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 examine the clinical feasibility of mixed reality navigation (MRN) technology based on multimodal imaging for the resection of intracranial eloquent lesions. Methods: Fifteen patients with intracranial eloquent lesions admitted to the Department of Neurosurgery, the First Medical Center, People's Liberation Army General Hospital from September 2020 to September 2021 were retrospectively enrolled. There were 7 males and 8 females, aged (50±16) years (range: 16 to 70 years). Postoperative pathological diagnosis included meningioma (n=7), metastatic carcinoma (n=3), cavernous hemangioma, glioma, ependymoma, aneurysmal changes and lymphoma (n=1, respectively). The open-source software was used to perform the three-dimensional visualization of preoperative images, and the self-developed MRN system was used to perform the fusion and interaction of multimodal images, so as to formulate the surgical plan and avoid damaging the eloquent white matter fiber tracts. Traditional navigation, intraoperative ultrasound and fluorescein sodium angiography were used to determine the extent of lesion resection. The intraoperative conditions of MRN-assisted surgery were analyzed, and the setup time and localization error of MRN system were measured. The changes of postoperative neurological function were recorded. Results: MRN based on multimodal imaging was achieved in all patients. The MRN system setup time (M(IQR)) was 36 (12) minutes (range: 20 to 44 minutes), and the localization error was 3.2 (2.0) mm (range: 2.6 to 6.7 mm). The reliability of eloquent white matter fiber tracts localization based on MRN was rated as "excellent" in 11 cases, "medium" in 3 cases, and "poor" in 1 case. There were no perioperative death and no new impairment in motor, language, or visual functions after operation. Transient limb numbness occurred in 1 patient after operation, and recovered to the preoperative state in 2 weeks after operation. Conclusion: The MRN system based on multimodal imaging can improve the surgical accuracy and safety, and reduce the incidence of iatrogenic neurological dysfunction.
Humans ; Augmented Reality ; Reproducibility of Results ; Retrospective Studies ; Multimodal Imaging

Objective:To observe the effect of exercise on cognitive function and the expression of NeuN and SynapsinI in prefrontal cortex of rats after cerebral ischemia-reperfusion. Methods:Forty health male Sprague-Dawley rats were randomly divided into sham group (S group, n = 10), model group (M group, n = 10), sham & exercise group (SE group, n = 10) and model & exercise group (ME group, n = 10). The left middle cerebral artery was occluded for one hour and reperfused. SE and ME groups accepted treadmill training, for 14 days. The cognitive function of rats was evaluated with open field experiment and new object recognition experiment. The number and distribution of nerve cells in rat brain were observed with Nissl staining and immunofluorescence staining. The SynapsinI expression in serum was detected with ELISA. Results:Compared with S group, the activity, times of crossing, length and activity time in central area of open field experiment decreased in M group, as well as the cognitive index and length of new object recognition experiment (P < 0.05). Compared with M group, all the indexes increased in ME group (P < 0.05). The number of Nissl bodies decreased in M group (P < 0.05) and the arrangement was disordered, while the number of Nissl bodies increased in ME group (P < 0.05) compared with M group. The NeuN positive cells was more in S group than in M group (P < 0.05), and it was more in ME group than in M group (P < 0.05); as well as that of SynapsinI. The expression of SynapsinI decreased in M group (P < 0.05), and increased in ME group (P < 0.05). Most results of behavioral experiments positively correlated with the expression of Nissl, NeuN and SynapsinI (r > 0.221, P < 0.05). Conclusion:Cerebral ischemia-reperfusion can cause cognitive impairment in rats. Exercise can alleviate nerve injury and improve cognitive function, which may relate to promoting the expression of NeuN and SynapsinI in prefrontal cortex, to increase the number of neurons and synapses.

Objective: To explore the effect of perioperative chemotherapy on the prognosis of gastric cancer patients under real-world condition. Methods: A retrospective cohort study was carried out. Real world data of gastric cancer patients receiving perioperative chemotherapy and surgery + adjuvant chemotherapy in 33 domestic hospitals from January 1, 2014 to January 31, 2016 were collected. Inclusion criteria: (1) gastric adenocarcinoma was confirmed by histopathology, and clinical stage was cT2-4aN0-3M0 (AJCC 8th edition); (2) D2 radical gastric cancer surgery was performed; (3) at least one cycle of neoadjuvant chemotherapy (NAC) was completed; (4) at least 4 cycles of adjuvant chemotherapy (AC) [SOX (S-1+oxaliplatin) or CapeOX (capecitabine + oxaliplatin)] were completed. Exclusion criteria: (1) complicated with other malignant tumors; (2) radiotherapy received; (3) patients with incomplete data. The enrolled patients who received neoadjuvant chemotherapy and adjuvant chemotherapy were included in the perioperative chemotherapy group, and those who received only postoperative adjuvant chemotherapy were included in the surgery + adjuvant chemotherapy group. Propensity score matching (PSM) method was used to control selection bias. The primary outcome were overall survival (OS) and progression-free survival (PFS) after PSM. OS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the last effective follow-up or death. PFS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the first imaging diagnosis of tumor progression or death. The Kaplan-Meier method was used to estimate the survival rate, and the Cox proportional hazards model was used to evaluate the independent effect of perioperative chemo therapy on OS and PFS. Results: 2 045 cases were included, including 1 293 cases in the surgery+adjuvant chemotherapy group and 752 cases in the perioperative chemotherapy group. After PSM, 492 pairs were included in the analysis. There were no statistically significant differences in gender, age, body mass index, tumor stage before treatment, and tumor location between the two groups (all P>0.05). Compared with the surgery + adjuvant chemotherapy group, patients in the perioperative chemotherapy group had higher proportion of total gastrectomy (χ(2)=40.526, P<0.001), smaller maximum tumor diameter (t=3.969, P<0.001), less number of metastatic lymph nodes (t=1.343, P<0.001), lower ratio of vessel invasion (χ(2)=11.897, P=0.001) and nerve invasion (χ(2)=12.338, P<0.001). In the perioperative chemotherapy group and surgery + adjuvant chemotherapy group, 24 cases (4.9%) and 17 cases (3.4%) developed postoperative complications, respectively, and no significant difference was found between two groups (χ(2)=0.815, P=0.367). The median OS of the perioperative chemotherapy group was longer than that of the surgery + adjuvant chemotherapy group (65 months vs. 45 months, HR: 0.74, 95% CI: 0.62-0.89, P=0.001); the median PFS of the perioperative chemotherapy group was also longer than that of the surgery+adjuvant chemotherapy group (56 months vs. 36 months, HR=0.72, 95% CI:0.61-0.85, P<0.001). The forest plot results of subgroup analysis showed that both men and women could benefit from perioperative chemotherapy (all P<0.05); patients over 45 years of age (P<0.05) and with normal body mass (P<0.01) could benefit significantly; patients with cTNM stage II and III presented a trend of benefit or could benefit significantly (P<0.05); patients with signet ring cell carcinoma benefited little (P>0.05); tumors in the gastric body and gastric antrum benefited more significantly (P<0.05). Conclusion: Perioperative chemotherapy can improve the prognosis of gastric cancer patients.
Chemotherapy, Adjuvant ; Female ; Gastrectomy ; Humans ; Male ; Neoadjuvant Therapy ; Neoplasm Staging ; Prognosis ; Retrospective Studies ; Stomach Neoplasms/surgery*

BackgroundCurrently available evaluation criteria for penile tumescence and rigidity have been fraught with controversy. In this study, we sought to establish normative Chinese evaluation criteria for penile tumescence and rigidity by utilizing audiovisual sexual stimulation and RigiScan™ test (AVSS-Rigiscan test) with the administration of phosphodiesterase-5 inhibitor.

MethodsA total of 1169 patients (aged 18-67 years) complained of erectile dysfunction (ED) underwent AVSS-RigiScan test with the administration of phosphodiesterase-5 inhibitor. A total of 1078 patients whose final etiological diagnosis was accurate by means of history, endocrine, vascular, and neurological diagnosis, International Index of Erectile Function 5 questionnaire, and erection hardness score were included in the research. Logistic regression model and receiver operating characteristic curve analysis were performed to determine the cutoff value of the RigiScan™ data. Then, the multivariable logistic analysis was used in the selected variables.

ResultsA normal result is defined as one erection with basal rigidity over 60% sustained for at least 8.75 min, average event rigidity of tip at least 43.5% and base at least 50.5%, average maximum rigidity of tip at least 62.5% and base at least 67.5%, △tumescence (increase of tumescence or maximum-minimum tumescence) of tip at least 1.75 cm and base at least 1.95 cm, total tumescence time at least 29.75 min, and times of total tumescence at least once. Most importantly, basal rigidity over 60% sustained for at least 8.75 min, average event rigidity of tip at least 43.5%, and base at least 50.5% would be the new normative Chinese evaluation criteria for penile tumescence and rigidity. By multivariable logistic regression analysis, six significant RigiScan™ parameters including times of total tumescence, duration of erectile episodes over 60%, average event rigidity of tip, △tumescence of tip, average event rigidity of base, and △tumescence of base contribute to the risk model of ED. In logistic regression equation, predict value P < 0.303 was considered as psychogenic ED. The sensitivity and specificity of the AVSS-RigiScan test with the administration of phosphodiesterase-5 inhibitor in discriminating psychogenic from organic ED was 87.7% and 93.4%, respectively.

ConclusionsThis study suggests that AVSS-RigiScan test with oral phosphodiesterase-5 inhibitors can objectively assess penile tumescence and rigidity and seems to be a better modality in differentiating psychogenic from organic ED. However, due to the limited sample size, bias cannot be totally excluded.

Adolescent ; Adult ; Aged ; Erectile Dysfunction ; drug therapy ; metabolism ; Female ; Humans ; Logistic Models ; Male ; Middle Aged ; Phosphodiesterase 5 Inhibitors ; therapeutic use ; Young Adult

Objective:To discuss the effect of liraglutide on glycemic control and reduction of cardiometabolic risk factors in patients with newly diagnosed type 2 diabetes (T2DM) and metabolic syndrome (MS).Methods:Sixty-three cases with newly diagnosed T2DM (HbA1c 7.5%-11%) and MS were selected, and randomly divided 1∶1 into metformin group (0.85 g,oral administration, two times a day) and liraglutide group (1.2 mg, subcutaneous injection, one time a day).The primary endpoint was change in metabolic parameters.Results:Sixty patients completed the study.There was a reduction in weight,body mass index,waist circumference,fasting glycemia,HbA1c, total and LDL-cholesterol, and triglycerides in both groups(P<0.01).Liraglutide was superior to metformin in reducing weight, BMI, and waist circumference (P<0.05).There was no adverse effect in two groups.Conclusions:Liraglutide is associated with improved glycemic control and reduction of cardiometabolic risk factors in newly diagnosed T2DM and the MS.

Renal cell cancer (RCC) remains one of the most lethal types of cancer in adults. MicroRNAs (miRNAs) play key roles in the pathogenesis of RCC. The role of miR-206 in RCC has not been fully understood. The purpose of this study was to examine the role of miR-206 in the regulation of proliferation and metastasis of RCC and the possible mechanism. miR-206 expression was detected by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in RCC cell lines (786-O and OS-RC-2 cells) and clinical samples. MTS [3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H-tetrazolium] method, colony formation and transwell assay were used to detect the tumor-suppressing ability of miR-206 in RCC. Luciferase assay was performed to verify the precise target of miR-206. The results showed that the expression of miR-206 was significantly down-regulated in RCC tissues and cells. The expression level of cyclin G-associated kinase (GAK), a master regulator of tumor proliferation and metastasis, was up-regulated with the decrease in miR-206 in RCC tissues as well as RCC cell lines. In addition, the miR-206 inhibitor promoted the proliferation, migration and invasion of 786-O and OS-RC-2 cells. Bioinformatics combined with luciferase and Western blot assays revealed that miR-206 inhibited the expression of GAK. Moreover, miR-206 regulates RCC cell growth partly through targeting GAK. Our study indicated that miR-206 functions as a tumor suppressor in regulating the proliferation, migration and invasion of RCC by directly targeting GAK, and it holds promises as a potential therapeutic target for RCC.
Adult ; Aged ; Carcinoma, Renal Cell ; genetics ; metabolism ; pathology ; Cell Line, Tumor ; Cell Movement ; Cell Proliferation ; Female ; Gene Expression Regulation, Neoplastic ; Humans ; Intracellular Signaling Peptides and Proteins ; genetics ; metabolism ; Kidney Neoplasms ; genetics ; metabolism ; pathology ; Male ; MicroRNAs ; genetics ; Middle Aged ; Protein-Serine-Threonine Kinases ; genetics ; metabolism

Objective To learn medical waste management status of pathogenic microorganism laboratories in Putuo District, and provide evidence for laboratory medical waste and laboratory biosafety management. Methods 57 laboratories which generate medical waste were investigated and analyzed through questionnaire and on-site supervision and inspection. Results There were differences in the medical waste management system in units with different nature and levels of the laboratories.Medical waste disposal facilities in the laboratory of non-medical and health units were deficient.Centralized disposal capacity of medical waste could not meet the demands of small medical institutions and non-medical health units. Conclusion The management of the weak link for the pathogenic microorganism laboratories needs to be strengthened; the medical waste management system needs to be improved; new work concept of pre-trial in laboratory construction needs to be introduced; and contradictions between medical waste disposal demand and disposal capacity needs to be resolved.It is also suggested that laboratoriesshould be under classified administration according to the different nature of their affiliated institutions.

OBJECTIVETo compare the differences in intrapulmonary shunt (Qs/Qt) and arterial oxygenation between selective left lower lobar blockade by Coopdech endobronchial blocker tubes (BB) and one lung ventilation (OLV) by left-sided double-lumen endobronchial tubes (DLT) in patients with normal pulmonary function.

METHODSThirty-six patients (aged 32-64 years) scheduled for lower esophageal surgery were allocated randomly into BB and DLT groups (n=18). Anesthesia was induced and maintained with Propofol by target controlled infusion with intravenous administration of sufentanil and cisatracurium if needed. A 35 to 39 French tube was placed in the DLT group, and an 8.0-mm (internal diameter) single-lumen endotracheal tube was used in the BB group where a 9 French Coopdech BB was advanced into the left lower lobar bronchus guided by a fiberoptic bronchoscope. The variables recorded were blood gas analysis data from the venous and arterial blood samples at 20 min after two-lung ventilation in supine position (T(1)), 20 min after initiation of one-lung ventilation or selective left lower lobar blockade by inflating BB balloons in the right lateral decubitus position (T(2)), total collapse of the left lung or the left lower lobe after the pleura was opened (T(3)), and before tracheal extubation (T(4)). Qs/Qt was calculated using a standard formula based on the three-compartment model. Upon pleura opening, the effectiveness of lung collapse was evaluated by the surgeon who performed the surgery. Chest radiograph and arterial blood gas analyses were performed the day after the operation.

RESULTSBoth of the groups were similar with regard to rank of the surgical exposure, pH, PaCO(2), hemoglobin from T(1) to T(4), Qs/Qt, PaO(2), PO(2), and oxygenation index at T1. In BB group, a significant reduction of Qs/Qt and greater improvements in PaO(2), PO(2), oxygenation index at T(2), T(3) and T(4) were observed in comparison with those in DLT group (P<0.05 or <0.01). No lobe collapse was observed postoperatively in BB group, but 2 patients in DLT group showed left lower lobe atelectasis. The patients in BB group showed better postoperative arterial oxygenation and shorter postoperative hospital stay (P<0.01).

CONCLUSIONSelective left lower lobar blockade by Coopdech endobronchial blocker tube during lower esophageal surgery provides a lower intraoperative intrapulmonary shunt and a better intra- and postoperative arterial oxygenation..

Adult ; Blood Gas Analysis ; Bronchoscopes ; Continuous Positive Airway Pressure ; instrumentation ; methods ; Esophageal Neoplasms ; surgery ; Female ; Fiber Optic Technology ; Humans ; Intubation, Intratracheal ; methods ; Lung ; physiology ; Male ; Middle Aged ; Oxygen ; administration & dosage ; blood ; pharmacology ; Pulmonary Ventilation ; Thoracic Surgical Procedures ; methods

Mechanical loading is the main "instructive" factor of bone formation. The mechanism becomes the heat point in the field of bone science, biomedicine project and rehabilitation research. Mechanical vibration is one of the mechanic stimulation. Evidences show that vibration has obvious anabolic effect, and will have a broad landscape in the treatment of osteoporosis. But in the present studies, there were incorporated with the vibration frequency, and intensity, in particularly, few reports about the mechanism of vibration to bone. It will provide theoretic foundation for further systematic, sound research and its clinical application.
Animals ; Biomechanical Phenomena ; Bone Diseases ; physiopathology ; therapy ; Bone and Bones ; physiology ; physiopathology ; Humans ; Musculoskeletal Manipulations ; Osteogenesis ; Vibration ; therapeutic use