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 explore the relationship between intestinal bacterial overgrowth (SIBO) and ulcerative colitis (UC).Methods:From December 2023 to June 2024, 85 patients with UC from the Gastroenterology Department of the Luquan branch of the Second Hospital of Hebei Medical University were enrolled. The lactulose hydrogen-methane breath test was performed to assess the prevalence of SIBO. Clinical data, including basic information, clinical manifestations, endoscopic manifestations, inflammatory indicators, current medication regimen, and past medical history, were collected. Furthermore, the body mass index (BMI), modified Mayo score, and patient-reported outcome (PRO2) score were calculated to evaluate disease activity in each patient. The Student′s t-test, Chi-square test, non-parametric test, and multiple logistic regression were used to analyze the data and explore the relationship between SIBO and UC. Results:The incidence of abdominal pain and bloating in patients who were SIBO positive with UC was higher than in those who were SIBO negative [abdominal pain: 50.0%(10/20) vs. 23.1%(15/65), χ2=5.34, P=0.021; abdominal distension: 40.0% (8/20) vs. 13.8% (9/65), χ2=5.01, P=0.025]; the difference was statistically significant ( P<0.05). Patients who were SIBO positive with UC were more likely to develop hypoproteinemia and anemia than those who were SIBO negative [hypoproteinemia: 50.0% (10/20) vs. 15.4% (10/65), χ2=8.35, P=0.004; anemia: 35.0% (7/20) vs. 9.2% (6/65), χ2=5.98, P=0.014]; the difference was statistically significant ( P<0.05). In the intestinal methanogen overgrowth (IMO) positive group, the number of patients with UC with 1-2 stool times/day was higher, and the distribution of stool times between the IMO positive and IMO negative groups was significantly different ( χ2=6.45, P=0.040). Furthermore, combined hypoproteinemia and anemia were risk factors for SIBO in patients with UC (hypoproteinemia OR=4.331, 95% CI 1.117-16.799, P=0.034; anemia OR=5.515, 95% CI 1.231-24.700, P=0.026). Conclusions:We observed a clinical overlap between SIBO and UC. SIBO could be targeted to optimize the treatment of patients with UC in the future.

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 explore the relationship between intestinal bacterial overgrowth (SIBO) and ulcerative colitis (UC).Methods:From December 2023 to June 2024, 85 patients with UC from the Gastroenterology Department of the Luquan branch of the Second Hospital of Hebei Medical University were enrolled. The lactulose hydrogen-methane breath test was performed to assess the prevalence of SIBO. Clinical data, including basic information, clinical manifestations, endoscopic manifestations, inflammatory indicators, current medication regimen, and past medical history, were collected. Furthermore, the body mass index (BMI), modified Mayo score, and patient-reported outcome (PRO2) score were calculated to evaluate disease activity in each patient. The Student′s t-test, Chi-square test, non-parametric test, and multiple logistic regression were used to analyze the data and explore the relationship between SIBO and UC. Results:The incidence of abdominal pain and bloating in patients who were SIBO positive with UC was higher than in those who were SIBO negative [abdominal pain: 50.0%(10/20) vs. 23.1%(15/65), χ2=5.34, P=0.021; abdominal distension: 40.0% (8/20) vs. 13.8% (9/65), χ2=5.01, P=0.025]; the difference was statistically significant ( P<0.05). Patients who were SIBO positive with UC were more likely to develop hypoproteinemia and anemia than those who were SIBO negative [hypoproteinemia: 50.0% (10/20) vs. 15.4% (10/65), χ2=8.35, P=0.004; anemia: 35.0% (7/20) vs. 9.2% (6/65), χ2=5.98, P=0.014]; the difference was statistically significant ( P<0.05). In the intestinal methanogen overgrowth (IMO) positive group, the number of patients with UC with 1-2 stool times/day was higher, and the distribution of stool times between the IMO positive and IMO negative groups was significantly different ( χ2=6.45, P=0.040). Furthermore, combined hypoproteinemia and anemia were risk factors for SIBO in patients with UC (hypoproteinemia OR=4.331, 95% CI 1.117-16.799, P=0.034; anemia OR=5.515, 95% CI 1.231-24.700, P=0.026). Conclusions:We observed a clinical overlap between SIBO and UC. SIBO could be targeted to optimize the treatment of patients with UC in the future.

ObjectiveTo investigate the clinical efficacy and safety of iguratimod combined with the Chinese medicine Runzaoling in the treatment of primary Sjögren's syndrome （pSS）. MethodSeventy-two patients treated in the Department of Rheumatology and Immunology of the Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine（TCM） from January 2021 to June 2022 who met the Western medical diagnosis of pSS and had the TCM syndrome of Yin deficiency and heat toxin syndrome were randomly assigned into an observation group and a control group， with 36 patients in each group. The observation group was treated with iguratimod combined with Runzaoling， and the control group was treated with iguratimod. The treatment in both groups lasted for 12 weeks. The clinical symptoms， EULAR Sjogren's syndrome patient reported index （ESSPRI）， EULAR Sjögren's syndrome disease activity index （ESSDAI）， erythrocyte sedimentation Rate （ESR）， C-reactive protein （CRP）， immunoglobulin （IgG）， Schirmer score， and saliva flow of the two groups were determined before and after treatment. Furthermore， the incidence of adverse reactions was compared between the two groups. ResultThe total response rate in the observation group was 75.0% （27 patients with response and 9 patients with no response）， which was higher than that （61.11%， 22 patients with response and 14 patients without response） in the control group （P<0.05）. After treatment， the ESSPRI， ESSDAI， and TCM syndrome scores in both groups decreased and the decreases were more obvious in the observation group than in the control group （P<0.05）. The treatment in both groups recovered the ESR， CRP， IgG， Schirmer score， and saliva flow （P<0.05）. Moreover， the observation outperformed the control group in terms of the ESR， CRP， IgG， and saliva flow （P<0.05） and had no significant difference in the Schirmer score compared with the control group. During the treatment period， 2 patients in the observation group had nausea， and 1 patient had an abnormal liver function， which were relieved after symptomatic treatment and did not affect the treatment. In the control group， 1 patient withdrew from the study due to rashes and showed no special discomfort in the follow-up 4 weeks， and 1 patient had nausea， which was relieved after symptomatic treatment. ConclusionIguratimod combined with Runzaoling has good clinical efficacy and safety in the treatment of pSS.