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 observe the value of 18F-prostate specific membrane antigen(PSMA)-1007 PET/MRI for diagnosing seminal vesicle invasion(SVI)of prostatic cancer(PCa).Methods Totally 92 male patients with PCa who underwent radical prostatectomy were retrospectively enrolled and divided into positive group(n=26)and negative group(n=66)based on postoperative pathology showed SVI or not.PET/MRI parameters,including maximum standard uptake value(SUVmax),minimum apparent diffusion coefficient(ADCmin),mean apparent diffusion coefficient(ADCmean),SUVmax/ADCmin,SUVmax/ADCmean,PSMA tumor volume(PSMA-TV)and total lesion PSMA(TL-PSMA)were compared between groups.The receiver operating characteristic curve was drawn,and the efficacy of each parameter for diagnosing SVI was analyzed.Results Among 92 cases of PCa,18F-PSMA-1007 PET/MRI showed 30 cases with SVI and 62 cases without SVI,with accuracy of 73.91％,sensitivity of 61.54％,specificity of 78.79％,positive predictive value of 53.33％and negative predictive value of 83.87％.Significant differences of ADCmin,PSMA-TV and TL-PSMA were found between groups(all P＜0.05).The area under the curve(AUC)of SUVmax,ADCmin,ADCmean,SUVmax/ADCmin,SUVmax/ADCmean,PSMA-TV and TL-PSMA for diagnosing SVI of PCa was 0.554,0.341,0.396,0.603,0.581,0.755 and 0.705,respectively.The AUC of PSMA-TV was higher than other parameters except for TL-PSMA,with sensitivity of 84.60％and specificity of 56.10％.Conclusion 18 F-PSMA-1007 PET/MRI was helpful for diagnosing SVI of PCa.

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 observe the value of 18F-prostate specific membrane antigen(PSMA)-1007 PET/MRI for diagnosing seminal vesicle invasion(SVI)of prostatic cancer(PCa).Methods Totally 92 male patients with PCa who underwent radical prostatectomy were retrospectively enrolled and divided into positive group(n=26)and negative group(n=66)based on postoperative pathology showed SVI or not.PET/MRI parameters,including maximum standard uptake value(SUVmax),minimum apparent diffusion coefficient(ADCmin),mean apparent diffusion coefficient(ADCmean),SUVmax/ADCmin,SUVmax/ADCmean,PSMA tumor volume(PSMA-TV)and total lesion PSMA(TL-PSMA)were compared between groups.The receiver operating characteristic curve was drawn,and the efficacy of each parameter for diagnosing SVI was analyzed.Results Among 92 cases of PCa,18F-PSMA-1007 PET/MRI showed 30 cases with SVI and 62 cases without SVI,with accuracy of 73.91％,sensitivity of 61.54％,specificity of 78.79％,positive predictive value of 53.33％and negative predictive value of 83.87％.Significant differences of ADCmin,PSMA-TV and TL-PSMA were found between groups(all P＜0.05).The area under the curve(AUC)of SUVmax,ADCmin,ADCmean,SUVmax/ADCmin,SUVmax/ADCmean,PSMA-TV and TL-PSMA for diagnosing SVI of PCa was 0.554,0.341,0.396,0.603,0.581,0.755 and 0.705,respectively.The AUC of PSMA-TV was higher than other parameters except for TL-PSMA,with sensitivity of 84.60％and specificity of 56.10％.Conclusion 18 F-PSMA-1007 PET/MRI was helpful for diagnosing SVI of PCa.

Objective To evaluate the scientificity,transparency and applicability of Chinese guidelines and expert consensuses on nursing published in 2022,in order to improve the quality of guidelines and consensuses.Methods Databases including Medline,Embase,Web of Science,CBM,CNKI,WanFang database,Chinese Medical Journal,and related websites were electronically searched,as well as China Hong Kong,Macao and Taiwan medical journals,to collect Chinese guidelines and expert consensuses on nursing from January to December 2022.STAR tool was used to evaluate the quality of each guidelines and consensuses by 3 assessors independently.Total score,scoring rate of each domain and item were adopted to analyze the outcomes.Results A total of 3 guidelines and 33 expert consensuses were included.The total guidelines and expert consensuses STAR score(33.5±14.3).The quality of guidelines and consensuses was low.The quality of guidelines was moderate with average score of 55.1,and the quality of consensuses was low with average score of 31.5.The included guidelines and consensuses had a highest score rate(52.4％)in the domain of recommendation.Among 39 items of STAR tool,the top 4 items including listing participants and institutions,explaining additional instructions for implementation,describing consensus method,and listing references for recommendations had a high score rate of 100％,83.3％,77.8％,75.0％respectively.However,the items of registration,providing registration information,protocols being searched on public platforms and explaining the role of funding had a low score rate,urgent need for attention and upgrading.Conclusion The overall quality of the Chinese guidelines and expert consensuses on nursing published in 2022 was low.As a medical and nursing practice guidance document,the quality of guidelines and expert consensuses should be improved by encouraging registration,strengthening management of interest conflict,enhancing the rigor of guideline developing process,and expanding the dissemination.

Hepatocellular carcinoma(HCC),commonly known as primary liver cancer,is a major cause of malignant tumors and cancer-related deaths in China,accounting for approximately 85％of all cancer cases in the country.Several guidelines have been used to diagnose and treat liver cancer.However,these guidelines provide a broad definition for classifying advanced liver cancer,with an emphasis on a singular approach,without considering treatment options for individual patients.Therefore,it is necessary to establish a comprehensive and practical expert consensus,specifically for China,to enhance the diagnosis and treatment of HCC using the Delphi method.The classification criteria were refined for Chinese patients with HCC,and the corresponding optimal treatment regimen recommendations were developed.These recommendations took into account various factors,including tumor characteristics,vascular tumor thrombus grade,distant metastasis,liver function status,portal hypertension,and the hepatitis B virus replication status of patients with primary HCC,along with treatment prognosis.The findings and rec-ommendations provide detailed,scientific,and reasonable individualized diagnosis and treatment strategies for clinicians.

AIM: To investigate the preoperative ocular symptoms and the characteristics of asymptomatic ocular surface abnormalities in hospitalized patients with primary pterygium.METHODS: Cross-sectional study. Hospitalized patients diagnosed with primary pterygium and scheduled to receive pterygium excision surgery at the Xiamen Eye Center of Xiamen University from August 2022 to October 2022 were enrolled. Ocular surface disease index questionnaire(OSDI), six examinations including non-invasive tear film break-up time, Schirmer I test, tear meniscus height, lid margin abnormality, meibomian gland dropout and tear film lipid layer thickness, and anterior segment optical coherence tomography(AS-OCT)were performed and statistically analyzed.RESULTS: A total of 178 cases(178 eyes), with a mean age of 54.39±10.75 years old, were recruited, including 75 males(42.1%)and 103 females(57.9%). The average values of ocular surface parameters in these patients included OSDI: 11.47±9.69, tear film break-up time: 7.10±3.86 s; tear meniscus height: 0.16±0.07 mm, Schirmer I test values: 14.39±7.29 mm/5 min, and pterygium thickness: 504.74±175.87 μm. Totally 161 eyes(90.4%)presented with abnormal lid margin, 44 eyes(24.7%)presented with meibomian gland dropout score ≥4, 52 eyes(29.2%)presented with low lipid layer thickness. In the 6 objective examinations, abnormalities in at least 4 of these tests were found in 85.4% of eyes. Pterygium morphology was classified into four grades: 10 eyes(5.6%)of grade Ⅰ, 93 eyes(52.2%)of grade Ⅱ, 60 eyes(33.7%)of grade Ⅲ, and 15 eyes(8.4%)of grade Ⅳ. In patients with a higher grade of pterygium, the tear film break-up time was lower, and the proportion of abnormal lid margin was also significantly higher(P<0.05). The patients were further divided into two subgroups, including 121 eyes(68.0%)with normal OSDI <13 in the normal group and 57 eyes(32.0%)with OSDI ≥13 in the abnormal group. No significant difference was found in the proportion of meibomian gland dysfunction between the two groups of patients(71.9% vs. 71.9%, P=0.872). In addition, there were differences in the number of abnormal objective examinations(4.11±0.85 vs. 4.91±0.99, P<0.001).CONCLUSIONS: Asymptomatic ocular surface abnormalities were present preoperatively in patients hospitalized for primary pterygium. A comparable high incidence of structural or functional meibomian gland dysfunction existed in pterygium patients with or without apparent ocular discomfort. More attention should be paid to the ocular surface abnormalities in those asymptomatic patients before primary pterygium surgery.

Humans ; MicroRNAs/genetics* ; Cell Line, Tumor ; Osteosarcoma/pathology* ; Neoplasm Invasiveness ; Cell Proliferation ; Bone Neoplasms/pathology* ; Cell Movement ; Neoplasm Metastasis

Objective:To compare 3D-printing-assisted surgery and conventional surgery in the treatment of Schazker type Ⅵ tibial plateau fractures.Methods:A retrospective study was conducted to analyze the clinical data of 50 patients with type Ⅵ tibial plateau fracture who had been treated from January 2019 to December 2021 at the 5 Departments of Orthopedics in The First Affiliated Hospital of Nanchang University, The First People's Hospital of Jiujiang, Pingkuang General Hospital, Ganzhou People's Hospital, and Nanchang Hongdu Hospital of Traditional Chinese Medicine. The patients were divided into 2 groups according to their different treatment methods. In the 3D printing group of 25 cases treated by 3D-printing-assisted surgery, there were 14 males and 11 females, with an age of (42.5±9.1) years; in the conventional group of 25 cases treated by conventional surgery, there were 13 males and 12 females with an age of (42.2±9.3) years. The 2 groups were compared in terms of operation time, intraoperative blood loss, intraoperative fluoroscopy frequency, fracture healing time, postoperative complications, the Rasmussen radiological scores and the American Hospital for Special Surgery (HSS) knee function scores at 6 and 12 months after operation.Results:There was no significant difference in the preoperative general data between the 2 groups, indicating comparability ( P>0.05). The operation time [(125.4±10.6) min], intraoperative blood loss [(206.2±16.3) mL], intraoperative fluoroscopy frequency [(9.2±2.7) times] and fracture healing time [(3.0±0.7) months] in the 3D printing group were all significantly less than those in the conventional group [(168.2±14.1) min, (303.2±20.4) mL, (15.5±3.5) times and (4.1±0.8) months] while the Rasmussen radiological scores (17.6±1.2 and 17.9±0.6) and HSS knee scores (90.8±6.4 and 91.5±5.6) at 6 and 12 months after operation in the 3D printing group were all significantly higher than those in the conventional group (16.2±2.6 and 16.7±2.2; 84.5±9.2 and 87.6±8.0) (all P<0.05). In the 3D printing group, there were 1 case of wound infection and 1 case of wound dehiscence after operation. In the conventional group, there were 2 cases of wound skin necrosis, 3 cases of wound dehiscence, 1 case of traumatic arthritis, 2 cases of wound infection, and 1 case of screw loosening. The incidence of complications in the 3D printing group (8.0%, 2/28) was significantly lower than that in the conventional group (36.0%, 9/25) ( P<0.05). Conclusion:In the treatment of Schatzker type VI tibial plateau fractures, compared with conventional surgery, 3D-printing-assisted surgery can lead to better curative outcomes, because it is conducive to lowering surgical difficulty, reducing postoperative complications, and promoting fracture union and functional recovery of the knee.

Objective:To investigate the impact of recombinant human epidermal growth factor (rh-EGF) on the epithelial recovery and the tear film stability after trans-epithelial corneal collagen crosslinking in patients with progressive keratoconus.Methods:A randomized controlled clinical trail was designed.Consecutive 66 patients (37 males and 29 females) with an average age of (21.27±3.80) years old diagnosed with primary progressive keratoconus and hospitalized in Xiamen Eye Center Affiliated to Xiamen University from October, 2016 to January, 2017 were enrolled and treated with unilateral enhanced transepithelial corneal crosslinking surgery by iontophoresis, and the patients were randomly divided into control group and experimental group according to random number table method, with 33 patients 33 eyes in each group.The eyes in the control group were treated with carboxy-methylcellulose sodium lubricant eye drops and the eyes in the experimental group were treated with rh-EGF eye drops.The ocular surface disease index (OSDI) questionare, slit lamp examination, Schirmer Ⅰ test, corneal fluorescein sodium staining scoring, non-contact tonometry, uncorrected visual acuity, best corrected visual acuity, bulbar conjunctival congestion scoring, lacrimal sevretion test, non-invasive break-up time of tear film (NIBUT), as well as tear meniscus height analysis were performed before surgery, and on day 1, day 3, day 5, day 7, day 14 and day 28 after surgery.This study followed the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Xiamen Eye Center Affiliated to Xiamen University (No.2016-ME-003).Results:On day 7 after surgery, the OSDI values were increased in both groups than the preoperative value, while the value in the experimental group was significantly lower than that in the control group ( P<0.05). There were statistically significant differences in the overall corneal epithelial staining score values between the two groups at different time points ( Fgroup=16.701, P<0.01; Ftime=454.418, P<0.01). The corneal epithelial staining score in the experimental group on day 3 and day 5 after surgery were significantly lower than those in the control group (1.79±0.65 vs. 2.70±0.68; 0.91±0.46 vs. 1.55±0.51) (both at P<0.01). The conjunctival congestion score in the experimental group was significantly lower than that of the control group on day 3 and day 5 after surgery (both at P<0.05). There were statistically significant differences in the overall NIBUT values between the two groups at different time points ( Fgroup=13.084, P<0.01; Ftime=34.383, P<0.01). The NIBUT values were significantly decreased rapidly on day 7, day 14 and day 28 after surgery in both groups (all at P<0.01), but gradually recovered.The NIBUT of the experimental group on day 7 and day 14 after surgery were significantly higher than those of the control group ([8.18±2.26]seconds vs. [5.93±2.33]seconds; [9.49±1.95]seconds vs. [7.52±2.27]seconds) (both at P<0.01). No statistical differences were found in the tonometry value, visual acuity, value of Schirmer I test as well as tear meniscus height at any time point before or after surgery between the two groups (all at P>0.05). Conclusions:Recombinant human epidermal growth factor has positive effects in the patients received enhanced transepithelial corneal crosslinking surgery, presenting with promotion of epithelial healing, relief of post-operative discomfort, and the recovery of tear film stability.