1.Assessment of efficacy and safety of first-line EGFR-TKI combined with radiotherapy in EGFR-mutant lung cancer with brain metastases
Xin YIN ; Yanhua ZHOU ; Weili YI ; Jian HUANG ; Mengting LAI ; Zhili CHEN ; Dongning HUANG ; Li QIN
Chinese Journal of Radiation Oncology 2025;34(11):1102-1110
Objective:To evaluate the efficacy and safety of combining third-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) with brain radiotherapy in patients with newly diagnosed EGFR mutation-positive non-small cell lung cancer (NSCLC) with brain metastases. Methods:A retrospective analysis was performed on the clinical data of patients with newly diagnosed EGFR-mutant NSCLC with brain metastases who received first-line treatment with third-generation EGFR-TKI with or without brain radiotherapy at the Fourth Affiliated Hospital of Guangxi Medical University between January 2018 and December 2022. Patients treated with EGFR-TKI plus brain radiotherapy were assigned to the combination group, while those treated with EGFR-TKI alone were assigned to the monotherapy group. Intracranial progression-free survival (iPFS), progression-free survival (PFS), overall survival (OS), intracranial disease control rate (iDCR), intracranial objective response rate (iORR), and adverse events were compared between groups. Subgroup analyses were performed according to EGFR exon 19 deletion (19del) and exon 21L858R mutation status. Survival was estimated using the Kaplan-Meier method, with the log-rank test applied for group comparisons and univariate analysis, while multivariate analysis was conducted using Cox proportional hazards regression model. Results:A total of 107 patients were included: 57 (53%) in the monotherapy group and 50 (47%) in the combination group. The combination therapy significantly improved iORR (80% vs. 60%, P=0.023), prolonged median OS (37.7 vs. 31.6 months, P=0.004), and extended median iPFS (21.8 vs. 16.7 months, P=0.018). The iDCR was 100% in both groups, and the difference in median PFS was not statistically significant (18.6 vs. 15.2 months, P=0.086). In the 19del subgroup ( n=53), patients in the combination group had longer OS ( P=0.028) and iPFS ( P=0.028). In the 21L858R subgroup ( n=54), the median OS was also longer in the combination group ( P=0.050). Multivariate analysis identified TKI monotherapy and an Eastern Cooperative Oncology Group (ECOG) performance status score=2 as independent adverse prognostic factors for iPFS, while TKI monotherapy, age ≥65 years, ECOG score=2, and >3 brain metastases were the independent adverse prognostic factors for OS. The incidence of adverse events did not differ significantly between groups (all P>0.05). Conclusions:First-line combination therapy with third-generation EGFR-TKI and cranial radiotherapy provides superior efficacy and acceptable safety compared with EGFR-TKI monotherapy in patients with EGFR-mutant lung adenocarcinoma and brain metastases. Both EGFR 19del and 21L858R mutation subgroups benefit from the combined treatment approach.
2.Assessment of efficacy and safety of first-line EGFR-TKI combined with radiotherapy in EGFR-mutant lung cancer with brain metastases
Xin YIN ; Yanhua ZHOU ; Weili YI ; Jian HUANG ; Mengting LAI ; Zhili CHEN ; Dongning HUANG ; Li QIN
Chinese Journal of Radiation Oncology 2025;34(11):1102-1110
Objective:To evaluate the efficacy and safety of combining third-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) with brain radiotherapy in patients with newly diagnosed EGFR mutation-positive non-small cell lung cancer (NSCLC) with brain metastases. Methods:A retrospective analysis was performed on the clinical data of patients with newly diagnosed EGFR-mutant NSCLC with brain metastases who received first-line treatment with third-generation EGFR-TKI with or without brain radiotherapy at the Fourth Affiliated Hospital of Guangxi Medical University between January 2018 and December 2022. Patients treated with EGFR-TKI plus brain radiotherapy were assigned to the combination group, while those treated with EGFR-TKI alone were assigned to the monotherapy group. Intracranial progression-free survival (iPFS), progression-free survival (PFS), overall survival (OS), intracranial disease control rate (iDCR), intracranial objective response rate (iORR), and adverse events were compared between groups. Subgroup analyses were performed according to EGFR exon 19 deletion (19del) and exon 21L858R mutation status. Survival was estimated using the Kaplan-Meier method, with the log-rank test applied for group comparisons and univariate analysis, while multivariate analysis was conducted using Cox proportional hazards regression model. Results:A total of 107 patients were included: 57 (53%) in the monotherapy group and 50 (47%) in the combination group. The combination therapy significantly improved iORR (80% vs. 60%, P=0.023), prolonged median OS (37.7 vs. 31.6 months, P=0.004), and extended median iPFS (21.8 vs. 16.7 months, P=0.018). The iDCR was 100% in both groups, and the difference in median PFS was not statistically significant (18.6 vs. 15.2 months, P=0.086). In the 19del subgroup ( n=53), patients in the combination group had longer OS ( P=0.028) and iPFS ( P=0.028). In the 21L858R subgroup ( n=54), the median OS was also longer in the combination group ( P=0.050). Multivariate analysis identified TKI monotherapy and an Eastern Cooperative Oncology Group (ECOG) performance status score=2 as independent adverse prognostic factors for iPFS, while TKI monotherapy, age ≥65 years, ECOG score=2, and >3 brain metastases were the independent adverse prognostic factors for OS. The incidence of adverse events did not differ significantly between groups (all P>0.05). Conclusions:First-line combination therapy with third-generation EGFR-TKI and cranial radiotherapy provides superior efficacy and acceptable safety compared with EGFR-TKI monotherapy in patients with EGFR-mutant lung adenocarcinoma and brain metastases. Both EGFR 19del and 21L858R mutation subgroups benefit from the combined treatment approach.
3.Analysis of the efficacy and influencing factors after the First 131Ⅰ treatment after surgery for differentiated thyroid cancer
Shaoneng TAO ; Junliang GE ; Jiwen YANG ; Xiaolei CHEN ; Weili YIN ; Yingying WANG ; Xiaocen LIU
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(12):1435-1440
AIM:To explore the therapeutic effica-cy and influencing factors of differentiated thyroid cancer(DTC)after the first postoperative 131Ⅰ treat-ment.METHODS:We retrospectively analyzed the clinical data of 116 DTC patients treated with 131Ⅰfor the first time after thyroid cancer surgery in the Department of Nuclear Medicine of the First Affili-ated Hospital of Wannan Medical College,analysed their therapeutic efficacy,and Univariate and multi-variate Logistic analyses were performed for the factors that may affect the efficacy of the treat-ment,respectively,and established ROC curves to analyse the diagnostic and ER efficacy of those with psTg and TTR that had a significant effect on the multifactorial Logistic analyses.RESULTS:In DTC patients who were followed up 3-9 months af-ter the first postoperative 131Ⅰ treatment,69.0%(80/116)achieved ER.Univariate analysis revealed no statistical significance between ER and NER groups in terms of age,gender,TSH,TgVR,maximum tu-mour diameter,presence of lymph node metasta-sis,bilaterality of tumour,multifocality and clinical stage(P>0.05).While 131Ⅰ dose,nsTg,psTg,TgV and TTR(Tg/TSH ratio)were statistically significant(P<0.05).The results of multifactorial Logistic analysis showed that psTg and TTR were independent risk factors for the first 131Ⅰ treatment after DTC,with a psTg OR of 5.950(95%CI 1.437-24.639,P<0.05)and a TTR OR of 4.137(95%CI 1.073-15.947,P<0.05).The best threshold value of psTg for ROC curve analysis to predict the efficacy of the first postoperative 131Ⅰ treatment for DTC was 8.935 μg/L,with a sensitivity of 80.6%,a specificity of 83.6%,and a Yuden's index of 0.64.And the best threshold value of TTR for predicting the efficacy of the first postoperative 131Ⅰ treatment for DTC was 125.72 ng/mIU,with a sensitivity,specificity of 80.6%and 91.2%,and the Yuden index was 0.618.psTg and TTR areas under the curve were 0.839 and 0.833,respectively.psTg<8.935 μg/L patients achieved ER after 3-9 months of follow-up in DTC patients(67/74,90.5%).psTg>8.935 μg/L patients achieved ER(13/42,30.95%).Correspondingly TTR<125.72 ng/mIU achieved ER(65/72,90.2%).psTg>125.72 ng/mIU achieved ER(15/44,34.1%).CONCLUSION:The efficacy of the first 131Ⅰ treatment after surgery for differentiated thyroid cancer is significant.psTg and TTR are independent risk factors for the first 131Ⅰ treatment after DTC and have an important predictive value of efficacy.
4.Quality Evaluation of the Randomized Controlled Trials of Chinese Medicine Injection for Acute Cerebral Infarction in Last Five Years Based on ROB and CONSORT-CHM Formulas 2017
Ziteng HU ; Qianzi CHE ; Ning LIANG ; Yujing ZHANG ; Yaxin CHEN ; Fuqiang ZHANG ; Weili WANG ; Haili ZHANG ; Wenjie CAO ; Yijiu YANG ; Tian SONG ; Dingyi WANG ; Xingyu ZONG ; Cuicui CHENG ; Yin JIANG ; Yanping WANG ; Nannan SHI
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(7):32-37
Objective To evaluate the risk of bias and reporting quality in randomized controlled trials(RCTs)of the Chinese medicine injection for acute cerebral infarction in the last five years.Methods RCTs literature on Chinese medicine injection in the treatment of acute cerebral infarction was systematically searched in CNKI,Wanfang Data,VIP,China Biology Medicine Database(CBM),PubMed,Embase and Cochrane Library from April 20,2018 to April 20,2023.The risk of bias and reporting quality of included RCTs were evaluated using the Cochrane Risk of Bias Tool(ROB 1.0)and CONSORT-CHM Formulas 2017,respectively.Results A total of 4 301 articles were retrieved,and 408 RCTs were included according to inclusion and exclusion criteria.The ROB evaluation results showed that the the majority of studies were rated as having an unclear risk of bias due to the lack of reporting on allocation concealment,blind method,trial registration information,and funding sources.The evaluation results of CONSORT-CHM Formulas 2017 showed that the number of reported papers of 17 items was greater than or equal to 50%,and the number of reported papers of 25 items was less than 10%,and most of the RCTs did not show the characteristics of TCM syndrome differentiation and treatment.Conclusion The quality of Chinese medicine injection in the treatment of acute cerebral infarction RCTs is generally low.It is recommended that researchers refer to the methodology design of RCTs and international reporting standards,improve the trial design,standardize the trial report,and highlight the characteristics of TCM syndrome differentiation and treatment.
5.Tildrakizumab for moderate-to-severe plaque psoriasis in Chinese patients: A 12-week randomized placebo-controlled phase III trial with long-term extension
Chen YU ; Songmei GENG ; Bin YANG ; Yunhua DENG ; Fuqiu LI ; Xiaojing KANG ; Mingye BI ; Furen ZHANG ; Yi ZHAO ; Weili PAN ; Zhongwei TIAN ; Jinhua XU ; Zhenghua ZHANG ; Nan YU ; Xinsuo DUAN ; Shuping GUO ; Qing SUN ; Weiquan LI ; Juan TAO ; Zhijun LIU ; Yuanyuan YIN ; Gang WANG
Chinese Medical Journal 2024;137(10):1190-1198
Background::There is a need for effective and safe therapies for psoriasis that provide sustained benefits. The aim of this study was to assess the efficacy and safety of tildrakizumab, an anti-interleukin-23p19 monoclonal antibody, for treating moderate-to-severe plaque psoriasis in Chinese patients.Methods::In this multi-center, double-blind, phase III trial, patients with moderate-to-severe plaque psoriasis were enrolled and randomly assigned (1:1) to receive subcutaneous tildrakizumab 100 mg or placebo at weeks 0 and 4. Patients initially assigned to placebo were switched to receive tildrakizumab at weeks 12, 16, and every 12 weeks thereafter. Patients in the tildrakizumab group continued with tildrakizumab at week 16, and every 12 weeks until week 52. The primary endpoint was the Psoriasis Area and Severity Index (PASI 75) response rate at week 12.Results::At week 12, tildrakizumab demonstrated significantly higher PASI 75 response rates (66.4% [73/110] vs. 12.7% [14/110]; difference, 51.4% [95% confidence interval (CI), 40.72, 62.13]; P <0.001) and Physician’s Global Assessment (60.9% [67/110] vs. 10.0% [11/110]; difference, 49.1% [95% CI, 38.64, 59.62]; P <0.001) compared to placebo. PASI 75 response continued to improve over time in both tildrakizumab and placebo-switching to tildrakizumab groups, reaching maximal efficacy after 28 weeks (86.8% [92/106] vs. 82.4% [89/108]) and maintained up to 52 weeks (91.3% [95/104] vs. 87.4% [90/103]). Most treatment-emergent adverse events were mild and not related to tildrakizumab. Conclusion::Tildrakizumab demonstrated durable efficacy through week 52 and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis.Trial registration::ClinicalTrials.gov, NCT05108766.
6.Analysis of the efficacy and influencing factors after the First 131Ⅰ treatment after surgery for differentiated thyroid cancer
Shaoneng TAO ; Junliang GE ; Jiwen YANG ; Xiaolei CHEN ; Weili YIN ; Yingying WANG ; Xiaocen LIU
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(12):1435-1440
AIM:To explore the therapeutic effica-cy and influencing factors of differentiated thyroid cancer(DTC)after the first postoperative 131Ⅰ treat-ment.METHODS:We retrospectively analyzed the clinical data of 116 DTC patients treated with 131Ⅰfor the first time after thyroid cancer surgery in the Department of Nuclear Medicine of the First Affili-ated Hospital of Wannan Medical College,analysed their therapeutic efficacy,and Univariate and multi-variate Logistic analyses were performed for the factors that may affect the efficacy of the treat-ment,respectively,and established ROC curves to analyse the diagnostic and ER efficacy of those with psTg and TTR that had a significant effect on the multifactorial Logistic analyses.RESULTS:In DTC patients who were followed up 3-9 months af-ter the first postoperative 131Ⅰ treatment,69.0%(80/116)achieved ER.Univariate analysis revealed no statistical significance between ER and NER groups in terms of age,gender,TSH,TgVR,maximum tu-mour diameter,presence of lymph node metasta-sis,bilaterality of tumour,multifocality and clinical stage(P>0.05).While 131Ⅰ dose,nsTg,psTg,TgV and TTR(Tg/TSH ratio)were statistically significant(P<0.05).The results of multifactorial Logistic analysis showed that psTg and TTR were independent risk factors for the first 131Ⅰ treatment after DTC,with a psTg OR of 5.950(95%CI 1.437-24.639,P<0.05)and a TTR OR of 4.137(95%CI 1.073-15.947,P<0.05).The best threshold value of psTg for ROC curve analysis to predict the efficacy of the first postoperative 131Ⅰ treatment for DTC was 8.935 μg/L,with a sensitivity of 80.6%,a specificity of 83.6%,and a Yuden's index of 0.64.And the best threshold value of TTR for predicting the efficacy of the first postoperative 131Ⅰ treatment for DTC was 125.72 ng/mIU,with a sensitivity,specificity of 80.6%and 91.2%,and the Yuden index was 0.618.psTg and TTR areas under the curve were 0.839 and 0.833,respectively.psTg<8.935 μg/L patients achieved ER after 3-9 months of follow-up in DTC patients(67/74,90.5%).psTg>8.935 μg/L patients achieved ER(13/42,30.95%).Correspondingly TTR<125.72 ng/mIU achieved ER(65/72,90.2%).psTg>125.72 ng/mIU achieved ER(15/44,34.1%).CONCLUSION:The efficacy of the first 131Ⅰ treatment after surgery for differentiated thyroid cancer is significant.psTg and TTR are independent risk factors for the first 131Ⅰ treatment after DTC and have an important predictive value of efficacy.
7.Research advances in the minimally invasive treatment of benign prostatic obstruction
Weili RONG ; Dehong CAO ; Jinze LI ; Yin HUANG ; Bo CHEN ; Zeyu CHEN ; Jianzhong AI ; Liangren LIU ; Lu YANG ; Qiang WEI
Journal of Modern Urology 2023;28(1):78-82
The number of benign prostatic obstruction (BPO) patients in China is increasing, and patients tend to be younger and younger. The former "gold standard" scheme of transurethral resection of the prostate (TURP) is more suitable for patients with prostate volume ranging from 40 mL to 80 mL, which may lead to excessive resection in patients with small prostate volume and low efficiency in patients with large prostate volume. New minimally invasive techniques have been introduced,including prostate artery embolization, laser surgery (such as holmium, green, diode, and thulium), minimally invasive simple prostatectomy, transperineal laser ablation, prostatic urethral lift,and robot-assisted water jet ablation of the prostate. These methods are alternatives to TURP and increasingly used in the treatment of BPO. This article reviewed the advances in minimally invasive treatment of BPO.
9.PINK1 kinase dysfunction triggers neurodegeneration in the primate brain without impacting mitochondrial homeostasis.
Weili YANG ; Xiangyu GUO ; Zhuchi TU ; Xiusheng CHEN ; Rui HAN ; Yanting LIU ; Sen YAN ; Qi WANG ; Zhifu WANG ; Xianxian ZHAO ; Yunpeng ZHANG ; Xin XIONG ; Huiming YANG ; Peng YIN ; Huida WAN ; Xingxing CHEN ; Jifeng GUO ; Xiao-Xin YAN ; Lujian LIAO ; Shihua LI ; Xiao-Jiang LI
Protein & Cell 2022;13(1):26-46
In vitro studies have established the prevalent theory that the mitochondrial kinase PINK1 protects neurodegeneration by removing damaged mitochondria in Parkinson's disease (PD). However, difficulty in detecting endogenous PINK1 protein in rodent brains and cell lines has prevented the rigorous investigation of the in vivo role of PINK1. Here we report that PINK1 kinase form is selectively expressed in the human and monkey brains. CRISPR/Cas9-mediated deficiency of PINK1 causes similar neurodegeneration in the brains of fetal and adult monkeys as well as cultured monkey neurons without affecting mitochondrial protein expression and morphology. Importantly, PINK1 mutations in the primate brain and human cells reduce protein phosphorylation that is important for neuronal function and survival. Our findings suggest that PINK1 kinase activity rather than its mitochondrial function is essential for the neuronal survival in the primate brains and that its kinase dysfunction could be involved in the pathogenesis of PD.
10.Study on the intrapulmonary vascular volume in normal preschool children based on computer aided measurement
Meng LI ; Cong SHEN ; Weili YANG ; Nan YIN ; Leitao WEN ; Youmin GUO
Chinese Journal of Radiology 2022;56(8):873-878
Objective:To investigate the development of intrapulmonary vascular volume (IPVV) in normal preschool children based on quantitative measurement on chest CT.Methods:The CT data of 407 normal preschool children (236 males and 171 females, aged 1-72 months, with a median of 36 months) who underwent chest CT examination from January 2014 to May 2017 in the "Digital Lung" imaging database were retrospectively collected. The pulmonary vessels were segmented by the "Digital Lung" automatic detection tool, and the IPVV of the whole lung, the right lung, the left lung and each lobe were obtained, and the IPVV upper/lower and IPVV left/right were calculated. According to the age, the subjects were divided into infant period (0-12 months), early childhood period (13-36 months) and preschool period (37-72 months), with 30 cases (17 males and 13 females), 175 cases (95 males and 80 females) and 202 cases (124 males and 78 females) respectively. Spearman correlation analysis was used to evaluate the correlation between IPVV and month age. One-way analysis of variance or Kruskal-Wallis H test was used to compare the differences of IPVV, IPVV upper/lower and IPVV left/right between different months of age. Independent sample t test or Mann-Whitney U test was used to compare the differences of IPVV between different genders, and the normal reference range of IPVV in normal preschool children of different months of age was established. Results:The IPVV of the whole lung, right lung, left lung and each lung lobe were positively correlated with age, the correlation coefficient was 0. 638-0.820 in males and 0. 683-0.791 in females (all P<0.001). There was no significant difference in IPVV of whole lung, right lung, left lung and each lobe between male and female from 0 to 12 months (all P>0.05), but there was significant difference in IPVV of whole lung, right lung, left lung and each lobe between male and female from 13 to 36 months (all P<0.05). There were significant differences in IPVV of the whole lung, right lung, left lung and upper lobe of both lungs between boys and girls from 37 to 72 months (all P<0.05). IPVV upper/lower in the right lung (χ 2=14.00, 12.87, P=0.001, 0.002) and IPVV upper/lower in the left lung (χ 2=6.65, 22.84, P=0.036,<0.001) were significantly different in both boys and girls among 3 months of age. And with the increase of age, it showed a decreasing trend. There was no significant difference in IPVV upper/lower between boys and girls at the same age (all P>0.05).There was no significant difference in IPVV left/right among different months and between different sexes (all P>0.05). Finally, the normal reference value range of IPVV of different genders in infancy, early childhood and preschool age was calculated. Conclusions:The increase of pulmonary vessels in normal preschool children is positively correlated with age. There is no significant difference in IPVV between boys and girls in infant period, but IPVV in boys is larger than that in girls in early childhood period and preschool period. IPVV in the lower lung increased faster than that in the upper lung, but there was no significant difference between the left and right lungs.

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