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 study of primary colorectal adenocarcinoma histone H2B single prime generalization (uH2B) and its relationship with clinicopathological parameters.Methods Colonic canceRtissue samples and para-carcinoma tissue of gastrointestinal surgery resection of 83 cases were selected from January 2013 to January 2016 in ouRhospital,and normal colon tissue of 20 cases was collected,and uH2B protein expression level in tissue samples was observed using immunohistochemical staining,and its relationship with clinical pathological parameters of patients with primary colonic carcinoma was analyzed.Results The positive expression rate of uH2B protein in colon canceRtissues was 46.99%,which was loweRthan 83.13% of adjacent tissues and 90.00% in normal colon mucosa,the differences were statistically significant (P<0.05);But there was no significant difference in the positive expression of uH2B protein in adjacent tissues and normal colonic mucosa (P>0.05);The positive expression rate of tumoRuH2B protein in colon canceRtissues in the TNM stage was correlation with degree of differentiation and lymph node metastasis (P<0.05),and it had no significant relationship with the patient′s age,gender,tumoRinvasion depth,tumoRsize (P>0.05).Conclusion The decreased expression rate of uH2B protein in colon carcinoma tissue is correlated with the TNM stage,differentiation degree and lymph node metastasis of the patients.

Objective To study of primary colorectal adenocarcinoma histone H2B single prime generalization (uH2B) and its relationship with clinicopathological parameters.Methods Colonic canceRtissue samples and para-carcinoma tissue of gastrointestinal surgery resection of 83 cases were selected from January 2013 to January 2016 in ouRhospital,and normal colon tissue of 20 cases was collected,and uH2B protein expression level in tissue samples was observed using immunohistochemical staining,and its relationship with clinical pathological parameters of patients with primary colonic carcinoma was analyzed.Results The positive expression rate of uH2B protein in colon canceRtissues was 46.99%,which was loweRthan 83.13% of adjacent tissues and 90.00% in normal colon mucosa,the differences were statistically significant (P<0.05);But there was no significant difference in the positive expression of uH2B protein in adjacent tissues and normal colonic mucosa (P>0.05);The positive expression rate of tumoRuH2B protein in colon canceRtissues in the TNM stage was correlation with degree of differentiation and lymph node metastasis (P<0.05),and it had no significant relationship with the patient′s age,gender,tumoRinvasion depth,tumoRsize (P>0.05).Conclusion The decreased expression rate of uH2B protein in colon carcinoma tissue is correlated with the TNM stage,differentiation degree and lymph node metastasis of the patients.

ObjectiveTo explore the expression of MRP1 and CD34 in colorectal carcinoma tissue and the relationship with clinicopathological factors.MethodsImmunohistochemical streptavidin-perosidase method was used to examine the expression of MRP1 and CD34 in 53 cases with colorectal carcinoma and normal colorectal tissue.The correlation between the levels of MRP1and CD34 expression and clinicopathological factors were analyzed.ResultsThe positive expression rates of MRP1 in the carcinoma group and normal colorectal tissue group were 49.1％ and 15.1％ respectively,and there was a significant difference of the positive expression between the two groups( x2 =14.029,P ＜ 0.01 ).The expression of MRP1 had no correlation with the degree of differentiation,the depth of invasion,the metastasis of lymph node and all the other clinicopathological factors ( P ＞ 0.05 ).CD34 value in the carcinoma group and normal colorectal tissue group were ( 35.63 ± 12.23 ) MVD/HP and ( 6.12 ± 0.97) MVD/HP,respectively,and there was a significant difference between the two groups (t =17.565,P ＜ 0.01 ).CD34 was not correlated with age,sex,tumor size,localization of the primary tumor ( P ＞ 0.05 ),but correlated with Dukes staging,lymph node metastasis,differentiation of the tumor,depth of invasion( all P ＜ 0.05).ConclusionThe overexpression of MRP1 and CD34 protein may involve in colorectal carcinogenesis;MRP1 may involve in the primary multidrug resistance in colorectal carcinoma.; CD34 may involve in the colorectal carcinoma invasion and metastasis.Investigating the expression of MRP1 and CD34 in colorectal carcinoma simultaneously can provide new referential indexes for the treatment and prognosis of colorectal carcinoma.

Objective: To investigate the effect of scalp point-through-point acupuncture on 200 kDa neurofilament protein (NF-200) in rats with acute cerebral infarction and explore its mechanism on nerve plasticity in cerebral infarction rats. Methods: Healthy male Wistar rats were randomly allocated to sham operation (Group A), model (Group B) and acupuncture (Group C) groups. A rat middle cerebral artery occlusion (MCAO) model of cerebral ischemia was made. NF-200 mRNA was measured by reverse transcriptase polymerase chain reaction (RT-PCR) in each group on the 7th, 14th and 28th days. Results: The cerebral expression of NF-200 in group C was significantly different from those in groups A and B (P＜0.05); there was a significant difference between groups C and B or A at different time windows (P＜0.01),indicating that scalp point-through-point acupuncture could improve the cerebral expression of NF-200. Conclusion: Scalp point-through-point acupuncture can improve neural function,promote the recovery of limb function and increase the expression of NF-200 after cerebral ischemia, exerting a regulative effect on neuronal plasticity in the brain.

Objective Study the effect of Chuanxiongsu(ferulic acid) combined perindopril or perindopril alone in the treatment of essential hypertension (EH). Methods Sixty patients with EH were divided into two groups randomly and single blindly: group A received Chuanxiongsu combined with perindopril, while group B received perindopril alone(4-8 mg/d) only for four weeks. Plasma endothelin-1 concentration(ET-1) and nitric oxide (NO) concentration were determined with radiommunoassay(RIA). Blood pressure was monitored before and after treatment. Thirty healthy volunteers served as controls. Results SBP in group A was lower than that in group B(138.9?8.1 vs group B 143.1?8.5)mm Hg, P

Objective To evaluate the value of thoracotomy through small right subaxillary oblique incision for pediatric ventricular septal defect(VSD). Methods From November 2001 to December 2008,1539 children with VSD underwent thoracotomy through small right subaxillary oblique incision in our hospital.At the fourth intercostal space between the anterior and middle axillary lines,a straight or oblique incision was made,then along the inferior edge of the fourth rib the chest was opened,and the right edge of the pericardium was fixed at the thoracic retractor.Afterwards,off-pump circulation was established and minimally invasive cardiac surgery was carried out.Results The procedure was completed successfully in all the 1539 patients.The cross-clamp time was(22.8?11.4) min(11 to 48 min),and CPB time was(33.0?14.9) min(27 to 64 min).Two patients(0.13%,2/1539) died in 24 hours after the operation.One of them died of severe allergic reaction to protamine.And the other died of severe low cardiac output in 4 hours after the surgery,because of an injury to the left coronary artery.In this series,the postoperative complications included incisional infection in 3 cases,atelectasis in 9,perfusion lung in 5,low cardiac output in 5,infectious endocarditis in 3 and acute renal failure in 4.These 29 cases were discharged after the complications being cured.Follow-up was available in 1446 cases for(47.0?11.2) months(range,6~91 months).During the period,small residual shunts in the VSD were detected in 5 cases,and other cases showed no abnormalities.Conclusions Thoracotomy through small right subaxillary oblique incision is minimally invasive,safe and effective for pediatric VSD.

ObjectiveTo observe effects of rehabilitation training on behavior and sensory evoked potential of rats with acute cerebral infarction.Methods30 male Wistar rats were randomly divided into sham operation groups (group A), model group (group B), and rehabilitation group (group C). Animal model was made by blocking the middle cerebral artery (MCA). For each group, the Bederson Neural Function was scored and balancing wood, rotating bar, and net screen were tested at the 24 hours, 3rd day and 7th day after operation respectively. The sensory evoked potential (SEP) latency of each group was also tested right after operation and on the 7th day after operation.ResultsComparing with group A, Bederson Neural Function scores of groups B and C indicated significant differences at each time (P<0.01). The ability of grasping, walking and coordinating of all groups handicapped 24 hours after operation, however, with time continuing, every function of group A restored and that of group B or C improved partly, but showed significant difference compared with group A (P<0.01). On the 3rd day after operation, balancing wood test of group C was better than that of group B (P<0.05), on the 7th day after operation, except Bederson Neural Function scores, there were significant difference between groups C and B (P<0.01 or P<0.05). Right after operation, compared with group A, the SEP latency of group B and C showed significant difference (P<0.01), on the 7th day after operation, the SEP latency of group C improved significantly compared with itself right after operation (P<0.01).ConclusionThe rehabilitation training can improve the MCAO rats' ability of equilibrating,grasping and walking and adjust the abnormal latency of SEP after MCAO, and prevent the nerve cells from damage caused by ischemic trauma.

ObjectiveTo study the rehabilitative effects and pathological changes in rats after acute cerebral infarction. Methods 30 male Wister rats were randomly divided into 3 groups :Group A(sham group),Group B(model group) and Group C(rehabilitation group). Animal model was made by the middle cerebral artery occlusion(MCAO).For each group, Bederson Neural Function was scored and balancing wood,rotating bar,and net screen were tested at 24 hours,3 days and 7 days after operation respectively. On the 7th day after operation, pathological change of brain tissue was observed. ResultsCompared with Group A, Bederson Neural Function scores of Group B,C indicated significant differences at each time (P<0.01).The abilities of grasping, walking and coordinating of all the groups after 24 hours by operation handicapped, however with time continuing,every function of Group A restored and that of Group B or C improved partly,but showed significant difference compared with Group A(P<0.01).After 3 days by operation,balancing wood test of Group C was better than that of group B(P<0.05),after 7 days,except Bederson Neural Function score,there were difference between Group C and B(P<0.05 or P<0.01).After 7 days by operation,compared with Group A,brain tissue of infarction area in Group B indicated significantly edema, neural cells decreased. Compared with Group B, the edema in Group C decreased and neural cells increased.ConclusionsRehabilitation therapy can improve the MCAO rats' ability of equilibrating, grasping and walking, and decrease edema, increase neural cells in infarction areas.

Objective To observe the effects of perindopril on changes of endothelin(ET)and atrial natriuretic peptide (ANP) in patients with essential hypertension (EH).Methods Thirty patients with EH were given with perindopril for four consecutive weeks.Plasma ET and ANP were examined with radioimmunoassay (RIA) before and after treatment,with thirty healthy volunteers as controls.Results Plasma levels of ET and ANP were higher in EH groups before treatment than those in controls (P＜0.01),and decreased significantly after treatment than those before treatment (P＜0.01).Conclusion The influence of perindopril on ET and ANP is correlated to its hypotensive effects in EH patients.