1.Effects of lung protective ventilation strategy on inflammatory mediators in bronchial alveolar lavage fluid in pulmonary and extrapulmonary acute respiratory distress syndrome
Ying SHENG ; Xiaohong XIE ; Bo GAO ; Jingen WANG ; Jinfang CAI
Chinese Journal of Postgraduates of Medicine 2013;(9):1-5
Objective To observe the effects of lung protective ventilation strategy (LPVS) on inflammatory mediators in bronchial alveolar lavage fluid (BALF) in pulmonary and extrapulmonary acute respiratory distress syndrome(ARDS).Methods All of 62 extrapulmonary ARDS(ARDSexp) cases and 60 pulmonary ARDS (ARDSp) cases were divided into observation group and control group by table of random digit.ARDSexp and ARDSp observation group were received LPVS treatment [tidal volume 6-8 ml/kg,positive end expiratory pressure (PEEP) 5-15 cm H2O (1 cm H2O =0.098 kPa)],and ARDSexp and ARDSp control group were received the routine ventilation strategy (tidal volume 10-12 ml/kg,PEEP 4-8 cm H2O).All groups were treated with the same conventional therapy of ARDS,same model and parameter of mechanical ventilation.The level of tumor necrosis factor (TNF)-α,interleukin (IL)-6,IL-8 in BALF were tested by enzyme linked immunosorbent assay on the 1st,4th,7th day in each group.The oxygenation index was tested at 8 o'clock each morning.Results There were 4 ARDSexp cases and 6 ARDSp cases who were expelled,because of death within 7 days.ARDSexp observation group was in 28 cases,ARDSexp control group was in 30 cases,ARDSp observation group was in 28 cases,ARDSp control group was in 26 cases.The oxygenation index had no significant difference between ARDSexp and ARDSp observation group and corresponding ARDSexp and ARDSp control group on the 1st and 2nd day (P > 0.05).But the oxygenation index in ARDSexp and ARDSp observation group were significantly higher than that in ARDSexp and ARDSp control group from 3rd to 7th day (P < 0.05).The oxygenation index in ARDSexp observation group was significantly higher than that in ARDSp observation group except 1st day (P <0.05).The oxygenation index in ARDSexp and ARDSp observation group were significantly better with the time passing (P < 0.05).The BALF levels of TNF-α,IL-6 and IL-8 in ARDSexp and ARDSp observation group were significantly lower than those in corresponding ARDSexp and ARDSp control group on the 4th and 7th day (P< 0.05).The BALF levels of TNF-α,IL-6 and IL-8 in ARDSexp observation group and ARDSexp control group were significantly lower than those in corresponding ARDSp observation group and ARDSp control group (P< 0.05).The BALF levels of TNF-α,IL-6 and IL-8 in ARDSexp and ARDSp observation group were decreased significantly with the time passing (P <0.05).Conclusion It is more reasonable to decrease the BALF levels of inflammatory mediators,increase oxygenation index for ARDS patients to with LPVS treatment,then for ARDSexp patients obviously.
2.Application of 3% hypertonic saline in patients with severe craniocerebral injury after operation
Ying SHENG ; Xiaohong XIE ; Jinfang CAI ; Jingen WANG ; Bo GAO
Chinese Journal of Postgraduates of Medicine 2012;35(17):7-10
Objective To study the application of 3% hypertonic saline (HS) in patients with severe craniocerebral injury after operation.Methods Sixty-eight cases with severe craniocerebral injury after operation were divided by random digits table method into HS group and control group with 34 cases each.The patients in control group were treated with 125 ml 20% mannitol every 6 hours or 8 hours.The patients in HS group were given conventional mannitol and added with 130 ml 3% HS every 12 hours or 8 hours through fast intravenous drip altemated with mannitol.The levels of intracranial pressure (ICP),mean arterial pressure (MAP),central venous pressure (CVP) were recorded within 6 hours,12 hours,24 hours of the 1st day,24 hours of the 2nd day,24 hours of the 3rd day,24 hours of the 5th day.The Na+ level of blood serum and the plasma osmotic pressure were recorded and calculated within 12 hours,24 hours of the 1st day,24 hours of the 2nd day,24 hours of the 3rd day,24 hours of the 5th day.The Glasgow coma scale( CCS) score was accounted within 24 hours of the 1 st day,24 hours of the 3rd day,24 hours of the 5th day.Results Compared with control group,the level of ICP in HS group decreased at every time point (P < 0.05).The tendency of ICP in two groups was not significant on the 1st and 2rid day (P > 0.05 ),but the level of ICP within 24 hours of the 3rd and 5th day obviously increased compared with those of the 1st and 2nd day (P<0.05).The levels of MAP and CVP in HS group were significantly higher than those in control group within 6 hours,12 hours and 24 hours of the 1 st day and 24 hours of the 2nd day [ ( 87.98 ± 5.03 ),(88.56 ± 5.36),(87.04 ±6.90),(90.03 ±5.19) mm Hg (1 mm Hg =0.133 kPa) vs.(77.98 ±5.09),(79.98 ±6.09),(80.98 ± 5.27),(81.98 ± 4.32) mm Hg and (9.23 ± 1.24),(9.67 ± 1.35),( 10.21 ± 1.38 ),( 10.56 ± 1.96)mm Hg vs.(7.15 ± 2.01 ),(8.32 ± 1.53),(8.67 ± 1.89),(9.22 ± 2.03) mm Hg] (P < 0.05),but the values within 24 hours of the 3rd and 5th day between two groups had no significant differences (P> 0.05 ).The Na+ level of blood serum and the plasma osmotic pressure in HS group at every time point was obviously higher than that in control group (P< 0.05).The GCS scores within 24 hours of the 1st,3rd and 5th day in HS group were (4.21 ± 2.31 ),(5.44 ± 2.46 ),(7.23 ± 1.64 ) scores,respectively,while the scores in control group were (4.14 ± 2.10),(5.15 ± 2.31 ),(7.31 ± 2.12) scores,respectively ;the score within 24 hours of the 5th day in two groups was obviously higher than that of the 1st day respectively (P< 0.05 ),but the scores between two groups had no statistical significance (P> 0.05 ).Conclusions Adding 3% HS is more effective to decrease ICP,improve the brain perfusion and reduce the adverse reactions.3% HS can be used as the first-line therapy for patients with severe craniocerebral injury after operation.
3.Application of Kangxiuke apozem in the treatment of severe burn shock
Liangliang CAI ; Longwei XIE ; Junjie YU ; Guozhong Lü ; Jingen LU ; Lingtao DING
International Journal of Traditional Chinese Medicine 2012;34(9):794-796
ObjectiveTo observe the clinical effect of Kangxiuke apozem in the treatment of severe bum shock.Methods40 patients of severe burn shock were randomly divided into a treatment group and a control group,with 20 patients in each group.All the patients were treated by the same route of counter-shock therapy,and the treatment group was additionally given Kangxiuke apozem (nasal feeding,qd,150 ml/d).Level of blood lactic acid,heart rate and urinary volume were evaluated by time.Main shock symptoms,including restlessness,hydrodipsia,perspiration and coldness,were observed.ResultsThe treatment group was significantly superior to the control group in the amelioration of blood lactic acid,heart rate and urinary volume ( t =10.485、3.219、7.429,P< 0.01 ).The symptomatic extinction of restlessness,hydrodipsia,perspiration and coldness in the extremities in the treatment group were significantly superior to those in the control group (x2=10.16、7.37、5.63、4.29,P<0.05).ConclusionAt the same time of routine counter-shock therapy,thereby prompt burn patients to smoothly go through shock period and decreas late complications.
4.Pharmacokinetic study of the complication of Ephedra sinica and Prunus armeniaca in bronchial asthma model rats
Linlin CHEN ; Jingen XIE ; Xuecheng FAN ; Qian RAO ; Tianyi YANG ; Jiayu TIAN ; Xiong XIAO ; Wenjun GAO ; Wenhong LI
China Pharmacy 2024;35(13):1588-1593
OBJECTIVE To study the pharmacokinetic changes in the plasma and cerebrospinal fluid of bronchial asthma model rats after the complication of Ephedra sinica and Prunus armeniaca. METHODS SD male rats were randomly divided into blank group, model group, E. sinica group (12 g/kg, calculated by raw drug, similarly hereinafter), P. armeniaca group (6 g/kg) and E. sinica-P. armeniaca drug-pair group (12 g/kg of E. sinica+6 g/kg of P. armeniaca), with 6 rats in each group. Except for the blank group, the bronchial asthma model was induced by spraying rats in each group with an equal volume mixture of 2% acetylcholine chloride and 0.4% histamine phosphate, once a day, for 7 d. One hour before modeling every time, rats in each group were gavaged with the corresponding drug/normal saline, once a day, for 7 d. After the final administration and provocation of asthma, blood and cerebrospinal fluid collection were performed at different time points. The plasma and cerebrospinal fluid samples were pre-treated (with geranylgeranyl as the internal standard), and the mass concentrations of ephedrine/pseudoephedrine, methyl ephedrine and amygdalin in both samples were determined by liquid chromatography-tandem mass spectrometry. DAS 2.0 pharmacokinetic software was used to determine the main pharmacokinetic parameters through the non-atrial chamber model and to compare the changes of the pharmacokinetic parameters before and after the combination of the two drugs. RESULTS Compared with E. sinica group, cmax and AUC0-21.33 h (or AUC0-10.67 h) of ephedrine/pseudoephedrine and methyl ephedrine in the plasma and cerebrospinal fluid of rats were significantly reduced in E. sinica-P. armeniaca drug-pair group, while CLZ/F and VZ/F were significantly increased (P<0.05 or P<0.01); tmax of methyl ephedrine in the cerebrospinal fluid was significantly shortened (P< 0.05).Compared with P. armeniaca group, the t1/2 of amygdalin in the plasma of rats in E. sinica-P. armeniaca drug-pair group was significantly shortened, and CLZ/F was significantly increased (P<0.01); the tmax of bitter amygdalin in the cerebrospinal fluid was significantly shortened, and the AUC0-10.67 h, CLZ/F, and VZ/F were significantly increased (P<0.01). CONCLUSIONS The combination of E. sinica and P. armeniaca accelerates the absorption and elimination of ephedra alkaloids, thus reducing the accumulation of ephedra alkaloids in the bronchial asthma model rats.
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