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 provide reference for formulating relatively unified quality control strategies and meeting the requirements of homogenization construction of blood banks across Chongqing area by retrospectively analyzing sampling results of different blood components during the past two years in all levels of blood banks in Chongqing area. 【Methods】 The key quality data of blood components prepared by 6 blood banks in Chongqing were analyzed retrospectively. According to the issuing units to the clinical during the past two years, the research objects were selected as leukocyte-depleted suspended RBCs, cryoprecipitate, pathogen inactivated fresh frozen plasma(FFP) and apheresis platelets. The quality data of the above-mentioned blood components from January 2019 to June 2021 were collected and analyzed. 【Results】 For leukocyte-depleted suspended RBCs(1U)prepared by 5 blood banks, statistically significant differences in Hb, residual white blood cells and hemolysis rate at the end of storage, except for Hct, were noticed(P<0.05). For cryoprecipitate, the content of blood coagulation factor Ⅷ and fibrinogen were statistically different among 3 blood banks in 1U specification(P<0.05) and among 5 blood banks in 2U specification(P<0.05). For pathogen inactivated FFP, the content of blood coagulation factor Ⅷ, plasma proteins, and residual methylene blue were statistically different among 3 blood banks(P<0.05). For apheresis platelets, Plt, white/red blood cells contamination and pH at the end of storage were statistically different among 3 blood banks(P<0.05). 【Conclusion】 The quality data of blood components, prepared by different blood banks, meet the requirements of national standard, however, certain differences are existing among blood banks.Key points during the process of collection, preparation, storage and transportation need to be cleared and unified, so as to reduce the differences between each other, and determine the direction and basis for homogeneity construction in the next step.

Objective To investigate the effect of quantitative ultrasound bone mineral density test on the screening of osteoporosis in patients with knee osteoarthritis and to explore the relationship between knee osteoar-thritis and osteoporosis. Methods 160 patients with knee osteoarthritis were divided into 4 groups:Ⅰ,Ⅱ,ⅢandⅣby Kellgren-Lawrence and measured height,weight,age,quantitative ultrasound bone mineral density and dual energy X-ray bone density.We compared the T values measured by quantitative ultrasound bone mineral density test and dual energy X-ray bone density,assessed the accuracy of quantitative ultrasound bone mineral density test for osteoporosis,and investigated the correlation between the value of quantitative ultrasound bone mineral density and knee osteoarthritis in different grades. Results Quantitative ultrasound bone mineral density was positively correlated with dual energy X-ray bone density(r = 0.751,P < 0.05). The AUC of diagnosis of osteoporosis by quantitative ultrasound bone mineral density test with T<-2.5 was 0.774,95% CI was 0.676 and 0.791,specificity was 96.7%,sensitivity was 85.7% and Youden index was 82.4%.With an increase in the grades of Kellgren-Law-rence,the knee osteoarthritis gradually worsened.The T values of quantitative ultrasound bone mineral density and dual energy X-ray bone density increased gradually in negative direction,and the difference was statistically signifi-cant(P<0.001).Conclusions Quantitative ultrasound bone mineral density test has good specificity and sensi-tivity and can be used to screen patients with knee osteoarthritis. The more severe the knee osteoarthritis is,the easier to develop osteoporosis.

BACKGROUND: Osteoporosis is a serious threat to the health and quality of life in the elderly. It is important to establish an ideal experimental animal model to study the etiology and treatment of osteoporosis.OBJECTIVE: To establish a rat model of osteoporosis induced by different dosages of retinoic acid, thus selecting the optimal dosage.METHODS: Eighty female Sprague-Dawley rats were randomly divided into control, low-, middle- and high-dosage groups based on body mass (n=20 per group), The rats in the latter three groups were induced with 80, 100, and 120 mg/(kg?d) retinoic acid via gastric lavage for 14 days.RESULTS AND CONCLUSION: Compared with the control group, the bone mineral density, number of osteoblasts and osteoclasts, and bone microarchitecture in the low-dosage group showed no significant changes, while there were significant decrease in the serum level of calcium and bone mineral density of femur, significant increase in the number of osteoclasts at the femur and significant changes in the femoral microarchitecture in the middle- and high-dosage groups, especially in the middle-dose group. To conclude, 120 mg/(kg?d) retinoic acid via gastric lavage for 14 days can induce a stable osteoporosis model in rats.

BACKGROUND: Ankle fracture combined with deltoid ligament rupture and distal tibiofibular syndesmosis injury occurs occasionally. Its treatment with distal tibiofibular syndesmosis screw fixation or deltoid ligament repair remains controversial. The former appears with poor reduction, broken nails, secondary surgery and other problems.OBJECTIVE: To observe the clinical effectiveness of suture anchor repair for ankle fracture combined with deltoid ligament injury.METHODS: Twelve patients with ankle fracture combined with deltoid ligament injury were selected from the First Affiliated Hospital of Guangzhou University of Chinese Medicine between January 2013 and December 2015. All patients were treated with open reduction, internal fixation, and anchor repair, but without distal tibiofibular syndesmosis screw fixation. The curative efficacy and joint stability were observed.RESULTS AND CONCLUSION: (1) All patients were followed-up for more than 12 months. (2) The modified Baird-Jackson scoring system showed excellent in nine cases, good in two cases, average in one case, poor in none case, and the excellent and good rate was 92%. (3) At 1 year after internal fixation, the X-ray examination showed the malleolus gap and talus slope angle of the affect side were (3.47±0.12) mm and (0.45±0.18)°, and the malleolus gap and talus slope angle of the healthy side were (3.44±0.05) mm and (0.43±0.14)°, and there was no significant difference between two sides (P > 0.05). (4) These results indicate that the suture anchor can repair the anatomy and biomechanics of deltoid ligament with stable ankle joint, and secondary surgery is unnecessary.

To improve the quality of teaching, teaching reform and exploration on integration of Ttradition Chinese Orthopedics curriculum has been carried out by orthopedics teaching and research section in our school. Putting Traditional Chinese Orthopedics as the framework of curriculum knowledge, the im-portant and difficult points of Human Anatomy and Clinical Medical Science were combined, which builds the overall teaching mode of normal-disease-cases and get some results. The evaluation of teaching effect shows thatthe integration of Traditional Chinese Orthopedicscourse will enable students to lay a solid the-oretical foundation and improve their ability.

BACKGROUND:Fracture healing is the coupling interaction of osteoblasts and osteoclasts that promotes bone growth, in which osteoblast-mediated bone resorption and osteoclasts-mediated bone reconstruction make the bone reconstruction in a dynamic equilibrium to promote bone growth. However, the majorities of the current studies focus on osteogenic or osteoclastic mechanism alone, and ignore the interaction mechanism between these two cels under co-existing conditions.
OBJECTIVE:To investigate the effects of Kidney Chinese Herbs on osteoblasts and osteoclasts coupling of osteoprotegerin-receptor activator of nuclear factor kappaB ligand-receptor activator of nuclear factor kappaB and its mechanism of action in fracture treatment.
METHODS: Mouse osteoblasts and osteoclasts were isolated and cultured in vitro to establish the mouse “osteoblast-osteoclast co-culture system” as a research platform. Then, Kidney Chinese Herbs at doses of 1.25, 2.5, 6.25 g/(kg?d) were given intragastricaly for 7 consecutive days. Mice in the blank control group were fed with the same volume of normal saline.
RESULTS AND CONCLUSION:The alkaline phosphatase activity in osteoblasts co-cultured with osteoclasts was significantly higher than that in osteoblasts cultured alone at 24 hours of culture (P < 0.05). Real-time PCR showed that in the co-culture system, the expression of alkaline phosphatase, Runt related transcription factor 2 and osteoprotegerin were increased in a dose-dependent manner (P < 0.05). Western blot assay showed 6.25 g/(kg?d) Kidney Chinese Herbs could dramaticaly promote the expression of osteoprotegerin and receptor activator of nuclear factor kappaB ligand, but restrained the expression of receptor activator of nuclear factor kappaB (P < 0.05). These findings indicate that Kidney Chinese Herbs can dynamicaly regulate the osteoprotegerin-receptor activator of nuclear factor kappaB ligand-receptor activator signaling pathway, and has a positive effect to promote bone reconstruction and rehabilitation.

ObjectiveTo analyze the relationship between pancreatic cancer (PC) and diabetes mellitus (DM),and the clinical and pathological features of pancreatic cancer in patients with DM.MethodsFrom January,2008 to December,2010,151 patients with PC and 195 comparable patients without PC were enrolled in a case-control study to analyze the relationship between PC and DM.ResultsThe OR was 5.91 (95％ CI 3.03-8.00,P＜0.05) in PC patients with DM for less than 2 years,and 1.308 (95％ CI 0.37-4.60,P＞0.05) in patients with DM for 2 to 5 years,and 1.16(95％ CI 0.44-3.19,P＞0.05) for patients with DM for more than 5 years.There was no significant difference between PC patients with and without DM in gender,age,body-mass index (BMD,obstructive jaundice,tumour location and tumour metastases (P＞0.05).ConclusionsThere was a significant correlation between PC and DM.De novo DM may be a clinical manifestation in patients with PC.PC patients with concurrent DM have no particular clinical and pathological features.

Objective To investigate an early diagnostic method and a rapid efficient treatment method to teat osteofascial compartment syndrome(OCS). Methods From January 2007 through December 2008,16 male patients with OCS were treated in our department.They were aged from 15 to 55 years (average,32 years).Twelve patients had OCS at the leg and 4 at the foot.All patients had no vascular or nerval injury.The modified Whiteside method was used to measure the pressue of the osteofascial compartment.All patients were treated with open decompression and vacuum sealing drainage (VSD).After swelling subsided,the wounds were directly sutured,decompresively sutured or treated with skin grafting. Merchant scoring was used to evaluate the postoperative efficacy in terms of limb-affected function,pain,gait,joint function,joint stability and range of motion. Results All patients were followed up for 12 to 14 months (average,13 months).All incisions closed up.Fourteen patients obtained excellent recovery of the function and sensation of the distal limb-affected;one patient had hypoesthesia and numbness at the the distal limb-affected; one patient had contracture,numbness and functional disturbance.By the Merchant scoring system,9 cases were excellent,5 good and 2 fair,giving a good to excellent rate of 87.5％. Conclusions The modified Whiteside method used to meausre the interstitial pressure is a reliable early diagnostic method for OCS.Decompression plus VSD may lead to rapid and efficient treatment of OCS and a reduced disability rate of the limb-affected.

Under the guidance of the learning theory of constructivism,the mode of curriculum educational reform is designed and experimented on the"acupuncturology" on-line study website using the method of action research.The action experiment contains 3 kinds of different teaching modes: the teaching center mode,the study center mode and teacher donimated-students centered mode.A whole process intervention to question senses is carried on.The relative theoretical basis and problem-solving research methods are found out during the experiment.Phase summary is formed and the teaching project is constantly revised and become perfect.