Efficacy, safety, and immunogenicity of an oral recombinant Helicobacter pylori vaccine in children in China: a randomised, double-blind, placebo-controlled, phase 3 trial.

BACKGROUND: Helicobacter pylori is one of the most common gastric pathogens, affecting at least half the world's population, and is strongly associated with gastritis, peptic ulcer, gastric adenocarcinoma, and lymphoma. We aimed to assess the efficacy, safety, and immunogenicity of a three-dose oral recombinant H pylori vaccine in children in China. METHODS: We did this randomised, double-blind, placebo-controlled, phase 3 trial at one centre in Ganyu County, Jiangsu Province, China. Healthy children aged 6-15 years without past or present H pylori infection were randomly assigned (1:1), via computer-generated randomisation codes in blocks of ten, to receive the H pylori vaccine or placebo. Participants, their guardians, and study investigators were masked to treatment allocation. The primary efficacy endpoint was the occurrence of H pylori infection within 1 year after vaccination. We did analysis in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT02302170. FINDINGS: Between Dec 2, 2004, and March 19, 2005, we randomly assigned 4464 participants to either the vaccine group (n=2232) or the placebo group (n=2232), of whom 4403 (99%) participants completed the three-dose vaccination schedule and were included in the per-protocol efficacy analysis. We extended follow-up to 3 years. We recorded 64 events of H pylori infection within the first year (14 events in 2074·3 person-years at risk in the vaccine group vs 50 events in 2089·6 person-years at risk in the placebo group), resulting in a vaccine efficacy of 71·8% (95% CI 48·2-85·6). 157 (7%) participants in the vaccine group and 161 (7%) participants in the placebo group reported at least one adverse reaction. Serious adverse events were reported in five (<1%) participants in the vaccine group and seven (<1%) participants in the placebo group, but none was considered to be vaccination related. INTERPRETATION: The oral recombinant H pylori vaccine was effective, safe, and immunogenic in H pylori-naive children. This vaccine could substantially reduce the incidence of H pylori infection; however, follow up over a longer period is needed to confirm the protection of the vaccine against H pylori-associated diseases. FUNDING: Chongqing Kangwei Biological Technology.

Glycyrrhetinic Acid protects the heart from ischemia/reperfusion injury by attenuating the susceptibility and incidence of fatal ventricular arrhythmia during the reperfusion period in the rat hearts.

BACKGROUND/AIMS: Licorice has been used to treat many diseases, including palpitations, in both Eastern and Western societies for thousands of years. It has been reported that glycyrrhetinic acid (GA), an aglycone saponin extracted from licorice root, exerts protective effects on the cardiovascular system, limits infarct sizes and protects against the development of arrhythmia. However, the mechanisms underlying the effects of glycyrrhetinic acid on the cardiovascular system remain poorly understood. This study aimed to determine the mechanisms underlying the protective effects of GA against lethal cardiac arrhythmias induced via ischemia-reperfusion in rat hearts, and to examine its electropharmacological properties. MATERIALS AND METHODS: Anesthetized rats were divided into control (CTL), GA5, GA10, and GA20 groups. GA was administered intravenously 15 min before the occlusion of the left anterior descending coronary artery, at dosages of 5, 10 and 20 mg/kg, respectively. Single ventricular myocytes were isolated using enzymolysis. The whole-cell patch clamp technique was utilized to record Ica, L, Ito and action potentials (APs). RESULTS: During reperfusion, the incidence of ventricular fibrillation (VF) was decreased in each of the groups compared with the CTL group (p<0.05). The ventricular tachycardia (VT)/VF score was significantly decreased in the GA20 group. Action potential durations (APDs) were prolonged by GA; both L-type calcium current (Ica-L) and transient outward potassium current (Ito) were blocked in a concentration-dependent manner by GA. CONCLUSION: These results suggest that GA attenuates both the susceptibility to and the incidence of fatal ventricular arrhythmia during reperfusion in rat hearts via the prolongation of the APD and the inhibition of both Ica-L and Ito. GA appears to be a promising antiarrhythmic agent in the setting of ischemia/reperfusion.

[Effects of glycyrrhetinic acid on sodium ion channel currents of rats' ventricular myocardial cells].

OBJECTIVE: To study the effects of glycyrrhetinic acid (GA) on the sodium ion channel currents (I(Na)) of rats' ventricular myocardial cells, and to explore its anti-arrhythmic mechanisms at the ion channel level. METHODS: Single ventricular myocardial cells was isolated from SD rats. The whole cell patch clamp was used to record the effects of GA on I(Na) of rats' ventricular myocardial cells. RESULTS: GA could inhibit I(Na) of rats' ventricular myocardial cells dose-dependently. GA at 1, 5, and 10 micromol/L decreased I(Na) of rats' ventricular myocardial cells from (-4.26 +/- 0.15) nA to (-3.54 +/- 0.10) nA, (-2.19 +/- 0.09) nA, and (-1.25 +/- 0.08) nA, respectively. GA at 1, 5, and 10 micromol/L inhibited I(Na) by 16.08% +/- 2.3%, 50.82% +/- 3.56%, and 75.98% +/- 5.12%, showing statistical difference when compared with the control group (P < 0.05). GA at 10 micromol/L shifted I(Na) current-voltage curve more positively, but the activation potential and the peak potential were not changed. CONCLUSION: GA inhibited the I(Na) of rats' ventricular myocardial cells dose-dependently, which was possibly associated with its antiarrhythmia effects.

[The influence of different processing on the content of flavones of Dendranthema morifolium].

OBJECTIVE: To investigate the effect of different processing methods on the content of luteolin-7-O-beta-D-glucoside, acacetin-7-O-beta-D-glucoside, luteolin, and acacetin of Dendranthema morifolium. METHODS: The optimal conditions were achieved on phenomenex, synergi Fusion-RP (5 microm, 4.6 mm x 250 mm)analytical column with a gradient mobile phase consisting of methanol and 0.1% phosphoric acid and detection wavelength set at 350 nm. RESULTS: The significant effect of different processing methods on the content of luteolin-7-O-beta-D-glucoside, acacetin-7-O-beta-D-glucoside, luteolin and acacetin was proved. CONCLUSION: Different processing methods have significant effect on flavonoids of Dendranthema morifolium, it should be paid attention to drying temperature while sulphur fumigation.

Photophysical and electrochemical properties of donor-acceptor conjugated oligomers based on 3,4-ethylenedioxythiophene and deficient rings.

The photophysical and electrochemical properties of four novel donor-accepter (D-A) conjugated oligomers a-d based on 3,4-ethylenedioxythiophene (EDOT) and electrondeficient heterocycle rings were investigated. The UV-vis absorption spectroscopy, fluorescence emission spectroscopy and cyclic voltammertry studies suggest that the oligomers are expected to provide enhanced charge-transporting properties for the development of efficient electroluminescent materials. Furthermore, the third-order nonlinear optical (NLO) measurements made by Z-scan technique indicate that they have good third-order NLO response and are desired materias for fabricating nonlinear photonic devices. In the solid state of these oligomers, a strong tendency of self-assembled structure was also revealed by X-ray diffraction (XRD) patterns in powder.

[Chemical constituents of Carya cathayensis and their antitumor bioactivity].

OBJECTIVE: To investigate the chemical constituents of Carya cathayensis and their antitumor bioactivity. METHODS: The compounds were isolated by Sephadex LH-20 and silica gel column chromatography. Their structures were identified by physicochemical properties and spectroscopic analysis. Then their cytotoxic activity was studied. RESULTS: Five compounds were elucidated as chrysophanol (1), physcion (2), beta-sitosterol (3), pinostrobin(4), 4,8-dihydroxy-1-tetralone (5). CONCLUSION: Compounds 2 and 5 are isolated from Carya cathayensis for the first time. In the MTT antitumor experiments, the compounds 1,4 and 5 have the cytotoxic activity to KB cell.

[Poking reduction cannulated screw for the treatment of Sandersâ ¡ calcaneal fracture].

OBJECTIVE: To evaluate clinical effect of poking reduction cannulated screw based on Pingle orthopedic muscle-bone interoperability balance theory in treating Sanders Ⅱ calcaneal fracture. METHODS: From October 2014 to December 2017, 28 patients with Sanders Ⅱ calcaneal fracture were treated with poking reduction cannulated screw guided by Pingle orthopedic muscle-bone interoperability balance theory, including 20 males and 8 females, aged from 24 to 55 years old with an average of (37.2±3.9) years old. Calcaneal width, Bhler angle, and Gissane angle were measured before and after operation, and Maryland Score before and 6 months after operation were compared. RESULTS: All patients were followed up from 12 to 16 months with an average of (13.7±1.3) months. All fractures healed normally, and healing time ranged from 9 to 12 weeks with an average of (10.2±1.3) weeks. No postoperative wound infection, cortical necrosis, or osteomyelitis occurred. The width of the calcaneus decreased from (34.15±2.58) mm before surgery to (30.49±2.37) mm after surgery, Bhler angle increased from (14.16±3.27)° before operation to (31.95±3.07)°after operation, Gissane angle decreased from (128.45±9.04)° before operation to (120.83±8.15)° after operation. Maryland Score was 15.68±4.73 before operation, and was improved to 88.32±2.65 at 6 months after operation;19 patients got excellent result, 6 good, 2 fair and 1 poor. CONCLUSION: Poking reduction cannulated screw based on Pingle orthopedic muscle-bone interoperability balance theory in treating Sanders Ⅱ calcaneal fracture has certain clinical effects, high acceptation of patient, and without special demand for soft tissue around fracture. But it should avoid choosing severe comminuted Sanders Ⅲand Ⅳcalcaneal fracture.

Green tea drinking, high tea temperature and esophageal cancer in high- and low-risk areas of Jiangsu Province, China: a population-based case-control study.

Epidemiological studies suggested drinking green tea is inversely associated with esophageal cancer but results remain inconclusive. Moreover, inconsistent observations found high temperature drinks are associated with esophageal cancer. A population-based case-control study was conducted in a high-risk area (Dafeng) and a low-risk area (Ganyu) of esophageal cancer in Jiangsu province China from 2003 to 2007. It aimed to explore green tea drinking and tea temperature with the risk of esophageal cancer, and to compare the difference between different risk regions. Using identical protocols, 1,520 cases and 3,879 healthy controls were recruited as study subjects in 2 regions. Detailed information was collected to assess green tea drinking habits. Unconditional logistic regression was used to obtain OR and 95% CI. Results showed that ever drinking green tea elevated OR in both counties (Dafeng OR = 1.2, 95% CI = 0.9-1.5; Ganyu: OR = 1.9, 95% CI = 1.4-2.4). Drinking tea at high temperature was found to increase cancer risk in both areas (Dafeng: OR = 1.9, 95% CI = 1.2-2.9; Ganyu OR = 3.1 95% CI = 2.2-4.3). However, after further adjustment for tea temperature, ever drinking tea was not related to cancer in either county (Dafeng: OR = 1.0, 95% CI = 0.7-1.3; Ganyu: OR = 1.3, 95% CI = 0.9-1.7). For dose-response relationships, we observed positive relationship with monthly consumption of tea (p for trend = 0.067) and tea concentration (p for trend = 0.006) after further adjustment for tea temperature. In conclusion, green tea drinking was not inversely associated with esophageal cancer in this study. However, drinking tea at high temperatures significantly increased esophageal cancer risk. There was no obvious difference of green tea drinking between low- and high-risk areas.

Association of smoking, alcohol drinking and dietary factors with esophageal cancer in high- and low-risk areas of Jiangsu Province, China.

AIM: To study the main environmental and lifestyle factors that account for the regional differences in esophageal cancer (EC) risk in low- and high-risk areas of Jiangsu Province, China. METHODS: Since 2003, a population-based case-control study has been conducted simultaneously in low-risk (Ganyu County) and high-risk (Dafeng County) areas of Jiangsu Province, China. Using identical protocols and pre-tested standardized questionnaire, following written informed consent, eligible subjects were inquired about their detail information on potential determinants of EC, including demographic information, socio-economic status, living conditions, disease history, family cancer history, smoking, alcohol drinking, dietary habits, frequency, amount of food intake, etc. Conditional logistic regression with maximum likelihood estimation was used to obtain Odds ratio (OR) and 95 % confidence interval (95% CI), after adjustment for potential confounders. RESULTS: In the preliminary analysis of the ongoing study, we recruited 291 pairs of cases and controls in Dafeng and 240 pairs of cases and controls in Ganyu, respectively. In both low-risk and high-risk areas, EC was inversely associated with socio-economic status, such as level of education, past economic status and body mass index. However, this disease was more frequent among those who had a family history of cancer or encountered misfortune in the past 10 years. EC was also more frequent among smokers, alcohol drinkers and fast eaters. Furthermore, there was a geographic variation of the associations between smoking, alcohol drinking and EC risk despite the similar prevalence of these risk factors in both low-risk and high-risk areas. The dose-response relationship of smoking and smoking related variables, such as age of the first smoking, duration and amount were apparent only in high-risk areas. On the contrary, a dose-response relationship on the effect of alcohol drinking on EC was observed only in low-risk areas. CONCLUSION: The environmental risk factors, together with genetic factors and gene-environmental interactions might be the main reason for this high-risk gradient in Jiangsu Province, China.

Roles and mechanisms of ginseng in protecting heart.

Ginseng, the root of Panax ginseng C. A. Mayer, has long been used clinically in China to treat various diseases. Multiple effects of ginseng, such as antitumor, antiinflammatory, antiallergic, antioxidative, antidiabetic and antihypertensive have been confirmed by modern medicine. Recently, the clinical utilization of ginseng to treat heart diseases has increased dramatically. The roles of ginseng in protecting heart are foci for research in modern medical science and have been partially demonstrated, and the mechanisms of protection against coronary artery disease, cardiac hypertrophy, heart failure, cardiac energy metabolism, cardiac contractility, and arrhythmia are being uncovered progressively. However, more studies are needed to elucidate the complex mechanisms by which ginseng protects heart. All such studies will provide evidence of ginseng's clinical application, international promotion, and new drug development.