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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.
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Humanos , Masculino , Antineoplásicos Hormonales/uso terapéutico , Pueblos del Este de Asia , Hormona Liberadora de Gonadotropina/agonistas , Goserelina/uso terapéutico , Antígeno Prostático Específico , Neoplasias de la Próstata/tratamiento farmacológico , TestosteronaRESUMEN
End-stage renal disease(ESRD) patients with malignant renal tumor has its unique clinicopathological characteristics, and there are currently few domestic related studies. A retrospective analysis was performed on the clinical data of 16 ESRD patients with malignant renal tumor in Jiangxi Provincial People's Hospital. Their ages ranged from 20 to 70 yrs (mean 47.6 yrs). Most of the patients were asymptomatic and all underwent radical nephrectomy or radical nephroureterectomy. Clear cell carcinoma occurred in 11 cases, and papillary renal cell carcinoma in 2 cases. The vast majority of 13 cases were low-stage, low-grade tumors. All 13 cases were followed up for an average of 43.7 months and no recurrence or metastasis was found. In addition, the patients of renal sarcomatoid carcinoma, renal pelvis carcinoma and renal sarcoma survived for 2 to 20 months with poor prognosis.
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Objective@#To investigate the epidemiological and clinical characteristics of 91 cases of dengue fever outbreak in Jiangxi Province in 2019, and to strengthen the management and prevention of dengue fever.@*Methods@#The clinical data, laboratory results and etiology tests of 91 patients with dengue fever from the Ninth Hospital of Nanchang, Zhangshu People′s Hospital, Fengcheng People′s Hospital and Nanchang County People′s Hospital from July 31, 2019 to September 27, 2019 were retrospectively collected. The t test was used for continuous variables and chi-square test was used for categorical variables.@*Results@#A total of 91 dengue fever patients were reviewed. The patients age ranged from 4 to 87 years old, and the majority were adult patients. Most patients were farmers and they all had mosquito-biting history. Local cases were the major source of this outbreak. The incubation time was (5.19±2.96) days. All patients had fever over 38 ℃. Thirty-eight (41.8%) patients developed rashes, mainly distributed on the limbs and trunk, and 15 patients (16.5%) developed myalgia and fatigue. The incidence of rashes in patients admitted in September was 15.9% (7/44), which was significantly lower than 68.1% (32/47) in July and August (χ2=25.262, P<0.01). The incidence of headache in patients admitted in September was 27.3%(12/44), which was significantly lower than 78.7% (37/47) in July and August (χ2 =24.206, P<0.01). Among the 91 patients, 64 (70.3%) patients had white blood cell counts less than 4×109/L, 14(15.4%) patients had platelet counts less than 50×109/L. The positive rate of dengue non-structural protein 1 (NS1) antigen was 100.0%(37/37), the positive rates of dengue antibody IgM and IgG were 50.0%(11/22) and 13.6%(3/22), respectively. Among the 113 serum samples tested for dengue virus RNA, 106 were identified with dengue virus type-1 and two were dengue virus type-2. In 22 patients who received tests within 7 days, the positive rate of NS1 antigen was 100.0% (22/22), the IgM and IgG positive rates were 50.0%(11/22) and 13.6% (3/22), respectively, and 19 patients were infected with dengue type-1. Among the IgM antibody positive cases, the onset days before sampling was (5.09±1.64) days, longer than that of IgM antibody negative cases ((2.82±1.83) days), with statistical significance (t=3.063, P=0.007). The onset time before sampling in dengue virus RNA-positive group was (3.53±1.87) days, which was shorter than that of RNA-negative group ((6.67±0.58) days), and the difference was statistically significant (t=2.839, P=0.013).@*Conclusions@#The dengue fever outbreak cases in Jiangxi Province in 2019 have typical clinical manifestations of dengue fever. Using the NS1 antigen test, IgM and IgG antibody tests and real-time fluorescent quantitative polymerase chain reaction for dengue virus genotyping during early onset of the disease can assistant clinicians in clinical management, controlling infectious source and stopping disease transmission.
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Objective To investigate the epidemiological and clinical characteristics of 91 cases of dengue fever outbreak in Jiangxi Province in 2019,and to strengthen the management and prevention of dengue fever.Methods The clinical data,laboratory results and etiology tests of 91 patients with dengue fever from the Ninth Hospital of Nanchang,Zhangshu People's Hospital,Fengcheng People' s Hospital and Nanchang County People's Hospital from July 31,2019 to September 27,2019 were retrospectively collected.The t test was used for continuous variables and chi-square test was used for categorical variables.Results A total of 91 dengue fever patients were reviewed.The patients age ranged from 4 to 87 years old,and the majority were adult patients.Most patients were farmers and they all had mosquito-biting history.Local cases were the major source of this outbreak.The incubation time was(5.19±2.96)days.All patients had fever over 38℃.Thirty-eight(41.8％)patients developed rashes,mainly distributed on the limbs and trunk,and 15 patients(16.5％)developed myalgia and fatigue.The incidence of rashes in patients admitted in September was 15.9％(7/44),which was significantly lower than 68.1％(32/47)in July and August(x2 = 25.262,P ＜0.01).The incidence of headache in patients admitted in September was 27.3％(12/44),which was significantly lower than 78.7％(37/47)in July and August(x2=24.206,P ＜ 0.01).Among the 91 patients,64(70.3％)patients had white blood cell counts less than 4×109/L,14(15.4％)patients had platelet counts less than 50×109/L.The positive rate of dengue non-structural protein 1(NS1)antigen was 100.0％(37/37),the positive rates of dengue antibody IgM and IgG were 50.0％(11/22)and 13.6％(3/22),respectively.Among the 113 serum samples tested for dengue virus RNA,106 were identified with dengue virus type-1 and two were dengue virus type-2.In 22 patients who received tests within 7 days,the positive rate of NS1 antigen was 100.0％(22/22),the IgM and IgG positive rates were 50.0％(11/22)and 13.6％(3/22),respectively,and 19 patients were infected with dengue type-1.Among the IgM antibody positive cases,the onset days before sampling was(5.09±1.64)days,longer than that of IgM antibody negative cases((2.82± 1.83)days),with statistical significance(t = 3.063,P = O.007).The onset time before sampling in dengue virus RNA-positive group was(3.53±1.87)days,which was shorter than that of RN A-negative group((6.67± 0.58)days),and the difference was statistically significant(t = 2.839,P = 0.013).Conclusions The dengue fever outbreak cases in Jiangxi Province in 2019 have typical clinical manifestations of dengue fever.Using the NS1 antigen test,IgM and IgG antibody tests and real-time fluorescent quantitative polymerase chain reaction for dengue virus genotyping during early onset of the disease can assistant clinicians in clinical management,controlling infectious source and stopping disease transmission.
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Objective To investigate the impact of paced QRS duration (pQRSd) on heart function in patients with right ventricular apical pacing. Methods Seventy-six patients with Ⅲ° atrioventricular block received pacemaker treatment were enrolled and randomized into group A (pQRSd 0.05). At 24 months after implanting, LAD、LVEDD、LVESD of group B increased significantly compared with those of group A [LAD,( 44.5 ± 6.2) mm vs (41.6 ± 5.1) mm, LVEDD, (52.7 ± 9.3) mm vs (48.2 ± 7.5) mm, LVESD, (37.5 ± 5.6) mm vs (33.8 ± 4.9)mm, each P 0.05)between two groups during 24-month follow-up. Conclusion The prolonged paced QRS duration has a detrimental effect on long-term cardiac function during RVA pacing in patients with Ⅲ°atrioventricular block.
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Objective To observe the effects of lung protective ventilation strategy (LPVS) on inflammatory mediators in bronchial alveolar lavage fluid (BALF) in pulmonary and extrapulmonary acute respiratory distress syndrome(ARDS).Methods All of 62 extrapulmonary ARDS(ARDSexp) cases and 60 pulmonary ARDS (ARDSp) cases were divided into observation group and control group by table of random digit.ARDSexp and ARDSp observation group were received LPVS treatment [tidal volume 6-8 ml/kg,positive end expiratory pressure (PEEP) 5-15 cm H2O (1 cm H2O =0.098 kPa)],and ARDSexp and ARDSp control group were received the routine ventilation strategy (tidal volume 10-12 ml/kg,PEEP 4-8 cm H2O).All groups were treated with the same conventional therapy of ARDS,same model and parameter of mechanical ventilation.The level of tumor necrosis factor (TNF)-α,interleukin (IL)-6,IL-8 in BALF were tested by enzyme linked immunosorbent assay on the 1st,4th,7th day in each group.The oxygenation index was tested at 8 o'clock each morning.Results There were 4 ARDSexp cases and 6 ARDSp cases who were expelled,because of death within 7 days.ARDSexp observation group was in 28 cases,ARDSexp control group was in 30 cases,ARDSp observation group was in 28 cases,ARDSp control group was in 26 cases.The oxygenation index had no significant difference between ARDSexp and ARDSp observation group and corresponding ARDSexp and ARDSp control group on the 1st and 2nd day (P ＞ 0.05).But the oxygenation index in ARDSexp and ARDSp observation group were significantly higher than that in ARDSexp and ARDSp control group from 3rd to 7th day (P ＜ 0.05).The oxygenation index in ARDSexp observation group was significantly higher than that in ARDSp observation group except 1st day (P ＜0.05).The oxygenation index in ARDSexp and ARDSp observation group were significantly better with the time passing (P ＜ 0.05).The BALF levels of TNF-α,IL-6 and IL-8 in ARDSexp and ARDSp observation group were significantly lower than those in corresponding ARDSexp and ARDSp control group on the 4th and 7th day (P＜ 0.05).The BALF levels of TNF-α,IL-6 and IL-8 in ARDSexp observation group and ARDSexp control group were significantly lower than those in corresponding ARDSp observation group and ARDSp control group (P＜ 0.05).The BALF levels of TNF-α,IL-6 and IL-8 in ARDSexp and ARDSp observation group were decreased significantly with the time passing (P ＜0.05).Conclusion It is more reasonable to decrease the BALF levels of inflammatory mediators,increase oxygenation index for ARDS patients to with LPVS treatment,then for ARDSexp patients obviously.
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Objective To study the application of 3％ hypertonic saline (HS) in patients with severe craniocerebral injury after operation.Methods Sixty-eight cases with severe craniocerebral injury after operation were divided by random digits table method into HS group and control group with 34 cases each.The patients in control group were treated with 125 ml 20％ mannitol every 6 hours or 8 hours.The patients in HS group were given conventional mannitol and added with 130 ml 3％ HS every 12 hours or 8 hours through fast intravenous drip altemated with mannitol.The levels of intracranial pressure (ICP),mean arterial pressure (MAP),central venous pressure (CVP) were recorded within 6 hours,12 hours,24 hours of the 1st day,24 hours of the 2nd day,24 hours of the 3rd day,24 hours of the 5th day.The Na+ level of blood serum and the plasma osmotic pressure were recorded and calculated within 12 hours,24 hours of the 1st day,24 hours of the 2nd day,24 hours of the 3rd day,24 hours of the 5th day.The Glasgow coma scale( CCS) score was accounted within 24 hours of the 1 st day,24 hours of the 3rd day,24 hours of the 5th day.Results Compared with control group,the level of ICP in HS group decreased at every time point (P ＜ 0.05).The tendency of ICP in two groups was not significant on the 1st and 2rid day (P ＞ 0.05 ),but the level of ICP within 24 hours of the 3rd and 5th day obviously increased compared with those of the 1st and 2nd day (P＜0.05).The levels of MAP and CVP in HS group were significantly higher than those in control group within 6 hours,12 hours and 24 hours of the 1 st day and 24 hours of the 2nd day [ ( 87.98 ± 5.03 ),(88.56 ± 5.36),(87.04 ±6.90),(90.03 ±5.19) mm Hg (1 mm Hg =0.133 kPa) vs.(77.98 ±5.09),(79.98 ±6.09),(80.98 ± 5.27),(81.98 ± 4.32) mm Hg and (9.23 ± 1.24),(9.67 ± 1.35),( 10.21 ± 1.38 ),( 10.56 ± 1.96)mm Hg vs.(7.15 ± 2.01 ),(8.32 ± 1.53),(8.67 ± 1.89),(9.22 ± 2.03) mm Hg] (P ＜ 0.05),but the values within 24 hours of the 3rd and 5th day between two groups had no significant differences (P＞ 0.05 ).The Na+ level of blood serum and the plasma osmotic pressure in HS group at every time point was obviously higher than that in control group (P＜ 0.05).The GCS scores within 24 hours of the 1st,3rd and 5th day in HS group were (4.21 ± 2.31 ),(5.44 ± 2.46 ),(7.23 ± 1.64 ) scores,respectively,while the scores in control group were (4.14 ± 2.10),(5.15 ± 2.31 ),(7.31 ± 2.12) scores,respectively ;the score within 24 hours of the 5th day in two groups was obviously higher than that of the 1st day respectively (P＜ 0.05 ),but the scores between two groups had no statistical significance (P＞ 0.05 ).Conclusions Adding 3％ HS is more effective to decrease ICP,improve the brain perfusion and reduce the adverse reactions.3％ HS can be used as the first-line therapy for patients with severe craniocerebral injury after operation.