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 explore the risk factors of acute renal injury (AKI) in exertional heat radiation disease (EHS) .Methods:In november 2019, the clinical data of 69 EHS patients admitted from July 2015 to September 2019 were reviewed. The general data, laboratory indexes, Glasgow score (GCS) at admission, 24-hour acute physiology and chronic health score Ⅱ (APACHE Ⅱ) , exposure time rate and physical labor intensity were collected. According to the occurrence of AKI, the patients were divided into AKI group and non-AKI group, 31 and 38 in each group. The differences of general data and laboratory indexes between the two groups were compared, and the t and Mann-Whitney U test were used to compare the two groups. The enumeration data are expressed by examples and constituent ratio (%) . Independent sample χ 2 test is used for inter-group comparison, and multiple test is used for multi-sample comparison. The correlation was analyzed by linear regression. Risk factors were analyzed by Logistic regression analysis. Results:At discharge, 31 of 69 EHS patients developed AKI. Compared with the non-AKI group, the heart rate, white blood cell count, lactic acid, D-dimer and myoglobin were higher; MAP, platelet count and PH were lower in the AKI group. The difference was statistically significant ( P<0.05) . APACHE Ⅱ score, core temperature, time to drop to 38.5 ℃, contact time rate, platelet count, pH, lactic acid, D-dimer and myoglobin were all correlated with creatinine ( r=0.57, 0.42, 0.80, 0.78, 0.57, 0.43, 0.51, 0.55, 0.79) . APACHE Ⅱ score, time to drop to 38.5C, Lac and MYO are the risk factors of AKI in EHS patients. Multivariate Logistic regression analysis showed that the time required to drop to 38.5C was an independent risk factor for the occurrence of AKI. Conclusion:AKI is a serious complication of EHS. EHS complicated with AKI, should be identified early and effective intervention measures should be taken.

Objective:To explore the risk factors of acute renal injury (AKI) in exertional heat radiation disease (EHS) .Methods:In november 2019, the clinical data of 69 EHS patients admitted from July 2015 to September 2019 were reviewed. The general data, laboratory indexes, Glasgow score (GCS) at admission, 24-hour acute physiology and chronic health score Ⅱ (APACHE Ⅱ) , exposure time rate and physical labor intensity were collected. According to the occurrence of AKI, the patients were divided into AKI group and non-AKI group, 31 and 38 in each group. The differences of general data and laboratory indexes between the two groups were compared, and the t and Mann-Whitney U test were used to compare the two groups. The enumeration data are expressed by examples and constituent ratio (%) . Independent sample χ 2 test is used for inter-group comparison, and multiple test is used for multi-sample comparison. The correlation was analyzed by linear regression. Risk factors were analyzed by Logistic regression analysis. Results:At discharge, 31 of 69 EHS patients developed AKI. Compared with the non-AKI group, the heart rate, white blood cell count, lactic acid, D-dimer and myoglobin were higher; MAP, platelet count and PH were lower in the AKI group. The difference was statistically significant ( P<0.05) . APACHE Ⅱ score, core temperature, time to drop to 38.5 ℃, contact time rate, platelet count, pH, lactic acid, D-dimer and myoglobin were all correlated with creatinine ( r=0.57, 0.42, 0.80, 0.78, 0.57, 0.43, 0.51, 0.55, 0.79) . APACHE Ⅱ score, time to drop to 38.5C, Lac and MYO are the risk factors of AKI in EHS patients. Multivariate Logistic regression analysis showed that the time required to drop to 38.5C was an independent risk factor for the occurrence of AKI. Conclusion:AKI is a serious complication of EHS. EHS complicated with AKI, should be identified early and effective intervention measures should be taken.

Objective: To evaluate the effects of office blood pressure(OBP)combined with ambulatory blood pressure monitoring(ABPM)on the diagnosis of hypertension. Methods: The residents aged 35-79 years without hypertension history,whose casual OBP were 120~159 mm Hg/80~99 mm Hg,were enrolled from 4 communities of Hangzhou and Zhuji from 2015 to 2018. They were performed OBP measurements on other two days in 4 weeks and ABPM in a week. There were 2 criteria of OBP as elevated OBP on the first day or in 3 different days,and 4 criteria of ABPM as elevated mean BP in 24 hours, daytime, nighttime and either of the above time. Receiver operating characteristic(ROC)curve was employed to evaluate the effects of different OBP criteria combined with ABPM criteria on the diagnosis of masked hypertension(MH)and white-coat hypertension(WCH). Results: Taking 3-day-OBP as a golden standard,the 1-day-OBP with 4 ABPM criteria had the areas under the ROC curve(AUC)of 0.79-0.81,sensitivity of 57.58%-62.77% and specificity of 100.00% in MH;had the AUC of 0.95-0.98,sensitivity of 100.00% and specificity of 88.96%-96.80% in WCH. The Kappa values were all less than 0.6,known as low consistency. Taking either time of ABPM as a golden standard,24 hours,daytime and nighttime ABPM criteria with OBP had the AUC of 0.90-0.92,sensitivity of 79.17%-83.90% and specificity of 100.00% in MH(all Kappa>0.6),when with 1-day-OBP,the Kappa values were all more than 0.8,known as high consistency;had the AUC of 0.95-1.00,sensitivity of 100.00% and specificity of 89.54%-99.37% in WCH,the Kappa values of daytime ABPM were all more than 0.6,known as high consistency. Conclusions If limited by options, 1-day-OBP could be used instead of 3-day-OBP for detection of WCH or exclusion of MH yet with less accuracy; 24 hours or daytime ABPM instead of either time of ABPM was reliable.

Objective:To evaluate the prognostic value of different critical care scoring systems in 28-day survival rate of patients with heat stroke.Methods:A retrospective analysis was conducted on the clinical data of 71 patients with heat stroke admitted to the department of emergency medicine of Beijing Luhe Hospital. Capital Medical University from July 2015 to September 2018. The general information and the worst values of vital signs and related pathophysiological indicators within 24 hours were collected and the sequential organ failure assessment (SOFA) , multiple organ dysfunction (MODS) , simplified acute physiological scoreⅡ (SAPS Ⅱ) and acute physiology and chronic health evaluationⅡ (APACHE Ⅱ) were calculated. The patients were divided into the survival group ( n=45) and the non-survival group ( n=26) according to 28-day prognosis, and the clinical data and scores of the two groups were compared.The ROC curve was drawn to analyze the evaluation value of each scoring system on the survival rate of patients at 28-day. Kaplan-Meier method was used to plot the survival curve of patients. Results:There were no significant differences in age, sex, vital signs and laboratory parameters between two groups ( P>0.05) . In non-survival patients, SOFA, SAPS Ⅱ, APACHE Ⅱ scores were significantly elevated in the survival group ( P<0.05) . ROC curve analysis showed that the area under ROC curve (AUC) of SOFA score for predicting 28-day survival rate was the highest, which was significantly higher than the APACHE Ⅱ, SAPS Ⅱ, MODS score. When the best cut-off value of SOFA score was 9.0, the sensitivity was 84.6%, and the specificity was 71.1%. Kaplan-Meier survival analysis showed that 28-day survival rate after hospital discharge in patients with SOFA score<9 ( n=27) was significantly higher than that in patients with SOFA score ≥9.0 (χ 2=1.0, P<0.01) . Conclusion:SOFA, APACHE Ⅱ, SAPS Ⅱ on admission have been proved to have good prognostic ability to predict 28-day prognosis in heat stroke patients. Among them, SOFA score system has more accurate prediction value.

Objective:To evaluate the prognostic value of different critical care scoring systems in 28-day survival rate of patients with heat stroke.Methods:A retrospective analysis was conducted on the clinical data of 71 patients with heat stroke admitted to the department of emergency medicine of Beijing Luhe Hospital. Capital Medical University from July 2015 to September 2018. The general information and the worst values of vital signs and related pathophysiological indicators within 24 hours were collected and the sequential organ failure assessment (SOFA) , multiple organ dysfunction (MODS) , simplified acute physiological scoreⅡ (SAPS Ⅱ) and acute physiology and chronic health evaluationⅡ (APACHE Ⅱ) were calculated. The patients were divided into the survival group ( n=45) and the non-survival group ( n=26) according to 28-day prognosis, and the clinical data and scores of the two groups were compared.The ROC curve was drawn to analyze the evaluation value of each scoring system on the survival rate of patients at 28-day. Kaplan-Meier method was used to plot the survival curve of patients. Results:There were no significant differences in age, sex, vital signs and laboratory parameters between two groups ( P>0.05) . In non-survival patients, SOFA, SAPS Ⅱ, APACHE Ⅱ scores were significantly elevated in the survival group ( P<0.05) . ROC curve analysis showed that the area under ROC curve (AUC) of SOFA score for predicting 28-day survival rate was the highest, which was significantly higher than the APACHE Ⅱ, SAPS Ⅱ, MODS score. When the best cut-off value of SOFA score was 9.0, the sensitivity was 84.6%, and the specificity was 71.1%. Kaplan-Meier survival analysis showed that 28-day survival rate after hospital discharge in patients with SOFA score<9 ( n=27) was significantly higher than that in patients with SOFA score ≥9.0 (χ 2=1.0, P<0.01) . Conclusion:SOFA, APACHE Ⅱ, SAPS Ⅱ on admission have been proved to have good prognostic ability to predict 28-day prognosis in heat stroke patients. Among them, SOFA score system has more accurate prediction value.

Objective: To investigate the prognostic value of arterial blood lactate for patients with cardiogenic shock receiving extracorporeal membrane oxygenation(ECMO). Methods: A retrospective analysis was conducted. Twenty-three patients diagnosed with cardiogenic shock receiving veno-arterial(V-A) ECMO admitted to department of Emergency Intensive Care Unit(EICU) of Beijing Luhe Hospital Affiliated to Capital Medical University from January 2017 to December 2018 were enrolled. Results: There were 10 cases in the survival group and 13 cases in the death group. Compared with survival group, APACHE-Ⅱ score was higher, CRRT applied higher percentage, PH and oxygenation index was worse in the death group(P<0.05). The lactate of the death group was significantly higher than that of the survival group at initial time at EICU, 1 h before ECMO and 0h before ECMO(P<0.05). During the ECMO operation, lactate levels in the death group at 8 h and 12 h were significantly higher than those in the survival group(P<0.05). There was no statistically significant difference in lactate clearance rate between the two groups before and after ECMO operation in each observation period(P>0.05). On the 2nd day of ECMO operation, CRRT usage time was shorter and daily liquid balance was more negative in the survival group(P<0.05). APACHE-Ⅱscore, initial lactate at EICU, lactate at ECMO 8 h and lactate at ECMO 12 h had predictive value for 30-day death of patients. The area under ROC curve(AUC) of initial lactate at EICU was 0.845, and 95% confidence interval(95%CI)=0.653-1.000. The AUC of ECMO 8 h lactate was 0.836, 95%CI: 0.634-1.000. The AUC of ECMO 12 h lactate was 0.873, 95%CI: 0.697-1.000. The AUC of APACHE-Ⅱscore was 0.891, 95%CI: 0.717-1.000. The sensitivity and specificity of prognosis prediction were 72.7% and 100% when lactate was more than 7.3 mmol/L at the time of admission into EICU as the optimal critical value. Conclusion Arterial blood lactate could be used as an important marker for evaluating the prognosis of cardiogenic shock patients on ECMO. The value of lactate clearance rate may be affected by combined CRRT.

OBJECTIVE: To investigate the levels of cortisol and inflammatory factors and their influencing factors in patients with occupational noise-induced hearing loss(ONID). METHODS: A total of 106 ONID patients were selected as the ONID group, and 50 healthy participants without noise exposure were selected as the control group by judge sampling method. The levels of salivary cortisol in the two groups were detected by enzyme-linked immunosorbent assay.The serum levels of cortisol, tumor necrosis factor alpha(TNF-α), interleukin-6(IL-6) and C-reactive protein(CRP) in the peripheral blood were detected by electrochemiluminescence assay. Tinnitus Handicap Inventory was used to evaluate the disability levels of tinnitus in ONID patients. RESULTS: The level of salivary cortisol in the morning and in the nighttime, and cortisol, TNF-α, IL-6 in the serum were higher in the ONID group compared with that in the control group(P<0.05). There was no significant difference in the serum level of CRP between these two groups(P>0.05). Spearman correlation analysis results showed that the level of cortisol in the saliva and in the serum was not correlated with TNF-α and IL-6(P>0.05). Analysis of multiple linear regression showed that the levels of serum cortisol and salivary cortisol in the morning in the ONID patients were positively correlated with noise exposure level(P<0.05). The level of TNF-α in the serum was positively correlated with tinnitus score(P<0.05). CONCLUSION: Hyperactivity of hypothalamus-pituitary-adrenal axis and inflammation activation may exist in patients with ONID. The cortisol can be used as a biomarker for the effect of noise-stress.

Objective To develop a humidification fluid dropping joint for the breathing machine to solve the problems in humidification fluid retension,pipeline leakage,pipeline fixation and etc.Methods A Infusion extension tube was involved in with 10 cm length left at the injector end.A hole was made at the side wall of the L-shaped joint of the breathing machine,whose internal diameter equaled to the external diameter of the extension tube.The extension tube was put into the joint through the hole,and the depth of imbedded tube was within 4 and 6 cm.Sealing and fixation at the connection between the tube and hole were executed with 502 glue and short tourniquet.Results The humidification fluid dropping joint could be connected with infusion apparatus of the pump or the infusion extension tube of the micro pump,which behaved well in eliminating accumulated humidification fluid,sputum suction,humidification and facilitating mechanical ventilation.Conclusion The joint developed gains advantages in easy manufacture,reducing complications and increasing the dependence on artificial airway,and thus is worthy promoting clinically.

[ Abstract] Objective To investigate the clinical efficacy of preoperative three-dimensional radiotherapy (3DRT) with or without concurrent chemotherapy for esophageal carcinoma.Methods We retrospectively analyzed 103 esophageal carcinoma patients who received preoperative 3DRT with or without concurrent chemotherapy from 2004 to 2014 in Cancer Hospital CAMS.The median radiation dose was 40 Gy, and the TP or PF regimen was adopted for concurrent chemotherapy if needed.The overall survival (OS) and disease-free survival ( DFS) were calculated by the Kaplan-Meier method, and the survival difference and univariate prognostic analyses were performed by the log-rank test.The Cox proportional hazards model was used for multivariate prognostic analysis.Results The number of patients followed at 3-years was 54.The 3-year OS and DFS rates were 61.1% and 54.9%, respectively, for all patients.There were no significant differences between the 3DRT and concurrent chemoradiotherapy (CCRT) groups as to OS (P=0.876) and DFS (P=0.521).The rates of complete, partial, and minimal pathologic responses of the primary tumor were 48.0%, 40.2%, and 11.8%, respectively.There were significant differences in OS and DFS between the complete, partial, and minimal pathologic response groups (P=0.037 and 0.003). No significant difference in pathologic response rate was found between the 3DRT and CCRT groups (P=0.953).The lymph node metastasis rate was 26.5%, and this rate for the complete, partial, and minimal pathologic response groups was 14%, 30%, and 67%, respectively, with a significant difference between the three groups (P=0.001).The OS and DFS were significantly higher in patients without lymph node metastasis than in those with lymph node metastasis (P=0.034 and 0.020).The surgery-related mortality was 7.8% in all patients.Compared with the 3DRT group, the CCRT group had significantly higher incidence rates of leukopenia (P=0.002), neutropenia (P=0.023), radiation esophagitis (P=0.008), and radiation esophagitis ( P=0.023).Pathologic response of the primary tumor and weight loss before treatment were independent prognostic factors for OS and DFS (P=0.030,0.024 and P=0.003,0.042). Conclusions Preoperative 3DRT alone or with concurrent chemotherapy can result in a relatively high complete pathologic response rate, hence increasing the survival rate.Further randomized clinical trials are needed to confirm whether preoperative CCRT is better than 3DRT in improving survival without increasing the incidence of adverse reactions.