Safety of a 90-min duration of intravenous infusion of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma in a tertiary hospital in China: a prospective, open-label, exploratory clinical trial.

This study aimed to analyze the safety and applicability of a 90-min duration of infusion (SDI) of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma (NHL) in a tertiary hospital in China. This exploratory clinical trial was performed at Jiangsu Province Hospital. All patients were treated with the standard infusion regimen for the first infusion. If no grade ≥3 infusion-related reactions (IRRs) occurred, the subsequent infusions were given as SDI. The primary endpoint was the incidence of IRR during the standard infusion (3-4 h) and 90-min SDI regimens. This study enrolled 208 patients and all completed cycle 1. Forty-one patients (19.71%) had IRRs: five (2.40%) with grade 1, twenty-eight (13.46%) with grade 2, and eight (3.85%) with grade 3. The 41 patients had 71 IRRs, mainly fever (40.85%), chest pain/tightness (12.68%), and dyspnea (9.86%). The occurrence of IRRs in the first infusion was significantly lower in patients who received oral acetaminophen prophylaxis than those who did not (10.72% vs 30.21%, P<0.001). For the subsequent cycles with 90-min SDI, only two (0.25%) IRRs occurred among 814 infusions (one grade 1 hand numbness and one grade 2 chill/fever). The 90-min obinutuzumab SDI might be safe and feasible in patients with B-cell NHL in China.

Safety of a 90-min duration of intravenous infusion of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma in a tertiary hospital in China: a prospective, open-label, exploratory clinical trial

This study aimed to analyze the safety and applicability of a 90-min duration of infusion (SDI) of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma (NHL) in a tertiary hospital in China. This exploratory clinical trial was performed at Jiangsu Province Hospital. All patients were treated with the standard infusion regimen for the first infusion. If no grade ≥3 infusion-related reactions (IRRs) occurred, the subsequent infusions were given as SDI. The primary endpoint was the incidence of IRR during the standard infusion (3-4 h) and 90-min SDI regimens. This study enrolled 208 patients and all completed cycle 1. Forty-one patients (19.71%) had IRRs: five (2.40%) with grade 1, twenty-eight (13.46%) with grade 2, and eight (3.85%) with grade 3. The 41 patients had 71 IRRs, mainly fever (40.85%), chest pain/tightness (12.68%), and dyspnea (9.86%). The occurrence of IRRs in the first infusion was significantly lower in patients who received oral acetaminophen prophylaxis than those who did not (10.72% vs 30.21%, P<0.001). For the subsequent cycles with 90-min SDI, only two (0.25%) IRRs occurred among 814 infusions (one grade 1 hand numbness and one grade 2 chill/fever). The 90-min obinutuzumab SDI might be safe and feasible in patients with B-cell NHL in China.

A risk prediction model for evaluating thrombosis extension of muscle calf venous thrombosis after craniotomy.

Objective: To explore the risk factors of muscle calf venous thrombosis (MCVT) after craniotomy and construct a risk prediction model, so as to provide tool for evaluating the prognosis of MCVT after craniotomy. Methods: Retrospective analysis was performed on the data of patients undergoing craniotomy complicated with MCVT from January 1, 2018 to December 31, 2020. A prediction model was established by Logistic regression, and the predictive efficacy of the model was tested by ROC curve. The accuracy of the risk model was evaluated by Hosmer-Lemeshow (H-L) test, and the model was verified internally by cross validation. Results: Among the 446 patients who underwent craniotomy complicated with MCVT, 112 cases (25.11%) had thrombosis extension. D-dimer, Capirini scores, length of hospital stay, malignant tumor, fracture, use of dehydrating agents and hemostatic agents were independently related to thrombosis extension after craniotomy. The area under ROC curve (AUROC) of the prediction model was 0.918 (0.888, 0.942), and the sensitivity and specificity of the maximum Youden index were 85.3% and 78.2%, respectively. H-L test showed that the prediction model was accurate (χ 2 = 12.426, P = 0.133). The internal verification results of the prediction model showed that the AUROC value of the prediction model is 0.892. Conclusion: The prediction model has a good prediction efficacy on the prognosis of post-craniotomy patients complicated with MCVT, and can be used as a tool to evaluate the risk of thrombosis extension.

Factors Related to Activation in Chinese Patients With Chronic Obstructive Pulmonary Disease: A Cross-Sectional Survey Study.

BACKGROUND: Improving patient activation can lead to better health outcomes among patients with chronic obstructive pulmonary disease (COPD). However, no studies have focused on the issue of activation in patients with COPD in China. PURPOSE: This study was designed to explore the status of activation in patients with COPD in China and explicate the significant influencing factors. METHODS: One hundred seventy patients with COPD were recruited using a convenience sampling method from eight tertiary and secondary hospitals in Nanjing, China. Sociodemographic, clinical, and patient-reported factor data were collected. Univariate analysis and multivariate linear regression were performed. RESULTS: Only 10.6% of the patients were identified as activated for self-management. Multivariate linear regression analysis revealed four explanatory elements as significantly associated with patient activation, including social support (ß = .463, p < .001), free medical insurance (ß = .173, p = .007), smoking status (ß = -.195, p = .002), and health status (ß = -.139, p = .04). CONCLUSIONS/IMPLICATIONS FOR PRACTICE: The findings of this study indicate that a minority of patients with COPD are activated for self-management in China. Having a higher level of patient activation was associated with having better social support, having free medical insurance, being a nonsmoker, and having a better health status. Creating a supportive environment, promoting smoking cessation, and improving medical security and health status may be considered as potential strategies to activate patients into better self-management.

Effects of Vitamin D3 on Intestinal Flora in a Mouse Model of Inflammatory Bowel Disease Treated with Rifaximin.

BACKGROUND Rifaximin is an antimicrobial agent used to treat inflammatory bowel disease (IBD). Vitamin D3 can control IBD due to its effects on inflammatory cytokines. The purpose of this study was to assess the effect of vitamin D3 on the intestinal flora of a dextran sulfate sodium (DSS)-induced mouse model treated with rifaximin. MATERIAL AND METHODS The mouse model of IBD was developed using DSS (4%) administered via the drinking water. Twenty-four male C57BL6 mice were divided into the control group with a normal diet (N=6), the DSS group with a normal diet (N=6), the DSS group with a normal diet treated with rifaximin (N=6), and the DSS group with a normal diet treated with rifaximin and vitamin D3 (N=6). After 14 days, the colonic tissue was studied histologically. Serum levels of tumor necrosis factor-alpha (TNF-alpha) and interleukin-1ß (IL-1ß) and enzyme-linked immunosorbent assay (ELISA) were used to measure the level of IL-6 and P65, and phospho-p65 was measured by western blot. 16S rRNA gene sequencing was used to analyze fecal samples. RESULTS In the DSS mouse model of IBD, rifaximin reduced the inflammation severity of the colon and reduced the expression of phospho-p65, p65, TNF-alpha, and IL-6. In the DSS+rifaximin+vitamin D3 group, the therapeutic influences of rifaximin, in terms of weight loss and colonic disease activity, were significantly reduced, and the gut microbiota of the mice were completely changed in composition and diversity. CONCLUSIONS In a mouse model of IBD, treatment with vitamin D3 significantly increased the metabolism of rifaximin and reduced its therapeutic effects.

Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis in patients with solid cancers: A randomized controlled trial.

BACKGROUND: Peripherally-inserted central catheter-related venous thrombosis has serious complications including the loss of vascular access, recurrent venous thrombosis, and post-thrombotic syndrome. Current guidelines recommend non-pharmacological strategies to prevent peripherally-inserted central catheter-related venous thrombosis. There is little evidence for the effectiveness of handgrip exercise on the prevention of peripherally-inserted central catheter-related venous thrombosis. OBJECTIVES: To examine the effectiveness of handgrip exercise using an elastic ball to prevent peripherally-inserted central catheter-related venous thrombosis in patients with solid cancers. DESIGN: A randomized controlled trial. SETTINGS: One teaching hospital in Nanjing, China. PARTICIPANTS: In total, 120 subjects with solid cancers were eligible; each had a new peripherally-inserted central catheter. They were recruited and randomly assigned into two exercise groups and one control group. METHODS: Subjects from exercise groups 1 and 2 performed a 3-week, 25-repetition handgrip exercise, 3 and 6 times daily, respectively. The control group subjects performed a gentle limb exercise with no frequency and intensity requirements. Ultrasound was used to detect venous thrombosis development and examine axillary vein blood flow over the three points. RESULTS: There were 32 cases of peripherally-inserted central catheter-related venous thrombosis detected. Two venous thrombosis cases in the control group were symptomatic, but all venous thrombosis cases in the exercise groups were asymptomatic. All venous thromboses were partial. There were significant differences in the incidence of venous thrombosis among the three groups (χ2 = 12.813, p = 0.002; χ2 = 9.340, p = 0.009; χ2 = 11.480, p = 0.003; and χ2 = 10.534, p = 0.005, respectively) at days 2, 3 and 21. The incidence of venous thrombosis in the two exercise groups was lower than that in the control group over the 3 time points (all, p < 0.05). The between-group effects and interaction effect in vein maximum velocity and time-mean flow velocity showed significant differences (F = 4.180, p = 0.025; F = 4.010, p = 0.045; and F = 2.928, p = 0.025) at days 2, 3, and 21, respectively. The axillary vein blood flow parameters in the control group were lower than those in the two exercise groups at day 21 (all, p < 0.05). However, no significant differences occurred in the incidence of venous thrombosis and axillary vein blood flow parameters between the two exercise groups. CONCLUSION: Handgrip exercise using an elastic ball daily for three weeks could decrease the incidence of peripherally-inserted central catheter-related venous thrombosis. The method is simple, with no negative consequence reported. Further studies are required to confirm this conclusion and to explore the optimal frequency of handgrip exercise.

Efficacy of intermittent pneumatic compression for venous thromboembolism prophylaxis in patients undergoing gynecologic surgery: A systematic review and meta-analysis.

We sought to comprehensively assess the efficacy of Intermittent Pneumatic Compression (IPC) in patients undergoing gynecologic surgery. A computerized literature search was conducted in Pubmed, Embase and Cochrane Library databases. Seven randomized controlled trials involving 1001 participants were included. Compared with control, IPC significantly lowered the deep vein thrombosis (DVT) risk [risk ratio (RR) = 0.33, 95% confidence interval (CI): 0.16 - 0.66]. The incidence of DVT in IPC and drugs group was similar (4.5% versus. 3.99%, RR = 1.19, 95% CI: 0.42 - 3.44). With regards to pulmonary embolism risk, no significant difference was observed in IPC versus control or IPC versus drugs. IPC had a lower postoperative transfusion rate than heparin (RR = 0.53, 95% CI: 0.32 - 0.89), but had a similar transfusion rate in operating room to low molecular weight heparin (RR = 1.06, 95% CI: 0.69 - 1.63). Combined use of IPC and graduated compression stockings (GCS) had a marginally lower risk of DVT than GCS alone (RR = 0.38, 95% CI: 0.14 - 1.03). In summary, IPC is effective in reducing DVT complications in gynecologic surgery. IPC is neither superior nor inferior to pharmacological thromboprophylaxis. However, whether combination of IPC and chemoprophylaxis is more effective than IPC or chemoprophylaxis alone remains unknown in this patient population.

Efficacy of Exercise Interventions in Patients with Acute Leukemia: A Meta-Analysis.

BACKGROUND: Decreased physical performance and impaired physiological and psychological fitness have been reported in patients with acute leukemia (AL). We performed a meta-analysis to assess the efficacy of exercise in patients with AL. METHODS: In this meta-analysis, the electronic databases MEDLINE, Embase, Cochrane, Web of Science, SPORTDiscus, CINAHL and PEDro were searched through November 2015. Three authors participated in the study selection, data extraction and quality assessment. The instrument used for quality assessment was derived from the Cochrane Handbook for Systematic Reviews of Interventions. Analyses were performed according to the recommendations of The Cochrane Collaboration using Review Manager 5.3. RESULTS: Nine trials (8 randomized controlled trials and 1 quasi-experimental design trial) with 314 AL participants were included in this meta-analysis. The pooled standardized mean differences between the exercise and control groups were 0.45 (95% confidence interval (CI): 0.09 to 0.80, P value = 0.01, P for heterogeneity = 0.23, I2 = 28%) for cardiorespiratory fitness and 0.67 (95% CI: 0.28 to 1.06, P value = 0.0007, P for heterogeneity = 0.14, I2 = 43%) for muscle strength. Based on the data for fatigue, anxiety, and depression, there were no significant differences in these parameters between the exercise and control groups. CONCLUSIONS: Exercise has beneficial effects on cardiorespiratory fitness, muscle strength and functional mobility; however, no significant improvements in fatigue, anxiety, depression or quality of life were observed. Further large-scale randomized trials are needed to assess the safety, feasibility and efficacy of exercise programs for AL patients.