1.A comparative study of statistical protocols for external quality assessment of semen
Xiyan WU ; Xinhua PENG ; Weina LI ; Jingliang HE ; Huilan WU ; Wenbing ZHU ; Jinchun LU
Chinese Journal of Clinical Laboratory Science 2023;41(10):778-781
Objective To compare the effects of different statistical protocols on the results of external quality assessment(EQA)of se-men,and select appropriate statistical protocols for the promotion of EQA of semen.Methods Taking sperm concentration as an ex-ample,the semen EQA data of 20 laboratories in Hunan Province in 2022 were selected,and the advantages and disadvantages of the traditional statistical scheme(TSS),robust statistical scheme(RSS)and traditional statistical scheme after eliminating the"outliers"(TSEOS)combined with robust statistical technology were analyzed and compared.Results The"outliers"could not be excluded from the sperm concentration data of the four groups in the TSS,which led to the difference between TSS and RSS or TSEOS.The num-ber of qualified laboratories for TSS and RSS were 19 vs 16,19 vs 16,19 vs 19,and 19 vs 19,respectively.Conclusion The results of RSS are similar to those of TSEOS.Compared with TSS,RSS do not need to remove outlier data steps,and are more suitable for se-men EQA data analysis with small data volume.
2.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
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
3.Research advances in autophagy-related signal molecules in nonalcoholic fatty liver disease
Jingxia HE ; Xiuqin AN ; Jinchun LIU
Journal of Clinical Hepatology 2021;37(9):2220-2224
Nonalcoholic fatty liver disease (NAFLD) has become one of the main causes of chronic liver diseases worldwide and is closely associated with metabolic syndrome. In-depth studies on the pathogenesis of NAFLD in recent years have shown that autophagy is a highly conservative process in eukaryotes and plays an important role in the progression of NAFLD, and therefore, it is expected to become a new target for the treatment of NAFLD. This article reviews the research advances in autophagy-related signal molecules in NAFLD, in order to provide new ideas for the treatment of NAFLD.
4.Application of holographic image navigation in urological laparoscopic and robotic surgery
Gang ZHU ; Jinchun XING ; Guobin WENG ; Zhiquan HU ; Ningchen LI ; He ZHU ; Pingsheng GAO ; Zhihua WANG ; Weizhi ZHU ; Kai ZHANG ; Hongbo LI ; Zhun WU ; Rui ZHU ; Xifeng WEI ; Yanan WANG ; Qun XIE ; Bing FU ; Xinghuan WANG ; Lin QI ; Xin YAO ; Tiejun PAN ; Delin WANG ; Nan LIU ; Jianguang QIU ; Jianggen YANG ; Bao ZHANG ; Zhuowei LIU ; Hui HAN ; Gang LI ; Bin ZHANG ; Manli NA ; Jingjing LU ; Lei WANG ; Zichen ZHAO ; Yanqun NA
Chinese Journal of Urology 2020;41(2):131-137
Objective To evaluate the clinical value of holographic image navigation in urological laparoscopic and robotic surgery.Methods The data of patients were reviewed retrospectively for whom accepted holographic image navigation laparoscopic and robotic surgery from Jan.2019 to Dec.2019 in Beijing United Family Hospital and other 18 medical centers,including 78 cases of renal tumor,2 cases of bladder cancer,2 cases of adrenal gland tumor,1 cases of renal cyst,1 case of prostate cancer,1 case of sweat gland carcinoma with lymph node metastasis,1 case of pelvic metastasis after radical cystectomy.All the patients underwent operations.In the laparoscopic surgery group,there were 27 cases of partial nephrectomy,1 case of radical prostatectomy,2 cases of radical cystectomy and 2 cases of adrenalectomy.In the da Vinci robotic surgery group of 54 cases,there were 51 cases of partial nephrectomy,1 case of retroperitoneal lymph node dissection,1 case of retroperitoneal bilateral renal cyst deroofing and 1 case of resection of pelvic metastasis.There were 41 partial nephrectomy patients with available clinical data for statistic,with a median age of 53.5 years (range 24-76),including 26 males and 15 females.The median R.E.N.A.L score was 7.8 (range 4-11).Before the operation,the engineers established the holographic image based on the contrast CT images and reports.The surgeon applied the holographic image for preoperative planning.During the operation,the navigation was achieved by real time fusing holographic images with the laparoscopic surgery images in the screen.Results All the procedures had been complete uneventfully.The holographic images helped surgeon in understanding the visual three-dimension structure and relation of vessels supplying tumor or resection tissue,lymph nodes and nerves.By manipulating the holographic images extracorporeally,the fused image guide surgeons about location vessel,lymph node and other important structure and then facilitate the delicate dissection.For the 41 cases with available clinical data including 23 cases of robotic-assisted partial nephrectomy and 18 cases of laparoscopic nephrectomy,the median operation time was 140 (range 50-225) min,the median warm ischemia time was 23 (range 14-60) min,the median blood loss was 80(range 5-1 200) ml.In the robotic surgery group,the median operation time was 140 (range 50-215)min,the median warm i schemia time was 21 (range 17-40)min,the median blood loss was 150(range 30-1 200)ml.In the laparoscopic surgery group,the median operation time was 160(range 80-225)min,the median warm ischemia time was 25 (range 14-60)min,the median blood loss was 50 (range 5-1 200) ml.All the patients had no adjacent organ injury during operation.There were 2 cases with Clavien Ⅱ complications.One required transfusion and the other one suffered hematoma post-operation.However,the tumors were located in the renal hilus for these 2 cases and the R.E.N.A.L scores were both 11.Conclusions Holographic image navigation can help location and recognize important anatomic structures during the surgical procedures..This technique will reduce the tissue injury,decrease the complications and improve the success rate of surgery.
5.Short-term safety assessment of raltitrexed intraperitoneal perfusion in patients with rectal cancer
He LIU ; Hong ZHANG ; Jinchun CONG ; Mingming CUI ; Dingsheng LIU ; Chunsheng CHEN
Journal of International Oncology 2018;45(10):593-598
Objective To investigate the short-term safety of raltitrexed intraperitoneal perfusion in patients with rectal cancer undergoing laparoscopic Dixon surgery.Methods Totally 175 patients with rectal cancer at the Department of Colorectal Oncological Surgery,Shengjing Hospital of China Medical University were analyzed retrospectively from June 2016 to December 2017.All the patients were divided into raltitrexed intraperitoneal perfusion group (n =89) and saline intraperitoneal peffusion group (n =86) according to whether given raltitrexed intraperitoneal perfusion or not.The hematological indexes of the two groups before operation and 3 days after operation were recorded.The postoperative exhaust time and postoperative drainage volume within 24 hours were calculated.The postoperative complications including anastomotic leakage,peritoneal irritation sign,incision infection and pulmonary infection were evaluated.Results The surgery was performed successfully in all patients.There were no significant differences in the sex (x2 =0.000,P =0.990),depth of tumor invasion (x2 =0.003,P =0.956),degree of lymph node metastasis (Z =-0.590,P =0.556),TNM stage (Z =0.081,P =0.936) or pathological type (Z =1.092,P =0.896) between the two groups.There were no significant differences in postoperative exhaust time [(75.49 ± 3.97) h vs.(74.28 ±3.46) h,t =0.479,P =0.523],postoperative drainage volume within 24 hours [(201.1 ±54.1) ml vs.(242.8±25.7) ml,t=0.338,P=0.656],anastomotic leakage (1.1% vs.2.3%,x2 =0.351,P=0.554),peritoneal irritation sign (1.1% vs.2.3%,x2 =0.351,P =0.554),incision infection (2.2% vs.3.5%,x2 =0.243,P =0.622) and pulmonary infection (2.2% vs.2.3%,x2 =0.001,P =0.972) between the two groups.Additionally,there were no significant differences in the counts of erythrocytes [(3.56 ±0.27) × 1012/L vs.(3.63 ±0.26) × 1012/L,t =0.716,P =0.152],leukocytes [(7.63 ±0.20) x 109/L vs.(8.24 ±0.26) × 109/L,t =0.176,P =0.872],blood platelets [(170.13 ±20.12) × 109/L vs.(180.18 ±21.03) × 109/L,t =0.103,P =0.975],glutamic-pyruvic transaminase [(13.25 ± 2.31) U/L vs.(13.28 ± 1.46) U/L,t =0.321,P =0.713],glutamic-oxalacetic transaminase [(16.51 ± 1.28) U/L vs.(16.23 ±2.03) U/L,t=0.131,P=0.894] and creatinine [(77.36 ±6.49) μmol/L vs.(78.39 ±6.64)μmol/L,t =0.499,P =0.519] 3 days after operation between the two groups.Conclusion Raltitrexed intraperitoneal perfusion in Dixon surgery exhibits high safety,and no significant effect on postoperative recovery.It is easy to operate and has good feasibility,which is worthy to be used in clinic.
6.Application Investigation and Analysis of Fibrinogen in Our Hospital
Xianxi GUO ; Wen HE ; Gang LIU ; Hua LI ; Jinchun SONG ; Jian YANG
China Pharmacist 2017;20(11):2040-2042
Objective:To investigate the clinical application of fibrinogen (FIB) in a certain hospital to enhance the rational use in clinics.Methods:A retrospective investigation was adopted to analyze the clinical application of FIB in a certain hospital in 2016. Results:Totally 489 inpatients were treated with FIB in 2016,and among them,243 cases were surgery patients and another 246 ones were non-surgery patients. The main involved departments were cardiovascular surgery,cardiovascular medicine,emergency,intensive medicine,gynaecology and obstetrics, gastroenterology and neurosurgery. The rationality of indication was 80.0% (391/489), and the non-indication use mainly existed in cardiovascular surgery and cardiovascular medicine departments. Among the 391 cases with in-dication,3 cases were with improper compatibility,17 cases with low dosage, and the irrationality of usage and dosage was 17.9% (20/391). Conclusion:The clinical application of FIB is basically rational in the hospital,while non-indication use still exists during the perioperative period in cardiovascular and cerebrovascular surgery,and nonstandard usage and dosage appear in clinics from time to time. The prescription comment on blood products such as FIB should be enhanced in order to improve the rational use in clinics.
7.Comparison of the value of LDL-C and non-HDL-C in differential diagnosis of familial hypertriglyceridemia and familial combined hyperlipidemia
Xiaoyan FU ; Huiya JIN ; Jinchun HE ; Li YAN ; Na SU ; Haitao YU ; Jing YANG
Journal of Xi'an Jiaotong University(Medical Sciences) 2017;38(3):427-430,436
Objective To evaluate the value of low-density lipoprotein-cholesterol (LDL-C) and non-high-density lipoprotein-cholesterol (non-HDL-C) in differential diagnosis of familial hypertriglyceridemia (FHTG) and familial combined hyperlipidemia (FCHL).Methods We recruited 9 FHTG pedigrees (94 subjects) and 24 FCHL pedigrees (94 subjects) and then divided them into affected groups and non-affected groups according to lipid abnormality.Another 10 normal control pedigrees (57 subjects) served as controls.We compared the routine lipid levels such as triglyceride (TAG),total cholesterol (TC),HDL-C and LDL-C and non-HDL-C between the groups.After stratification based on TAG level,we observed the relationship between LDL-C and non-HDL-C.Last we confirmed and analyzed the cut-off value of differential diagnosis between FHTG and FCHL with receiver operating characteristic (ROC) curve.Results The levels of TAG,TC,and non-HDL-C were significantly higher in the affected group of FHTG than in the non-affected group of FHTG and the normal group (P<0.01 or P<0.05).The levels of TAG,TC,HDL-C,LDL-C and non-tHDL-C wcrc significantly higher in the affected group of FCHL than in the non-affected group of FCHL and the normal group (P<0.01 or P<0.05).The levels of TAG were significantly higher (P<0.01) while TC,HDL-C,LDL-C and non-HDL-C levels were significantly lower (P< 0.01 or P<0.05) in the affected group of FHTG than in the affected group of FCHL.The association between LDL-C and non-HDL-C was positive both in FHTG and FCHL,but the relationship became weaker as TAG level increased.The cut-off value of LDL-C and non-HDL-C was 3.575 mmol/L and 4.525 mmol/L,respectively.Conclusion In addition to the routinely used lipid indexes,non-HDL-C may be a new index for differential diagnosis of FHTG and FCHL,and may be superior to LDL-C in this regard.
8.Determination of Entrapment Efficiency of Buthionine Sulfoximine Nanoparticles in Different Entrapping Systems by HPLC
Xiaoqing YANG ; Cong WU ; Xiaoyan HE ; Yan PENG ; Lingli ZHANG ; Jinchun SONG
China Pharmacist 2016;19(7):1399-1402
Objective:To establish an HPLC method to determine the entrapment efficiency of buthionine sulfoximine (BSO) nan-oparticles in different entrapping systems .Methods:Free BSO was separated from the loaded nanoparticles by high speed centrifugation in two entrapping systems and the entrapment efficiency of buthionine sulfoximine nanoparticles was determined by HPLC .A WondaSil C18 column (250 mm ×4.6 mm, 5 μm) was used and the mobile phase was methanol-water (20 ∶80).The flow rate was 0.4 ml· min-1 and the column temperature was 30℃.The detection wavelength was set at 210 nm and the volume of injection was 20 μl.Re-sults:BSO had a good linear relationship within the range of 2.0-320.0μg· ml-1(r=0.999 7).The average recovery was 101.05%and RSD was 0.74%(n=9).The average entrapment efficiency of HP/CaCO3/CaHPO4/BSO nanoparticles and HP/PS/CaCO3/BSO hydrid nanovesicles was 25.63% and 58.62%, respectively.Conclusion:The method has good repeatability and high accuracy and sensitivity, which is applicable to determine the entrapment efficiency of BSO nanoparticles .HP/PS/CaCO3/BSO hydrid nanovesicles entrapped system is superior to HP/CaCO3/CaHPO4/BSO nanoparticles entrapped system .
9.The relationship of tumor marker and CD4+T cells before and after radiotherapy on patients
Jiang ZHU ; Jinxiang HE ; Jinchun HE
International Journal of Laboratory Medicine 2016;37(20):2828-2830
Objective The study is aimed to research into the effect of CD4+ T cells on patients with severe advanced breast cancer under radiotherapy that cannot be treated with surgery ,by observing the variation of CEA ,AFP ,CA125 and CA15‐3 before and after the radiotherapy applied .Methods We identified the CEA ,AFP ,CA125 and CA15‐3 densities in blood serum for a group of 38 patients with advanced breast cancer and a group of 30 normal people with chemiluminescence immune assay ,and we deter‐mined the CD3+ ,CD4+ ,CD8+ T percentage in peripheral blood and the ratio of CD4+ /CD8+ with flow cytometry .Results The group with normal CD4+ T percentage went through a decreased in CEA ,AFP ,CA125 ,CA15‐3 densities after the radiotherapy ,and the variation was significant(P<0 .05) .The group of people with abnormal CD4+ T percentage go through CEA ,CA15‐3 densities decrease after the radiotherapy ,and the variation was statistically significant(P< 0 .05) .Conclusion For those with advanced breast cancer and cannot be treated with surgery ,the influence of radiotherapy on CEA ,AFP ,CA125 ,CA15‐3 densities is significant in the group of patients with CD4+ T percentage ,adn has better therapeutic effect .
10.Establishment of a ICR mouse model of systemic C. albicans infection induced by oral inoculation
Yinzhu LUO ; Jinchun PAN ; Lifang HE ; Fangui MIN ; Qiuying YE ; Rui CHEN ; Yue WU ; Ren HUANG ; Yu ZHANG
Acta Laboratorium Animalis Scientia Sinica 2016;24(6):591-595
Objective To establish a mouse model of systemic C. albicans infection by oral inoculation of the pathogen and observe the proliferation and distribution of C. albicans in vivo tissues. Methods Male ICR mice(n=46) were used as the experiment group(n=40) and blank group (n=6). Cotton swabs with C. albicans were used to infect the mice (7 × 106 CFU/mL), and the blank group with saline. The mice of the experiment group were randomly divided into two groups:model group A for clinical assessment (n=20) and model group B for tissue fungal burden detection (n=20). Clinical score, survival and autopsy were carried out among the model group A. Five mice were randomly killed from the model group B at 3 d, 5 d and7 d after infection, respectively ( blank group killed 2 mice each time) . Microbial load tablet method was used to detect the tissue fungal burdens in different tissues, meanwhile samples of tongue, esophagus, stomach, liver, kidney, lung of infected mice were taken for pathological examination. Results White spot appeared on the surface of tongue since 3 d postinfection and increased with time and finally caused death. The mortality reached over 50% at 5 d. C. albicans was not only detected from the tongue (87?5%), stomach (87?5%), liver (54?5%), kidney (50?5%), lung (20%) and heart (4%), but also was microscopically seen mycelia proliferation in the tongue, stomach, liver, and kidney , yet not seen in the control group, showing that C. albicans caused disseminated systemic infection through mucosal infection in mice. Conclusions C. albicans can induce opportunistic systemic infection by breakthrough the mucosal immune barrier, so as to increase the infection to death.

Result Analysis
Print
Save
E-mail