1.Germicidal Efficacy of Phthalaldehyde Disinfectant: An Experimental Study
Chunmei LI ; Xiaozhu ZHONG ; Jincheng YANG
Chinese Journal of Nosocomiology 2006;0(07):-
OBJECTIVE To evaluate the germicidal efficacy of phthalaldehyde disinfectant.METHODS Suspension quantitative bactericidal test was used to observe its bactericidal efficacy and stability.RESULTS The temperature was 20-21℃.The results showed that the average killing rates of Escherichia coli,Staphylococcus aureus and Candida albicans exposed to the solution containing 5 664mg/L phthalaldehyde for 1 min were 99.99%,and the(average) killing rates of spores of Bacillus subtilis var.niger exposed to the solution containing 5 664mg/L(phthalaldehyde) for 60 min and 90 min was 99.94% and 100%,respectively.When its stock solution was stored at 56℃ under airtight condition for 2 weeks,the content of phthalaldehyde decreased by 3.27%.CONCLUSIONS The phthalaldehyde disinfectant is a good and stable bactericide.
2.The effect of Glutamine on the shape of residual intestine and colon in rats with short bowel syndrome
Hanrong LIU ; Tianfang HUA ; Fuquan ZHONG ; Jincheng KONG
Parenteral & Enteral Nutrition 2001;8(1):25-27
Objectives:To investigate the effect of glutamine on the shape of residual intestine and colon in rats with short bowel syndrome. Methods:23 male Sprague-Dawley rats,underwent a 80% small bowel resection,were randomly divided into three groups:food group(n=8) rats,fed rat chow and water libitum after operation;TPN group(n=8),infused with Gln-supplied TPN;and normal control group.On seventh day after operation,rats were weighted and remaining jejunum、remaining ileum and colon were harvested for histological observation(light microscopy and electron microscopy). Results:There was significant difference in rat average weight between food group and Gln group after operation.Jejunal mucosal villus height(VH) and mucosal thickness(MT) and ileal mucosal VH in food group were significantly increased than those in control group.Jejunal mucosal VH and MT in control group were significantly higher than in TPN group.Ileal mucosal crypt depth(CD) and MT in control group were also significantly higher than in TPN group.Jejunal and ileal mucosal VH、CD and MT in Gln group were significantly higher than in TPN group.Colonic MT in food group was significantly higher than in control group.Colonic MT in Gln group was significantly bigger than in TPN group. Conclusions:After 80% intestinal resection,the remaining intestine can develop the adaptation,but the adaptation is incomplete.TPN therapy can maintain body weight,but only TPN can not result in the adaption.Gln-supplied TPN can stop the remaining itestinal mucosal atrophy,and promote the remaining intestinal adaptation and colonic mucosal hypertrophy.
3.Effects of intravenous long chain triglyceride or long/medium chain triglyceride fat emulsion on lipid mediators during ANP in rats
Kejian HUANG ; Tianfang HUA ; Jincheng KONG ; Honghui HU ; Fuquan ZHONG ; Yanling ZHANG ;
Parenteral & Enteral Nutrition 1997;0(04):-
Objectives:To investigate the effects of intravenous LCT or MCT/LCT fat emulsions on the lipid mediators and pancreatic histological changes in ANP rats. Methods:Forty three male SD rats were randomized to groups as follow.Group A~C were without ANP, group A:normal controls, group B:normal rats having received lipid based TPN and group C:operation control(OC) group having received the glucose fluid.Group D~F were with ANP,glucose group,Intralipid group and Lipofundin group.The amylase and prostaglandins in serum were determined in group A.Pancreatic histological examinations were also performed.In group B~F,Amylases or prostaglandins in serum were determined at 4,48 and 72 h, and pancreatic histological examination and pathological scoring were also completed. Results:Intralipid had no effects on serum prostaglandins when it was infused to normal rats.In groups of ANP,intravenous fat emulsion increased the 6 keto PGF 1? ,and PGE 2 concentration in serum at 4 h.Pancreatic hemorrhagic and fat necrosis were significantly reduced in Lipofundin group. Conclusions:Intravenous fat emulsion does not worsen the damages to pancreas in ANP.MCT/LCT fat emulsion is more suitable for patients with ANP.
4.Performance evaluation of the chemiluminescence immunoassay for mycoplasma pneumonia antibody detecting
Dongmiao CHEN ; Yajie ZHANG ; Tingting SHEN ; Zhibin OU ; Jincheng ZHONG ; Yan NING ; Congrong WANG
Chinese Journal of Laboratory Medicine 2017;40(12):965-969
Objective Assessing the detection performance of testing mycoplasma pneumonia(MP) type-specific antibodies by Chemiluminescence immunoassay(CLIA), in order to evaluate the feasibility of screening MP infection by CLIA.Methods Total of 280 cases of respiratory disease patients,20 examples infected mycoplasma pneumonia and 20 cases health volunteers as the control group were enrolled in this study from August 2016 to October 2017 in the Nanfang Hospital,Southern Medical University,testing MP antibodies by CLIA,Enzyme linked immunosorbent assay(ELISA)and Passive agglutination method(PA) respectively.According to the performance evaluation scheme, we evaluate the performance indexs of detecting MP antibodies by CLIA, including lower limit of detection, intra-batch precision, inter-batch precision,linearity range,clinical coincidence rate and consistency compared with ELISA and PA,and the results were analyzed by EXCEL and SPSS version 22.0.Results MP-IgG CLIA reagent:Limit of blank, Limit of detection and Limit of quantitation were 1.9 AU/ml,4.5 AU/ml and 5.1 AU/ml respectively;Coefficient Variation(CV)of intra-batch precision in high and low concentration levels were 2.98% and 2.45%respectively; CV of inter-batch precision in high and low concentration levels were 6.44% and 6.83% respectively;both the Linear range and Clinical report range are from 2.0 AU/ml to 253.0 AU/ml;the linear regression equation R 2≥0.990 0,0.85≤b≤1.15.MP-IgM CLIA reagent: CV of intra-batch precision in high and low concentration levels were 2.55% and 2.86% respectively; CV of inter-batch precision in high and low concentration levels were 4.82% and 5.46% respectively.The total clinical coincidence rate of MP-IgG and MP-IgM detected by CLIA were 90.0%and 97.5%respectively.The kappa values of MP-IgG and MP-IgM detected by CLIA and ELISA were 0.763(P=0.000)and 0.804(P=0.023)respectively, with Consistent percentage of 88.9% and 91.4% respectively.The kappa value of CLIA and PA was 0.541(P=0.063)with a consistent percentage of 79.6%.Conclusions The results of study show that detecting MP type-specific antibodies by CLIA meet the prescribed performance indexes. Detecting MP type-specific antibodies by CLIA,which is precise, speedy and automated, could be applied to clinical and replace ELISA and PA, becoming the prior choice in clinical for MP infection screening.
5.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