[Quadruple regimens using domestically manufactured drugs in gastritis and duodenal ulcer patients for Helicobacter pylori eradication: a perspective, multicenter, randomized controlled trial].

OBJECTIVE: To observe the effects and safety of quadruple regimens including domestically manufactured rabeprazole used as first line/initial therapy for Helicobacter pylori(H.pylori) eradication in gastritis and duodenal ulcer patients, and to investigate the effects of extended use of bismuth after the quadruple therapy on eradication of H. pylori. METHODS: From January to August 2013, 430 patients with chronic gastritis or duodenal ulcer who were confirmed as H. pylori positive in gastroscopy for upper gastrointestinal symptoms were enrolled from 12 centers in China for initial treatment using quadruple regimens for H. pylori eradication. The study was a prospective, multicenter, randomized double-blinded double-dummy parallel-controlled clinical trial. The 310 chronic gastritis patients were divided into 2 groups: group A1 was given quadruple regime (rabeprazole+ amoxicillin+ clarithromycin+ bismuth potassium citrate) for 10 days followed by bismuth-placebo for 21 days; group A2 was given the quadruple regimen for 10 days and then bismuth potassium citrate for 21 days. The duodenal ulcer patients were given the quadruple for 10 days, then rabeprazole for 14 days. All the patients took (13)C urea breath test to detect H. pylori 28 days after medicine withdrawal. RESULTS: Altogether 428 cases were enrolled and 404 completed the trial. The total eradication rate in the chronic gastritis patients was 85.1% (262/308, intention-to-treat (ITT)analysis), which was 81.7% (125/153, ITT) in the A1 group and 88.4% (137/155, ITT) in the A2 group; the eradication rate in the duodenal ulcer patients was 85.8% (103/120, ITT). No severe adverse effects were reported. The symptoms (pain, burning sensation, reflux, belching, nausea, and vomiting) improvement status was similar among A1 and A2 groups. CONCLUSIONS: The quadruple regimen using rabeprazole manufactured in China and administered for 10 days as first line/initial therapy in chronic gastritis and duodenal ulcer patients could achieve good H. pylori eradication rate. The extended use of bismuth after 10-day quadruple regimen might further improve the eradication rate. The regimens containing proton-pump inhibitor and bismuth may be well tolerated and safe in clinical application.

[Detection of Helicobacter pylori by immunoblot: a multiple-center study].

OBJECTIVE: To evaluate the accuracy and effectiveness of Helicobacter pylori(H.pylori)antibody detection kit (immunoblot) in typing H. pylori strains, and to investigate the relationship between characteristics of H. pylori strains and clinical outcomes. METHODS: A total of 378 patients with upper gastrointestinal symptoms who had received gastroscopy and had pathological results within the period from March to August 2012 were collected from 6 centers in China.In all the patients, H. pylori antibody detection kit was used to detect and type serum H. pylori antibodies.The sensitivity, specificity, and accuracy of immunoblot in diagnosing H. pylori infection were evaluation in comparison to (13)C urea breath test (UBT) as the"gold standard". The results were also compared with those colloidal gold method.The relationship between H. pylori typing and clinical conditions was analyzed. RESULTS: Totally 378 patients were enrolled, in which 257 had H. pylori-positive (13)C UBT results, and 121 were negative.With (13)C UBT as the"gold standard", the sensitivity, specificity, positive predictive value, negative predictive value, and concordance rate of H. pylori antibodies detection kit(immunoblot)were 97.7%, 86.8%, 94.0%, 94.6%, and 94.2%, respectively; the sensitivity, specificity, positive predictive value, negative predictive value, and concordance rate of colloidal gold method were 84.4%, 92.6%, 96.0%, 73.7%, and 87.0%, respectively.In patients diagnosed as H. pylori-positive by (13)C UBT and immunoblot, 93.0%(53/57) in H. pylori eradication failure patients and 93.8%(182/194)in untreated patients were infected with type Ⅰ H. pylori as detected by immunoblot, with no statistically significant difference (P=0.764). The type Ⅰ strains positive rate was 94.2%(65/69), 89.9%(62/69)and 98.2% (55/56) in non-atrophy gastritis, atrophy gastritis, and duodenal ulcer untreated patients, respectively, the positive rate of type Ⅰ strains higher in duodenal ulcer cases than in gastritis ones, but with no statistically significant difference(P=0.185). CONCLUSIONS: Compared with the"gold standard"(13)C UBT, the accuracy of H. pylori antibody detection kit (immunoblot) and that of colloidal gold method are both fairly high.Different H. pylori strains may have significantly different potential in causing diseases, as typeⅠtrain appeared to be more virulent than type Ⅱ strain, especially in causing peptic ulcer.There was no obvious difference between eradication failure and untreated patients in terms of positive rate of type Ⅰ H. pylori strains, hence further study is needed to explore the relationship between type Ⅰ H. pylori and eradication rates.

[Risk factors associated with Helicobacter pylori infection in army and navy recruits].

OBJECTIVE: To explore the Helicobacter pylori (Hp) infection rate among army and navy recruits, examine its associated risk factors and provide theoretic rationales for Hp control. METHODS: A cross-sectionalstudy was performed for 1 732 subjects (aged 17-24 years) selected from 18 new recruit populations in Inner Mongolia and Zhoushan area from September 2013 to November 2013.Hp infection was detected by (13)C-urea breath test. Meanwhile, a questionnaire containing 62 potential factors related to Hp infection was surveyed. In addition, (13)C-urea breath test was performed in 513 navy veterans (aged 19-51 years) in Zhoushan area from April 2013 to October 2013. The data of risk factors were analyzed by χ(2) test and multivariate Logistic regression. RESULTS: A total of 2 162 soldiers were enrolled and 1 649 new recruits completed two surveys. The overall Hp infection rate was 46.5% (768/1 649), which is lower than the previous studies (52.9%). And it was 47.0% (377/802) in army new recruits and 46.0% (390/847) in navy new recruits. For new recruits, Hp infection was associated with number of family members, washing tableware with detergents, first drinking age and paring fruits before eating (all P < 0.05). However, there was no association with age, education level or washing hands before meal (all P > 0.05). The Hp infection rate was higher in recruits from the West China and North China.In addition, the infection rate was 60.8% (312/513) in a population of 513 veterans. It was 46.6% (768/1 649) in recruits less than onemonth of service, 59.2% (180/304) in recruits less than two years of service and 63.2% (132/209) in recruits more than two years of service, the difference had statistical significance(P < 0.05). Logistic analysis of multiple variables showed that number of family members, washing tableware with detergents, first drinking age and paring fruits before eating were independent risk factors (OR = 1.574, 0.538, 0.638, 0.855; 95%CI:1.077-2.301, 0.362-0.798, 0.486-0.837, 0.457-0.961). CONCLUSIONS: The Hp infection rate is similar between army and navy recruits. It has dropped significantly and its epidemic region changed in new male recruits compared to a decade ago in china. Hp infection clustered within families. The factors including fewer family members, washing tableware without detergents, first drinking at young age and no paring fruits before eating are risk factors of Hpinfection. And a longer service time is associated with higher Hp infection rate in recruits.

[Significance of Septin9 gene methylation detection of plasma circulation DNA in colorectal cancer screening].

OBJECTIVE: To explore the role of detecting the methylation status of gene Septin9 (SEPT9) in plasma for colorectal cancer screening in Chinese population. METHODS: Patients were collected from Beijing Military General Hospital since September 2013 to February 2014. The performance of SEPT9 assay was validated in a single-blind study of 80 cases with colonoscopy and pathologically verified colorectal cancer and 52 normal controls. The detection of Septin9 gene methylation in peripheral blood was performed by fluorescence quantitative polymerase chain reaction (PCR). And immunoassay fecal occult blood test was conducted to compare the superiority of methylated Septin9 for screening colorectal cancer. RESULTS: The Septin9 assay successfully identified 75.0% (95%CI:64.7%-83.6%) of cancers at a specificity of 98.1% (95%CI:90.9%-99.9%). And it was superior to fecal occult blood screening for colorectal cancer (sensitivity 79.5% vs 53.8%, P < 0.05). CONCLUSION: Determination of SEPT9 methylation status is an innovative non-invasive plasma screening test for colorectal cancer.

[Jinghuaweikang capsules combined with triple therapy in the treatment of Helicobacter pylori associated gastritis and duodenal ulcer and analysis of antibiotic resistance: a multicenter, randomized, controlled, clinical study].

OBJECTIVE: To explore the efficacy of Jinghuaweikang capsules plus triple therapy (LACJ) in treatment of Helicobacter pylori (H. pylori) associated gastritis or duodenal ulcer, compare it with bismuth-containing quadruple therapy (LACB) and standard triple therapy (LAC) and analyze the antibiotic sensitivity of gastric mucosal H. pylori strains from the failed patients. METHODS: A total of 565 patients with H. pylori infection were recruited from 11 hospitals from January 2010 to June 2011. There were 336 males and 229 females. They underwent gastroendoscopy examination due to upper gastrointestinal symptoms and had never received H. pylori eradication therapies. Duodenal ulcer patients were divided randomly into LACJ therapy group, LACB therapy group and LAC therapy group while gastritis patients LACJ therapy group and LACB therapy group. Group LAC received lansoprazole 30 mg + amoxicillin 1000 mg + clarithromycin 500 mg, twice a day, for 7 d (d1-7). Group LACJ: LAC therapy plus Jinghuaweikang, 3 capsules, twice a day, for 7 d (d1-7) then Jinghuaweikang, 3 capsules, twice a day, for 14 d (d8-21). Group LACB: LAC plus bismuth potassium citrate 220 mg, twice a day, for 7 d (d1-7) and then bismuth potassium citrate 220 mg, twice a day, for 14 d (d8-21). All duodenal ulcer patients received lansoprazole (30 mg, once a day) for 14 days after the first 7-day of treatment (d 8-21). At least 28 days after the end of treatment, all patients underwent (13)C urea breath test. Gastric mucosa was collected under endoscopy from the failed patients. The detection technique of gene chip was employed to detect antibiotics resistant gene from mucosa. RESULTS: The eradication rates of duodenal ulcer patients in groups LACJ, LACB and LAC were as follows: per-protocol (PP), 80.2% (77/96), 89.9% (89/99) and 72.2% (70/97) (P = 0.007), intention-to-treat (ITT), 78.6% (77/98), 88.1% (89/101) and 70.0% (70/100) (P = 0.007). No statistical differences existed between groups LACJ and LACB or LAC (all P > 0.05). But there were statistical differences between groups LACB and LAC (both P = 0.002). The eradication rates of PP and ITT of chronic gastritis patients in groups LACJ and LACB were as follows: 75.8% (97/128), 74.6% (97/130) vs 83.8% (109/130), 80.1% (109/136) (both P > 0.05). The symptomatic improvements of abdominal pain, burning and acid reflux of duodenal ulcer patients in group LACJ were higher than those in groups LACB and LAC. There were statistical differences between groups LACJ and LAC (all P < 0.05). The symptomatic improvements of bloating and belching for chronic gastritis patients in group LACJ were higher than those of group LACB. But no significant difference existed between two groups (all P > 0.05). Sixty samples of gastric mucosa were collected from the failed patients. The detection rates of antibiotic-resistant gene to clarithromycin and amoxicillin were 60.0% (36/36) and 18.3% (11/60) respectively. CONCLUSIONS: The efficacy of LACJ for the treatment of H. pylori infection patients is similar to LACB and superior to LAC. And the symptomatic improvement of patients is better than the other two regimens. The main cause of treatment failure is antibiotic resistance of H. pylori strains.

[Detection of APC gene germline mutation in Chinese familial adenomatous polyposis by direct sequencing in combination with multiplex ligation-dependent probe amplification].

OBJECTIVE: To investigate the characteristics of APC gene germline mutation in Chinese patients with familial adenomatous polyposis (FAP). METHODS: The genomic DNA was extracted from peripheral venous blood drawn from probands of 14 Chinese FAP families from Beijing, Hebei, Henan, Anhui, Inner Mongolia, Shanxi and Fujian. The APC gene was amplified by PCR and underwent direct sequencing. Large fragment deletion was detected by multiplex ligation-dependent probe amplification (MLPA) only in micromutation-negative samples found by sequencing. RESULTS: APC gene micromutations were found in 9 probands and the micromutation detection rate was 64.3%, including 6 frameshift mutations, 2 splicing mutations and 1 nonsense mutation. Large fragment deletions of APC gene were detected in 2 probands (14.3%). The total mutation detection rate of micromutation and large fragment deletion was 78.6%. Four novel micromutations and 2 novel large fragment deletions were found, including c.2336-2337insT, c.3923-3929delAAGAAAA, c.532-2A > T, c.4179-4180GAdelinsT, large fragment deletions of exons 11 and 10A and large fragment deletion of exon 15 start. CONCLUSIONS: In Chinese FAP patients, the germline mutation type of APC gene is variable; the majority is of frameshift mutation. The most common mutation site is exon 15. The mutation detection rate of APC gene can be boosted effectively by direct sequencing in combination with MLPA.

Clinicopathological features of non-familial colorectal cancer with high-frequency microsatellite instability / 中国医学科学杂志(英文版)

<p><b>OBJECTIVE</b>To explore the clinicopathological features of non-familial colorectal cancer with high-frequency microsatellite instability (MSI-H).</p><p><b>METHODS</b>One hundred and fifty patients with colorectal cancer who had no family history were enrolled in this study from June 2006 to June 2008. Five standard microsatellite loci including BAT25, BAT26, D2S123, D5S346, and D17S250 were amplified with immunofluorescent polymerase chain reaction. The patient information including age, sex, and tumor location was recorded. Pathological features including differentiation, mucinous differentiation, histological heterogeneity, and Crohn's-like reaction were observed under light microscope. The presence of tumor-infiltrating lymphocytes (TLs, CD4+ and CD8+) was detected by means of immunohistochemistry. A regression equation was obtained by stepwise logistic regression analysis to evaluate the relationship between MSI-H phenotype in colorectal cancer and pathological features.</p><p><b>RESULTS</b>MSI-H phenotype occurred in 13.33% of the 150 patients with non-familial colorectal cancer. Poor differentiation, histological heterogeneity, Crohn's-like reaction, and presence of TLs were found to be independent factors to identify MSI-H non-familial colorectal cancer. Logistic regression equation showed an overall sensitivity of 70.0%, specificity of 99.2%, and accuracy of 95.3% in identifying MSI-H non-familial colorectal cancer.</p><p><b>CONCLUSION</b>MSI-H non-familial colorectal cancer manifests specific pathological features, which may be relied upon for effective identification of that disease.</p>