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 clinical outcomes of single oral dydrogesterone with vaginal progesterone gel plus oral dydrogesterone in gonadotropin-releasing hormone (GnRH) antagonist cycles with fresh embryo transfer.Methods:This study retrospectively analyzed 658 treatment cycles of fresh embryo transfer cycle with GnRH antagonist protocol from December 2015 to December 2020 in the Center of Reproductive Medicine of the University of Hong Kong-Shenzhen Hospital. Each cycle was the first fresh stimulation cycle of the patients. The patients were divided into two groups according to different luteal support regimens. Group A included 368 cycles with a regimen of 30 mg dydrogesterone tablets orally daily, while group B included 290 cycles with a regimen of 90 mg vaginal progesterone gel vaginally daily combined with 20 mg dydrogesterone tablets orally daily. A 1∶1 propensity score matching (PSM) was carried out to adjust for numerical differences and to balance between the two groups, and further they were divided into cleavage stage embryo transfer cycles and the blastocyst transfer cycles according to the different type of embryo for layer analysis, and the laboratory results and assisted reproductive outcomes of the two groups were compared.Results:After matching, the baseline characteristics were comparable between the two groups, with 251 cycles remaining in each group for retrospective analysis. After PSM, statistically significant differences were observed between group A and group B in laboratory data including the number of fertilized oocytes [5 (2, 7) vs. 6 (3, 9), P=0.002], cleavage rate [100.0% (86.31%, 100.0%) vs. 87.28% (75.32%, 100.0%), P<0.001], and available embryo rate [80.18% (54.64%, 100.0%) vs. 67.48% (50.62%, 100.0%), P=0.019]. However, there were no significantly statistical differences in other laboratory data and clinical outcomes (all P>0.05). If we divided the data into two comparison according to the different type of embryo, there were no significantly statistical differences in clinical pregnancy rate, embryo implantation rate, live birth rate, miscarriage rate, multiple pregnancy rate, ovarian hyperstimulation syndrome incidence, and ectopic pregnancy rate neither in day 2 cleavage stage embryo transfer cycles nor in the blastocyst transfer cycles. Conclusion:In this study, the clinical outcomes are similar between taking 30 mg of dydrogesterone tablets orally alone and taking 20 mg of dydrogesterone tablets orally combined with vaginal progesterone gel in the fresh embryo transfer cycle of the GnRH antagonist protocol. Moreover, taking dydrogesterone tablets orally alone can be a new option for luteal support in the fresh cycle of the GnRH antagonist protocol.

Objective:To compare the clinical outcomes of single oral dydrogesterone with vaginal progesterone gel plus oral dydrogesterone in gonadotropin-releasing hormone (GnRH) antagonist cycles with fresh embryo transfer.Methods:This study retrospectively analyzed 658 treatment cycles of fresh embryo transfer cycle with GnRH antagonist protocol from December 2015 to December 2020 in the Center of Reproductive Medicine of the University of Hong Kong-Shenzhen Hospital. Each cycle was the first fresh stimulation cycle of the patients. The patients were divided into two groups according to different luteal support regimens. Group A included 368 cycles with a regimen of 30 mg dydrogesterone tablets orally daily, while group B included 290 cycles with a regimen of 90 mg vaginal progesterone gel vaginally daily combined with 20 mg dydrogesterone tablets orally daily. A 1∶1 propensity score matching (PSM) was carried out to adjust for numerical differences and to balance between the two groups, and further they were divided into cleavage stage embryo transfer cycles and the blastocyst transfer cycles according to the different type of embryo for layer analysis, and the laboratory results and assisted reproductive outcomes of the two groups were compared.Results:After matching, the baseline characteristics were comparable between the two groups, with 251 cycles remaining in each group for retrospective analysis. After PSM, statistically significant differences were observed between group A and group B in laboratory data including the number of fertilized oocytes [5 (2, 7) vs. 6 (3, 9), P=0.002], cleavage rate [100.0% (86.31%, 100.0%) vs. 87.28% (75.32%, 100.0%), P<0.001], and available embryo rate [80.18% (54.64%, 100.0%) vs. 67.48% (50.62%, 100.0%), P=0.019]. However, there were no significantly statistical differences in other laboratory data and clinical outcomes (all P>0.05). If we divided the data into two comparison according to the different type of embryo, there were no significantly statistical differences in clinical pregnancy rate, embryo implantation rate, live birth rate, miscarriage rate, multiple pregnancy rate, ovarian hyperstimulation syndrome incidence, and ectopic pregnancy rate neither in day 2 cleavage stage embryo transfer cycles nor in the blastocyst transfer cycles. Conclusion:In this study, the clinical outcomes are similar between taking 30 mg of dydrogesterone tablets orally alone and taking 20 mg of dydrogesterone tablets orally combined with vaginal progesterone gel in the fresh embryo transfer cycle of the GnRH antagonist protocol. Moreover, taking dydrogesterone tablets orally alone can be a new option for luteal support in the fresh cycle of the GnRH antagonist protocol.

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 evaluate the fixation with a locking fibular intramedullary nail for treatment of extra-articular distal tibial fracture complicated with fibular fracture (AO/OTA 43A).Methods:A retrospective study was conducted to analyze the data of 31 patients who had been treated by fixation with a locking fibular intramedullary nail for extra-articular distal tibial fracture complicated with fibular fracture at Department of Orthopaedics, The 909th Hospital of Joint Logistics Support Force between January 2018 and December 2021. There were 20 males and 11 females; (41.5±15.7) years in age; AO classification of the distal tibial fractures: 10 cases of type 43A1, 10 cases of type 43A2, and 11 cases of type 43A3; 11 open fractures and 20 closed fractures. Fracture healing, fibular alignment, tibiotalar angle, and incidence of complications were regularly followed up and recorded after surgery. At the last follow-up, the ankle joint function was assessed using the Olerud Molander ankle score (OMAS) and the ankle-hindfoot score of American Orthopaedic Foot and Ankle Society (AOFAS).Results:All the 31 patients were followed up for (17.5±3.3) months after surgery. All of them achieved fine fracture union. The union time was (3.9±0.8) months for tibial fractures, and (3.6±0.9) months for fibular fractures. No internal fixation failure was observed. The last follow-up revealed the following: the fibular alignment was 1.8°±1.3° and the ankle tibiotalar angle 9.1°±2.3°; no fibular rotation, shortening, or separation displacement happened; the OMAS score was (88.3±6.2) points, and the AOFAS ankle-hindfoot score (87.4±6.0) points. Two patients required removal of the distal locking screw of the fibular intramedullary nail due to soreness around the lateral malleolus caused by screw loosening. There were no other related complications.Conclusion:Fixation with a locking fibular intramedullary nail is an effective treatment for extra-articular distal tibial fracture complicated with fibular fracture, demonstrating advantages of firm fixation, limited complications, minimal trauma and soft tissue irritation, and good clinical efficacy.

Objective To compare the clinical efficacy of luteal phase support with oral dydrogesterone tablets and vaginal progester-one gel combined with oral dydrogesterone tablets during hormone replacement therapy-frozen embryo transfer(HRT-FET).Methods A retrospective analysis was conducted on a total of 489 cycles which underwent HRT-FET at the Center of Reproductive Medicine,the University of Hong Kong-Shenzhen Hospital from November 2018 to June 2022.There were 226 cycles underwent with oral dydrogester-one tablets as luteal support,and 263 cycles underwent with vaginal progesterone gel combined with oral dydrogesterone tablets as luteal support.The primary observation index was the delivery rate.The pregnancy outcomes of HRT-FET in the two groups were compared and analyzed,and the related factors were analyzed.Results There were no significant differences in the age,body mass index,number of antral follicles,total number of eggs,serum levels of estradiol and progesterone on the second day of the menstrual cycle and the day before endometrial transformation between the two pregnant women(P＞0.05).There were also no significant differences in the abortion rate,ectopic pregnancy rate,biochemical pregnancy rate,clinical pregnancy rate,delivery rate,and neonatal weight between the two groups(P＞0.05).In the second day of cleavage stage embryo transfer subgroup,there were no significant differences in the abortion rate,ectopic pregnancy rate,biochemical pregnancy rate,clinical pregnancy rate,delivery rate,and neonatal weight between the two groups(P＞0.05),and in the fifth day of blastocyst transfer subgroup,there were also no significant differences in abortion rate,ectopic pregnancy rate,biochemical pregnancy rate,clinical pregnancy rate,delivery rate between the two groups(P＞0.05),and in the oral dydrogesterone tablets group,the neonatal weight was significantly higher than that of the vaginal progesterone gel combined with oral dydrogesterone tablets,and the difference was statistically significant(P＜0.05).The multivariate Logistic regression analysis showed that different luteal support protocols had no significant impact on the delivery rate(OR=0.703,95％CI:0.461-1.062,P=0.09).Conclusion There were no significant differences between oral dydrogesterone tablets and vaginal progesterone gel combined with oral dydrogesterone tablets in clinical pregnancy rate and delivery rate during HRT-FET.Therefore,the use of oral dydrogesterone tablets a-lone can be a new option for luteal support in HRT-FET.

Recent studies have shown that non-alcoholic fatty liver disease (NAFLD) can influence the incidence, outcome, and recurrence risk of ischemic stroke independently of traditional risk factors. This article reviews the relationship, related mechanisms, and treatment decisions between NAFLD and ischemic stroke, in order to provide reference for clinical diagnosis and treatment decisions.

Objective To analyze the correlation between coronary artery lesion complexity and left ventricular funotion index of patients.Methods A total of 69 patients with coronary heart disease were selected in the study and were divided into low- risk(27 cases),medium-risk(23 cases) and high-risk (19 cases) groups according to the SYNTAX score.The difference in left ventricular function among the three groups were compared by ANOVA, and the correlation between coronary artery SYNTAX score and left ventricular function index was evaluated by Spearman rank correlation analysis.Results The differences in left ventricular end-diastolic volume(EDV),end-systolic volume(ESV),stroke volume(SV),ejection fraction(EF) and muscle mass(MM) among the groups were statistically signifcant (F=7.254,9.181, 13.004, 7.544 and 5.276,P<0.05).The coronary SYNTAX score was negatively corelated with the EF (r=-0.702,P<0.05),but positively correlated with the MM (r=0.638, P<0.05).Conclusion Coronary SYNTAX score is negatively correlated with left ventricular EF, but positively correlated with MM.

Objective To explore the correlation between serum uric acid level and coronary artery SYNTAX score of coronary heart disease.Methods A total of 69 patients of coronary heart disease were enrolled according to SYNTAX score.The patients were divided into the low risk group (27 cases),medium risk group (23 cases) and high risk group (19 cases).The differences of serum uric acid concentrations among the three groups were compared by ANOVA.Spearman rank correlation analysis was used to analyze the correlation between serum uric acid concentrations and coronary artery SYNTAX scores.Results ANOVA analysis showed that the differences of serum uric acid concentrations among the groups were statistical significant (F=4.74,P＜0.05).The Spearman correlation analysis showed that serum uric acid concentrations were positively correlated with coronary SYNTAX score (r =0.58,P ＜0.05).Conclusion Serum uric acid level and severity of coronary artery disease are positively correlative.

Objective To investigate protective effects of the hydrogen saturated saline on acute lung injury and pulmonary fibrosis in rats with paraquat (PQ) poisoning. Method Forty-eight Sprague-Dawley rats were randomly divided into 3 groups, namely control group, PQ poisoning group and intervention group (n = 16 rats in each group) . Animals in PQ poisoning group and intervention group were fed with PQ in dosage of 50 mg / kg. Rats of control group were fed equivalent amount of distilled water instead. One hour after administration of PQ, rats of intervention group were treated with 5 ml / kg hydrogen saturated saline injected intra-peritoneally twice a day until the rats were sacrificed. The rats of poisoning group and control group were treated with intra-peritoneal injection of equivalent amount of normal saline. Arterial partial pressure of oxygen ( PaO2 ), 8-hydroxy-2' -desoxyguanosine (8-OHDG) and transforming growth factor β1 (TGF-β1) of lung tissue were measured on the 3rd and 21st day after PQ administration. Quantitative data was expressed as mean ±standard deviation (x-±s) . SPSS version 12. 0 package was applied for variance analysis and SNK-q test, and statistical differences were considered significant when P ＜ 0. 05. Results ① PaO2 decreased significantly in poisoning group (9. 34 ± 0. 47 kPa) and intervention group (10. 30±0.62 kPa) compared with control group (11.87 +/- 0.42 kPa) on the 3d (P ＜0.01), and as intervention group was compared with poisoning group, there was a significant difference ( P ＜ 0. 05 ) . On the 21st day, PaO2 was still lower in poisoning group (8. 36 ±0. 51 kPa) and intervention group ( 10. 14 ±0. 27 kPa) than that in control group ( 11.87 +0. 24 kPa) (P ＜0. 01 and P ＜0. 05, respectively), and as intervention group was compared with poisoning group, there was a significant difference ( P ＜ 0. 01 ) . ②The levels of 8-OHDG in lung tissue increased significantly in poisoning group (23.58±7. 18 ng/ml ) and intervention group (9. 49± 2. 45 ng/ml) on the 3rd day after PQ administration compared with control group (7.71 + 1.96 ng/ml) (P＜0. 01 and P＜0. 05, respectively), and as intervention group was compared with poisoning group there was a significant difference ( p ＜0. 01 ) . There were no significant differences in 8-OHDG level found among the groups on the 21st day after PQ administration (P ＞ 0. 05 ) . ③ The level of TGF-β1 (measured by mean optic density, MOD) in lung tissue of rats in poisoning group ( 10. 11±2.49 MOD) and intervention group (8. 14 + 1.58 MOD) exhibited in higher levels than control group (5.93 + 1. 98 MOD) on the 3rd and (5.97 + 2. 35 MOD) on the 21st day after PQ administration (P ＜0. 01 and P ＜0. 05, respectively), and however, a lower level of TGF-β1 was observed in intervention group on 3d and 21d compared with poisoning group (P ＜0. 05 and P ＜0. 01, respectively) . Conclusions Hydrogen saturated saline can alleviate oxidative stress, mitigate oxidative damage and inhibit pulmonary fibrosis of lung induced by PQ intoxication.