1.Arthritis increases the risk of prostate cancer:Results from the National Health and Nutrition Examination Survey 2005–2018 and two-sample Mendelian randomization analysis
Xiaobin YUAN ; Ruikang SHI ; Qiang JING ; Xiaoming CAO ; Xuhui ZHANG
Investigative and Clinical Urology 2025;66(3):215-226
Purpose:
It was aimed to clarify the casual connection between prostate cancer (PCa) and arthritis by utilizing two-sample Mendelian randomization (MR) analysis and data from National Health and Nutrition Examination Survey (NHANES) database.
Materials and Methods:
This study utilized NHANES data. Through association analysis and risk stratification analysis, the association between arthritis and PCa were examined. MR analysis was performed to elucidate the causal relationship between arthritis and PCa. Sensitivity analysis and Steiger directionality test confirmed the reliability of the MR analysis results.
Results:
A total of 23,608 (PCa:controls=413:23,195) participants after a sample exclusion and variable definition process were screened in NHANES database. Adjustments across three diverse models consistently revealed a notable influence of arthritis on PCa progression. Arthritis was identified as a risk factor for PCa (odds ratio [OR] 1.88, 95% confidence interval [CI] 1.36–2.62, p<0.001). Subsequent analysis indicated that in the arthritis-adjusted model with multiple covariates, the area under the curve of the receiver operating characteristic curve was 0.94. The inverse variance weighting method of MR analysis showed a causal relationship between rheumatoid arthritis (RA) and PCa (OR 1.090, 95% CI 1.053–1.128, p<0.001) as well as osteoar-thritis and PCa (OR 1.002, 95% CI 1.001–1.004, p=0.002). This suggested that RA and osteoarthritis were risk factors for PCa. The heterogeneity (p>0.05), horizontal pleiotropy (p>0.05), leave-one-out and Steiger test confirmed reliability of MR results.
Conclusions
NHANES database and MR analyses identified arthritis as a risk factor for PCa, offering fresh avenues for preventive and therapeutic approaches.
2.Fecal Metabolomics Study of Persistent Diarrhea with Spleen Yang Deficiency Syndrome
Sha ZHANG ; Bin YUAN ; Xiaobin CHEN
Journal of Nanjing University of Traditional Chinese Medicine 2024;40(6):633-639
OBJECTIVE To explore the syndrome material basis of spleen yang deficiency syndrome in children with diarrhea from the perspective of fecal metabolism.METHODS 20 children with persistent diarrhea of spleen yang deficiency syndrome were selected as the observation group,and 20 healthy children were selected as the normal control group.After collecting the fecal samples of each group,the samples were analyzed by gas chromatography-mass spectrometry,and the differences in metabolites between the two groups were compared.RESULTS There were 25 potential biomarkers related to persistent diarrhea with spleen yang deficiency syndrome,among which 9 were down-regulated,namely L-glutamine,L-Glutamic acid,4-hydroxybenzaldehyde,L-cysteine,orni-thine,L-isoleucine,succinic acid,β-alanine,fumaric acid,in persistent diarrhea with spleen yang deficiency syndrome.There were 16 kinds of upregulation in the stool of children,including serine,ribonic acid,α-linolenic acid,benzoic acid,fructose,L-alanine,pyroglutamic acid,pyruvate,hypoxanthine,capric acid,L-aspartic acid,and other metabolites.There were 7 related pathways in-volved,including the metabolism of alanine,aspartic acid and glutamate,the metabolism of D-glutamine and D-glutamate,the me-tabolism of pyruvate,the metabolism of arginine and proline,arginine biosynthesis,glycolysis/gluconeogenesis,citric acid cycle(TCA cycle.CONCLUSION Compared with healthy children,children with persistent diarrhea with spleen yang deficiency syndrome may experience disturbances in neural regulation metabolism,abnormal energy metabolism,and enhanced anaerobic fermentation in the body.The discovery of related differential metabolites may lay a certain material foundation for the pathogenesis,diagnosis,and treat-ment of persistent diarrhea with spleen yang deficiency syndrome in children.
3.Fourth investigation and analysis of the quality control situation in the critical care medicine of traditional Chinese medicine hospitals in Sichuan province
Jun CHEN ; Xingyue CHEN ; Kunlan LONG ; Rui YUAN ; Song ZHANG ; Xiaobin LI ; Xingmei ZHONG ; Kaichen ZHANG ; Peng DING ; Peiyang GAO
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2024;31(4):459-464
Objective To enhance the quality of medical services in the intensive care unit(ICU)of provincial traditional Chinese medicine(TCM)hospitals.Methods In November 2023,Sichuan Provincial Critical Care Medicine Quality Control Center of TCM launched the"quality control supervision project scoring standard for critical care medicine of TCM"to conduct quality control evaluation and business guidance for all TCM hospitals with independent ICU.The survey covered structural indicators,control indicators,participation of TCM,development of new technologies,and diagnosis and treatment programs for dominant diseases.Results In terms of structural indicators:a total of 110 TCM hospitals in the province have independent ICU,an increase of 1.12 times compared with 2019.The control indicators showed that the ICU patients admission rate was higher than that of the national ICU admission rate in 2017,and the admission rate of patients with acute physiology and chronic health evaluation Ⅱ(APACHEⅡ)score≥15 points increased.However,the mortality of ICU exceeded the national average.The implementation of core indicators had been significantly improved,but the incidence of outcome indicators such as ICU ventilator-associated pneumonia(VAP),ICU intravascular catheter-related bloodstream infection(CRBSI),and ICU catheter-related urinary tract infection(CAUTI)had increased since 2019,mainly in secondary hospitals.The average number of new technologies was about(5.5±3.4),the participation rate of TCM decreased,and the dominant diseases increased compared with 2019,mainly sepsis,respiratory failure and hemorrhagic stroke.Conclusions The number of ICU units in TCM hospitals at all levels in Sichuan province has grown rapidly,and key performance indicators have also improved compared to previous periods.However,greater efforts are still needed in preventing the occurrence rates of VAP,CRBSI,and CAUTI.There is a shortage of medical resources allocation,and the imbalance in regional medical resources and professional training remains an urgent issue to be addressed.Additionally,the participation rate of TCM and the dominant diseases need further enhancement.
4.The correlation and predictive value of GCS score,Lac,and blood transfusion in patients with hemorrhagic shock
Dongqiao YANG ; Yuan CHEN ; Xiaobin TANG ; Yifang SU
China Modern Doctor 2024;62(21):42-46
Objective To analyze the correlation between Glasgow coma score(GCS),blood lactic acid(Lac),and blood transfusion volume in traumatic emergency hemorrhagic shock patients,and their predictive value for patient prognosis.Methods Retrospective collection of clinical data from 128 trauma emergency shock patients who were treated and followed up in the Emergency Medical Center,Jinhua People's Hospital from March 2021 to May 2023.They were divided into good prognosis group(n=106)and poor prognosis group(n=22)according to their prognosis.The general information,GCS score,Lac level,and blood transfusion volume of two groups were compared.Using Cox regression model to analyze the influencing factors of prognosis in trauma emergency hemorrhagic shock patients.Establish receiver operating characteristic(ROC)curve to analyze the predictive value of GCS score,Lac level,and blood transfusion volume on the prognosis of trauma emergency hemorrhagic shock patients.Results Among 128 patients,22 had poor prognosis,accounting for 17.19%.The initial 24-hour blood transfusion volume,Lac,and white blood cell(WBC)in poor prognosis group were higher than those in good prognosis group,while the admission GCS score and hemoglobin(Hb)level were lower than those in good prognosis group,and the differences were statistically significant(P<0.05).Pearson correlation analysis showed that the initial 24-hour blood transfusion volume was negatively correlated with admission GCS score and admission Hb level(P<0.05),and positively correlated with admission Lac level(P<0.05).The initial 24-hour blood transfusion volume,admission GCS score,admission Lac,and admission Hb levels are all independent risk factors affecting the prognosis of trauma emergency hemorrhagic shock patients(P<0.05).The initial 24-hour blood transfusion volume,admission GCS score,admission Lac,admission Hb level,and combined predicted area under the curve(AUC)were 0.722,0.872,0.881,0.798,and 0.931,respectively,with sensitivity of 68.2%,76.6%,85.7%,75.7%,and 88.8%,and specificity of 70.8%,81.0%,78.5%,81.0%,and 85.7%,respectively.Paired Z-tests showed that the combined AUC was higher than a single indicator,and both sensitivity and specificity were optimal(P<0.05).Conclusion The initial 24-hour blood transfusion volume,admission GCS score,admission Lac,and admission Hb levels are all independent risk factors for poor prognosis in trauma emergency hemorrhagic shock patients,and the combined prediction of the four has the highest efficacy value.
5.Analyzing and monitoring real-world clinical safety of ensartinib for the treatment of patients with ALK-positive non-small cell lung cancer
Xiaobin YUAN ; Yang WANG ; Min YANG ; Pengxiang WU ; Zhilin SHEN ; Yongbin MA ; Lieming DING
Journal of International Oncology 2023;50(3):150-156
Objective:To evaluate the safety of ensartinib in the treatment of anaplastic lymphoma kinase (ALK) -positive non-small cell lung cancer (NSCLC) in the real-world clinical setting.Methods:Clinical data of 2 221 patients with ALK-positive locally advanced or metastatic NSCLC who received ensartinib treatment (225 mg/d) from December 16, 2020 to December 16, 2021 were collected and analyzed to assess drug adverse reactions in all population including elderly patients (≥ 65 years old) .Results:Among the total 2 221 patients, 511 patients (23.01%) experienced adverse events, including 8 patients (0.36%) who experienced serious adverse events. Adverse events led to dose modification in 67 patients (3.02%) and discontinuation in 18 patients (0.81%). The common adverse events were rash (407/2 221, 18.33%), pruritus (41/2 221, 1.85%), constipation (41/2 221, 1.85%), and facial edema (31/2 221, 1.40%). Thirty-six patients (1.62%) experienced ≥grade 3 adverse events. After symptomatic treatment of 511 patients with adverse reactions, 50 patients (9.78%) were healed, 271 patients (53.03%) were improved, 120 patients (23.48%) were persisted, and 70 patients (13.71%) were unknown due to loss of follow-up or other reasons. Forty-three patients (1.94%) reported 57 unintended adverse reactions. Among the 599 elderly patients, 116 patients (19.37%) experienced adverse events, including 1 patient (0.17%) who experienced serious adverse events. Adverse events led to dose modification in 25 patients (4.17%) and discontinuation in 5 patients (0.83%). The common adverse events of elderly patients were rash (88/599, 14.69%), constipation (14/599, 2.34%), facial edema (12/599, 2.00%), and pruritus (10/599, 1.67%). Twelve patients (2.00%) experienced ≥grade 3 adverse events. Among the 116 elderly patients with adverse reactions following the symptomatic treatment, 11 patients (9.48%) were healed, 58 patients (50.00%) were improved, 28 patients (24.13%) were persisted, and 19 patients (16.39%) were unknown due to loss of follow-up or other reasons. During the treatment, 1 patient (0.05%) experienced grade 2 interstitial lung disease, and no patient died due to adverse events.Conclusion:Ensartinib has a favorable safety profile in the real-world populations, with the most frequent adverse events being rash, mostly mild, and low incidence of ≥grade 3 adverse events. Overall, adverse reactions were tolerable and manageable.
6.Comparison of the efficacy of cervical decompression performed at different times in the treatment of incomplete cervical spinal cord injury
Shuai LI ; Yuan HE ; Yanzheng GAO ; Dianming JIANG ; Jun SHU ; Jian CHEN ; Jinpeng DU ; Lei ZHU ; Yunfei HUANG ; Zhen CHANG ; Liang YAN ; Hua HUI ; Xiaobin YANG ; Lingbo KONG ; Baorong HE
Chinese Journal of Trauma 2023;39(12):1070-1078
Objective:To compare the efficacy of cervical decompression performed at different times in the treatment of incomplete cervical spinal cord injury.Methods:A multicenter retrospective cohort study was conducted to analyze the clinical data of 96 patients with incomplete cervical spinal cord injury admitted to six hospitals including Honghui Hospital affiliated to Xi'an Jiaotong University, etc, from May 2018 to May 2021. There were 36 females and 60 males, aged 28-42 years [(35.2±6.7)years]. The injured segments were at C 3 in 7 patients, C 4 in 15, C 5 in 20, C 6 in 23 and C 7 in 31. According to the American Spinal Injury Association (ASIA) scale, there were 59 patients with grade B, 27 grade C, and 10 grade D. A total of 36 patients underwent cervical decompression within 24 hours after injury (early group), 33 patients within 24-72 hours after injury (late group), and 27 patients within 4-14 days after injury (delayed group). The operation time, intraoperative blood loss, postoperative drainage, length of hospital stay, Cobb angle, height of intervertebral space and space occupation of the spinal canal before surgery and at postoperative 3 days, and ASIA score, ASIA motor score, ASIA light tactile score, ASIA acupuncture sensation score, visual analog scale (VAS) score, Japanese Orthopedic Association (JOA) score, neck dysfunction index (NDI) before surgery and at postoperative 3 months, 1 year and at the last follow-up and incidence of complications were compared among the three groups. Results:All the patients were followed up for 12-21 months [(16.4±4.2)months]. There was no significant difference in the operation time among the three groups (all P>0.05). The intraoperative blood loss and postoperative drainage volume in the early group were (312.5±5.2)ml and (165.3±45.8)ml, which were higher than those in the late group [(253.5±40.0)ml, (120.4±60.6)ml] and the delayed group [(267.3±36.8)ml and (130.4±38.6)ml] (all P<0.01). There was no significant difference between the late group and the delayed group (all P>0.05). The length of hospital stay in the early group was (5.2±1.6)days, which was shorter than that in the late group [(7.6±2.3)days] and the delayed group [(8.0±1.3)days] (all P<0.05), but there was no significant difference between the late group and the delayed group ( P>0.05). There was no significant difference in the Cobb angle, height of intervertebral space and space occupation of the spinal canal among the three groups before and at postoperative 3 days (all P>0.05). There was no significant difference in the ASIA score, ASIA motor score, ASIA light tactile score, ASIA acupuncture sensation score, VAS score, JOA score and NDI among the three groups before surgery (all P>0.05). At postoperative 3 months, 1 year and at the last follow-up, the ASIA grading of the early group was better than that of the late group and the delayed group ( P<0.05 or 0.01), but there was no statistically significant difference between the late group and the delayed group (all P>0.05). The ASIA motor scores of the early group were (56.4±4.5)points, (76.3±3.6)points and (85.4±6.5)points at postoperative 3 months, postoperative 1 year and the last follow-up, respectively, which were higher than those in the late group [(52.3±2.4)points, (60.3±8.6)points and (72.3±2.4)points] and the delayed group [(51.9±2.3)points, (62.8±4.6)points and (71.9±1.3)points]; the ASIA light tactile scores of the early group were (70.2±2.9)points, (72.6±4.3)points and (78.3±2.3)points, which were higher than those in the late group [(66.2±3.7)points, (68.3±1.6)points and (73.3±1.6)points] and the delayed group [(65.2±2.1)points, (67.8±1.9)points and (72.3±2.5)points]; acupuncture sensation scores of the early group were (71.9±3.1)points, (80.1±3.8)points and (89.1±7.6)points, which were higher than those in the late group [(67.4±2.7)points, (72.6±3.7)points and (77.9±1.8)points] and the delayed group [(68.3±2.2)points, (72.6±3.1)points and (77.2±1.9)points] (all P<0.05). VAS scores of the early group at postoperative 3 months, 1 year and at the last follow-up were (4.3±0.6)points, (2.4±0.3)points and (1.6±0.2)points, which were lower than those in the late group [(5.1±1.3)points, (4.1±0.6)points and (3.0±0.6)points] and the delayed group [(5.0±1.7)points, (4.0±0.8)points and (3.1±0.2)points]; JOA scores of the early group were (12.8±1.6)points, (14.4±2.6)points and (17.9±3.3)points, which were higher than those in the late group [(11.9±1.9)points, (13.3±1.6)points and (8.9±1.3)points] and the delayed group [(11.6±1.8)points, (13.2±1.4)points and (9.3±2.1)points]; NDI scores of the early group were 12.1±3.3, 10.1±2.1 and 7.3±1.4, which were lower than those in the late group (14.4±3.1, 12.3±1.6 and 8.9±1.3) and the delayed group (14.1±2.3, 12.9±1.9 and 9.5±2.1) (all P<0.05). There was no significant difference in all the above-mentioned scores at postoperative 3 months, 1 year and at the last follow-up between the late group and the delayed group (all P>0.05). The incidence of complications was 25.0% (9/36) in the early group, 27.3% (9/33) in the late group and 37.0% (10/27) in the delayed group (all P>0.05). Conclusion:Compared with within 24-72 hours and 4-14 days after injury, cervical decompression performed within 24 hours after injury for patients with incomplete cervical spinal cord injury can shorten the length of hospital stay, improve the function of the spinal cord nerves and relieve pain, with no increase of the incidence of complications.
7.Correlation between systemic immune-inflammation index and prognosis in patients with hepatic alveolar echinococcosis
Xiaobin CHEN ; Jiaqi YUAN ; Zhixin WANG ; Haining FAN ; Zhaojun XU ; Xuepeng MEI ; Haijiu WANG ; Jiamin MA ; Ying ZHOU ; Lizhao HOU
Journal of Clinical Hepatology 2021;37(2):375-379
ObjectiveTo investigate the correlation between systemic immune-inflammation index (SII) and prognosis in patients with hepatic alveolar echinococcosis. MethodsA retrospective analysis was performed for the clinical data of 242 patients who were admitted to Department of Hepatopancreatobiliary Surgery, Qinghai University Affiliated Hospital, from January 2015 to December 2018 and underwent surgery for hepatic alveolar echinococcosis, and SII was calculated. The chi-square test was used for comparison of categorical data between two groups, and a Spearman correlation analysis was performed. The receiver operating characteristic (ROC) curve was used to determine the optimal cut-off value of SII; the Kaplan-Meier method was used to plot survival curves and analyze overall survival time in the two groups, and the log-rank test was used for comparison of survival rates between the two groups; univariate and multivariate Cox regression analyses were used to identify the influencing factors for the prognosis of patients with hepatic alveolar echinococcosis. ResultsThe Spearman correlation analysis showed that SII was positively correlated with the postoperative fatality rate of patients with hepatic alveolar echinococcosis (r=0.267, P<0.001). The ROC curve showed that the optimal cut-off value of SII before surgery was 758.92, and based on this, 242 patients with hepatic alveolar echinococcosis were divided into low SII (SII ≤758.92) group with 126 patients and high SII (SII >758.92) group with 116 patients. The low SII group had 1-, 3-, and 5-year survival rates of 98.20%, 88.47%, and 6610%, respectively, and the high SII group had 1-, 3-, and 5-year survival rates of 90.80%, 53.05%, and 27.40%, respectively. The low SII group had a cumulative survival rate of >50% and a mean survival time of 55.584 months (95% confidence interval[CI]: 53550-57.617), while the high SII group had a cumulative survival rate of <50%, a mean survival time of 39.384 months (95% CI: 35.070-43.698), and a median survival time of 43 months (95% CI: 34.694-51.306). The low SII group had a significantly better survival rate than the high SII group, and there was a significant difference in overall survival rate between the two groups (χ2=46.979, P<005). The univariate analysis showed that SII >758.92 (hazard ratio [HR]=5.907, 95% CI: 3.386-10.306, P=0.001) was an influencing factor for the overall survival time of patients with hepatic alveolar echinococcosis, and the multivariate Cox regression analysis showed that preoperative peripheral blood SII (HR=3.507, 95% CI: 1.911-6.435, P=0.001) was an independent risk factor for the overall survival rate of patients with hepatic alveolar echinococcosis. ConclusionPreoperative SII level is clearly correlated with the prognosis of patients with hepatic alveolar echinococcosis and can thus be used as a clinical indicator to evaluate the prognosis of patients. The higher the peripheral blood SII before surgery, the worse the prognosis of patients.
8.Effect of improved urethral irrigation on urethral stricture in patients with closed bulbar urethral injury
Xuhui ZHANG ; Fan LIU ; Qiqi QIN ; Xiaobin YUAN ; Tao ZHANG
Chinese Journal of Postgraduates of Medicine 2020;43(5):385-388
Objective:To explore the effect of improved urethral irrigation on urethral stricture in patients with closed bulbar urethral injury.Methods:The clinical data of 65 male patients with closed bulbar urethral injury complicated with difficult catheterization from January 2014 to January 2018 in the First Hospital of Shanxi Medical University were retrospectively analyzed. Among them, 30 cases were treated with flexible cystoscope-guided catheterization and external urethral orifice nursing (routine group), and 35 cases were treated with flexible cystoscope-guided catheterization and urethral drug flushing (improved group). The incidence of urethral stricture 1 and 6 months after catheter removal, number of urethral dilatation and maximum urinary flow rate 6 months after catheter removal, visual analogue score (VAS) during indwelling catheter were compared between 2 groups.Results:Both groups indwelled the catheters successfully. During indwelling catheter, the inflammatory secretion in improved group was less and thinner than that in routine group. There was no significant difference in the incidence of urethral stricture 1 month after catheter removal and VAS during indwelling catheter between 2 groups ( P>0.05); the incidence of urethral stricture and number of urethral dilatation 6 months after catheter removal in improved group were significantly lower than those in routine group: 5.7% (2/35) vs. 26.7% (8/30) and (7.1±1.0) times vs. (11.4±1.8) times, the maximum urinary flow rate 6 months after catheter removal was significantly higher than that in routine group: (19.8 ± 2.9) ml/s vs. (16.3±2.3) ml/s, and there were statistical differences ( P<0.05 or <0.01). Conclusions:The system of improved urethral irrigation can be easily fabricated and can achieve convenient application. This improved treatment can facilitate the discharge of urethral secretions, alleviate the urethral inflammation, reduce the urethral scar formation, and can prevent the incidence of bulbar urethral stricture effectively.
9.Curative effect of direct decompression plus lumbo-iliac fixation for Denis type II sacrum fracture combined with sacral foraminal bone space-occupying lesion and sacral nerve injury
Bolong ZHENG ; Leihong YUAN ; Xiaobin YANG ; Lingbo KONG ; Lixue YANG ; Dingjun HAO ; Hua GUO ; Baorong HE
Chinese Journal of Trauma 2020;36(3):240-245
Objective:To discuss the curative effect between direct decompression and indirect decompression plus lumbo-iliac fixation for treatment of Denis type II sacrum fracture combined with sacral foraminal bone space-occupying lesion and sacral nerve injury.Methods:A retrospective case-control study was performed on clinical data of 47 patients with Denis type II sacrum fracture combined with sacral foraminal bone space-occupying lesion and sacral nerve injury admitted to Honghui Hospital Affiliated to Xi'an Jiaotong University School of Medicine from March 2012 to March 2017. All patients underwent lumbo-iliac internal fixation. The operation time ranged from 3 to 14 days after injury, with an average of 6 days. In direct decompression group ( n=26), the sacral foramina mass was removed during the operation and direct decompression was performed. There were 16 males and 10 females, with age of (36.2±8.4)years. In indirect decompression group ( n=21), indirect decompression through traction and distraction was performed. There were 11 males and 10 females, with the age of (38.7±9.8)years. Operation time, intraoperative blood loss, bone union, Mears imaging evaluation, Gibbons score, and Majeed function score were compared between the two groups. Postoperative complications were observed as well. Results:All patients were followed up for 1233 months, with an average of 16.7 months. The operation time and intraoperative blood loss in direct decompression group were (112.3±26.3)minutes and (512.1±29.4)ml, which had no significant differences in comparison with that in indirect decompression group [(129.3±25.1)minutes and (529.7±22.1)ml] ( P>0.05). Bone union was observed in all patients. According to the Mears imaging evaluation, the direct decompression group had anatomical reduction in 17 patients, and satisfactory reduction in 9, and the indirect decompression group had anatomical reduction in 15 patients and satisfactory reduction in 6 ( P>0.05). At the last follow-up, Gibbons score in direct decompression group was lower than that in the indirect decompression group [(1.2±0.3)points vs. (2.2±0.5)points] ( P<0.01); Majeed function score in direct decompression group was higher than that in indirect decompression group [(87.3±11.4)points vs. (68.5±16.7)points] ( P<0.01). In direct decompression group, 1 patient had deep wound infection, while in indirect decompression group, 1 patient had pressure sore due to the protrusion of the tail of the iliac screws on the skin. Conclusion:For Denis type II sacrum fracture combined with sacral foraminal bone space-occupying lesion and sacral nerve injury, direct decompression with lumbo-iliac fixation can obtain better neural functional recovery and functional recovery of life compared with the indirect decompression.
10.Pharmacology and Clinical Evaluation of Ensartinib Hydrochloride Capsule.
Yang WANG ; Xiaobin YUAN ; Jiayan XIONG ; Zhidong HAO ; Xingzhe PENG ; Wanlin CHEN ; Lingling CUI ; Hua LI ; Xiulan WANG ; Xiangbo HE ; Min YANG ; Congxin LIANG ; Yongbin MA ; Lieming DING ; Li MAO
Chinese Journal of Lung Cancer 2020;23(8):719-729
Lung cancer is one of the most common malignancies with the highest incidence rate and mortality rate worldwide, and non-small cell lung cancer (NSCLC) accounts for about 85%. Only 5% NSCLC patients are anaplastic lymphoma kinase (ALK) rearrangement positive NSCLC, but the prognosis of these patients is poor, and treatment is urgent. Ensartinib (X-396), a next-generation ALK tyrosine kinase inhibitor (ALK-TKI), has shown greater potency on inhibiting ALK activity and controlling brain metastases than crizotinib, which is indicated for the treatment of crizotinib-resistant, ALK-positive NSCLC patients. Several phase I to III clinical trials included both healthy volunteers and NSCLC patients have been conducted both in China and abroad. In this review, we briefly summarized the results of these trials, and preliminary efficacy, safety, pharmacology and pharmacokinetics/pharmacodynamics of ensartinib were discussed.

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