行HpSA试验的评估。995例因消化不良症状接受胃镜检查者纳入本研究，所有患者均以HpSA试验、快速尿素酶试验（RUT）和组织学（或培养）方法检测H.pylori。以RUT和组织学（或培养）联合检测作为“金标准”，两项试验均阳性者定为H.pylori感染。结果：以光密度值≥0.16为阳性，HpSA检测诊断H.pylori感染的敏感性为93.5%(478/511)，特异性为94.2%(456/484)，阳性预测值为94.5%(478/506)，阴性预测值为93.3%(456/489)，总的检测准确性为93.9%(934/995)。结论：HpSA试验是一种简便、准确的非侵入性H.pylori感染检测方法。     

Evaluation of endoscopy-based diagnostic methods for the detection of Helicobacter pylori.

BACKGROUND: Helicobacter pylori is an etiological factor in duodenal ulcer. Few studies have objectively assessed the accuracy of diagnostic methods for the detection of H. pylori. METHODS: The sensitivity and specificity of histology, touch smear, rapid urease test (RUT) and brush cytology of endoscopic antral biopsy from patients with duodenal ulcer were compared. Forty-nine patients were evaluated before, and 34 after, eradication therapy. Each time, sampling was done for all 4 tests. The infection status for each sample was established by a positive concordance of results of three of four tests. RESULTS: The highest degree of agreement was between RUT and cytology (kappa = 0.69). Brush cytology (100%) followed by RUT (94.5%) were the most sensitive tests. Histology had the highest specificity (89.3%). A combination of RUT or brush cytology with histology had the maximum chance of detecting H. pylori. As single tests, brush cytology and touch smear had high diagnostic accuracies with a Youdin J value of 1.79 and 1.78, respectively. CONCLUSION: The best method for diagnosis of H. pylori is a combination of the rapid urease test or brush cytology with histology. Brush cytology or touch smear are diagnostic tests of choice if a single test is desired.     

Usefulness of the Helicobacter pylori stool antigen test for detection Helicobacter pylori infection

Several diagnostic tests are available for evaluating Helicobacter pylori (H. pylori) infection: histological examination, culture of gastric biopsy specimens, rapid urease test, urea breath test and serology. In this study, we assessed the reliability of a newly developed enzyme immunoassay HpSA (H. pylori Stool Antigen) kit for detecting H. pylori antigen in stool. Eighty-five patients (50 males, 35 females; mean age 41.6 +/- 9.8 years) with dyspeptic symptoms who were examined by upper gastrointestinal endoscopy. The patients with a history of previous treatment with proton pump inhibitors, bismuth compounds or antibiotics were excluded. During the endoscopic examination biopsies were taken from antrum and corpus for rapid urease test and histological examination. Stool specimens were submitted to the laboratory and HpSA test was performed. H. pylori was considered in condition with rapid urease test and histopathological examination for H. pylori positive. Forty-six of 85 patients were positive and remaining 39 patients were negative for H. pylori with the rapid urease test and pathologic evaluation. When 0.160 was adopted as the cut-off value, in accordance with the manufacturer's recommendations; stool antigen has been detected in 45 of the 46 H. pylori positive patients. The sensitivity and specificity of HpSA test were 97.8%, 94.9% respectively. These results indicate that HpSA is a highly reliable diagnostic method for H. pylori infection.     

PCR法诊断幽门螺杆菌感染的评价

目的系统评估聚合酶链反应扩增尿素酶Ａ基因（ＰＣＲ法）对幽门螺杆菌（Ｈｐ）感染的诊断价值．方法采用金标准及ＰＣＲ法检测６９例患者（慢性胃炎５２例、消化性溃疡１２例、胃癌５例）胃粘膜内Ｈｐ．结果金标准诊断有Ｈｐ感染３４例，ＰＣＲ法诊断３５例Ｈｐ阳性；金标准诊断３５例无Ｈｐ感染，ＰＣＲ法诊断３４例Ｈｐ阴性．故ＰＣＲ法敏感度为１００％，特异度为９７１％，粗一致性为９８５％，调整一致性为９８６％，误诊率（假阳性率）为２９％，漏诊率（假阴性率）为０，正确诊断指数（ｒ）为１０，阳性预测值（＋ＰＶ）为９７１％，阴性预测值（ＰＶ）为１００％，阳性似然比（ＬＲ＋）为３５，阴性似然比（ＬＲ）为０．结论ＰＣＲ法对胃粘膜Ｈｐ感染的诊断价值高于细菌培养、组织病理学，尿素酶试验各单项方法．     

幽门螺杆菌检测方法研究新进展

本文就近年来幽门螺杆菌检测方法新进展作一简要的概述,主要从细菌培养、快速尿素酶实验、组织学检查、尿素呼气实验、抗体检测、粪便抗原检测和分子生物学检测等几个方面展开。     

New fecal test for non-invasive Helicobacter pylori detection: A diagnostic accuracy study

AIM To assess the diagnostic accuracy of a new fecal test for detecting Helicobacter pylori(H. pylori), using ~(13)Curea breath test as the reference standard, and explore bacterial antibiotic resistance. METHODS We conducted a prospective two-center diagnostic test accuracy study. We enrolled consecutive people≥ 18 years without previous diagnosis of H. pylori infection, referred for dyspepsia between February and October 2017. At enrollment, all participants underwent 13 C-urea breath test. Participants aged over 50 years were scheduled to undergo upper endoscopy with histology. Participants collected stool samples 1-3 d after enrollment for a new fecal investigation(THD fecal test). The detection of bacterial 23 S rRNA subunit gene indicated H. pylori infection. We also used the index diagnostic test to examine mutations conferring resistance to clarithromycin and levofloxacin. Independent investigators analyzed index test and reference test standard results blinded to the other test findings. We estimated sensitivity, specificity, positive(PPV) and negative(NPV) predictive value, diagnostic accuracy, positive and negative likelihood ratio(LR), together with 95% confidence intervals(CI).RESULTS We enrolled 294 consecutive participants(age: Median 37.0 years, IQR: 29.0-46.0 years; men: 39.8%). Ninetyfive(32.3%) participants had a positive ~(13)C-urea breath test. Twenty-three(7.8%) participants underwent upper endoscopy with histology, with a full concordance between ~(13)C-urea breath test and histology in detecting H. pylori infection. Four(1.4%) out of the 294 participants withdrew from the study after the enrollment visit and did not undergo THD fecal testing. In the 290 participants who completed the study, the THD fecal test sensitivity was 90.2%(CI: 84.2%-96.3%), specificity 98.5%(CI:96.8%-100%), PPV 96.5%(CI: 92.6%-100%), NPV 95.6%(CI: 92.8%-98.4%), accuracy 95.9%(CI: 93.6%-98.2%), positive LR 59.5(CI: 19.3-183.4), negative LR 0.10(CI: 0.05-0.18). Out of 83 infected participants identified with the THD fecal test, 34(41.0%) had bacterial genotypic changes consistent with antibiotic-resistant H. pylori infection. Of these, 27(32.5%) had bacterial strains resistant to clarithromycin, 3(3.6%) to levofloxacin, and 4(4.8%) to both antibiotics. CONCLUSION The THD fecal test has high performance for the non-invasive diagnosis of H. pylori infection while additionally enabling the assessment of bacterial antibiotic resistances.