Objective:To compare the efficacy and safety of LY01011,a recombinant anti-RANKL fully human monoclonal antibody injection,versus denosumab in the treatment of bone metastases from solid tumors.Methods:A randomized,double-blind,positive drug parallel-controlled,multicenter clinical trial was conducted.A total of 850 subjects were randomly assigned(1:1)to either the experimental group(424 subjects)or the control group(426 subjects).The experimental group received 13 doses of LY01011,while the control group received 3 doses of denosumab followed by 10 doses of LY01011.Results:The primary efficacy endpoint was the natural logarithmic change from baseline in urinary N-terminal telopeptide of type I collagen corrected by urinary creatinine(uNTX/uCr)at week 13.The change was-1.740(0.042 0)in the experimental group and-1.745(0.042 1)in the control group.The least-squares mean difference between groups was 0.005(90%CI:-0.088 to 0.097),indicating no statistically significant difference(P>0.05).Safety profiles,including treatment-emergent adverse events,laboratory tests,vital signs,physical examinations,and electrocardiograms,were comparable between groups(P>0.05).Conclusions:LY01011 demonstrated biosimilarity to denosumab,with favorable safety profile,tolerability,and potential for clinical application.

Objective:To compare the efficacy and safety of LY01011,a recombinant anti-RANKL fully human monoclonal antibody injection,versus denosumab in the treatment of bone metastases from solid tumors.Methods:A randomized,double-blind,positive drug parallel-controlled,multicenter clinical trial was conducted.A total of 850 subjects were randomly assigned(1:1)to either the experimental group(424 subjects)or the control group(426 subjects).The experimental group received 13 doses of LY01011,while the control group received 3 doses of denosumab followed by 10 doses of LY01011.Results:The primary efficacy endpoint was the natural logarithmic change from baseline in urinary N-terminal telopeptide of type I collagen corrected by urinary creatinine(uNTX/uCr)at week 13.The change was-1.740(0.042 0)in the experimental group and-1.745(0.042 1)in the control group.The least-squares mean difference between groups was 0.005(90%CI:-0.088 to 0.097),indicating no statistically significant difference(P>0.05).Safety profiles,including treatment-emergent adverse events,laboratory tests,vital signs,physical examinations,and electrocardiograms,were comparable between groups(P>0.05).Conclusions:LY01011 demonstrated biosimilarity to denosumab,with favorable safety profile,tolerability,and potential for clinical application.

This article interprets the " Screening for and Managing the Person with Frailty in Primary Care: Guidelines " developed in 2020 by the International Conference on Frailty and Sarcopenia Research (ICFSR) . This article also analyzes the characteristics of frailty assessment tools and management strategies for frail elderly in order to provide new ideas for the assessment and management of frail elderly in China, and achieve healthy aging of the elderly.

Objective To investigate the effect of seasonal and meteorological factors on the onset of stroke in Qinghai Plateau area.Methods Patients with stroke admitted to Qinghai Provincial People's Hospital from December 1,2011 to November 30,2016 were enrolled retrospectively.The meteorological data provided by Qinghai Meteorological Bureau were used to analyze the distribution of the number of cases in different seasons in Qinghai area and the relationship between the incidence of stroke and plateau meteorological factors.Results A total of 9 412 patients with acute ischemic stroke were enrolled,aged 15～95 years.There were significant statistical differences in the number of cases of ischemic stroke,cerebral hemorrhage,and subarachnoid hemorrhage in different seasons (all P ＜ 0.05).Among them,the number of cases with ischemic stroke increased first and then gradually decreased with the changes of spring,summer,fall and winter,while cerebral hemorrhage and subarachnoid hemorrhage showed a trend of decreasing first and then increasing gradually.There were significant differences in the number of cases in different relative humidity,temperature,and temperature differences (all P ＜ 0.05).Conclusion There are seasonal differences in the incidence of stroke in the plateau area,which may be associated with the influence of plateau meteorological factors.