BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

Objective: To investigate the deposition rate of Artemisia pollen in different nasal cavity regions and its influence factors in residents of northwest China. Methods: Thirty healthy adults from northwest China were enrolled. The computational fluid dynamics (CFD) and discrete phase model (DPM) were used for numerical simulation of nasal structures. The pollen deposition fraction in each anatomical part was counted and the effects of pollen density and breathing rate on deposition were analyzed. SPSS 19.0 software was used for statistical analysis. Results: The hottest deposition parts of Artemisia pollen were nasal septum (30.70%±12.27%), vestibule (27.45%±8.21%), middle turbinate area (13.59%±8.98%) and nasopharynx (7.14%±5.90%). When the inspiratory flow rate increased to 30 L/min, the deposition rates of pollen in nasal vestibule and nasal septum were significantly higher than that at the rate of 15 L/min (43.20%±11.14% vs 27.45%±8.21%, 51.48%±9.77% vs 30.70%±12.27%, t value was -8.126,-5.264, respectively, all P<0.05), which indicated that with the increase of the inspiratory flow rate, the deposition hotspot moved forward. Compared with the wet Artemisia pollen, the deposition rate of the dry pollen in nasal vestibule and nasal septum decreased significantly (16.55%±4.33% vs 27.45%±8.21%, 7.09%±3.69% vs 30.70%±12.27%, t value was 8.669, 9.173, respectively, all P<0.05). The escape rate at outlet increased from 17.00%±9.57% to 43.48%±13.43% (t=-9.282, P<0.05). Conclusions The deposition of Artemisia pollen in nasal cavity is highly concentrated. The inhalation velocity and the dry-wet degree of pollen are the main determinants of the deposition site.

Objective To investigate the risk factors of repeated episodes of child otitis media with effusion(OME).Methods One hundred and twenty-one children cases of repeated OME within 1 year in the Affiliated Children's Hospital of Nanjing Medical University from February 2013 to August 2015 were selected as the repeated group and contemporaneous 125 cases of non-repeated OME were selected as the control group.The repeated OME related factors were performed the univariate and multivariate analysis.Furthermore the occurrence rates of main risk factors and annual onset frequency of nasal disease were compared among different age groups.Results The Logistic multivariate regression analysis results indicated that younger age,allergic rhinitis,recurrent upper respiratory tract infections,tonsil hypertrophy Ⅳ°,adenoid hypertrophy Ⅲ °and Ⅳ ° and poor mastoid gasification were major risk factors for recurrence of OME.The incidence rate of repeated upper respiratory tract infections in the 3-＜7 years old group and ＜3 years old group was obviously higher than that in the7-14 years old group(P＜0.05),adenoid hypertrophy in the ＜3 years old group and 7-14 years old group was lower than that in the 3-＜7 years old group(P＜0.05).The annual onset frequency of nasal disease in the repeated group was significantly higher than that in the control group(P=0.000).Conclusion Child OME is the results of multivariate factors combined action.The smaller the age,the more the annual onset frequency and the higher the possibility of OME repeated onset.

Objective To explore the doctor-nurse integrated health care management model in perioperative nursing management of transvaginal natural orifice transluminal endoscopic surgery (NOTES). Methods A total of 70 female patients underwent transvaginal NOTES. All patients were randomly divided into the control and the study groups. The control group adopted the traditional model of care, and the study group implemented a layered panel system of integrated health care nursing mode, which consisted of three lines (leader), second line, front-line doctors, anesthesiologists consisting of the doctor series and secondary responsibility leader, a responsibility of nurses, operating room nurses laparoscopy group traveling together constituted a series of nurses′ health care integration of the health care team. The average length of stay, preoperative waiting days, awareness of the disease, early postoperative activities and reasonable diet, patient satisfaction with care, doctors′ satisfaction with nurses′ operation and overall satisfaction with health care work were compared. Results The preoperative waiting days, average length of stay, surgical satisfaction, patients′ satisfaction, doctors-nurses′overall satisfaction in the study group were (3.95±0.51) d, (11.58±1.83) d, (95.48±3.82)%, (99.26± 0.61)%, (96.33±0.29)%, the control group were (5.50±0.68) d, (15.79±2.14) d, (82.08±7.21)%, (92.18± 3.54)%, (80.03 ± 5.88)%, the differences were statistically significant (t=-4.431-6.172, P < 0.05). The patients awareness of the disease, early postoperative activities and reasonable diet (postoperative eating time) in the study group were (92.77 ± 0.59)%, (1.60 ± 0.63) d, (2.20 ± 0.54) d, the control group were (93.15 ± 0.47)%, (1.90 ± 0.42) d, (2.40 ± 0.33) d, the difference was not statistically significant (t=-0.898,-0.771,-0.201, P>0.05). Conclusions The implementation ofdoctor-nurse integrated health carenew model can optimize the collocation of medical health care integration, enhance the quality of care, improve patient experience, and improve patients′and doctors′satisfaction for nursing work.

AIM:To investigate the function of macrophage differentiation antigen-1 (Mac-1) in receptor acti-vator of nuclear factor-κB ligand ( RANKL )-induced osteoclast differentiation and the mechanisms .METHODS: The spleen cells were isolated from 4-week-old C57BL/6J mice, and cultured with RANKL, macrophage colony-stimulating fac-tor and CD11b and CD18 antibodies for 1 week.The actin bundles were stained with rhodamine-labeled phalloidin, and nu-clei were stained with DAPI.CD11b and CD18 antibodies, lentivirus with interfering vector plasmid of target gene Itgam (encoding CD11b) and empty virus (control virus) were used to treat osteoclasts for 1 week, and then immunofluorescence staining was performed.CD11b antibody, lentivirus and control virus were used to treat osteoclasts for 1 week, and total protein was taken for Western blot .RESULTS:Lower multinuclear positive rates in the groups treated with CD 11b anti-body were observed than that in the groups treated with CD 18 antibody and control group .Lower immunofluorescence inten-sity of Syk, CD11b and NFATc1 was found in CD11b antibody group than that in control group .Lower Syk, CD11b and NFATc1 immunofluorescence intensity was also observed in lentivirus group than that in control virus group .The results of Western blot analysis showed that the protein levels of CD 11b, Syk, NFATc1, c-Fos and p-ERK/ERK in CD11b antibody group were decreased as compared control group .Compared with control virus group , the protein levels of CD11b, Syk, NFATc1, c-Fos and p-ERK/ERK in lentivirus group were also decreased .CONCLUSION:CD11b subunit of Mac-1 pro-motes osteoclast differentiation by up-regulating c-Fos, ERK activity and NFATc1.

Objective To discuss the tympanic membrane puncture or tympanostomy tube under endotoscope combined with adenoidectomy under nasal endoscopy on the influence of invalid conservative treatment of pediatric secretory otitis media.Methods A total of 112 cases of secretory otitis media with invalid conservative treatment were selected in the department of otorhinolaryngology of children′s hospital of Nanjing Medical University from July 2013 to August 2015.They were divided into three groups,the group A of 38 cases(68 ears)underwent transnasal endoscopic pure adenoidectomy;the group B of 37 cases(60 ears)underwent transnasal endoscopic adenoidectomy combined with tympanocentesis;the group C of 37 cases(59 ears)underwent tympanostomy tube insertion.The clinical treatment effect,the period of middle ear effusion,postoperative recurrence and complication were observed and compared.Results The total effective rate of the 3 groups was improved after 3 months(P<0.05);the total effective rate in group B and group C at one week and 3 months after operation were higher than those of group A(P<0.05);and the total effective rate in group C at 3 months after operation was significantly higher than that of group B(P<0.05).The level of auditory brainstem evoked potential(ABR)and the latency of ABR wave Ⅰ latency were decreased at 1 year after operation(P<0.05);the ABR changes in group B and group C at 1 week and 1 year after operation were lower than those in group A(P<0.05).The incidence of recurrence rate and the period of middle ear effusion in group C were lower than those in group A and B(P<0.05).The incidence of complication of group A was lower than those of group B and group C(P<0.05).Conclusion Using tympanostomy tube combined with adenoidectomy under endoscope can improve the children with hearing,which not only can shorten the time of the middle ear effusion,but also effectively reduce the recurrence rate.

Objective Magnetic resonance diffusion tensor imaging (DTI) was applied to study the cantral auditong pathway in patients with .Methods A total of 30 cases of acquired hearing loss patients were divided into 2 groups ,group 1 (15 ,sudden deafness) and group 2 (15 ,with duration up to 2 years SNHL group from the time of onset) .A total of 15 cases of normal-hearing patients on MRI examination were selected as the control group for the same period .All subjects received DTI of whole brain .The values of the whole brain DTI were obtained from the inferior colliculus and lateral lemniscus ,consisting of the fractional anisotropy (FA) ,radial diffusion (RD) ,axi‐al dispersion (AD) and mean diffusivity .Results There were significant differences(P<0 .05) in FA of bilateral in‐ferior colliculus among sudden deafness group ,SNHL of 2 -year -history group and the control group by ANO‐VA .FA of inferior colliculus in the control group was higher than that of in the SNHL group ,but lower than that of in the sudden deafness group .RD of lateral lemniscus in the SNHL group was higher than that of in the sudden deafness group(P<0 .05) ,MD of lateral lemniscus in the sudden deafness group was higher among the other 2 groups ,and there were signigicant(P<0 .05) .For AD of the inferior colliculug and lateral lemniscus ,there were no differ‐ences among the 3 groups (P>0 .05) .Conclusion There was no obviously abnormal change on the central auditory processing in sudden deafness group ,but significant destruction was found on 2 years SNHL group .It indicated that central auditory processing of the history of sensorineural deafness affected the structural changes of the central au‐ditory pathway .

OBJECTIVE: To investigate the effect of IL-17 and IL-23 in the pathogenesis of allergic rhinitis(AR) and non. allergic rhinitis(NAR). METHOD: Selected 156 cases of patients with allergic rhinitis (AR group) and 59 cases of patients with non-allergic rhinitis (NAR group), 60 cases of healthy people (control group). All cases in AR group and NAR groups were evaluated by a visual analog scale (VAS) score of nasal symptoms. Collected peripheral blood and nasal secretions in all cases and then detected IL-17 and IL-23 expression levels. RESULT: There was no significant difference in VAS score of AR group and NAR group (P>0. 05). IL-17 and IL-23 levels of serum and nasal secretions in AR group and NAR group were both higher than control group, with a highly significant difference (P <0. 05). The research showed a clear correlation between expression of IL-17 and IL-23 both in serum and nasal secretions of AR group and NAR(P<0. 05). CONCLUSION IL-17 and IL-23 may be important cytokines and IL-23/IL-17 pathway may play a significant role in the pathogenesis of allergic rhinitis and non-allergic rhinitis.
Case-Control Studies ; Humans ; Interleukin-17 ; blood ; metabolism ; Interleukin-23 ; blood ; metabolism ; Nasal Mucosa ; metabolism ; Rhinitis ; blood ; metabolism ; Rhinitis, Allergic ; blood ; metabolism

Objective To explore the measure of the peri-operative care in patients undergoing nephroureterectomy with transvaginal NOTES-assisted hybrid endoscopy.Methods Nursing measures and the effect of 3 patients who underwent transvaginal NOTES-assisted hybrid endoscopy in nephroureterectomy were retrospectively analyzed.Results All procedures were successfully completed.There were no intraoperative or postoperative complications.All patients were cured and discharged.Conclusions For the patients receiving transvnginal NOTES-assisted hybrid endoscopy in nephroureterectomy,good psychological care,adequate preoperative preparation,postoperative care,and health education can reduce postoperative complications and play an important role in the success of the operation.

OBJECTIVE: To investigate the expression and significance of related receptors of Notch signaling pathway in mouse model of allergic rhinitis (AR). METHOD: Sixteen BALB/c mice of seven-eight weeks old were randomly assigned to two groups,including controls group and model group. AR model mice was sensitized with ovalbumin(OVA). Symptom score, hematoxylin-eosin for pathological alteration and infiltration of inflammatory cells in nasal mucosa were analyzed as well as enzyme linked immunosorbent assay was taken to detect IgE in pe- ripheral serum. Nasal septum mucosa and peripheral blood mononuclear cells were collected from 16 BALB/c mouse(8 Allegic rhinitis,8 controls). Notch 1-4 were checked by real-time quantitative polymerase chain reaction and flow cytometry from different levels. RESULT: BALB/c mice model of allergic rhinitis was established successfully. The mRNA of Notch1, Notch3, Notch4 in nasal septum mucosa of allergic rhinitis mice model groups were obviously higher than that in normal controls, and the difference were statistically significant (P < 0.01). However, The expression of Notch2 is lower than the control group and the difference was statistically significant (P < 0.05). In line with the above, the protein expression of Notch1, Notch3, Notch4 in peripheral blood mononuclear cells (PBMC) of model groups were significantly higher than that in health controls, and the difference were statistically significant (P < 0.01). But comparing control, expression of Notch2 was lower and the difference was statistically significant (P < 0.05). CONCLUSION There were significant changes of Notch genes in mouse model of AR. This intimated that related genes of Notch signaling pathway may paly important roles in the development and progression of AR and provide ideas for in depth study of the pathogenesis of AR.
Animals ; Disease Models, Animal ; Leukocytes, Mononuclear ; Mice ; Mice, Inbred BALB C ; Nasal Mucosa ; RNA, Messenger ; Receptors, Notch ; metabolism ; Rhinitis, Allergic ; metabolism ; Rhinitis, Allergic, Perennial