OBJECTIVE:To establish a method for simultaneous determination of 6 residual organic solvents in aprepitant raw material as methanol,ethanol,acetone,isopropyl alcohol,methyl tert-butyl ether and tetrahydrofuran.METHODS:Headspace capillary gas chromatography was adopted.The determination was performed on DB-624 capillary column using temperature programming.The temperature of injector port was 180 ℃,and flame ionization detector was used with temperature of 260 ℃.Nitrogen was used as carrier gas with flow rate 3.0 mL/min.The spilt ratio was 5 ∶ 1,and head-space injection volume was 1.0 mL.The head-space equilibrium temperature was set at 80 ℃,and equilibrium time was 40 min.RESULTS:The linear ranges of methanol,ethanol,acetone,isopropyl alcohol,methyl tert-butyl ether,tetrahydrofuran were 6.052-605.232 μ g/mL (r=0.999 9),9.987-998.718 μg/mL(r=0.999 9),9.998-999.768 μg/mL(r=0.999 8),9.986-998.634 μg/mL(r=0.999 9),9.991-999.090 μg/mL (r=0.999 7),1.461-146.133 μg/mL(r=0.999 5),respectively.The limits of quantitation were 1.782 1,2.079 0,0.749 8,1.777 8,0.223 1,0.607 0 μg/mL;the limits of detection were 0.594 0,0.693 0,0.249 9,0.592 6,0.074 4,0.202 3 μg/mL,respectively.RSD of precision test was lower than 2.0％.Only acetone and isopropyl alcohol were detected in stability test and reproducibility tests,RSD＜2.0％.Their recoveries were 99.34-100.75％ (RSD=0.52％,n=9),98.20％-100.24％ (RSD=0.69％,n=9),98.07％-100.07％ (RSD=0.84％,n=9),99.86％-101.32％ (RSD=0.58％,n=9),97.87％-104.02％ (RSD=2.13％,n=9),98.26 ％-100.58 ％ (RSD =0.75 ％,n =9),respectively.CONCLUSIONS:The established method is simple,accurate and reproducible,and can be used for simultaneous determination of 6 residual organic solvents in aprepitant raw material.

Objective To analyze the clinical characteristics and prognostic risk factors of esophageal signet ring cell carcinoma(SRCC)patients and construct a column chart prediction model.Methods The training queue consists of 226 patients diagnosed with esophageal SRCC from 2010 to 2017 in the SEER database,and the validation queue consists of 21 patients diagnosed with esophageal SRCC in our hospital from January 2010 to January 2019.Use Cox proportional risk regression model for single factor and multivariate analysis.Use the"rms"software package of R software to generate column charts.Results Univariate analysis showed that age,gender,tumor location,local invasion,lymph node metastasis,distant metastasis,surgical treatment,chemotherapy,and radiotherapy were risk factors affecting the prognosis of SRCC patients(P＜0.05);In multivariate cox regression analysis,the results showed that tumor location,local invasion,lymph node metastasis,distant metastasis,surgical treatment,chemotherapy,and radiotherapy were independent risk factors affecting the prognosis of SRCC patients(P＜0.05);A nomogram prediction model was successfully constructed using multivariate cox regression analysis,with a certain degree of predictive accuracy.Conclusion The nomogram prediction model was successfully constructed based on the risk factors affecting the prognosis of esophageal signet ring cell adenocarcinoma patients in the SEER database,which can provide more accurate predictions for the prognosis of esophageal SRCC patients.

Objective:To explore and think about the project management model of investigator-initiated trial (IIT), and the project management of industry sponsored trial (IST), we should standardize the management process of clinical research projects initiated by researchers, improve the management system of clinical research in medical institutions, improve the quality management level of clinical research, and protect the rights and interests of research participants.Methods:By taking the clinical research management of a medical and health institution in Hainan province as an example, one of the first pilot areas for the standardized management of clinical research by the National Health Commission, the difficulties in the management of clinical research initiated by researchers were sorted out, to analyze and standardize the management of clinical research project initiated by researchers.Results:Discussion Project management was the primary link and basic guarantee of standardized management of clinical research, and scientific and feasible project management was a powerful hand to carry out deep and high-quality IIT.Conclusions:It can be manifested in a Hainan provincial public medical institution that a feasible project management was the basement in carrying out the profound and high quality IIT. It is advicable to make full use of policy advantages and clinical resources to produce high-quality research results as well as build a high-level research hospital.

Objective:To compare the perioperative complications and prognosis of intracorporeal and extracorporea lileal conduit urinary diversion(ICUD or ECUD)following robot-assisted radical cystectomy(RARC).Methods:The data of 95 patients who underwent RARC treatment in Nanjing Drum Tower Hospital from March 2016 to June 2019 were retrospectively analyzed. Among them, 37 underwent ICUD and 58 underwent ECUD. In the ICUD group, there were 32 males and 5 females, aged(68.0±7.8) years, body mass index (BMI) of (24.1±3.4) kg/m 2, American Society of Anesthesiologists(ASA)score of 1-2 in 4 cases(10.8%), ASA score of 3-5 in 33 cases(89.2%), preoperative hemoglobin of(126.5±14.2)g/L, albumin of(39.0±2.2)g/L, and C-reactive protein of 4.0(2.0-8.5) mg/L. In the ECUD group, there were 53 males and 5 females, aged(67.5±9.0)years, BMI of(24.2±3.6)kg/m 2, ASA score of 1-2 in 16 cases(27.6%), ASA score of 3-5 in 42 cases (72.4%) , preoperative hemoglobin of(129.0±12.4)g/L, albumin (38.2±3.1) g/L, and C-reactive protein of 4.9 (3.1-14.4) mg/L. There was no significant difference in preoperative data between the two groups ( P>0.05). The two groups underwent RARC and pelvic lymph node dissection similarly. The ICUD group underwent a total intracorporeal ileal conduit and the ECUD group underwent extracorporeal ileal conduit with direct vision through a median incision in the lower abdomen.There were 32 cases (86.5%) and 46 cases (79.3%) undergoing expanded pelvic lymph node dissection in the ICUD group and the ECUD group respectively, and the difference was not statistically significant ( P=0.374). The complications were graded according to the Clavien-Dindo grading system. The perioperative complications and prognosis of the two groups were compared. Results:The operation time of the ICUD group and the ECUD group were (430±63) min vs. (410±69) min, respectively ( P=0.163). The estimated blood loss were (435±233) ml vs. (388±277) ml, respectively ( P=0.182). Intraoperative blood transfusion were 10 cases (27.0%) and 12 cases (20.7%)( P=0.475). None of the above differences were statistically significant. Postoperative albumin of the ICUD group and the ECUD group were (31.5±2.4) g/L vs. (31.0±2.8) g/L ( P=0.387), postoperative C-reactive protein were 30.9 (10.4-52.1) mg/L vs.29.5 (14.4-58.5) mg/L ( P=0.655) and postoperative hemoglobin were (110.0±13.8) g/L vs. (113.7±13.4) g/L ( P=0.187). The postoperative feeding recovery were 4(3-5) d vs. 4(3-5) d ( P=0.752) and the postoperative hospital stay were 13(10-19) d vs. 13(11-18) d ( P=1.000). There was no statistically significant difference in perioperative data. The postoperative pathological examination results of ICUD group and ECUD group showed that there were 17 cases (45.9%) vs.19 cases (32.8%) in T a/T 1/Tis stage, 12 cases (32.4%) vs. 18 cases (31.0%) in T 2 stage, 5 cases (13.5%) vs. 19 cases (32.8%) in T 3 stage, 3 cases (8.1%) vs. 2 cases (3.4%) in T 4 stage, respectively and the difference was not statistically significant( P=0.166). The number of lymph nodes removed were (18.2±6.7) vs.(16.5±7.9)( P=0.178) and the number of patients with positive lymph nodes were 6(16.2%) vs.11(19.0%), respectively( P=0.733). None of the patients had positive margins. There was no statistically significant difference in pathological examination overall. There were 14 cases (37.8%) in the ICUD group and 21 cases (36.2%) in the ECUD group experiencing complications within 30 days after operation and the difference was not statistically significant( P=0.872). The complications within 90 days after operation were 14 cases (37.8%) vs. 24 cases (41.4%) respectively and the difference was not statistically significant( P=0.731). Clavien-Dindo grade Ⅲ-Ⅴ complications in the two groups were 1 case (2.7%) vs.1 case (1.7%) respectively, with no significant difference ( P=0.849). One patient in the ICUD group developed an intestinal anastomotic leakage and underwent reoperation for repairing and 1 patient in the ECUD group developed mechanical intestinal obstruction and underwent reoperation. The rate of readmission within 90 days after operation of the ICUD group was lower than that of the ECUD group, but the difference was not statistically significant [3 cases (8.1%) vs. 11 cases (19.0%), P=0.090]. Postoperative follow-up was 13-53 months and the median follow-up of ICUD group and ECUD group were 19 months and 31 months respectively. There was no significant difference in the survival curve between the two groups( P=0.746). The 1-year survival rate was 91.9% in the ICUD group and 91.4% in the ECUD group. Routine re-examination of urinary system CT or B-ultrasound was performed 3 months, 6 months and 1 year after surgery. The incidence of ureteral dilatation/hydronephrosis in the ICUD group was lower than that of the ECUD group, with 4.1%(3 sides) vs. 14.7%(17 sides)( P=0.020). Conclusion:Compared with RARC+ ECUD, RARC+ ICUD does not increase the incidence of complications within 90 days after surgery and may reduce the risk of upper urinary tract dilatation.

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