Objective:To evaluate the efficacy, adverse reactions and compliance of vonoprazan (VPZ) dual therapy and bismuth-containing quadruple therapy with low-resistance antibiotics in the initial treatment of primary Helicobacter pylori ( H. pylori) infection. Methods:From March 7, 2022 to August 25, 2023, a total of 200 patients with H. pylori infection who visited the Department of Gastroenterology and Hepatology of the University of Hong Kong-Shenzhen Hospital were selected. According to the random number table method, the patients were randomly divided into the VPZ combined with amoxicillin treatment group (hereinafter referred as VPZ dual therapy group) and the proton pump inhibitor (PPI), tetracycline, full-dose (1 600 mg/d) metronidazole and bismuth treatment group (hereinafter referred as PPI quadruple therapy group). The patients of VPZ dual therapy group were given VPZ 20 mg (twice a day) combined with amoxicillin 1 000 mg (3 times a day), and the patients of PPI quadruple therapy group were given esomeprazol 20 mg (2 times a day), bismuth 0.6 g (twice a day), metronidazole 400 mg (4 times a day), and tetracycline 500 mg (3 times a day). The patients of both groups were treated for 14 days. The H. pylori infection status was re-examined 4 weeks after drug withdrawal. The results were analyzed by intention-to-treat (ITT) analysis, modified ITT analysis and per-protocol analysis (PPA). One-sided μ test was used for non-inferiority evaluation, and two-sided 95% confidence interval (95% CI) was obtained. Chi-square test was used for statistical analysis. Results:In the ITT analysis, 92.0% (92/100) of patients in the VPZ dual therapy group and 77.0% (77/100) of patients in the PPI quadruple therapy group completed the 14-day treatment, and the difference was statistically significant ( χ2=8.59, P=0.003). In the ITT analysis, the H. pylori eradication rates in the VPZ dual therapy group and the PPI quadruple therapy group were 96.0% (96/100) and 92.0% (92/100), respectively, and the difference was statistically significant (difference=4.0%, 95% CI -2.9% to 11.5%, P<0.001). In the modified ITT analysis, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 97.0% (96/99) and 95.8% (92/96), respectively, and the difference was statistically significant (difference=1.1%, 95% CI -4.9% to 7.6%, P=0.002). In the PPA, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 96.7% (89/92) and 97.4% (75/77), respectively, and the difference was statistically significant (difference=-0.7%, 95% CI -6.9% to 6.1%, P=0.009). In the ITT analysis, the incidence of adverse reaction in the VPZ dual therapy group was lower than that in the PPI quadruple therapy group (39.0%, 39/100 vs. 71.0%, 71/100), and the difference was statistically significant ( χ2=20.69, P<0.001). Conclusion:In initial treatment of H. pylori infection, the eradication rate of VPZ dual therapy is non-inferior to that of PPI quadruple therapy, and VPZ dual therapy demonstrates higher safety.

Objective:To evaluate the efficacy, adverse reactions and compliance of vonoprazan (VPZ) dual therapy and bismuth-containing quadruple therapy with low-resistance antibiotics in the initial treatment of primary Helicobacter pylori ( H. pylori) infection. Methods:From March 7, 2022 to August 25, 2023, a total of 200 patients with H. pylori infection who visited the Department of Gastroenterology and Hepatology of the University of Hong Kong-Shenzhen Hospital were selected. According to the random number table method, the patients were randomly divided into the VPZ combined with amoxicillin treatment group (hereinafter referred as VPZ dual therapy group) and the proton pump inhibitor (PPI), tetracycline, full-dose (1 600 mg/d) metronidazole and bismuth treatment group (hereinafter referred as PPI quadruple therapy group). The patients of VPZ dual therapy group were given VPZ 20 mg (twice a day) combined with amoxicillin 1 000 mg (3 times a day), and the patients of PPI quadruple therapy group were given esomeprazol 20 mg (2 times a day), bismuth 0.6 g (twice a day), metronidazole 400 mg (4 times a day), and tetracycline 500 mg (3 times a day). The patients of both groups were treated for 14 days. The H. pylori infection status was re-examined 4 weeks after drug withdrawal. The results were analyzed by intention-to-treat (ITT) analysis, modified ITT analysis and per-protocol analysis (PPA). One-sided μ test was used for non-inferiority evaluation, and two-sided 95% confidence interval (95% CI) was obtained. Chi-square test was used for statistical analysis. Results:In the ITT analysis, 92.0% (92/100) of patients in the VPZ dual therapy group and 77.0% (77/100) of patients in the PPI quadruple therapy group completed the 14-day treatment, and the difference was statistically significant ( χ2=8.59, P=0.003). In the ITT analysis, the H. pylori eradication rates in the VPZ dual therapy group and the PPI quadruple therapy group were 96.0% (96/100) and 92.0% (92/100), respectively, and the difference was statistically significant (difference=4.0%, 95% CI -2.9% to 11.5%, P<0.001). In the modified ITT analysis, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 97.0% (96/99) and 95.8% (92/96), respectively, and the difference was statistically significant (difference=1.1%, 95% CI -4.9% to 7.6%, P=0.002). In the PPA, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 96.7% (89/92) and 97.4% (75/77), respectively, and the difference was statistically significant (difference=-0.7%, 95% CI -6.9% to 6.1%, P=0.009). In the ITT analysis, the incidence of adverse reaction in the VPZ dual therapy group was lower than that in the PPI quadruple therapy group (39.0%, 39/100 vs. 71.0%, 71/100), and the difference was statistically significant ( χ2=20.69, P<0.001). Conclusion:In initial treatment of H. pylori infection, the eradication rate of VPZ dual therapy is non-inferior to that of PPI quadruple therapy, and VPZ dual therapy demonstrates higher safety.

Background Steel workers are exposed to occupational hazardous factors such as dust, noise, and heat, and often work in shifts, making them prone to sleep disorders. Objective To explore potential influencing factors of sleep disorders among workers in a steel enterprise in Gansu Province, and provide a basis for reducing the risk of sleep disorders among them. Methods From January to March 2022, a self-made questionnaire combined with the Pittsburgh Sleep Quality Index (PSQI) were used to investigate the employees of a steel enterprise in Gansu Province. According to their PSQI scores, they were divided into a normal sleep group and a sleep disorder group. The general demographic variables of the two groups were balanced by 1∶1 propensity score matching (PSM). Multiple logistic regression was used to analyze the contributing factors of sleep disorders. Restricted cubic spline (RCS) model was used to analyze potential dose-response relationship between weekly working hours and sleep disorders. Results The prevalence of sleep disorders in the steel workers was 48.06% (6029/12544). After PSM, 5847 pairs were successfully matched, and the distributions of matched variables were well balanced between the two groups. The results of multiple logistic regression showed that hypertension (OR=1.39, 95%CI: 1.24, 1.56), diabetes mellitus (OR=1.34, 95%CI: 1.07, 1.66), three-shift system (OR=1.26, 95%CI: 1.12, 1.41), dust exposure (OR=1.14, 95%CI: 1.01, 1.29), noise exposure (OR=1.23, 95%CI: 1.09, 1.39), heat exposure (OR=1.16, 95%CI: 1.04, 1.29), and work injury (OR=1.22, 95%CI: 1.02, 1.46) increased the risk of sleep disorders. Compared with workers with < 10 years of service, those with 10-20 years (OR=1.31, 95%CI: 1.19, 1.44), 20-30 years (OR=1.34, 95%CI: 1.19, 1.52), and ≥30 years of service (OR=1.35, 95%CI: 1.19, 1.53) had a higher risk of sleep disorders. Compared with non-exercise workers, the risk of developing sleep disorders was lower in workers with occasional exercise (OR=0.61, 95%CI: 0.56, 0.66) and regular exercise (OR=0.55, 95%CI: 0.49, 0.62). The RCS model showed that the weekly working hours and sleep disorders in the steel workers showed a nonlinear dose-response relationship (P<0.05 for overall trend, P<0.05 for nonlinear test). The relationship between weekly working hours and sleep disorders showed a "U" shaped distribution, with a significant increase in the risk of sleep disorders when the weekly working hours exceeded 49 h. Conclusion The non-occupational influencing factors of sleep disorders of employees in the steel enterprise include hypertension, diabetes, physical exercise, and occupational influencing factors include length of service, weekly working hours, shifts, dust exposure, noise exposure, heat exposure, and work injuries. It is recommended to consider both occupational and non-occupational factors to formulate appropriate sleep disorder prevention and control measures for steel employees to reduce the risk of sleep disorders.

{L-End}Objective To analyze the correlation between occupational burnout and sleep quality among steelworkers. {L-End}Methods A total of 11 491 steelworkers from a large steel enterprise in Gansu Province were selected as the research subjects using convenient sampling method. The Burnout Questionnaire and the Pittsburgh Sleep Quality Index Scale were used to investigate their occupational burnout and sleep quality. Hierarchical regression analysis was used to analyze the effects of occupational burnout on the sleep quality. {L-End}Results The detection rate of occupational burnout and sleep disorder were 50.4% and 39.0%, respectively. There was a positive correlation between the level of occupational burnout and the total score of sleep quality (Spearman correlation coefficient=0.454, P<0.05). The results of hierarchical regression analysis, adjusting for confounding factors such as gender, age, marital status, education level, alcohol consumption, exercise, weekly working hours, seniority, work shift, noise exposure, dust exposure, and high-temperature work, showed that the score of occupational burnout was positively related to the score of sleep quality(P<0.01), explaining 16.0% of the variance in the score of sleep quality among these steelworkers. {L-End}Conclusion The detection rate of occupational burnout and sleep disorders are relatively high among the steelworkers in this enterprise. Higher levels of occupational burnout are associated with poorer sleep quality. Alleviating occupational burnout among steelworkers may contribute to improving their sleep quality.

Objective:To explore the value of cardiovascular MR (CMR) T 1 mapping in evaluating myocardial injury in patients recovered from COVID-19. Methods:The clinical and image data of 15 patients with COVID-19 (9 with moderate clinical manifestation, 6 with severe clinical manifestation) who underwent CMR screening at 3 months after being discharged from the Second People′s Hospital of Fuyang City during May 2020 to June 2020 were prospective collected. Fifteen COVID-19 patients were selected as case group, and another 11 healthy volunteers were selected as control group. A standardized CMR protocol included cine, native and enhanced T 1 mapping, late gadolinium enhancement (LGE). Cardiac functional parameters, native T 1 value of left ventricular and extracellular volume fraction (ECV) were measured. One way ANOVA was used to assess the difference between CMR parameters among moderate and severe manifestation groups and control group, and LSD- t was used to assess the difference between the three groups. Results:LGE value was negative in all subjects. ECV values were higher in recovered COVID-19 patients with either moderate (27.9%±2.7%) or severe manifestation (30.0%±3.7%) than control group (23.2±1.9%) ( P<0.05); there was no significant difference of ECV values between recovered COVID-19 patients with moderate and severe manifestation ( P=0.100). There was no difference of native T 1 values and other functional and morphologic parameters of left ventricular and right ventricular among recovered COVID-19 patients with moderate and severe manifestation and control group ( P>0.05). Conclusion:CMR myocardial tissue ECV increase in patients who recovered from COVID-19, suggesting subclinical myocardial injury.

Tocilizumab has been reported to attenuate the "cytokine storm" in COVID-19 patients. We attempted to verify the effectiveness and safety of tocilizumab therapy in COVID-19 and identify patients most likely to benefit from this treatment. We conducted a randomized, controlled, open-label multicenter trial among COVID-19 patients. The patients were randomly assigned in a 1:1 ratio to receive either tocilizumab in addition to standard care or standard care alone. The cure rate, changes of oxygen saturation and interference, and inflammation biomarkers were observed. Thirty-three patients were randomized to the tocilizumab group, and 32 patients to the control group. The cure rate in the tocilizumab group was higher than that in the control group, but the difference was not statistically significant (94.12% vs. 87.10%, rate difference 95% CI-7.19%-21.23%, P = 0.4133). The improvement in hypoxia for the tocilizumab group was higher from day 4 onward and statistically significant from day 12 (P = 0.0359). In moderate disease patients with bilateral pulmonary lesions, the hypoxia ameliorated earlier after tocilizumab treatment, and less patients (1/12, 8.33%) needed an increase of inhaled oxygen concentration compared with the controls (4/6, 66.67%; rate difference 95% CI-99.17% to-17.50%, P = 0.0217). No severe adverse events occurred. More mild temporary adverse events were recorded in tocilizumab recipients (20/34, 58.82%) than the controls (4/31, 12.90%). Tocilizumab can improve hypoxia without unacceptable side effect profile and significant influences on the time virus load becomes negative. For patients with bilateral pulmonary lesions and elevated IL-6 levels, tocilizumab could be recommended to improve outcome.
Antibodies, Monoclonal, Humanized ; COVID-19/drug therapy* ; Humans ; SARS-CoV-2 ; Treatment Outcome

Objective:To analyze the clinical characteristics of patients with novel coronavirus pneumonia (COVID-19) and the factors influencing mild cases developing into severe cases, so as to provide a basis for clinical screening, prevention and treatment of potential severe cases.Methods:Retrospective analysis was performed on the clinical characteristics of 168 cases who were admitted to two tertiary general hospitals in Anhui province and diagnosed with COVID-19 from January 20 to March 4, 2020. According to the classification criteria in the COVID-19 diagnosis and treatment program (trial version 6) issued by the National Health Commission, the mild and common cases were classified as the mild group ( n=137), and the severe and critical cases were classified as the severe group ( n=31). The general data, epidemiological history, clinical manifestations, laboratory examination and imaging indexes of the two groups were compared. Univariate analysis was performed. Then multivariate Logistic regression analysis was conducted on the factors with statistically significant differences in univariate analysis to obtain independent influencing factors of the occurrence of severe COVID-19. Results:Among the 168 COVID-19 patients, 95 were male and 73 were female, with an average age of 42.6±15.8 years old. The mean age of the mild group was younger than that of the severe group (40.5±15.5 vs 51.6 ±14.1, P<0.01). The proportion of patients combined with hypertension (29.0% vs 10.9%), diabetes (25.8% vs 2.2%, P=0.005) and two or more underlying diseases (29.0% vs 4.4%, P=0.006) in the severe group were significantly higher than those in the mild group. In the severe group, the proportion of patients receiving initial treatment in Medical institutions below secondary hospitals was significantly higher than that in the mild group ( P<0.01), and the time between symptom onset and diagnosis was longer [(8.00±3.27) d vs (6.49±3.90) d, P=0.048]. There was no significant difference in the initial symptoms between the mild group and the severe group. However, the body temperature was higher in the severe group [(38.80±0.67)℃ vs (37.9±0.60)℃, P<0.01]. At the time of admission, the lymphocyte percentage of the severe group was significantly lower than that of the mild group [(18.20±9.13)% vs (24.43±10.43)%, P<0.01], while C-reactive protein, interleukin-6 (IL-6), D-dimer, LDH, aspartate and aminotransferase were significantly higher than that of the mild group ( P<0.01). CT imaging showed that 11 (8%) patients in the mild group had lesions confined to a single lobe of the lung, while all patients in the severe group had multi-lobe lesions ( P<0.01). All the 168 COVID-19 patients in this study were cured, and the length of hospital stay in the severe group was significantly longer than that in the mild group [(24.71±7.72) d vs (20.28±7.67) d, P=0.021]. According to multivariate binary Logistic regression analysis, age ( P=0.042), diabetes ( P=0.021), body temperature at admission ( P=0.001), and IL-6 measured at admission ( P=0.008) were independent factors affecting COVID-19 to severe progress. Conclusions:Strengthening the professional knowledge training of primary hospitals is helpful for early diagnosis of COVID-19. Patients with older age, combined with diabetes, high initial fever and significantly increased IL-6 level are more possibly to develop into severe disease. Early identification and prevention should be carried out.

Objective:To analyze the clinical characteristics of critical patients with coronavirus disease 2019 (COVID-19), build an early warning model for severe/critical type, and aim at providing reference for the prediction of severe/critical COVID-19.Methods:The clinical data of COVID-19 patients treated in the Second People' Hospital of Fuyang City from January 20th to February 18th in 2020 were retrospective analyzed, including the demographic and epidemiological date, vital signs and hematology indexes, etc. on admission. Patients were divided into the normal type (set as normal group) and severe/critical type (set as severe group) according to the COVID-19 treatment plan classification standard published by National Health Commission of the People's Republic of China. The differences between two groups were compared, and the variables with statistical significance were incorporated in the multivariate binary unconditional Logistic regression analysis to screen the risk factors of severe/critical type. Risk factors were summarized to establish an early warning model, and the receiver operating characteristic (ROC) curve was carried out to evaluate the significance of the early warning model in the screening of critically COVID-19.Results:A total of 155 patients with COVID-19 were admitted, including 125 patients of normal type and 30 patients of severe/critical type. ① Compared with normal group, patients in severe group were older, and with higher proportion of basic diseases, higher body mass index (BMI), higher incidence of tachypnea, persistent high fever, peripheral blood oxygen saturation (SpO 2) < 0.95, while the white blood cell count (WBC), CD4 + T lymphocyte, CD8 + T lymphocyte, lymphocyte count (LYM) were decreased obviously, the levels of interleukin-6 (IL-6), C-reactive protein (CRP) and serum amyloid a protein (SAA), and CT showed higher incidence of multi-pulmonary lobe lesions. There were no significant differences of gender, travel history from Wuhan, smoking history, shock index (SI) and CD4 +/CD8 + ratio between the two groups. ② Multivariate Logistic regression analysis showed that age ≥60 years old [odds ratio ( OR) = 1.620, P = 0.031], combined with underlying diseases ( OR = 1.521, P = 0.044), persistent high fever ( OR = 2.469, P = 0.014), WBC < 2.0×10 9/L and/or LYM < 0.4×10 9/L ( OR = 3.079, P = 0.006), pulmonary multilobar lesions ( OR = 1.367, P = 0.047), and IL-6 ≥ 30 ng/L ( OR = 2.426, P = 0.010) were the risk factors of severe/critical COVID-19. ③ The OR value corresponding to each risk factors were scored by rounding. Two points were scored for age≥60 years old, with underlying diseases, persistent high fever and IL-6 ≥ 30 ng/L, 3 points for WBC < 2.0×10 9/L and/or LYM < 0.4×10 9/L, 1 point for pulmonary multilobar lesions, and totally calculated as early warning model scores. The early warning model score of the severe group was significantly higher than that of the normal group (9.33±2.79 vs. 5.04±2.38, t = 9.010, P = 0.001). ④ The ROC curve analysis showed the area under ROC curve (AUC) of early warning model on the early screening of severe/critical patients in COVID-19 was 0.944, and 95% confidence interval (95% CI) was 0.903-0.985; and the sensitivity and specificity were 93.3% and 72.0% respectively while the cut-off was 6.5. Conclusions:There are many differences between severe/critical and mild COVID-19 patients. The establishment of early warning model could help to screen severe/critical patients at an early stage, with certain significance for guiding treatment.