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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.
Subject(s)
Humans , Male , Antineoplastic Agents, Hormonal/therapeutic use , East Asian People , Gonadotropin-Releasing Hormone/agonists , Goserelin/therapeutic use , Prostate-Specific Antigen , Prostatic Neoplasms/drug therapy , TestosteroneABSTRACT
AIM To explore the effects of Xuebijing Injection (Carthami Flos,Salviae miltiorrhizae Radix et Rhizoma,Paeoniae Radix Rubra,etc.) on serum CRP,TNF-α and IL-6 levels in patients with severe acute organophosphorus pesticide poisoning (AOPP).METHODS Seventy-two cases of patients with AOPP treated from Jan 2014 to Mar 2016 in the emergency department of our hospital were randomly divided into two groups,the control group treated with atropine,pralidoxime chloride and conventional treatment,and the observation group combined with Xuebijing Injection.The dynamic changes of serum CRP,TNF-α and IL-6 levels,and clinical curative effects were compared between the two groups.RESULTS The serum CRP,TNF-α and IL-6 levels in the two groups were decreased in turn before the treatment,at the 3rd,7th days after the treatment,and the serum CRP,TNF-α and IL-6 levels in the observation group were significantly lower than those in the control group;the dosage of atropine,time of cholinesterase activity recovered 60％ and hospital stay in the observation group were significantly less than those in the control group;the rebound rate of the observation group was lower than that of the control group.The acute respiratory distress syndrome (ARDS) rate in the observation group was significantly lower than that in the control group.All the differences had statistical significances (P ＜ 0.05).CONCLUSION Xuebijing Injection can effectively inhibit the inflammatory response,reduce the incidence of complications,shorten the course,and improve the clinical efficacy in the treatment of patients with AOPP.
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Objective To explore the effect of flexible ureteroscope in treatment of retained kidney calculi after percutaneous nephrolithotomy.Methods Thirty-six patients with retained kidney calculi after percutaneous nephrolithotomy who were treated with flexible ureteroscope were selected,and clinical data of the patients were retrospectively analyzed.Results In the 36 patients,26 patients were through the percutaneous nephroscope channel,and 10 patients were through the ureter channel.Except for 1 patient who stopped the operation because of poor visibility caused by active bleeding in percutaneous nephroscope channel lithotripsy 7 d after percutaneous nephrolithotomy,other patients did not appear severe complication.All the patients were rechecked plain abdominal radiograph the second,seventh and fourteenth day after this operation,and the eradication rates of calculi were 13.9％ (5/36),69.4％ (25/36) and 94.4％ (34/36).Two patients still had less than 0.4 cm retained calculi in lower renal calices and were followed up.Conclusions The retained kidney calculi after percutaneous nephrolithotomy can be effectually treated by flexible ureteroscope,and it can avoid secondary percutaneous nephrolithotomy or multichannel percutaneous nephrolithotomy,and inprove the eradication rate of complex kidney calculi by percutaneous nephrolithotomy.The method is economical,safe,simple and with little injury,and it is the effective supplement protocol of percutaneous nephrolithotomy.
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Objective To evaluate early diagnostic value of quantitative analysis of contrast-enhanced ultrasound (CEUS) in acute radiation-induced liver injury.Methods Sixty female rats were divided into two groups:50 rats in an experimental group (model group) and 10 rats in a negative control group.The rats in model group were radiated with stereotactic single dose of 20Gy on their liver to establish acute radiationinduced liver injury models.Each 10 rats from model groups and 2 rats from control group were randomly selected and underwent CEUS and histopathological examination on the 3,7,14,21,28 days after radiation.The degree of injury was classified into four groups according to pathological grading:non-injured group,mild injured group,moderated injured group and severe injured group.The dynamic images of CEUS were off-line analysis and the parameters of arrival time of contrast agent to hepatic artery (HAAT),the arrival time of contrast agent to hepatic vein (HVAT),and the transit time of hepatic artery-hepatic vein (HAHVTT) were recorded.Time intensity curve (TIC) of liver parenchyma drawn by the software of quantitative analysis was used to obtain quantitative parameters including time to peak (TTP) and peak intensity (PI).Results Along with the severity degree of radiation-induced liver injury,the quantitative parameters,PI decreased while TTP extended.PI of mild injured group,moderated injured group and severe injured group were lower than that of non-injured group (P ＜0.05).TTP of the three liver injuried groups was higher than non-injured group (P ＜0.05).The quantitative parameters HA-HVTT of moderated injured group and severe injured group were decreased than the non-injured group (P ＜0.05),whereas the difference between mild injured group and non-injured group was not significant.Conclusions Quantitative analysis of CEUS can provide a certain value for early diagnosis in acute radiation-induced liver injury.
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ObjectiveTo characterize the gene expression in acute phase of irradiated oligodendrocytes (OL) in vitro.Methods The total RNA was extracted from irradiated OLs with 10 Gy by 6 MV X-rays at 1 and 4 h.The Affymetrix RAT 230 2.0 microarray were used to evaluate and screen the gene expression profile.The quantitative real-time RT-PCR was performed to validate the microarray results of selected myelin basic protein (MBP) and neural cell adhesion molecule 1 ( NCAM-1 ) genes.Results Compared with un-irradiated OLs,there were 1079 different expressed genes in irradiated cells.Those genes were classified in 79 categories based on the functional classification.Some familiar genes associated with OL cellular physiological process,apoptosis,cell cycle control,metabolism,cell communication and receptor binding were included.Compared with the microarray results,the coincidence rate of real-time RT-PCR was 91.7%.The down-regulation of MBP and up-regulation of NCAM 1 gene expression were confirmed.Conclusions Radiation-induced changes in gene expression in OLs took place in acute phase and influenced by time-course.The changes of MBP and NCAM1 gene expression may play a key role in the pathogenesis of radiation-induced demyelination.
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Purpose:To evaluate the short-term effect of combination chemotherapy of oxaliplatin plus capecitabine on advanced cancer.Methods:32 patients of advanced gastric cancer were treated with oxaliplatin plus capecitabine for 76 weeks.Results:There were 6 CR, 16 PR, 8 NC, 2 PD, in our group and the overall response rate was 68.75% (22/32). The median alleviative time was 8 months, the median survival time was 12 months and the one-year survival rate was 55%. 30(93.75%) patients benefited from this method. The side effects were all tolerable which were alleviated by active therapy. There was no death and nobody stopped chemotherapy because of side effects.Conclusions:Combination chemotherapy of oxaliplatin plus capecitabine to treat advanced gastric cancers was certainly effective and tolerable to toxicities. This chemotherapy will be used as the first-line in more patients and is worthy of further study.[