1.Study on theimmediate separation feasibility of PLT preparation by adding to carboxylation chitosan
Jiandi LIU ; Tao ZHANG ; Wei KANG
Chinese Journal of Blood Transfusion 2017;30(7):815-818
Objective To investigate the use of chitin derivatives-carboxylation chitosan immediate separation feasibility of PLT preparation,and to look for a new direction in separation feasibility of blood components.Methods 40 samples of blood donors were divided into the experimental group,natural sedimentation control group and centrifugal control group randomLy in Dalian.2 mL of whole blood were mixed with different concentrations of carboxylation chitosan which were diluted by blood preservation solution Ⅱ by according to the ratio of 1 ∶4.plasma precipitation amount were surveyed after 4 hours,with numbers of red blood cells,white blood cell and platelet,PLT aggregation and the changes of red blood cell morphology were observed.Finally,suitable amount of MAP were added into the optimal chitosan in preservation,and hemolysis of red blood cells were tested in 35 days.Results Suitable amount of chitin experimental group blood sedimentation rate were significantly faster than static device control group,and plasma remaining trace red blood cells,PLT-rich,and 35 days no obvious hemolysis.Conclusion carboxylation chitosan could be used in PLT preparation.
2.Fingerprint of Ciwujia Injection and its application in quality control
Jiandi LIU ; Qionglin LIANG ; Guoan LUO ; Yiming WANG
Chinese Traditional Patent Medicine 1992;0(01):-
AIM: An effective and convenient method was established for HPLC fingerprints of Ciwujia Injection (Radix et Rhizoma seucaulis acanthopanacis senticost) which provided an approach for quality control in production. METHODS: Komasil-C_(18) column, phase A: 0.2% formic acid, phase B: 35% Acetonitrile, eluted with a gradient program and detected at 270 nm. The fingerprints of extraction from crude herbs, intermediate and finished product were compared. RESULTS: The fingerprint method for Ciwujia Injection was established. The similarity of 10 batches of Ciwujia Injection was not lower than 0.977. Obvious difference was carried on among the extraction from crude herbs, intermediate and finished product. CONCLUSION: This validated method is available for quality evaluation and quality control in Ciwujia Injection's production.
3.Effect of tempol on NF-κB signaling pathway in the rat model of myocardial hypertrophy
Jiandi LIU ; Long XIE ; Kun XIAO ; Jinhai ZHU ; Dongming XIE
Chinese Journal of Comparative Medicine 2018;28(1):64-69
Objective To investigate the effects of 2, 2, 6, 6-tetramethyl-4-piperidinol (tempol) on NF-κB signaling pathway of myocardial hypertrophy in rats. Methods The rat model of myocardial hypertrophy was established by intraperitoneal injection of isoprenaline (ISO) (5 mg/kg, twice per day, 2 weeks). A total of 42 male SD rats were randomly divided into 3 groups, including the control group, myocardial hypertrophy model group (ISO + sterile saline) and tempol treatment group (ISO + tempol) [tempol 100 mg/ (kg·d), 8 weeks]. Eight weeks after the corresponding drug intervention, the heart weight index (HWI) and left ventricular weight index (LVWI) were determined. Morphology and fibrosis of the myocardium were observed by HE staining, and the myocardial fibrosis of the rats was observed by Masson staining. The mRNA levels of TNF-α and IL-6 in the rat myocardial tissues were detected by qRT-PCR, and the expression levels of IκBα, p-p65 and p65 were detected by Western blot. Results Compared with the control group, the HWI and LVMI, mRNA levels of TNF-α and IL-6, and expression of p-p65/p65 in the model group were significantly increased (P< 0. 05), while the expression level of IκBα, an NF-κB inhibitory protein was significantly decreased (P<0. 05). The pathological examination of the myocardial tissues showed thickening and disordered arrangement of myocardial fibers, and increased cross-sectional area of the myocardial fibers. The pathology by Masson staining showed aggravated myocardial fibrosis and increased collagen fibers in the myocardial interstitium. Compared with the model group, the HWI and LVMI, the mRNA levels of TNF-α and IL-6, and the expression of p- p65/p65 of the tempol group were significantly decreased (P< 0. 05), while the expression level of IκBα was significantly increased (P< 0. 05). HE staining showed that the degrees of myocardial disarrangement and cardiomyocyte hypertrophy were decreased. Meanwhile, Masson staining showed that the extent of myocardial fibrosis was reduced, and the interstitial collagen fibers were decreased. Conclusions Tempol can improve the isoprenaline-induced myocardial hypertrophy, which may be closely related with the inhibition of the activity of NF-κB signaling pathway.
4.Expression and its clinical significance of serum insulin-like growth factors in patients with clear cell carcinoma of kidney
Yi HE ; Hua WANG ; Renye DING ; Jiandi LIU ; Linfeng LU ; Yanqin GU ; Zhenhua JIANG ; Zengfu YU ; Yansong HOU ; Hao CHEN ; Lingfeng WU
Chinese Journal of Geriatrics 2011;30(3):223-225
Objective To observe the expressions of serum insulin-like growth factor (IGF)- Ⅰ ,Ⅱ and IGF binding protein (IGFBP) 3, 5 and to explore the clinical significances in patients with clear cell carcinoma of kidney. Methods Enzyme-linked immunosorbent assay (ELISA) methods were adopted to examine serum expressions of IGF-Ⅰ , Ⅱ and IGFBP 3, 5 in 40 cases with clear cell carcinoma of kidney (renal carcinoma group) and 16 cases with hydronephrosis (control group) from May 2007 to December 2009. Results IGF- Ⅰ , Ⅱ and IGFBP 3,5 in renal carcinoma showed higher expressions before operation (985. 7 μg/L, 1154.0 μg/L,46.6 μg/L and 9.6 μg/L, respectively)than after operation (431.4 μg/L, 632.6 μg/L, 26.7 μg/L, and 6.7 μg/L, respectively, all P<0. 05 ~0.01). There were no significant differences in those indexes between pre- and post- operation in control group (P> 0. 05). Conclusions There are high expressions of serum IGF-Ⅰ , Ⅱ and IGFBP 3, 5 in renal carcinoma patients, and IGF- Ⅱ has clinical significance in diagnosis.
5.Establishment of evaluationpediatrics nursing- sensitive quality indicatorssystembasedon Donabedian structure-process-outcome theory
Meiping SHEN ; Shuohui CHEN ; Xinxin LIU ; Jiandi GAO ; Xiaohua WU ; Hongzhen XU ; Jihua ZHU
Chinese Journal of Practical Nursing 2018;34(26):2035-2041
ObjectiveA preliminary study on pediatrics nursing-sensitive qualityindicators was carried out to construct a systematic, scientific and sensitive quality system. Methods Delphi method was used to conduct two rounds of questionnaires for 55 pediatric nursing experts, used SPSS20.0 statistical software for data analysis. Analytic hierarchy process method was used to determine the weight of the indicators. Results The final determination agreed rate of experts equal to 75 percent, the importance of assignment mean was>3.5 and the variation coefficient<0.25, which including 5 structure indicators, 17 process indicators and 18 outcome indicators. Conclusion The evaluation system of pediatrics nursing-sensitive quality indicators was constructed in preliminary which could provide the reference and basis for pediatric nursing managers.
6.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