Cost-Effectiveness of Empirical Bismuth-Based Quadruple Therapy and Tailored Therapy After Clarithromycin Resistance Tests for Helicobacter pylori Eradication.

BACKGROUND: The eradication rate of clarithromycin-based standard triple therapy (STT) for Helicobacter pylori infection has decreased due to clarithromycin resistance (CR). We evaluated the cost-effectiveness of tailored therapy according to CR test results, and compared the results of STT with those of empirical bismuth quadruple therapy (BQT). METHODS: The prospectively collected data of 490 H. pylori-positive patients with chronic gastritis or peptic ulcer disease were retrospectively analyzed. Among them, 292 patients underwent CR testing using dual-priming oligonucleotide-based polymerase chain reaction. The tailored group (n = 292) consisted of patients treated with STT for 7 days and BQT for 10 days as per their CR test results. The remaining patients were assigned to the empirical group (n = 198) and received BQT for 10 days without a CR test. The eradication rate, adverse events and medical costs associated with H. pylori eradication therapy were investigated. RESULTS: In the tested patients (tailored group), the CR-positive rate was 32.2% (n = 94/292). The eradication rate according to an intention-to-treat analysis was 87.7% in the tailored group and 91.8% in the empirical group (P = 0.124); the respective rates were 94.4% and 97.9% by per-protocol analysis (P = 0.010). The frequency of adverse events was lower in the empirical group than the tailored group (35.1% vs. 52.7%, P < 0.001). Total per capita medical costs were $406.50 and $503.50, respectively. CONCLUSIONS: Ten-day empirical BQT was more effective, safer, and less expensive than tailored therapy based on a CR test for H. pylori eradication.

Clinicopathological characteristics of patients with pain after endoscopic submucosal dissection for gastric epithelial neoplasm.

BACKGROUND: Endoscopic submucosal dissection (ESD) is widely used for large superficial gastrointestinal tumors. Epigastric pain is a frequent complication of ESD. However, little is known about its incidence and associated factors. This study evaluated pain incidence and characteristics of patients with pain after gastric ESD. METHODS: We retrospectively analyzed a prospectively collected registry of clinical, endoscopic, and pathologic results of patients who underwent ESD for gastric adenoma or cancer from January 2010 to December 2015. A Visual Analogue Scale (VAS) was used to assess pain immediately after, and 2, 12, and 24 h after ESD. The primary outcome was the use of painkillers (VAS score > 4). Analyzed data included age, sex, pathology, specimen and tumor size, procedure time, and tumor location. RESULTS: Of 1226 patients, 461 (36.4%) needed a painkiller at least once after ESD (pain group). Compared with the no pain group, the pain group had more females, less alcohol consumption, larger tumor and specimen size, and more antral lesions. In multivariate analysis, female sex (OR 1.559, 95% CI 1.217-1.996, p < 0.001), antral tumor location (OR 1.780, 95% CI 1.398-2.265, p < 0.001), and procedure time over 30 min (OR 1.443, 95% CI 1.130-1.842, p = 0.003) were predictive factors for pain. CONCLUSION: This study showed that a considerable number of patients needed one or more painkiller doses after gastric ESD. The factors affecting pain included sex, procedure time, and lesion location. Endoscopists should use preemptive or aggressive pain management in high-risk patients after ESD.

Combination of Helicobacter pylori infection and the interleukin 8 -251 T > A polymorphism, but not the mannose-binding lectin 2 codon 54 G > A polymorphism, might be a risk factor of gastric cancer.

BACKGROUND: Mannose-binding lectin (MBL) acts in the innate immune response to Helicobacter pylori. Interleukin 8 (IL-8) is a potent cytokine produced by gastric epithelial cells in response to H. pylori. We aimed to investigate whether polymorphisms in MBL2 and IL-8 influence susceptibility to H. pylori infection, and the associations of these polymorphisms with the risk of gastroduodenal diseases in a Korean population. METHODS: We consecutively enrolled 176 H. pylori-negative control subjects, 221 subjects with H. pylori-positive non-atrophic gastritis, 52 mild atrophic gastritis (AG), 61 severe AG, 175 duodenal ulcer, and 283 gastric cancer (GC). Allele-specific PCR-RFLP was conducted for polymorphisms in MBL2 exon 1 (codon 52, 54, and 57) and IL-8 -251 T > A. IL-8 levels in gastric mucosal tissues and serum MBL levels were measured by enzyme-linked immunosorbent assay. RESULTS: MBL2 exon 1 polymorphic variants were found only in codon 54, and the allele frequencies did not differ significantly between the control and disease groups. Although serum MBL levels in codon 54 A/A mutants were markedly low, it did not influence susceptibility to H. pylori infection or the risk of gastroduodenal diseases. IL-8 levels were significantly different between T/T wild type, T/A heterozygote, and A/A mutant genotypes. IL-8 -251 A allele carriers (A/A + T/A) showed increased IL-8 levels, and were significantly associated with the risk of severe AG and GC. CONCLUSIONS: We suggest that a combination of H. pylori infection and the IL-8 -251 T > A polymorphism might increase the risk of severe AG and GC in a Korean population.

When Should Antiplatelet Agents Be Resumed After Successful Endoscopic Hemostasis in Patients with Peptic Ulcer Bleeding?

BACKGROUND: During treatment for peptic ulcer bleeding (PUB), it is imperative to determine the effect of antiplatelet agents on recurrent bleeding in order to balance risks and benefits. AIMS: We compared the rate of recurrent bleeding in antiplatelet users and non-users. METHODS: This retrospective study analyzed prospectively collected data from PUB patients treated by endoscopic modalities between August 2007 and December 2014. We evaluated and compared the rate of recurrent bleeding within 30 days in antiplatelet users and non-users; we also categorized antiplatelet users into continuation (≤3 days) and withdrawal (>3 days) groups. RESULTS: A total of 490 patients were enrolled in the study, 302 (61.6 %) and 188 (38.4 %) in the non-user and antiplatelet user groups, respectively. The recurrent bleeding rate among antiplatelet users (10.1 %) was significantly higher than that among non-users (5.0 %; p = 0.029). Among 188 antiplatelet users, 51 (27.1 %) and 137 (72.9 %) were assigned to the continuation and withdrawal groups, respectively. The rate of recurrent bleeding did not differ significantly between groups (11.7 vs. 5.9 %, p = 0.241). Multivariate analysis revealed chronic kidney disease as a risk factor [odds ratio (OR) 2.890, 95 % confidence interval (CI) 1.079-7.742, p = 0.035]. However, antiplatelet use (OR 1.691, 95 % CI 0.813-3.517, p = 0.160) was not. CONCLUSIONS: This study highlights the need for clinicians to consider underlying diseases in antiplatelet users under the appropriate antiplatelet therapy during the post-hemostasis period. Furthermore, the optimal time to resume antiplatelet agents may be 3 days after successful endoscopic hemostasis in patients with PUB.

Comparison of hemostatic forceps with soft coagulation versus argon plasma coagulation for bleeding peptic ulcer--a randomized trial.

BACKGROUND AND STUDY AIMS: Endoscopic high-frequency soft coagulation is used to manage visible bleeding or nonbleeding vessels during endoscopic submucosal dissection. The aim of the present study was to compare the efficacy of hemostasis by soft coagulation (using hemostatic forceps) with argon plasma coagulation (APC), in a prospective randomized trial. PATIENTS AND METHODS: From January 2013 to June 2014, 276 patients were randomly assigned into two groups: epinephrine injection plus APC (the APC group); or epinephrine injection plus soft coagulation using hemostatic forceps (the HFSC group). As the primary outcome we compared recurrent bleeding rates within 30 days after initial hemostasis in a noninferiority design. RESULTS: After exclusion, 75 patients in the APC group and 76 in the HFSC group were finally evaluated. In the APC group 72 patients (96 %) were successfully treated with the assigned treatment alone vs. 73 (96 %) in the HFSC group. Initial endoscopic hemostasis using a single or combined modality was achieved in all patients. Recurrent bleeding within 30 days was experienced by five patients (6.7 %) and seven patients (9.2 %) in the AFC and HFSC groups, respectively (P = 0.563), and within 7 days by three patients (4.0 %) and five patients (6.6 %), respectively (P = 0.719). We found no significant difference in the rates of adverse events (1.3 % vs. 2.6 %) or mortality (2.7 % vs. 2.6 %) between the groups. CONCLUSIONS: The efficacy and safety of soft coagulation using endoscopic hemostatic forceps is not inferior to APC when used to treat patients with bleeding peptic ulcers. Clinicaltrials.gov NCT02020603.

Efficacy of Lafutidine Versus Famotidine in Patients with Reflux Esophagitis: A Multi-Center, Randomized, Double-Blind, Non-inferiority Phase III Trial.

BACKGROUND: There has been no study on the efficacy of lafutidine for patients with reflux esophagitis in Korea. AIM: To evaluate the efficacy of a new-generation histamine-2 receptor antagonist, lafutidine, in comparison with famotidine in patients with reflux esophagitis. METHODS: This was a randomized, double-blind, non-inferiority trial enrolling patients with erosive esophagitis. The efficacy and safety of 20 mg lafutidine (treatment group) were compared with those of 40 mg famotidine (control group) and 20 mg omeprazole (reference group). The primary endpoint was the complete healing rates of reflux esophagitis on endoscopy after 8 weeks of treatment. The non-inferiority margin was assumed to be -15 %. RESULTS: The healing rates of reflux esophagitis on endoscopy after 8 weeks of treatment were 70.14 % (101/144) in the lafutidine, 63.45 % (92/145) in the famotidine, and 85.71 % (126/147) in the omeprazole group. The difference in healing rates between the lafutidine and famotidine groups was 6.69 % (95 % confidence interval = [-4.14 to 17.52]). In addition, lafutidine was superior to famotidine in clinical improvement (53.73 % vs. 39.55 %, P = 0.0200). CONCLUSIONS: Lafutidine was non-inferior to famotidine in healing of reflux esophagitis. Lafutidine, however, was superior to famotidine in terms of symptom relief of reflux esophagitis.

Is lesion size an independent indication for endoscopic resection of biopsy-proven low-grade gastric dysplasia?

BACKGROUND/AIM: The standard treatment for patients with gastric low-grade dysplasia (LGD) remains controversial, even though diagnosis of LGD is increasingly common as esophagogastrodeuodenoscopy becomes more available. The aim of this study was to identify a lesion size cut-off as an indication for endoscopic resection (ER) for patients with LGD. RESULTS: We retrospectively reviewed 285 lesions initially diagnosed as LGD by endoscopic forceps biopsies (EFB) from 2007 to 2010 in Kyung Hee University Hospital, Seoul, Korea. All patients underwent ER. A total of 285 lesions from 257 patients were assessed. After ER, 239 LGD (83.9 %) showed histological concordance and the remaining 46 (16.1 %) cases revealed an upgraded histology [22 high-grade dysplasia (7.7 %), and 24 differentiated adenocarcinoma (8.4 %)]. Univariate analyses demonstrated that lesion size, erythema, depression, and erosion were significant predictors of upgraded LGD (P < 0.001). Multivariate analysis showed that a lesion size ≥2 cm, erythema, and a depressed-type lesion were independent predictors of upgraded histology (P = 0.014, odds ratio 3.27, 95 % confidence interval 1.28-8.39). CONCLUSIONS: Our data suggest that a substantial number of LGD diagnoses based on EFB were not representative of the entire lesion. We recommend ER if gastric LGD has at least one of the following risk factors: surface erythema and a depressed type regardless of size, or ≥2 cm size regardless of abnormal surface configuration.

Elevation of PRKCDBP, a novel transcriptional target of TNF-α, and its downregulation by infliximab in patients with ulcerative colitis.

BACKGROUND: Protein kinase C delta binding protein (PRKCDBP/Cavin3/hSRBC) is a putative tumor suppressor that is downregulated in many human cancers. Recently, PRKCDBP was identified to be activated by nuclear factor-κB in response to tumor necrosis factor (TNF)-α. AIMS: To explore the potential of PRKCDBP as a diagnostic or prognostic marker for inflammatory bowel disease, the possible correlation between its expression status and TNF-α signaling was evaluated in ulcerative colitis (UC) patients, both pre- and post-infliximab (IFX) therapy. METHODS: In total, 31 IFX therapy-naïve patients (13 females; median age, 41 years) with moderate-to-severe UC who had been scheduled for IFX treatment were included. Immunohistochemical analysis of TNF-α and PRKCDBP expression was performed in rectal biopsies. RESULTS: A significant correlation was observed in immunoreactivity between TNF-α and PRKCDBP. IFX therapy reduced immunohistochemical expression of PRKCDBP and TNF-α (P < 0.001 and P = 0.005, respectively). The mean PRKCDBP expression level decreased from 54.5 to 30.2%, and that of TNF-α decreased from 54.5 to 36.2%. The immunohistochemical expression pre- and post-PRKCDBP therapy correlated significantly with TNF-α levels pre- and post-therapy (Spearman's rank correlation test; P = 0.005 and P = 0.001, respectively). CONCLUSIONS: These results demonstrate that mucosal expression of PRKCDBP correlated strongly with TNF-α expression in UC patients and that IFX therapy resulted in profound reductions in both PRKCDBP and TNF-α. Thus, these findings support that PRKCDBP expression is tightly controlled by TNF-α, and the anti-inflammatory effect of IFX may in part stem from blockade of the TNF-α-PRKCDBP signaling pathway.

Close observation of gastric mucosal pattern by standard endoscopy can predict Helicobacter pylori infection status.

BACKGROUND AND AIM: Common endoscopic findings in stomachs with Helicobacter pylori infections include antral nodularity, thickened gastric folds, and visible submucosal vessels. These findings are suggestive but not diagnostic of H. pylori infection. Magnifying endoscopy can reveal more precisely the abnormal mucosal patterns in an H. pylori-infected stomach; however, it requires more training, expertise, and time. We aimed to establish a new classification for predicting H. pylori-infected stomachs by non-magnifying standard endoscopy alone. METHODS: A total of 617 participants who underwent gastroscopy were prospectively enrolled from August 2011 to January 2012. We performed a careful close-up examination of the corpus at the greater curvature maintaining a distance ≤ 10 mm between the endoscope tip and the mucosal surface. We classified gastric mucosal patterns into four categories: normal regular arrangement of collecting venules (numerous minute red dots), mosaic-like appearance (type A; swollen areae gastricae or snakeskin appearance), diffuse homogenous redness (type B), and untypical pattern (type C; irregular redness with groove) to predict H. pylori infection status. RESULTS: The frequencies of H. pylori infection in patients with a normal regular arrangement of collecting venules pattern and types A, B, and C patterns were 9.4%, 87.7%, 98.1%, and 90.9%, respectively. The sensitivity, specificity, and positive and negative predictive values of all abnormal patterns for prediction of H. pylori infection were 93.3%, 89.1%, 92.3%, and 90.6%, respectively. The overall accuracy was 91.6%. CONCLUSIONS: Careful close-up observation of the gastric mucosal pattern with standard endoscopy can predict H. pylori infection status.

Acid suppression therapy as a risk factor for Candida esophagitis.

BACKGROUND/AIM: As the prevalence of reflux esophagitis increases, so does the use of gastric acid suppressants. This study aimed to document the prevalence of Candida esophagitis (CE) at a single Korean university hospital over the last 5 years and to evaluate its risk factors. METHODS: To investigate the prevalence of CE, we conducted a retrospective analysis of 55,314 individuals who underwent a screening esophagogastroduodenoscopy as part of a health check-up between January 2006 and December 2010 at Kyung Hee University Hospital in Seoul, Korea. A total of 250 patients who were treated for CE between January 2008 and August 2011 and 500 age- and sex-matched non-CE patients were enrolled in this study. The rates of recent gastric acid suppression therapy and other well-known risk factors in the two groups were compared. RESULTS: The prevalence of CE was 0.35 % and increased each year (linear-by-linear association, P = 0.001). Univariate analysis showed that gastric acid suppression therapy, malignancy, DM and steroid therapy were related to CE. Multivariate analysis also showed that gastric acid suppression therapy (OR 5.11, 95 % CI 2.92-8.93 and P < 0.001), malignancy (OR 18.68, 95 % CI 6.37-54.75 and P < 0.001), DM (OR 2.67, 95 % CI 1.70-4.21 and P < 0.001) and steroids therapy (OR 6.74, 95 % CI 1.37-33.05 and P = 0.019) were related to CE. CONCLUSIONS: The prevalence of CE in Korea is increasing. Also, our results indicate that acid suppression therapy is a meaningful risk factor for CE.

Benefits of Flavored Lactose-Free Milk for Korean Adults with Lactose Intolerance.

Although lactose-free dairy products for the clinical management of lactose intolerance (LI) are widely available, scientific evidence on their efficacy is still lacking. This study comparatively analyzed the efficacy of flavored lactose-free milk (LFM) and whole milk (WM) in reducing symptoms in South Korean adults with LI. This prospective study was conducted in adults suspected of LI. All screened participants underwent the hydrogen breath test (HBT) using 570 mL of chocolate-flavored WM (20 g of lactose) and responded to a symptom questionnaire. LI was confirmed when the ΔH2 peak exceeded 16 ppm above baseline values and with the occurrence of symptoms after WM consumption. The participants who were diagnosed with LI underwent the HBT again with 570 mL of chocolate-flavored LFM (0 g of lactose), followed by the symptom questionnaire survey after 1 week. After excluding 40 participants who did not meet the diagnostic criteria for LI and 2 who were lost to follow-up, a total of 28 lactose-intolerant individuals were enrolled in the study. The ΔH2 values in the first HBT were significantly higher than those in the second HBT (33.3 ± 21.6 ppm vs. 8.6 ± 6.3 ppm, P < .001). Similarly, there was a significant reduction in the total symptom score in the second HBT (4.18 ± 1.51 vs. 0.61 ± 0.98, P < .001). Flavored LFM is well tolerated in South Korean adults diagnosed with LI based on the HBT and symptom questionnaire results. Therefore, LFM may be a viable alternative to WM.

Spontaneous rupture of a sigmoid colon gastrointestinal stromal tumor manifesting as pneumoretroperitoneum with localized peritonitis: report of a case.

Colonic gastrointestinal stromal tumors (GISTs) account for only 5%-10% of tumors arising in the digestive tract. Spontaneous rupture is a very rare manifestation of a GIST; however, we report what to our knowledge is the first documented case of pneumoretroperitoneum caused by the rupture of a GIST. A 77-year-old woman was admitted to our hospital with acute abdominal pain and hematochezia. Colonoscopy showed luminal narrowing in the sigmoid colon, but no definite mucosal defect. Computed tomography (CT) showed an air-containing heterogeneous mass, 9.7 × 9.3 cm, in the pelvic cavity and a small amount of air in the retroperitoneum. Emergency laparotomy revealed a ruptured sigmoid colonic GIST with localized peritonitis. Pathologic examination confirmed that the tumor was composed mainly of round epithelioid cells. It was immunohistochemically positive for CD34 and negative for C-kit protein. This report describes how we successfully managed pneumoretroperitoneum with localized peritonitis caused by the spontaneous rupture of an epithelioid GIST originating from the sigmoid colon.

Appropriate indications for endoscopic submucosal dissection of early gastric cancer according to tumor size and histologic type.

BACKGROUND: Endoscopic submucosal dissection (ESD) is increasingly being performed for early gastric cancers (EGCs) that are larger than 2 cm and those that are not intestinal-type (IT) cancers by Lauren's classification. The technical feasibility of ESD for these EGCs has not been fully evaluated. OBJECTIVE: To identify appropriate expanded indications for ESD of EGC. DESIGN AND SETTING: A retrospective analysis of prospectively collected data was performed on consecutive patients who underwent ESD at a single tertiary center. PATIENTS AND METHODS: In total, 487 EGCs in 461 patients treated by ESD were classified by size and histologic type: IT EGCs 2 cm or less (257 lesions in 235 patients), IT EGCs larger than 2 cm (172 lesions in 168 patients), and non-IT EGCs (58 lesions in 58 patients). MAIN OUTCOME MEASUREMENTS: Curative resections were assessed among the 3 groups, and logistic regression analysis was used to analyze factors related to curative resection. RESULTS: The rates of curative resection significantly decreased from IT EGCs 2 cm or less (88.7%) to IT EGCs larger than 2 cm (73.3%) to non-IT EGCs (37.9%). Tumor size (>3 cm), ulceration, histologic type (non-IT), and piecemeal resection were independently unfavorable factors in curative resection. LIMITATIONS: Small sample size and short-term duration of follow-up study. CONCLUSIONS: ESD with curative intent is technically most feasible for nonulcerative and IT EGCs smaller than 3 cm.

[Successful resection of locally advanced gastrointestinal stromal tumor of the ampulla of Vater after treatment with imatinib].

Gastrointestinal stromal tumor (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract arising from Cajal's cells, expressing CD 117. The standard treatment for primary GIST is complete surgical resection. Imatinib mesylate, a specific tyrosine kinase inhibitor, is effective against locally advanced and metastatic GIST. There are several reports of the effect of preoperative imatinib in patients with unresectable and locally advanced primary GIST. We report a case of unresectable primary GIST of the ampulla of Vater, which we were able to completely resect after treatment with a dosage of imatinib 400 mg daily for 5 months. Twelve months later, the patient was treated with imatinib and doing well with no evidence of recurrence.

Effects of probiotics or broccoli supplementation on Helicobacter pylori eradication with standard clarithromycin-based triple therapy.

BACKGROUND/AIMS: The eradication failure rate of standard triple therapy (proton pump inhibitor, clarithromycin, and amoxicillin) for Helicobacter pylori infection has increased owing to antibiotic resistance in Korea. We assessed whether Saccharomyces boulardii probiotic or broccoli sprout extract sulforaphane supplementation could increase the H. pylori eradication rate and/or reduce antibiotic-associated adverse events. METHODS: A total of 217 patients with H. pylori-positive chronic gastritis or peptic ulcer disease were recruited. Clarithromycin resistance was assessed in all patients by testing for A2142G and A2143G point mutations in H. pylori 23S rRNA using a dual-priming polymerase chain reaction (PCR) oligonucleotide. Thirty-four patients (17.3%) were clarithromycin-resistant and were excluded from the study. Finally, 183 patients with infections not resistant to clarithromycin were randomly assigned to triple therapy only (group A, n = 61), triple therapy plus probiotics (group B, n = 61), or triple therapy plus sulforaphane (group C, n = 61) groups. CYP2C19 polymorphisms were examined at position G681A of exon 5 and G636A of exon 4 by PCR with restriction fragment length polymorphism (PCR-RFLP) analysis. H. pylori eradication was assessed by 13C-urea breath test 4 weeks after treatment completion. RESULTS: The eradication rates were similar among the groups both in the intention- to-treat (A = 85.2%, B = 89.6%, and C = 81.6%) and per-protocol (A = 89.2%, B = 86.8%, and C = 96.3%) analyses. The frequencies of overall adverse events in the groups also did not differ (A vs. B: p = 0.574; A vs. C: p = 1.000). CONCLUSION: Probiotic or sulforaphane with triple therapy for H. pylori infection neither increased the eradication rate nor reduced the occurrence of adverse events.

[Mesalazine-induced eosinophilic pneumonia in a patient with Crohn's disease].

Mesalazine (5-aminosalicylic acid) and sulfasalazine are widely used in the treatment of inflammatory bowel disease. The pulmonary toxicity related to sulfasalazine was well-recognized complication and it was caused by sulfapyridine moiety in sulfasalazine. However, the lung injury related to mesalazine has rarely been reported. A thirty five-year-old man with Crohn's disease who was treated with mesalazine complained fever and dry cough. The finding of bilateral wandering pulmonary infiltration, peripheral eosinophilia and increased eosinophils in bronchoalveolar lavage were consistent with eosinophilic pneumonia. His symptoms and laboratory findings were markedly improved after the discontinuation of mesalazine. The mesalazine-induced eosinophilic pneumonia was diagnosed according to his clinical course. This report shows that the eosinophilic pneumonia should be considered in patients who develop pulmonary involvement with inflammatory bowel disease receiving mesalazine therapy.

Clarithromycin resistance and female gender affect Helicobacter pylori eradication failure in chronic gastritis.

BACKGROUND/AIMS: The eradication rate of the first-line triple therapy (a proton pump inhibitor, clarithromycin, and amoxicillin) for Helicobacter pylori infection has gradually decreased in Korea. We evaluated whether clinical parameters, clarithromycin resistance, and CYP2C19 genotype can affect the eradication failure. METHODS: A total of 203 patients with H. pylori-positive chronic gastritis were consecutively enrolled. They received clarithromycin-based triple therapy for 7 days. A clarithromycin resistance test was performed by detection of A2142G and A2143G point mutations in H. pylori 23S rRNA. The CYP2C19 genotype was examined for polymorphism G681A of exon 5 and G636A of exon 4 by polymerase chain reaction with restriction fragment length polymorphism. Eradication was assessed by a 13C-urea breath test 4 weeks after treatment. RESULTS: Of 203 patients, 190 completed the study. The eradication rate was 64.0% according to intention-to-treat analysis and 68.4% by per-protocol analysis. CY-P2C19 genotypes were identified as follows: 75 poor metabolizers, 75 intermediate metabolizers, and 40 rapid metabolizers. Nonetheless, this polymorphism was not significantly associated with eradication failure (p = 0.682). Clarithromycin resistance was detected in 33/190 patients (17.4%), and their eradication rate was zero. Clarithromycin resistance (odds ratio [OR], 19.13; 95% confidence interval [CI], 9.35 to 35.09) and female gender (OR, 1.73; 95% CI, 1.15 to 4.25) were significantly associated with eradication failure. The other clinical parameters such as age, cigarette smoking, alcohol intake, the body mass index, hypertension, and diabetes were not significantly associated with eradication. CONCLUSION: Clarithromycin resistance and female gender are factors affecting H. pylori eradication failure in patients with chronic gastritis.

Lafutidine versus lansoprazole in combination with clarithromycin and amoxicillin for one versus two weeks for Helicobacter pylori eradication in Korea.

BACKGROUND AND AIMS: Lafutidine is a novel H(2)-receptor antagonist with gastroprotective activity that includes enhancement of gastric mucosal blood flow. The aim of the present study was to test the efficacy of 7- or 14-day lafutidine-clarithromycin-amoxicillin therapy versus a lansoprazole-based regimen for Helicobacter pylori eradication. METHODS: Four hundred and sixty-three patients with H. pylori-infected peptic ulcer disease were randomized to one of four regimens: (1) lafutidine (20 mg b.i.d.), clarithromycin (500 mg b.i.d.) and amoxicillin (1000 mg b.i.d.) for 7 days (the 7LFT group) or (2) for 14 days (the 14LFT group); (3) lansoprazole (30 mg b.i.d.), clarithromycin (500 mg b.i.d.), and amoxicillin (1000 mg b.i.d.) for 7 days (the 7LPZ group); or (4) for 14 days (the 14LPZ group). The eradication rates, drug compliance, and adverse effects among the four regimens were compared. RESULTS: The eradication rates by the intention-to-treat and per-protocol analyses in the 7LFT and 7LPZ groups were 76.5% and 81.6%, and 76.9% and 82.0% (p = .94 and .95), respectively. The eradication rates by intention-to-treat and per-protocol analyses in the 14LFT and 14LPZ groups were 78.2% and 82.2%, and 80.4% and 85.9% (p = .70 and .49), respectively. The treatment duration for 7 days or 14 days did not affect the eradication rates. In addition, the adverse effect rates and discontinuation rates were similar among the four groups. Furthermore, the ulcer cure rate and symptom response rate were similar in the lafutidine and lansoprazole groups. CONCLUSION: The results of this study showed that lafutidine-clarithromycin-amoxicillin therapy was a safe and effective as lansoprazole-based triple therapy for the eradication rate of H. pylori, and could be considered as an additional treatment option.

IL-1beta and IL-8, matrix metalloproteinase 3, and pepsinogen secretion before and after H. pylori eradication in gastroduodenal phenotypes.

OBJECTIVE: Relations between host genetic factors and clinical outcomes of Helicobacter pylori infection are variable among ethnicities. The aim of this study was to examine gastric mucosal cytokines, matrix metalloproteinase 3 (MMP-3), and serum pepsinogen levels before and after eradication of H. pylori according to IL-1B genotypes and benign gastroduodenal phenotypes in a Korean population. MATERIAL AND METHODS: A total of 349 Koreans including H. pylori-infected subjects (n=230) and H. pylori-negative controls (n=119) were enrolled. The former subjects were classified into groups according to the presence of non-atrophic gastritis (n=74), atrophic gastritis (n=56), gastric ulcer (n=37), and duodenal ulcer (n=63). IL-1B polymorphisms were genotyped by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Gastric mucosal IL-1beta, IL-8, and MMP-3, and serum pepsinogen I and II levels were measured by ELISA and radioimmunoassay, respectively. RESULTS: There were no significant differences between the IL-1B-31/-511 haplotype (TT/CC, CT/CT, and CC/TT) frequencies among the H. pylori-positive and -negative groups. The genotypes of IL-1B-31/-511 polymorphisms did not affect clinical phenotypes, inflammatory cytokines, MMP-3, and pepsinogen secretion. Subjects with H. pylori-infected atrophic gastritis exhibited significantly higher basal levels of cytokines and a lower pepsinogen I/II ratio than those of other groups. Following H. pylori eradication, inflammatory cytokines significantly decreased and the pepsinogen I/II ratio increased in all groups. CONCLUSIONS: Mucosal inflammatory cytokines, MMP-3, and pepsinogen secretion are related to gastroduodenal phenotypes but not to IL-1B genotypes. Eradication of H. pylori can reduce mucosal inflammation and restore pepsinogen secretion.