METHODS: This retrospective cohort study was conducted among stroke patients admitted to Jordan University Hospital from January 2015 to May 2021. Multivariable logistic regression was used to identify independent predictors for SAP. The predictive performance was assessed using C-statistics, described as the area under the receiver-operating characteristic curve (AUC, ROC) with a 95% confidence interval.
RESULTS: Four hundred and six patients were included in the analysis, and the prevalence of SAP was 19.7%. Multivariable logistic analysis showed that males (Adjusted Odds Ratio (AOR): 5.74; 95% Confidence Interval (95%CI): 2.04-1 6.1)], dysphagia (AOR: 5.29; 95% CI: 1.80-15.5), hemiparesis (AOR: 3.27; 95% CI: 1.13-9.47), lower GCS score (AOR: 0.73; 95% CI: 0.58-0.91), higher levels of neutrophil-lymphocyte ratio (NLR) (AOR: 1.15; 95% CI: 1.07-1.24), monocyte-lymphocyte ratio (MLR) (AOR: 1.49; 95% CI: 1.13-1.96), and neutrophil percentage to albumin ratio (NPAR) (AOR: 1.53; 95% CI: 1.33-1.76) were independent predictors of SAP. The NPAR demonstrated a significantly higher AUC than both the NLR (0.939 versus 0.865, Z = 3.169, p = 0.002) and MLR (0.939 versus 0.842, Z = 3.940, p
METHOD: We searched PubMed, Embase, EBSCOhost and ClinicalTrials.gov for the eligible RCTs which compared the efficacy and safety of combined atezolizumab and nab-paclitaxel with nab-paclitaxel alone. The outcomes analyzed included overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and treatment-related adverse effects (AEs).
RESULTS: A total of six RCTs were included in this MA. For efficacy, although OS was not significantly prolonged with combined atezolizumab and nab-paclitaxel (HR 0.90, 95% CI [0.79, 1.01], p=0.08), this combination therapy significantly improved PFS (HR 0.72, 95% CI [0.59, 0.87], p=0.0006) and ORR (RR 1.25, 95% CI [0.79, 1.01] p<0.00001). For safety, any AEs, haematological, gastrointestinal, and liver AEs showed no statistically significant differences between the atezolizumab and nab-paclitaxel combination group and nab-paclitaxel alone group. However, serious AEs, high grade, dermatological, pulmonary, endocrine, and neurological AEs were significantly lower with nab-paclitaxel alone compared to atezolizumab and nab-paclitaxel combined (p-value range from <0.00001 to 0,02).
CONCLUSION: Atezolizumab combined with nab-paclitaxel was associated with improved outcomes in the treatment of TNBC; however, this combination resulted in more toxicity compared to nab-paclitaxel alone. While nab-paclitaxel alone produced chemotherapy-related AEs, the combination of atezolizumab with nab-paclitaxel produced AEs, especially immune-related AEs such as haematological, pulmonary, endocrine, and neurological AEs.
TRIAL REGISTRATION: This research work of systematic review has been registered on PROSPERO (Registration number: CRD42022297952).
METHODS: We included patients from a multicentre longitudinal cohort (recruited between May 1, 2013, and Dec 31, 2019) with active SLE (SLEDAI-2K ≥6) coinciding with an abnormality in at least one of 13 routine laboratory tests, at a visit designated as baseline. At 12 months, we analysed associations between thresholds of improvement in individual laboratory test results, measured as continuous variables, and five clinical outcomes using logistic regression. Primary outcomes were damage accrual and lupus low disease activity state (LLDAS), and secondary outcomes were modified SLE responder index (mSRI), physician global assessment (PGA) improvement of at least 0·3, and flare.
FINDINGS: We included 1525 patients (1415 [93%] women and 110 [7%] men, 1328 [87%] Asian ethnicity) in separate subsets for each laboratory test. The strongest associations with LLDAS and damage protection were seen with improvements in proteinuria (complete response: adjusted odds ratio [OR] 62·48, 95% CI 18·79-208·31 for LLDAS, OR 0·22, 95% CI 0·10-0·49 for damage accrual), albumin (complete response: adjusted OR 6·46, 95% CI 2·20-18·98 for LLDAS, OR 0·42, 95% CI 0·20-1·22 for damage accrual), haemoglobin (complete response: adjusted OR 1·97, 95% CI 1·09-3·53 for LLDAS, OR 0·33, 95% CI 0·15-0·71 for damage accrual), erythrocyte sedimentation rate (complete response: adjusted OR 1·71, 95% CI 1·10-2·67 for LLDAS, OR 0·53, 95% CI 0·30-0·94 for damage accrual), and platelets (complete response: adjusted OR 4·82, 95% CI 1·54-15·07 for LLDAS, OR 0·49, 95% CI 0·20-1·19 for damage accrual). Improvement in serological tests were mainly associated with PGA and mSRI. White cell and lymphocyte count improvements were least predictive.
INTERPRETATION: Improvements in several routine laboratory tests correspond with clinical outcomes in SLE over 12 months. Tests with the strongest associations were discrepant with laboratory tests included in current trial endpoints, and associations were observed across a range of improvement thresholds including incomplete resolution. These findings suggest the need to revise the use of laboratory test results in SLE trial endpoints.
FUNDING: Abbvie.
METHODS: The Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, MEDLINE, China National Knowledge Infrastructure (CNKI) and Wanfang Database were searched for relevant randomized controlled trials up to March 2016. Two review authors independently selected trials for inclusion, extracted data, assessed the methodological quality and rated the quality of evidence with the Grading of Recommendations, Assessment, Development and Evaluation approach.
RESULTS: Twelve studies involving 655 participants were included. Evidence of low to moderate-quality showed that cordyceps plus conventional treatment compared to conventional treatment alone significantly improved C-reactive protein [standardized mean difference (SMD) -0.61; 95% confidence intervals (CI) -1.00 to -0.22], high-sensitivity C-reactive protein [weighted mean difference (WMD) -3.44 mg/L; 95% CI -3.89 to -2.99], serum albumin (WMD 3.07 g/L; 95% CI 1.59 to 4.55), malondialdehyde (WMD -1.95 nmol/L; 95% CI -2.24 to -1.66), and hemoglobin (WMD 9.56 g/L; 95% CI 3.65 to 15.47) levels. However, there was no significant improvement for serum creatinine and low-density lipoprotein cholesterol. Overall, most trials either did not monitor adverse events or poorly documented them.
CONCLUSION: Given the small number of trials included, the unclear methodological quality of the included trials, and the high heterogeneity in pooled analyses, the evidence obtained in this review is insufficient to recommend the use of cordyceps as adjunctive treatment in hemodialysis patients.
METHODS AND RESULTS: Ara h 2.02 cDNA was cloned into pNZ8048 for heterologous expression in L. lactis. The purified recombinant allergen showed IgE binding comparable with native Ara h 2. Balb/c mice were fed with either recombinant (rLl), nonrecombinant L. lactis (Ll) or NaHCO3 (Sham) prior to sensitization and challenged with rAra h 2.02, whereas the baseline group was only fed with Ll. Allergen-specific immunoglobulin and splenocyte cytokines responses were determined for each mouse. Mice fed with either Ll or rLl showed significant alleviation of IgE and IgG1 compared to the Sham group. Despite no significant decrease in Th2 (IL-4, IL-13, IL-6) or increase in Th1 (IFN-γ) cytokines, both groups showed lower IL-10 level, while the IL-4 : IFN-γ ratio was significantly lower for rLl compared to Ll group.
CONCLUSIONS: Oral administration of rLl harbouring Ara h 2.02 demonstrated alleviation of Th2-associated responses in allergen-challenged mice and a possible added allergen-specific prophylactic effect.
SIGNIFICANCE AND IMPACT OF THE STUDY: Ara h 2.02 coupled with the intrinsic properties of probiotic L. lactis as a delivery vehicle can be explored for the development of a commercially scalable vaccine.
MATERIALS AND METHODS: Male patients, ≤65 years old with severe haemophilia B (FIX activity ≤2%) requiring non-emergency surgery were enrolled in the surgical substudy of PROLONG-9FP. Dosing was based on World Federation of Hemophilia guidelines and patients' pharmacokinetics. Haemostatic efficacy was assessed on a 4-point scale. rIX-FP consumption and safety were monitored throughout the perioperative period.
RESULTS: This updated dataset reports on thirty (8 minor and 22 major) surgeries conducted in 21 patients. A single preoperative bolus was used in 96.7% (n = 29) of surgeries. After minor surgery, patients received a median (range) of 0 (0-3) infusions with a median (range) consumption of 0 (0-178.89) IU/kg in the 14-day postoperative period. In patients who underwent major surgery (including 15 patients undergoing joint replacement surgery), the median (range) number of infusions in the 14-day postoperative period was 5 (0-11) and median consumption was 221.7 (0-444.07) IU/kg. Haemostatic efficacy was rated as excellent or good in 87.5% (7/8) of minor surgeries and 95.5% (21/22) of major surgeries.
CONCLUSION: Surgical procedures can be performed using a single preoperative bolus of rIX-FP in nearly all patients. During postoperative care, use of rIX-FP necessitated infrequent infusions and low FIX consumption. Overall, data suggest rIX-FP simplifies perioperative care in patients with haemophilia B.