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 trends in incidence of malignant tumors in Yongkang City, Zhejiang Province from 2013 to 2019, so as to provide insights into formulation of the malignant tumor control strategy. Methods: Data pertaining to the incidence of malignant tumors from 2013 to 2019 were captured from the Zhejiang Chronic Disease Monitoring Information System. Based on the International Classification of Diseases 10th Revision (ICD-10) and data from the national population census, the constituent ratio, crude incidence and Chinese population-standardized incidence of malignant tumors were estimated, and the trends in incidence of malignant tumors were investigated using annual percent change (APC). Results: The annual mean crude incidence and Chinese population-standardized incidence of malignant tumors were 356.75/105 and 226.97/105, which both appeared an overall tendency towards a rise (APC=5.887% and 4.815%, both P<0.05). The crude incidence of malignant tumors appeared a tendency towards a rise among both men (APC=3.860%, P<0.05) and women (APC=8.534%, P<0.05) from 2013 to 2019, and the Chinese population-standardized incidence of malignant tumors appeared a tendency towards a rise among women (APC=8.392%, P<0.05). The largest increase in the crude incidence of malignant tumors was seen among women at ages of 15 to 44 years (APC=11.599%, P<0.05). In addition, the Chinese population-standardized incidence of lung cancer, colorectal cancer and thyroid cancer all showed a tendency towards a rise among men (all P<0.05), and the Chinese population-standardized incidence of lung cancer and thyroid cancer both appeared a tendency towards a rise among women (both P<0.05). Conclusions The incidence of malignant tumors showed a tendency towards a rise in Yongkang City from 2013 to 2019, and the elderly and young females are high-risk populations for malignant tumors. Lung cancer, thyroid cancer and colorectal cancer are cancers that should be given a high priority.

Objective:To study the pathogenesis and the risk factors of eye injury after non-ocular surgery in the patients underwent general anesthesia, and to provide the reference for its prevention, diagnosis and treatment.Methods:The clinical materials of two patients with eye injury after non-ocular surgery underwent general anesthesia were analyzed and the related literatures were reviewed.Results:A young woman patient underwent laparoscopic hysterectomy with general anesthesia while positioned Trendelenburg, the eyes were being closed naturally without protection, and corneal abrasion of both eyes occurred after operation.The lesion had completely resolved with no sequelae after treatment.An old man underwent cervical posterior laminoplasty with general anesthesia in prone position developed ischemic optic neuropathy (ION) after operation.The vision of the patients partly recovered after symptomatic treatment.Conclusion:Corneal abrasion is the most frequent ophthalmologic complication during general anesthesia, most of the patients have good prognosis.Postoperative visual loss (POVL) is the most severe ophthalmologic complication without effective treatment available, the delicate reasons and mechanisms are not totally clear, prevention outweighs treatment.

Objective To evaluate the effect of zinc deficiency factor on cognitive function after isoflurane anesthesia in mice with Alzheimer's disease (AD).Methods One hundred and forty-four APP/ PS1 transgenic mice with AD,weighing 22-28 g,aged 8-10 months,were divided into 6 groups (n=24 each) using a random number table:zinc adequate group (group ZA),zinc adequate plus isoflurane anesthesia group (group ZA+Iso),zinc deficiency group (group ZD),zinc deficiency plus isoflurane anesthesia group (group ZD+Iso),zinc treatment group (group ZT) and zinc treatment plus isoflurane anesthesia group (group ZT+Iso).The mice were fed a diet adequate in zinc and deionized water for 2 months in ZA and ZA+Iso groups.The mice were fed a diet low in zinc (0.01‰ zinc) and deionized water for 1 month in ZD and ZD+Iso groups.The mice were fed a diet adequate in zinc and 0.12‰ ZnSO4 · 7H2O water for 2 months in ZT and ZT+Iso groups.The mice underwent 2 h of anesthesia with 1.4％ isoflurane starting from the end of feeding in ZA+Iso,ZD+Iso and ZT+Iso groups.At 24 h after anesthesia,the mice were sacrificed and hippocampal tissues were obtained for determination of the contents of soluble amyloid beta protein 40 (Aβ40) and Aβ42 and insoluble Aβ40 and Aβ42 (using enzyme-linked immunosorbent assay) and expression of total Aβ,Aβ40,Aβ42,tau pSer396,tau pSer262 and tau pThr231 (by Western blot).Morris water maze test was performed at 24 h after anesthesia.Results There was no significant difference in each parameter between group ZA and group ZA+Iso and between group ZT and group ZT+Iso (P＞0.05).Compared with group ZD or group ZT+Iso,the escape latency was significantly prolonged,the space exploration time was shortened,the expression of hippocampal Aβ42,tau pSer396,tau pSer262 and tau pThr231 was up-regulated,and the contents of soluble and insoluble Aβ42 were increased in group ZD+Iso (P＜0.05 or 0.01).Conclusion Zinc deficiency can aggravate the impairment of cognitive function after isoflurane anesthesia in mice with AD,and the mechanism is related to the promotion of hippocampal Aβ aggregation and tau protein phosphorylation.

Objective To explore the biomechanis with different bone density by the pedicle screws fixation before and after fatigue test.Thus provide biomechanical basis for the clinical work.Methods A total of 27 fresh lumbar vertebrae samples of adult sheep (L1-L5) were equally divided into three groups,such as group A of decalcified with HCL 0 h,group B of decalcified with HCL 2 h and group C of decalcified with HCL 4 h,by using the random number table method,every groups was 9 models.Four screws was performed on the L4-L5 pedicle of vertebral arch of the three groups.Three groups were performed fatigue test of 250 000 times in 4 direction (flexion,extension,left lateral bending,right lateral bending) by (300+ 105) N load.The range of motion(ROM),the axial compressive stiffness were measured and the results in every group were compared before and after fatigue test.Results After fatigue test,ROM and the axial compressive stiffness had no significant change in group A (P＞0.05),but ROM of B group and C group were both increased and the axial compressive stiffness were decreased,Significance was found with and between groups.Conclusion The stability of people who are performed pedicle screws simplly may be decrease when the spine of osteopenia.

Objective To explore the difference of the expression level of FK506 Binding Protein 51 (FKBP51) in colorectal adenocarcinoma and normal colorectal tissues,and the correlation between FKBP51 expression level and clinicopathological characteristics,and to clarify whether FKBP51 is involved in the occurrence and development of colorectal cancer.Methods By immunohistochemical staining [streptavidin-peroxidase (SP) method] and Western blotting methods tested 31 cases of colorectal cancer tumor tissues and normal colorectal tissues far from tumor 5 cm,and explored the expression level difference of FKBP51.Combined with clinical data of patients,results were analyzed by statistical method x2 test of four case table data.Results The high expression rate of FKBP51 in tumor tissues was 74.19％ (23/31 cases),while the high expression rate of FKBP51 in normal tissue was 9.68％ (3/31 cases).The difference was significant.The expression level of FKBP51 in patients with colorectal carcinoma had no obvious correlation with gender (P =0.771),age (P =0.474),tumor location (P =0.213),degree of differentiation (P =0.318),lymph node metastasis (P =0.124),distant metastasis (P =0.318) and clinical stage (P =0.171);and the tumor size (P =0.049),depth of invasion related (P =0.031),the difference was statistically significant.Conclusions The expression of FKBP51 in colorectal cancer was strong,while weak expression in normal colorectal tissues.With the increase of tumor infiltration and deepening,the expression of FKBP51 became stronger,which indicated that FKBP51 participated in the genesis and development of colorectal cancer,and it might become a new target for individual therapy of colorectal cancer.

Objective To investigate the effect of the timing of endoscopic retrograde cholangiopancreatography(ERCP)treat-ment option on the respiratory burst and inflammatory factor level for acute obstructive suppurative cholangitis(AOSC)patients. Methods A total of 98 patients with AOSC who were treated in our hospital from January 2013 to June 2016 were retrospectively analyzed.The patients were divided into A group and B group according to the time of ERCP operation.42 cases in A group were received ERCP within 6 h after admission.56 cases in B group were received ERCP in 6-24 h after admission.,The serum levels of inflammatory cytokines were compared between the two groups before and after treatment.The apoptosis rate and respiratory burst rate of peripheral hematoma were compared between the two groups before and after treatment.The complications and death rate of the patients in the two groups were recorded.Results After treatment,the levels of TNF-α and IL-6 in the A group were signifi-cantly lower than those in the B group and the IL-10 level was significantly higher in the B group(P<0.05).After treatment,the rate of neutrophil apoptosis in the A group was significantly higher than that in the B group(P<0.05),and the respiratory burst level in the A group was significantly lower than that in the B group(P<0.05).The incidence number of complications and death in patients in group A was significantly lower than that in group B(P< 0.05).Conclusion ERCP treatment for patients with AOSC should be performed as early as possible and as soon as possible.Early ERCP treatment is safe and effective and can alleviate the inflammatory reaction of patients,improve the survival rate of patients,and is worthy of clinical promotion.

OBJECTIVETo analyze the diseases and effects of the manipulations to promoteby filiform needles, with the help of data mining technique.

METHODSLiterature about different manipulations to promoteby filiform needles in recent 60 years was collected in China National Knowledge Infrastructure(CNKI). Then databases were established to mine the relativities among the diseases, subjects, acupoints selection law,routes and directions of meridianand effects.

RESULTS①Total 489 articles were included. The basic manipulations with the frequency of 630 were on the top. The auxiliary and four methods ofrespectively appeared 70 times. The diseases in the internal medicine were treated with the basic and auxiliary methods of the higher frequencies, 311 and 44 times separately. While the four methods ofwere mostly used in the surgical area, 37 timestotally. ②The diseases treated from high to low by lifting, thrusting and twirling represented retention of urine, sequelae of stroke, pain in waist and lower limbs, of which the effect for retention of urine was better than those of the other two, and the lifting and thrusting method was superior to twirling. ③As for the auxiliary methods, 25 times were found about vibration needling; 18 times, twisting. The highest frequency of 6 times for the vibration needling was on the sequelae of stroke; while 4 times for the twisting, stranguria. ④As to the four methods of,was most frequently applied, and its highest frequency of 18 was onsyndrome.

CONCLUSIONSManipulations to promoteby filiform needles are crucial to achieving the effects of acupuncture. The basic methods are widely used in clinic and have been seen good efficacy. While the auxiliary means assist to promoteto stimulate the body,among which the four methods ofare mainly to smooth the meridians and driveof patients with surgical diseases and take meridian blocking the priority.

Objective:To observe the influence of inhaled anesthetic isoflurane in the neuronal protein damage and aggregation in the APP transgenic mouse hippocampus,and to investigate the intervention effect of trehalose. Methods:Sixty APP transgenic mice aged 12 months were divided into control group,isoflurane group (Iso group) and trehalose group (Tre group)(n=20).The rats in control group were not given any drugs and were put into the anesthetic box with continuonsly entering 2 L·min-1 oxygen for 2 h;the rats in Iso group and Tre group were respectively injected intraperitoneally with 2 mL saline or trehalose (400 μg·kg-1 )30 min before anesthesia,and then inhalated 1.4% isoflurane for 2 h.6 h after anesthesia,the hippocampus tissue of the mice was prepared,and DCFH-DA fluorescence was applied to detect the reactive oxygen species (ROS)level; 24 h after anesthesia, immunohistochemical method and Western blotting method were used to detect the contents of carbonyl compounds and nitrotyrosine and the Aβ1-42 protein expression level in hippocampus;TEM was applied to observe the formation of protein aggregates; TUNEL staining was performed to observe the apoptotic rate of hippocampal neurons. Results:Compared with control group, the ROS level, the expression levels of oxidative protein carbonyl compounds and nitrotyrosine,the expression level of Aβ1-42 protein,and the apoptotic rate of hippocampal neurons in Iso group were significantly increased (P < 0.05);compared with Iso group,the ROS level,the expression levels of oxidative protein carbonyl compounds and nitrotyrosine,the Aβ1-42 protein expression level, and the apoptotic rate of hippocampal neurons in Tre group were significantly decreased (P < 0.05).Conclusion:Isoflurane can induce the protein damage and aggregation,the apoptotic rate of hippocampal neurons,aggravate oxidative stress reaction,increase the apoptotic rate of brain hippocampal neurons in the APP transgenic mice;trehalose can intervene the neurotoxicity induced by inhaled anesthetics.

OBJECTIVETo analyze the effects of metacarpus and phalanx traction on correction of scar contracture of hand after burn on the palm side retrospectively.

METHODSA total of 32 patients with 39 affected hands with scar contracture on the palm side after burn were hospitalized from May 2010 to December 2014. Method of treatment: scar contracture was conservatively released followed by skin grafting, which was referred to as method A; Kirschner wire was inserted into the middle or distal phalanx of finger with contracture and the corresponding metacarpus in the shape of U for 2 to 7 weeks' traction, which was referred to as method B; traction frame was built based on the traction pile and anchor formed by Kirschner wire inserted through the second to the fifth metacarpus and distal phalanx of finger with contracture, and then the affected fingers were pulled into a straight position with rubber bands for 2 to 6 months, which was referred to as method C. Method A was used in patients who would be treated with thorough release of scar followed by skin grafting routinely. Method B was used in patients who would be treated with intramedullary Kirschner wire fixation after release of scar contracture and skin transplantation routinely. Method C was further used in patients when methods A and B failed to accomplish the expected result. Method C was used in the first place followed by method A in whom there might be vascular decompensation or exposure of tendon and bone after scar release, and those who failed to meet the expectation were treated with method C in addition. Patients who were unwilling to undergo surgery were treated with method C exclusively. During the course of treatment, the presence or absence of infection and slipping of Kirschner wire or its slitting through soft tissue were observed. The presence or absence of tendency of recurrence of scar contracture within 1 to 2 weeks after treatment was observed. The length of palmar skin measuring from the root of finger with contracture to wrist crease was measured before treatment, at the termination of treatment, and 1 month after the termination of treatment. Scar condition was assessed with the Vancouver Scar Scale (VSS) before treatment and 1, 3, and 6 month(s) after the termination of treatment. Before treatment and 1 month after the termination of treatment, the range of motion was measured with the Total Active Movement (TAM) method; band function was evaluated by the Jebsen Test of Hand Function (JTHF), and the completion time was recorded. Data were processed with analysis of variance, LSD-t test, and t test.

RESULTSTwenty-four patients with 27 affected hands were treated with scheme A + B; 5 patients with 7 affected hands were treated with method C exclusively; 2 patients with 3 affected hands were treated with scheme A + B + C; 1 patient with 2 affected hands were treated with scheme C + A + C. During the course of treatment, no complication such as infection or slicing of tissue was observed, but there was a slight shifting of U-shaped Kirschner wire in 14 affected hands of 13 patients. Tendency of recurrence of scar contracture was observed in 11 affected hands of 10 patients, but the scar contracture did not reoccur after treatment with orthosis. The skin length of palmar side was respectively (131.8 ± 9.8) and (127.6 ± 7.5) mm at the termination of treatment and 1 month after, and they were both significantly longer than that before treatment [(114.5 ± 2.4) mm, with values respectively 10.71 and 10.39, P values below 0.001]. The score of VSS was respectively (9.8 ± 2.4), (9.7 ± 1.7), (9.3 ± 0.8), and (7.7 ± 0.5) points before treatment and 1, 3, and 6 month(s) after the termination of treatment. Only the score at 6 months after the termination of treatment was significantly lower than that before treatment (t = 3.28, P < 0.01). The ratio of excellent and good results according to method TAM was respectively 2.6% (1/39) and 94.9% (37/39) before treatment and 1 month after the termination of treatment. The time for JTHF measurement was (13.9 ± 4.1) min before treatment, and it was shortened to (11.0 ± 2.8) min 1 month after the termination of treatment (t = 3.65, P < 0.001).

CONCLUSIONSSingle application of metacarpus and phalanx traction or its combination with skin transplantation after scar release in correcting scar contracture of the palm of hand after burn can lengthen the contracted tissue, and it is beneficial for the restoration of function and appearance of affected hand.

Burns ; rehabilitation ; therapy ; Cicatrix ; therapy ; Contracture ; surgery ; Hand Injuries ; rehabilitation ; therapy ; Humans ; Metacarpus ; Orthotic Devices ; Range of Motion, Articular ; Reconstructive Surgical Procedures ; methods ; Retrospective Studies ; Skin ; Skin Transplantation ; Tendons ; Time ; Traction ; Treatment Outcome