1.Effect of Xuebijing injection on hemodynamics and endothelial function in patients with severe sepsis:a prospective study
Jianzhuo HE ; Zhanpeng TAN ; Minzhou ZHANG ; Liheng GUO
Chinese Critical Care Medicine 2015;(2):127-132
ObjectiveTo investigate the effects of Xuebijing injection on hemodynamics, cardiac function, and endothelial function in patients with severe sepsis in order to study the therapeutic effect of Xuebijing in the treatment of severe sepsis.Methods A prospective randomized controlled trial was conducted. Sixty-six severe sepsis patients admitted to the Department of Critical Care Medicine of Guangdong Hospital of Traditional Chinese Medicine from March 2013 to February 2014 were enrolled. The patients were divided into control group (n = 31) and Xuebijing group (n= 35). The patients in both groups were treated according to 2012 international guidelines for management of severe sepsis and septic shock, and the patients in Xuebijing group received Xuebijing injection of 50 mL (added with 100 mL of 0.9% sodium chloride injection) twice a day for 5 days, and those in control group received instead 150 mL of 0.9% sodium chloride injection for 5 days. The heart rate (HR), mean arterial pressure (MAP), central venous pressure (CVP), and dosage of vasoactive drugs before and 1 day and 5 days after treatment were determined for hemodynamics assessment. Blood lactic acid (Lac), central venous oxygen saturation (ScvO2), and difference in arterial-venous blood carbon dioxide pressure (Pv-aCO2) were determined for microcirculation assessment. The left ventricular ejection fraction (LVEF), cardiac output (CO), left ventricular end diastolic diameter (LVEDD), the ratio of blood flow of mitral orifice between rapid filling period and atrial systole period (E/A), and B-type natriuretic peptide (BNP) were determined for cardiac function assessment. Vascular endothelial growth factor (VEGF) and soluble receptor (sFLT-1) were assessed for endothelial function assessment. The relationship among the indexes of the hemodynamics, microcirculation, cardiac function, and endothelial function was analyzed with Pearson related-analysis.Results After treatment, HR, MAP, CVP, Lac, ScvO2, and Pv-aCO2 were improved in both groups compared with those before treatment, and the dosage of norepinephrine (NE) was decreased in Xuebijing group. Compared with control group, MAP at 5 days after treatment in Xuebijing group was significantly increased [mmHg (1 mmHg =0.133 kPa): 74.9±10.7 vs. 70.2±6.6,P< 0.05], the dosage of NE was decreased [μg·kg-1·min-1: 0.01 (0.00, 0.22) vs. 0.10 (0.05, 0.80),P< 0.05], LVEF was significantly increased (0.617±0.125 vs. 0.533±0.129,P< 0.05), BNP was significantly decreased [ng/L: 117.3 (52.0, 443.0) vs. 277.2 (67.9, 2 370.2),P< 0.05], while VEGF showed no significant change (ng/L: 101.1±23.2 vs. 89.6±20.5,P> 0.05), and sFLT-1 was significantly decreased (ng/L:245.7±86.2 vs. 295.1±95.1,P< 0.05). It was shown by Pearson coefficient bivariate correlation analysis that sFLT-1 was negatively correlated with MAP and ScvO2 (r= -0.569,P= 0.000;r= -0.341,P= 0.008) 5 days after treatment, while it was positively associated with Lac and acute physiology and chronic health evaluationⅡ (APACHEⅡ) score (r= 0.749,P= 0.000;r= 0.645,P= 0.000).Conclusions In patients with severe sepsis, there are hemodynamics disorders and effect in microcirculation perfusion. Xuebijing injection can improve hemodynamics and cardiac function in the patients with severe sepsis, and the mechanism may be related to the improvement of endothelial function.
2.Expression of Bmi-1 and p16 gene in transitional cell carcinoma of bladder
Qingsong ZHAO ; Ye LIU ; Zhanpeng LU ; Duangai WEN ; Jun HE
Chinese Journal of Postgraduates of Medicine 2014;37(11):4-6
Objective To detect the expression of Bmi-1 and p16 gene in transitional cell carcinoma of bladder(TCC) tissue and explore its clinical significance.Methods The expression of Bmi-1 and p16 gene were detected by real-time quantitative polymerase chain reaction in 61 cases of TCC tissue and 12 cases of normal bladder tissue.Results The expression of Bmi-1 gene in TCC tissue was significantly higher than that in normal bladder tissue (0.242 ± 0.129 vs.0.031 ± 0.011),and the expression of p16 gene was significantly lower than that in normal bladder tissue (0.059 ± 0.021 vs.0.165 ± 0.029),there was significant difference (P < 0.05).The expression of Bmi-1 and p16 gene were highly correlated with pathological grades,clinical stages and tumor recurrence (P < 0.05 or < 0.01).But there were not correlated with age and gender (P > 0.05).There was a negative correlation between the expression of Bmi-1 gene and p16 gene in TCC tissue(rs =-0.714,P< 0.05).Conclusions Bmi-1 gene high expression and p16 gene low expression may be involved in the occurrence and development process of TCC.Bmi-1 may decrease the expression of p 16 gene in some ways,and then lead to the occurrence and development of TCC.
3.Effect of early enteral nutrition on serum endotoxin and intestinal permeability in patients with severe acute pancreatitis
Zhanpeng HE ; Yiping WANG ; Zhiwen WANG ; Hailing LI
Chinese Journal of Primary Medicine and Pharmacy 2018;25(10):1263-1266
Objective To study the effect of early enteral nutrition ( EN ) on the serum endotoxin and intestinal permeability in patients with severe acute pancreatitis ( SAP ) .Methods Seventy patients with SAP were selected as study objects ,and they were divided into parenteral nutrition ( PN) group and EN group according to the random number table method ,with 35 cases in each group.The PN group was given PN intervention ,while the EN group was given EN intervention .The levels of serum endotoxin and the ratio of the excretion rates of urinary lactulose and mannitol excretion before and after 1 week and 2 weeks of intervention , and the levels of inflammatory factors before and after treatment were measured .Results Before intervention ,the levels of serum endotoxin and the ratio of the excretion rates of urinary lactulose and mannitol excretion had no statistically significant differences between the two groups (t=0.274,P=0.452;t=0.035,P=0.885).After 1 week and 2 weeks of intervention,the levels of serum endotoxin and the ratio of the excretion rates of urinary lactulose and mannitol excretion in the EN group were significantly lower than those in the PN group (t=9.024,10.761,P=0.000,0.000;t=6.935,8.358,P=0.000, 0.000).After treatment,the levels of TNF -α,IL-1β,IL-6 and IL-8 in the EN group were significantly lower than those in the PN group (t=12.674,10.318,9.754,8.307,P=0.000,0.000,0.000,0.002).Conclusion EN has significant influence on the serum endotoxin and intestinal permeability in patients with SAP ,and compared with PN,EN can promote the clearance of serum endotoxin ,reduce the permeability of intestinal mucosa ,and it is worth promoting.
4.Effect of quantitative ultrasound bone mineral density test on the screening of osteoporosis in patient with knee osteoarthritis
Zhanpeng ZENG ; Caifeng DAI ; Weijie ZHENG ; Xian HE ; Benqian TAN
The Journal of Practical Medicine 2018;34(2):243-246
Objective To investigate the effect of quantitative ultrasound bone mineral density test on the screening of osteoporosis in patients with knee osteoarthritis and to explore the relationship between knee osteoar-thritis and osteoporosis. Methods 160 patients with knee osteoarthritis were divided into 4 groups:Ⅰ,Ⅱ,ⅢandⅣby Kellgren-Lawrence and measured height,weight,age,quantitative ultrasound bone mineral density and dual energy X-ray bone density.We compared the T values measured by quantitative ultrasound bone mineral density test and dual energy X-ray bone density,assessed the accuracy of quantitative ultrasound bone mineral density test for osteoporosis,and investigated the correlation between the value of quantitative ultrasound bone mineral density and knee osteoarthritis in different grades. Results Quantitative ultrasound bone mineral density was positively correlated with dual energy X-ray bone density(r = 0.751,P < 0.05). The AUC of diagnosis of osteoporosis by quantitative ultrasound bone mineral density test with T<-2.5 was 0.774,95% CI was 0.676 and 0.791,specificity was 96.7%,sensitivity was 85.7% and Youden index was 82.4%.With an increase in the grades of Kellgren-Law-rence,the knee osteoarthritis gradually worsened.The T values of quantitative ultrasound bone mineral density and dual energy X-ray bone density increased gradually in negative direction,and the difference was statistically signifi-cant(P<0.001).Conclusions Quantitative ultrasound bone mineral density test has good specificity and sensi-tivity and can be used to screen patients with knee osteoarthritis. The more severe the knee osteoarthritis is,the easier to develop osteoporosis.
5.Risk factors for intraoperative hemorrhage during endoscopic submucosal dissection for colorectal lesions
Rongrong YANG ; Mingyuan ZHANG ; Jian ZHANG ; Yiping WANG ; Zhanpeng HE ; Xinchen ZHANG ; Guanhua JIA ; Dongni WANG ; Yali WANG
Chinese Journal of Digestive Endoscopy 2023;40(2):131-139
Objective:To investigate the risk factors for intraoperative hemorrhage during endoscopic submucosal dissection (ESD) for colorectal lesions.Methods:Data of 386 patients with colorectal lesions, who underwent ESD at The Third People's Hospital of Datong and its cooperative hospital, Nanjing Drum Tower Hospital, from December 2019 to August 2021 were retrospectively analyzed. The patients were divided into the hemorrhage group ( n=85) and the non-hemorrhage group ( n=301) according to intraoperative hemorrhage. The correlationship of patients'basic information, lesion-related factors and hemorrhage during colorectal ESD was analyzed. Univariate and multivariate logistic regression were used to identify the risk factors for intraoperative hemorrhage during ESD. The risk predictive model of intraoperative hemorrhage during ESD was established according to the screened risk factors, and receiver operator characteristic (ROC) curve was used to evaluate the predictive model. Results:Univariate logistic regression showed that a history of diabetes ( OR=2.340, P<0.05), a history of coronary atherosclerotic heart diseases ( OR=3.100, P<0.05), the lesion located in the rectum ( OR=3.272, P<0.05), longer lesion ( OR=1.093, P<0.05), wider lesion ( OR=1.057, P<0.05), larger lesion ( OR=1.126, P<0.05), depressed lesion ( OR=6.128, P<0.05), the laterally spreading lesion ( OR=2.651, P<0.05), the lesion infiltrated into the SM-S layer ( OR=0.088, P<0.05), the lesion infiltrated into the SM-D layer ( OR=0.174, P<0.05), the diameter of hemorrhage vessels 0.5~<1.0 times of the diameter of incision knife ( OR=246.854, P<0.05), the postoperative pathology as early cancer ( OR=7.000, P<0.05) were risk factors for intraoperative hemorrhage during ESD. Considering the quantitative relationship between the length, the width and the area of lesions, multi-factor models were constructed using the length and area of lesions respectively. Forward stepwise regression was used to screen variables and determine the final model, and the results showed that a history of coronary atherosclerotic heart diseases, the depressed lesion, the longer lesion, the larger lesion, the diameter of hemorrhage vessels 0.5~<1.0 times of the diameter of the incision knife were independent risk factors for intraoperative hemorrhage during ESD. The two modeling results of the lesion length and the lesion area were very similar. Therefore, lesion length was recommended to describe lesions in clinical practice. Conclusion:A history of coronary atherosclerotic heart disease, the depressed lesion, the longer lesion, the larger lesion, the diameter of vessels 0.5~<1.0 times of that of the incision knife are independent risk factors for intraoperative hemorrhage during ESD.
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