Objective:To evaluate the efficacy and safety of QL1206(a denosumab biosimilar to Xgeva■)in breast cancer patients with bone metastasis(BM)through subgroup analysis of a randomized,double-blind phaseⅢtrial(No.NCT045...Objective:To evaluate the efficacy and safety of QL1206(a denosumab biosimilar to Xgeva■)in breast cancer patients with bone metastasis(BM)through subgroup analysis of a randomized,double-blind phaseⅢtrial(No.NCT04550949).Methods:This subgroup analysis included patients with BM from breast cancer enrolled in a phaseⅢtrial.Patients were randomized(1:1)to receive either three cycles of QL1206 or denosumab(120 mg subcutaneously every 4 weeks).Subsequently,they received 10 cycles of QL1206(120 mg)over 40 weeks,followed by a 20-week safety follow-up.The primary endpoint was the percentage changes from baseline to week 13 in urinary Ntelopeptide corrected for creatinine(u NTx/Cr).Results:The breast cancer cohort consisted of 311 patients.Vertebral involvement(66.4%)was the most prevalent BM site at enrollment,while 27.7%of patients presented with≥3 metastatic bone lesions.At week 13,QL1206 demonstrated a median u NTx/Cr reduction of-69.9%(range:-98.1%-568.0%)vs.-74.3%(range:-97.7%-386.3%)for denosumab.The analysis of covariance revealed comparable least-square means for log-transformed changes:-1.416[95%confidence interval(95%CI):-1.736 to-1.096]vs.-1.501(95%CI:-1.824 to-1.178),yielding an between-group difference of 0.085(90%CI:-0.062-0.232;P=0.343).After a 53-week treatment period,83.6%achieved bone density improvement/disease stabilization.Safety profiles were comparable between groups.Conclusions:QL1206 demonstrated similar efficacy and safety to the reference denosumab in patients with BM from breast cancer,supporting QL1206 as a new option for management of BM from breast cancer.展开更多
In early 2020,the new coronavirus pneumonia(COVID-19)broke out in China.Many medical-related products have rapidly appeared in the Artificial Intelligence(AI)field,which have played an important role in fighting again...In early 2020,the new coronavirus pneumonia(COVID-19)broke out in China.Many medical-related products have rapidly appeared in the Artificial Intelligence(AI)field,which have played an important role in fighting against the pandemic.This article summarizes the current research and application status of AI in radiology and pandemic control and analyzes the common problems of AI technology in the research of COVID-19 diagnosis.It mainly includes the thoughts on clinical study design,difficulties in research implementation and challenges in the reliability verification of AI models.In response to the above difficulties,suggestions are proposed for optimizing the scientificity and quality of AI diagnostic research.展开更多
Ischemic heart disease(IHD) is known as the leading cause of death in both genders. Moreover, significant sex differences were found in cardiac structure, function, pathophysiology, presentation, treatment, and outcom...Ischemic heart disease(IHD) is known as the leading cause of death in both genders. Moreover, significant sex differences were found in cardiac structure, function, pathophysiology, presentation, treatment, and outcome of IHD. The presence of unique risk factors such as exposure to menarche and pregnancy, more anemia, hypertension, and autoimmune disorders in women have recently received attention. Ischemic symptoms are more indefinite and vague in women compared to men as well as a delay in diagnosis, treatment, and worse outcomes compared to men. Women usually receive less evidence-based treatment and intervention, with less concern on preventive health care. Clinical trials primarily recruit male patients and women are underrepresented. Without any correct diagnosis, treatment, and prevention, these problems are accumulated and continue up to older age. Accordingly, with the belief of longer life in women and the increased prevalence of IHD with aging, it will become an important public health problem and concern in the future. This narrative review aimed to provide an overview of some of the differences between the two genders in terms of IHD with paying more attention to practical points.展开更多
Food allergy(FA)is one of the global human health problems,affecting about 1 in 12 children and 1 in 10 adults worldwide.Probiotics have alleviating effects on FA,but the mechanisms have not been fully understood.We s...Food allergy(FA)is one of the global human health problems,affecting about 1 in 12 children and 1 in 10 adults worldwide.Probiotics have alleviating effects on FA,but the mechanisms have not been fully understood.We sought to explore the therapeutic potential of probiotics Bifidobacterium longum CECT7894(B.longum CECT7894)on anaphylaxis in the ovalbumin(OVA)-induced FA model using an integrated multiomics approaches.The results revealed treatment with B.longum CECT7894 relieved OVA-induced allergic symptoms such as patho-logical changes in small intestine to some extent.Furthermore,probiotics utilization also reduced IgE levels.The transcriptomic data demonstrated that the expressions of genes associated with sphingolipid metabolism were altered in the group received B.longum CECT7894 compared to the sensitized group,including Sgpl1,Trpc1 and Prss8.In addition,the abundances of Sphingobacterium at the genus level,Sphingobacterium sp.21 and B.longum at the species level,which might related with sphingolipid metabolism,were significantly altered by B.longum CECT7894 when compared to the OVA group.Employed the metabolomics analysis,phytosphingosine,C16 sphinganine,sphinganine and sphingosine were identified as significantly changed metabolites and sphingolipid metabolism pathway was significantly enriched by pathway enrichment analysis.The Spearman’s correlation analysis further demonstrated that there were strong correlations between serum biochemical indicators,tran-scripts,gut microbiota and metabolites.Based on the findings described above,from the perspective of genes,gut flora and metabolites changes,it can be concluded that B.longum CECT7894 might suppress OVA-induced FA by regulating the sphingolipid metabolism pathway.展开更多
文摘Objective:To evaluate the efficacy and safety of QL1206(a denosumab biosimilar to Xgeva■)in breast cancer patients with bone metastasis(BM)through subgroup analysis of a randomized,double-blind phaseⅢtrial(No.NCT04550949).Methods:This subgroup analysis included patients with BM from breast cancer enrolled in a phaseⅢtrial.Patients were randomized(1:1)to receive either three cycles of QL1206 or denosumab(120 mg subcutaneously every 4 weeks).Subsequently,they received 10 cycles of QL1206(120 mg)over 40 weeks,followed by a 20-week safety follow-up.The primary endpoint was the percentage changes from baseline to week 13 in urinary Ntelopeptide corrected for creatinine(u NTx/Cr).Results:The breast cancer cohort consisted of 311 patients.Vertebral involvement(66.4%)was the most prevalent BM site at enrollment,while 27.7%of patients presented with≥3 metastatic bone lesions.At week 13,QL1206 demonstrated a median u NTx/Cr reduction of-69.9%(range:-98.1%-568.0%)vs.-74.3%(range:-97.7%-386.3%)for denosumab.The analysis of covariance revealed comparable least-square means for log-transformed changes:-1.416[95%confidence interval(95%CI):-1.736 to-1.096]vs.-1.501(95%CI:-1.824 to-1.178),yielding an between-group difference of 0.085(90%CI:-0.062-0.232;P=0.343).After a 53-week treatment period,83.6%achieved bone density improvement/disease stabilization.Safety profiles were comparable between groups.Conclusions:QL1206 demonstrated similar efficacy and safety to the reference denosumab in patients with BM from breast cancer,supporting QL1206 as a new option for management of BM from breast cancer.
基金the The Scientific Project of Shanghai Municipal Health Commission(No.ZHYL0202).
文摘In early 2020,the new coronavirus pneumonia(COVID-19)broke out in China.Many medical-related products have rapidly appeared in the Artificial Intelligence(AI)field,which have played an important role in fighting against the pandemic.This article summarizes the current research and application status of AI in radiology and pandemic control and analyzes the common problems of AI technology in the research of COVID-19 diagnosis.It mainly includes the thoughts on clinical study design,difficulties in research implementation and challenges in the reliability verification of AI models.In response to the above difficulties,suggestions are proposed for optimizing the scientificity and quality of AI diagnostic research.
文摘Ischemic heart disease(IHD) is known as the leading cause of death in both genders. Moreover, significant sex differences were found in cardiac structure, function, pathophysiology, presentation, treatment, and outcome of IHD. The presence of unique risk factors such as exposure to menarche and pregnancy, more anemia, hypertension, and autoimmune disorders in women have recently received attention. Ischemic symptoms are more indefinite and vague in women compared to men as well as a delay in diagnosis, treatment, and worse outcomes compared to men. Women usually receive less evidence-based treatment and intervention, with less concern on preventive health care. Clinical trials primarily recruit male patients and women are underrepresented. Without any correct diagnosis, treatment, and prevention, these problems are accumulated and continue up to older age. Accordingly, with the belief of longer life in women and the increased prevalence of IHD with aging, it will become an important public health problem and concern in the future. This narrative review aimed to provide an overview of some of the differences between the two genders in terms of IHD with paying more attention to practical points.
基金funded by grants from the Dipro Medical Research Foundation(DiPRO/2019Oct/7894/SHRJ02),China.
文摘Food allergy(FA)is one of the global human health problems,affecting about 1 in 12 children and 1 in 10 adults worldwide.Probiotics have alleviating effects on FA,but the mechanisms have not been fully understood.We sought to explore the therapeutic potential of probiotics Bifidobacterium longum CECT7894(B.longum CECT7894)on anaphylaxis in the ovalbumin(OVA)-induced FA model using an integrated multiomics approaches.The results revealed treatment with B.longum CECT7894 relieved OVA-induced allergic symptoms such as patho-logical changes in small intestine to some extent.Furthermore,probiotics utilization also reduced IgE levels.The transcriptomic data demonstrated that the expressions of genes associated with sphingolipid metabolism were altered in the group received B.longum CECT7894 compared to the sensitized group,including Sgpl1,Trpc1 and Prss8.In addition,the abundances of Sphingobacterium at the genus level,Sphingobacterium sp.21 and B.longum at the species level,which might related with sphingolipid metabolism,were significantly altered by B.longum CECT7894 when compared to the OVA group.Employed the metabolomics analysis,phytosphingosine,C16 sphinganine,sphinganine and sphingosine were identified as significantly changed metabolites and sphingolipid metabolism pathway was significantly enriched by pathway enrichment analysis.The Spearman’s correlation analysis further demonstrated that there were strong correlations between serum biochemical indicators,tran-scripts,gut microbiota and metabolites.Based on the findings described above,from the perspective of genes,gut flora and metabolites changes,it can be concluded that B.longum CECT7894 might suppress OVA-induced FA by regulating the sphingolipid metabolism pathway.
