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 short-term efficacy and safety through analyzing the results of 11 cases of video assisted minimally invasive cardiac surgery. Methods Eleven patients who had underwent video assisted minimally invasive cardiac surgery in the second hospital of Anhui medical university from November 2017 to August 2018 were retrospectively analyzed. One patient underwent simple atrial septal defect repair, 6 patients underwent atrial septal defect repair+tricuspid valve repair, 3 patients underwent mitral valve replacement, and 1 patient underwent mitral valve repair + tricuspid valve repair. Results All patients underwent video cardiac surgery without death, with no major bleeding (need secondary thoracotomy to stop bleeding) and no neurological complications. One patient of incision fat liquefaction healed after dressing change. One patient developed lower limb artery stenosis, which was treated conservatively and discharged after hospitalization. Conclusions Video assisted minimally invasive cardiac surgery can be safely applied to simple congenital heart disease and valve surgery as long as patients are strictly screened. Due to the advantages of small trauma, less bleeding, and quick recovery, it is worth promoting.

Objective To explore the difference in gastric residual volume (GRV) between singledose and split-dose bowel preparation before colonoscopy under general anesthesia.Methods From October 8th to December 30th in 2016,the out-patients undergoing gastroscopy and colonoscopy with anesthesia services on the same day were selected and divided into the traditional single-dose bowel preparation group and split-dose bowel preparation group.The GRV and intestinal preparation quality were compared between the two groups.T test was used for statistical analysis and multiple linear regression analysis was performed for the influence factors of GRV analysis.Results A total of 121 patients were enrolled,60 patients in the spilt-dose bowel preparation group and 61 in the traditional single-dose bowel preparation group.The mean GRV of the split-dose bowel preparation group was (17.3 ± 12.2) mL,which was lower than that of the single-dose bowel preparation group ((23.7 ± 14.6) mL),and the difference was statistically significant (t =2.642,P=0.009).The score of intestinal preparation quality of the split-dose bowel preparation group was 8.05 ± 0.85,which was higher than that of the single-dose bowel preparation group (7.67±1.19),and the difference was statistically significant (t =-2.002,P=0.048).Fasting time was related with GRV (odd ratios (OR)=1.732,95％ contidence interval (CI) O.299 to 3.168,P=0.018).Conclusion The GRV of patients with split-dose bowel preparation before colonoscopy is lower than that of traditional single-dose bowel preparation,thus reducing the risk of aspiration during anesthesia.

Objective To summarize and analyze clinical diagnosis and surgical treatment methods of 11 cases with congenital coronary arterial fistula (CCAF). Methods The clinical data of 11 patients who were definited by ultrasonic cardiogram, CT angiography (CTA) and coronary angiography were analyzed retrospectively. Four cases were simple CCAF, 7 cases coexisted with other heart abnormalities. Six cases were given surgical closure of fistula without cardiopulmonary bypass. One of the cases adopted coronary artery under the tangent cotton-padded mattress suture, and 4 cases fistula arterial were ligatured directly. Six cases were given surgical closure of fistula under cardiopulmonary bypass. The right coronary arterial was opened in three of the cases with right coronary artery aneurysm to close fistula. The chambers of heart in the others were opened to close fistula. Results All patients received surgical treatment successfully, and no death happened during the operation. The ultrasonic cardiography showed that all patients recovered well. Follow-up was conducted on 10 patients with the time period ranging from 3 months to 5 years. There was no death and no complication. Conclusions Combined application of ultrasonic cardiogram, coronary angiography and CTA increases the accuracy rate of diagnosis greatly and offers visual bases to formulate operation plan. Surgical operation is quite effective for congenital coronary arterial fistula after definite diagnosis. Operator should try to reserve the expanded coronary arterial, strengthen the anticoagulant after opeation to prevent thrombosis.

BACKGROUND:Pulsed laser deposition synthesis technology has been used to prepare new nano-hydroxyapatite thin film coating by colagen deposition on artificial mechanical heart valve. OBJECTIVE: To investigate the toxicity of new nano-hydroxyapatite thin film on human umbilical vein endothelial cels. METHODS: Human umbilical vein endothelial cels were cultured with nano-hydroxyapatite film room-temperature leaching solution, nano-hydroxyapatite film high-temperature leaching solution, high-density polyethylene and phenol solution. Within 72 hours, cel growth was observed under the inverted phase contrast microscope. At 7 days after culture, cel proliferation and toxicity grading were detected using Cel Counting Kit-8. RESULTS AND CONCLUSION:At 24 hours after culture, cels grew wel, showed fusiform shape, and had strongrefraction in the nano-hydroxyapatite film room-temperature leaching solution, nano-hydroxyapatite film high-temperature leaching solution, high-density polyethylene groups, and no significant differences in cel morphology and number were detected among above groups. Cels in the phenol solution group were suspended, round, pyknotic and dead. At 48 hours, except phenol solution group, cel number increased significantly, and cel grew densely in other three groups. At 72 hours, cels grew strongly, and the gap became smal obviously. Within 7 days after culture, cel proliferation activity was not significant in the nano-hydroxyapatite film room-temperature leaching solution, nano-hydroxyapatite film high-temperature leaching solution, and high-density polyethylene groups, which was significantly higher than in the phenol solution group (P < 0.05). The toxicity of nano-hydroxyapatite film graded 0 to 1. These results suggested that nano-hydroxyapatite artificial mechanical heart valve has good histocompatibility, but no toxicity.

BACKGROUND:A new type of nano-hydroxyapatite artificial mechanical heart valve has been developed using pulsed laser deposition technology at the Department of Materials, Hefei University and Anhui Institute of Optics and Fine Mechanics, Chinese Academy of Sciences, China. OBJECTIVE:To investigate the compatibility of nano-hydroxyapatite artificial mechanical heart valve with human umbilical vein endothelial cels. METHODS:Human umbilical vein endothelial cels were in vitroisolated, cultured and passaged to the 2-4 generations, and then the cel suspension was inoculated onto the nano-hydroxyapatite artificial mechanical heart valve. After 3, 7, 12 days of culture, the cel growth on the artificial mechanical heart valve was observed under scanning electron microscope. In addition, the human umbilical vein endothelial cels were respectively cultured in room-temperature and high-temperature extract liquids of nano-hydroxyapatite artificial mechanical heart valve, high-density polyethylene and phenol solution extracts for 72 hours, and then, the proliferation of cels was detected by MTT method. RESULTS AND CONCLUSION:Under the scanning electron microscope, the human umbilical vein endothelial cels were fusiform- or polygon-shaped with protuberances adhered to the artificial mechanical heart value at 3 days of culture; the cels were stretched thoroughly and fused at 7 days of culture; and the cels were confluent to pieces that tightly overlaid the heart valve surface and the extracelular matrix was formed localy at 21 days of culture. Results from MTT test displayed that the nano-hydroxyapatite artificial mechanical heart valve had no cytotoxicity to the human umbilical vein endothelial cels, indicating a good cytocompatibility.

Objective To explore the outcome of the tibial bone-skin flap grafts in the management of severe traumatic osteomyelitis complicated with bone and skin defect in leg.Methods Twenty-seven cases of the traumatic osteomyelitis complicated with bone and skin defect in leg were treated with vascularized tibial bone-skin flap grafe from August, 2007 to November, 2013.Reconstruction of limb tibia continuity and cover the wound.Results The tibial bone-skin flaps were completely survived in 26 of the 27 cases except 1 ease which was repaired by adjacent flap because of the disorder blood circulation.The followed-up showed that all flaps had good blood circulation.The infection was controlled completely.The leg function and contour were satisfactory.Conclusion The tibial boneskin flap has the advantages of abundant blood supply, full bone-skin flap supply, shortens hospitalization and suitable for treatment of traumatic osteomyelitis complicated with bone and skin defect in leg.

Objective To explore the curative effect of combination therapy of low-temperature plasma radiofrequency ablation and nasal endoscopy for chronic nasal sinusitis. Methods From January 2010 to January 2012,98 patients with chronic nasal sinusitis in our hospital were ramdomly divided into observation group and control group. The observation group (49 cases) received plasma radiofrequency ablation at low temperature combined nasal endoscopic treatment. The control group (49 cases) were performed only nasal endoscopic treatment. The curative effect of the 2 groups were compared. Results After 1 month and 1 year, the total effective rate of the observation group were 91. 84% and 89. 80%, the total effective rate of the control group were 77. 55% and 73. 47% respectively. To compare the total effective rate of 2 groups were compared,there were statistically significant differences(P<0. 05). Conclusion Curative effect of plasma radiofrequency ablation at low temperature and nasal endoscopy is distinct,it is worthy of being widely applied in clinic.

BACKGROUND:In early experiments, we prepared hydroxyapatite-coated mechanical heart valve embedded with col agen using impulse laser sediment method.
OBJECTIVE:To further analyze the histocompatibility and toxicity of hydroxyapatite-coated mechanical heart valve embedded with col agen.
METHODS:After passage, canine vascular endothelial cellsuspension was inoculated onto the hydroxyapatite-coated mechanical heart valve embedded with col agen. One group was inoculated in 5%CO2, 37 ℃ incubator for 3 weeks static culture, and the other group was inoculated in 5%CO 2 , 37 ℃ incubator for 3 weeks spinner culture. Scanning electron microscope was used to observe cellattachment on the material. 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay was used to the proliferative capacity of vascular endothelial cells cultured with the hydroxyapatite-coated mechanical heart valve embedded with col agen.
RESULTS AND CONCLUSION:During the spinner culture, adherent cells were found on the surface of mechanical heart valve, and the cells distributed evenly and confluent at 21 days to cover the surface of the material. The number of adherent cells in the spinner culture was higher than that in the static culture. The cells during the static culture were aggregated and distributed irregularly. The mechanical heart valve exhibited no effects on the proliferation of canine vascular endothelial cells which grew wel . These findings indicate that the hydroxyapatite-coated mechanical heart valve embedded with col agen exert no effect on proliferation of vascular endothelial cells, has no toxicity and has good biocompatibility.

Rhei Rhizoma is a Chinese medicine with multiple botanical origins. There is a problem to identify it with conventional methods. To compare the characteristics of chloroplast matK gene sequences of different Rheum species and authenticate inspected species, the matK gene sequences of different species from different origins were amplified, cloned, and sequenced. Genomic DNA of Rheum plants was extracted using modified DNA extracted Kit and matK gene sequences were analyzed by ContingExpress, DNAman and MEGA5.0. The length of matK gene sequences of Rheum palmatum, R. tanguticum and R. officinale were 1 518 bp containing 57 variable loci. According to the mutation sites, R. palmatum, R. tanguticum and R. officinale were divided into different genotypes separately. Based on the established method according to the loci 587, 707, 838, we successfully identified the genuine Rheum species from its adulterants.