1.A predictive value of post-thrombolysis hemorrhagic transformation in acute cerebral infarction predicted by Alberta stroke program early CT score, hemorrhage after thrombolysis score and related factors
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2017;24(4):351-354,408
Objective To observe the predictive value of Alberta stroke program early CT score (ASPECTS) and hemorrhage after thrombolysis score (HAT score) for the hemorrhagic transformation (HT) of acute cerebral infarction (ACI) patients after thrombolysis with Alteplase.Methods One hundred and twenty-one patients with ACI admitted to the Department of Neurology of Tianjin Jinghai District Hospital from January 2015to March 2017 were enrolled, they were all treated by using Alteplase 0.6 mg/kg for thrombolysis, maximum dose being 90 mg, and 1/10 of the total dose was intravenously injected in 1 minute, and then the residual part dissolved in 100 mL normal saline was intravenously dripped continuously for 1 hour. The ASPECTS and HAT score were carried out before the start of thrombolysis, and then the HT incidence situations in patients with different ASPECTSs and HAT scores were compared, and logistic regression analysis was used to analyze the risk factors of HT after thrombolysis in patients with ACI; then the receiver operating characteristic (ROC) curve was drawn, and the clinical value of HAT score and ASPECTS in diagnosing HT occurrence was analyzed.Results In cases with ACI, it was discovered that the higher the ASPECTS, the lower the incidence of HT, indicating that the incidences of HT in patients with ASPECTSs 0-4, 5-7, 8-10 were 57.1% (4/7), 26.7% (8/30), 14.3% (12/84) respectively; Similarly, in such cases, the higher the HAT scores, the higher the incidence of HT, showing that the incidences of HT of patients with HAT scores 0, 1, 2, ≥ 3 were 7.1% (4/56), 21.0% (8/38), 33.3% (7/21), 83.3% (5/6) respectively. The single factor analysis showed that the risk factors influencing the HT incidence included the systolic blood pressure on admission, anti-platelet medicine taken in the past history, the sign of high density of middle cerebral artery shown in head CT film on admission, the time of interval between the onset of the disease and the beginning of thrombolysis, HAT store and ASPECTS [odds ratio (OR) values were 0.972, 0.279, 0.992, 0.311, 2.628, 2.625, respectively, 95% confidence intervals (95%CI) were 0.9352-1.012, 0.093-0.836, 0.983-1.000, 0.105-0.916, 1.362-5.071, 1.522-4.525,P values were 0.034, 0.023, 0.042, 0.034, 0.003, 0.045 respectively]; the multifactorial logistic regression analysis showed that the independent risk factors influencing HT incidence were as follows: the systolic blood pressure on admission, anti-platelet medicines taken in the past history, the sign of high density of the middle cerebral artery shown in the head CT film on admission, the time of interval between the onset of the disease and the beginning of thrombolysis, HAT score and ASPECTS (OR values were 1.766, 1.012, 1.574, 1.030, 2.155, 2.431, 95%CI were 1.233-2.103, 1.009-1.204, 1.186-2.091, 1.009-1.053, 1.237-4.907, 1.213-5.815,P values were 0.023, 0.004, 0.002, 0.005, 0.007, 0.047); HAT score and ASPECTS could predict the risk of HT incidence after venous thrombolytic therapy, sensitivity, specificity, area under ROC curve (AUC), 95%CI in ASPECTS were higher than thoes of HAT score (94.4% vs. 94.0%, 61.4 vs. 41.0%, 0.77 vs. 0.70, 0.710-0.830 vs. 0.650-0.800).Conclusions It is shown in this study that the higher the ASPECTS, the lower the incidence of HT, and the higher the HAT score, the higher the incidence of HT; both HAT score and ASPECTS can predict the risk of HT incidence after venous thrombolytic therapy, and the predictive value of ASPECTS system is higher than that of HAT score.
2.The effect of age on short-time prognosis of acute cerebral infarction treated by alteplase
Linghua FAN ; Qi ZHANG ; Shujuan QIU
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2016;23(5):529-531
ObjectiveTo explore the effect of patients with acute cerebral infarction (ACI) at different ages receiving intravenous injection of alteplase for thrombolysis on their prognosis.Methods Ninety-eight ACI patients admitted to Jinghai Hospital of Tianjin from January 2014 to December 2015 were conducted in this study, and they were divided into elderly group (over 75 years old) and younger age group (under 50 years old). The patients in two groups of were given intravenous thrombolytic therapy with alteplase (0.9 mg/kg), 10% of the dose was intravenously injected, and continuously the remaining dose was pumped into the vein for 1 hour. Before the thrombolysis and 1 day and 21 days after thrombolysis, the score of United States National Institutes of Health Stroke Scale (NIHSS) was used to evaluate neurological deficits, the incidence of bleeding adverse event and mortality were recorded.Results Compared to the before thrombolysis, the NIHSS scores after thrombolysis on the 1st day and 21st day were significantly decreased in the two groups (the younger age group 1 day: 6±4 vs. 10±5, 21 days 2±2 vs. 10±5, the elderly group 1 day: 7±5 vs. 10±7, 21 days: 6±4 vs. 10±7, allP < 0.05), and NIHSS score in the younger age group was significantly lower than that in the elderly group on the 21st day after thrombolysis (2±2 vs. 6±4,P < 0.05). After thrombolysis, the incidence of minor mucocutaneous bleeding in elderly group was obviously higher than that in younger age group, the difference being statistically significant [7.69% (4/52) vs. 2.17% (1/46),P < 0.05]; the elderly group had higher symptomatic intracerebral hemorrhage and death events than those in younger age group [1 (1.92%) vs. 0].Conclusion Different ages of patients with ACI can benefit from intravenous thrombolysis with alteplase, showing the younger the age of the patients, the better the benefit they can get and have relatively better prognosis.
3.The effect of necrostatin-1 on expression of liver monocyte chemotactic protein-1 in septic rats
Linghua FAN ; Zhenwei LI ; Zheng FAN ; Yongqiang WANG
Chinese Critical Care Medicine 2016;28(3):262-266
Objective To investigate the effect of necrostatin-1 (Nec-1) on the expression of liver monocyte chemotactic protein-1 (MCP-1) in septic rats and its mechanism. Methods Forty-eight male Sprague-Dawley (SD) rats were randomly divided into sham group, model group, and Nec-1 group by randomized digital number method, with 16 rats in each group. The model of sepsis was reproduced by cecal ligation and puncture (CLP). Rats in sham group received anesthesia, and flipping the cecum followed by closure of the abdomen without ligation of the cecum. Rats in Nec-1 group were given 1 mg/kg Nec-1 [25 mg Nec-1 solution dissolved in 2.5 mL of dimethyl sulfoxide (DMSO)] through caudal vein 30 minutes before operation, while the rats in model group were given 0.1 mL/kg of DMSO only. Blood from abdominal aorta and liver tissue in each group were collected at 0 hour and 8 hours after operation. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were determined with automatic biochemistry analyzer. The pathological changes in liver were observed under light microscope using hematoxylin-eosin (HE) staining. The serum levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) were determined by enzyme linked immunosorbent assay (ELISA). The MCP-1 mRNA expression in the liver was determined by reverse transcription-polymerase chain reaction (RT-PCR). Results There was no significant differences in the levels of serum ALT, AST, TNF-α, IL-6 and expressions of liver MCP-1 mRNA at 0 hour among three groups, and the liver cellular structure was normal. At 8 hours, compared with sham group, the expressions of serum ALT, AST, TNF-α, IL-6 and liver MCP-1 mRNA were significantly increased in model group and Nec-1 group [ALT (U/L): 172.35±21.88, 129.67±18.20 vs. 60.04±11.74, AST (U/L): 511.03±34.92, 363.51±25.25 vs. 254.83±31.04, TNF-α(ng/L): 603.96±24.18, 483.87±26.60 vs. 265.74±15.14, IL-6 (ng/L): 975.62±65.37, 712.09±45.47 vs. 310.42±13.88, MCP-1 mRNA (2-ΔΔCt): 7.09±0.18, 5.51±0.45 vs. 0.99±0.06, all P < 0.05]. Levels of the above parameters in Nec-1 group at 8 hours were significantly decreased compared with those of model group (all P < 0.05). Under light microscopy, it was noted that the structure of hepatic lobules was destroyed, with exacerbation of immunocyte infiltration at 8 hours in model group. At 8 hours, it was found that Nec-1 alleviated the pathological damage in Nec-1 group. Conclusion Nec-1 can protect the liver of rats with sepsis, lower the expression of serum TNF-α and serum IL-6 and liver MCP-1 mRNA, and obviously reduce the damage of inflammation.
4.Research advance in relationship between D-dimer and clinical diseases
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2017;24(6):666-668
D-dimer is widely used as a kind of coagulation index in clinics and commonly used in the judgement of thrombotic diseases. Recently, studies have found that the D-dimer is related to many clinical diseases in multiple systems, such as the inflammatory, tumorous, etc. diseases can all result in blood coagulation, inducing D-dimer elevation, which may have certain prediction effects on many clinical diseases in determining their diagnosis, prognosis and disease situations. This study has summarized the relationships of D-dimer with many clinical diseases.
5.Risk factors of critically ill patients with gastrointestinal dysfunction and effects on prognosis
Junxiu MA ; Zhenwei LI ; Jiawei JIANG ; Wei CAO ; Linghua FAN
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2019;26(5):569-572
Objective To analyze the risk factors of gastrointestinal dysfunction in critically ill patients and provide reference for the prevention and treatment of gastrointestinal dysfunction. Methods A retrospective study was conducted, and the data of patients admitted to intensive care unit (ICU) of Jinghai District Hospital from September 2018 to March 2019 were collected. The data including sex, age, sequential organ failure score (SOFA), acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ), diagnosis in ICU, application of special drugs, hemoglobin (Hb), blood glucose, albumin (Alb) levels and presence or absence of bacteremia were collected. The patients were divided into gastrointestinal dysfunction group and non-gastrointestinal dysfunction group according to whether gastrointestinal dysfunction occurred or not. The general data, related final outcome and prognosis were compared between the two groups. Logistic regression analysis was used to analyze the risk factors affecting gastrointestinal dysfunction in critical ill patients, and the possible existing complications were recorded. The receiver operating characteristic curve (ROC) was drawn to evaluate the predictive values of risk factors. Results One hundred and thirty-eight patients were enrolled in this study, and 86 patients had gastrointestinal dysfunction. The SOFA score and proportions of using catecholamine and bacteremia in the gastrointestinal dysfunction group were significantly higher than those in the non-gastrointestinal dysfunction group [SOFA score: 7.2±3.8 vs. 5.8±3.6, the proportion of using catecholamine: 57.0% (49/86) vs. 38.5% (20/52), the proportion of bacteremia: 32.6%(28/86) vs.17.3%(9/52), all P < 0.05], Alb level was significantly lower than that in the non-gastrointestinal dysfunction group (g/L: 24.15±5.75 vs. 26.55±5.68, P < 0.05). Logistic regression analysis showed that the use of catecholamine, Alb level, bacteremia and SOFA score in ICU were the risk factors for occurrence of gastrointestinal dysfunction in ICU patients [odd ratios (OR) were 1.128, 0.547, 1.645, 1.958, 95% confidence intervals (95% CI) were 1.052-1.219, 0.384-0.765, 1.143-2.597, 1.925-1.993, P values were 0.011, 0.017, 0.021, 0.016, respectively]. Compared with the non-gastrointestinal dysfunction group, the incidence of bedsore, the proportion of energy intake unable to reach the target, the length of stay in ICU and the mortality in gastrointestinal dysfunction group were significantly increased [the incidence of bedsore: 53.5% (46/86) vs. 30.8% (16/52), the proportion of intake unable to reach the target: 27.9% (24/86) vs. 5.8% (3/52), the length of stay in ICU (days): 22.5±17.8 vs. 16.0±11.5, mortality rate: 51.2% (44/86) vs. 34.6% (18/52), all P < 0.05]. ROC curve analysis showed that the use of catecholamine, bacteremia present or not, Alb level and SOFA score showed certain extents of predictive values for the occurrence of gastrointestinal dysfunction in critically ill patients the area under ROC curve (AUC) were 0.794, 0.712, 0.705 and 0.882, respectively, 95% confidence interval (95% CI) were 0.708-0.880, 0.609-0.816, 0.579-0.830, 0.801-0.962, sensitivity were 58.8%, 42.5%, 76.3%, 75.0%, specificity were 100%, 60%, 100%, 85%, all P < 0.05. Conclusions The use of catecholamine, Alb level, bacteremia and high SOFA score are the risk factors of gastrointestinal dysfunction in critically ill patients. Prevention of gastrointestinal motility disorder can improve the treatment success rate of critical patients.
6. A multicenter prospective study on incidence and risk factors of postoperative pancreatic fistula after radical gastrectomy: a report of 2 089 cases
Zhaoqing TANG ; Gang ZHAO ; Lu ZANG ; Ziyu LI ; Weidong ZANG ; Zhengrong LI ; Jianjun QU ; Su YAN ; Chaohui ZHENG ; Gang JI ; Linghua ZHU ; Yongliang ZHAO ; Jian ZHANG ; Hua HUANG ; Yingxue HAO ; Lin FAN ; Hongtao XU ; Yong LI ; Li YANG ; Wu SONG ; Jiaming ZHU ; Wenbin ZHANG ; Minzhe LI ; Fenglin LIU
Chinese Journal of Digestive Surgery 2020;19(1):63-71
Objective:
To investigate the incidence of postoperative pancreatic fistula (POPF) and its risk factors after radical gastrectomy.
Methods:
The prospective study was conducted. The clinicopathological data of 2 089 patients who underwent radical gastrectomy in 22 medical centers between December 2017 and November 2018 were collected, including 380 in the Zhongshan Hospital of Fudan University, 351 in the Renji Hospital of Shanghai Jiaotong University School of Medicine, 130 in the Ruijin Hospital of Shanghai Jiaotong University School of Medicine, 139 in the Peking University Cancer Hospital, 128 in the Fujian Provincial Cancer Hospital, 114 in the First Hospital Affiliated to Army Medical University, 104 in the First Affiliated Hospital of Nanchang University, 104 in the Affiliated Hospital of Qinghai University, 103 in the Weifang People′s Hospital, 102 in the Fujian Medical University Union Hospital, 99 in the First Affiliated Hospital of Air Force Medical University, 97 in the Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, 60 in the Hangzhou First People′s Hospital Affiliated to Zhejiang University School of Medicine, 48 in the Fudan University Shanghai Cancer Center, 29 in the First Affiliated Hospital of Xi′an Jiaotong University, 26 in the Lishui Municipal Central Hospital, 26 in the Guangdong Provincial People′s Hospital, 23 in the Jiangsu Province Hospital, 13 in the First Affiliated Hospital of Sun Yat-Sen University, 7 in the Second Hospital of Jilin University, 4 in the First Affiliated Hospital of Xinjiang Medical University, 2 in the Beijing Chao-Yang Hospital of Capital Medical University. Observation indicators: (1) the incidence of POPF after radical gastrectomy; (2) treatment of grade B POPF after radical gastrectomy; (3) analysis of clinicopathological data; (4) analysis of surgical data; (5) risk factors for grade B POPF after radical gastrectomy. Measurement data with normal distribution were represented as
7.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