1.Volatile Component Differences in Xihuangwan Prepared with Natural and Artificial Musk Based on Non-targeted and Targeted Metabolomics
Jing WANG ; Fangzhu XU ; Li MENG ; Qizhen ZHU ; Huanjun ZHAO ; Caina YU ; Xuelian CHEN ; Hui GAO ; Zimin YUAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):194-201
ObjectiveHeadspace solid-phase microextraction-gas chromatography-mass spectrometry(HS-SPME-GC-MS) and GC-triple quadrupole MS(GC-QqQ-MS) in combination with non-targeted and targeted metabolomics were employed to systematically analyze the chemical composition differences of Xihuangwan prepared with natural musk and artificial musk, and establish an identification system for them. MethodsThe volatile components of 9 batches of Xihuangwan samples from 8 manufacturers were analyzed by HS-SPME-GC-MS non-targeted metabolomics, and identified by comparing their MS data with the National Institute of Standards and Technology(NIST) spectral library. Orthogonal partial least squares-discriminant analysis(OPLS-DA) was used to identify differential volatile components of Xihuangwan prepared with natural musk and artificial musk. Additionally, GC-QqQ-MS targeted metabolomics was applied to quantify the levels of α-pinene, β-elemene, muscone, dehydroepiandrosterone, bornyl acetate, and octyl acetate in 27 batches of samples from 9 manufacturers. Cluster analysis, principal component analysis(PCA), and partial least squares-discriminant analysis(PLS-DA) were conducted to further explore the differences in volatile components between Xihuangwan samples prepared with natural musk and artificial musk. ResultsNon-targeted metabolomics identified 291 volatile compounds in Xihuangwan, including alkanes, esters, alkanes, alcohols, ketones, naphthalenes and others. OPLS-DA analysis revealed distinct separation between Xihuangwan samples containing artificial musk(A1, C1, D1, E1, F1, G1, I1) and those containing natural musk(H1, H3). A total of 30 differential metabolites were identified. The relative contents of these 30 differential metabolites were visualized using a radar chart, revealing significant differences in the levels of octanol, borneol acetate and muscone. Cluster analysis and PCA results from targeted metabolomics indicated that Xihuangwan could be classified into two distinct groups:one composed of natural musk(H1, H3) and the other of artificial musk, sample H2. PLS-DA identified muscone, octyl acetate, and dehydroepiandrosterone as key differential volatile components. Although no significant difference was observed in the content of octyl acetate between the two groups, statistically significant differences were found for muscone and dehydroepiandrosterone(P<0.05). ConclusionMuscone and dehydroepiandrosterone can be used for the differentiation of Xihuangwan samples containing natural musk from those containing artificial musk. This study systematically and comprehensively analyzed the differences in the types and contents of major volatile components in Xihuangwan prepared with natural musk and artificial musk, providing a scientific basis for quality evaluation and control of Xihuangwan.
2.Volatile Component Differences in Xihuangwan Prepared with Natural and Artificial Musk Based on Non-targeted and Targeted Metabolomics
Jing WANG ; Fangzhu XU ; Li MENG ; Qizhen ZHU ; Huanjun ZHAO ; Caina YU ; Xuelian CHEN ; Hui GAO ; Zimin YUAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):194-201
ObjectiveHeadspace solid-phase microextraction-gas chromatography-mass spectrometry(HS-SPME-GC-MS) and GC-triple quadrupole MS(GC-QqQ-MS) in combination with non-targeted and targeted metabolomics were employed to systematically analyze the chemical composition differences of Xihuangwan prepared with natural musk and artificial musk, and establish an identification system for them. MethodsThe volatile components of 9 batches of Xihuangwan samples from 8 manufacturers were analyzed by HS-SPME-GC-MS non-targeted metabolomics, and identified by comparing their MS data with the National Institute of Standards and Technology(NIST) spectral library. Orthogonal partial least squares-discriminant analysis(OPLS-DA) was used to identify differential volatile components of Xihuangwan prepared with natural musk and artificial musk. Additionally, GC-QqQ-MS targeted metabolomics was applied to quantify the levels of α-pinene, β-elemene, muscone, dehydroepiandrosterone, bornyl acetate, and octyl acetate in 27 batches of samples from 9 manufacturers. Cluster analysis, principal component analysis(PCA), and partial least squares-discriminant analysis(PLS-DA) were conducted to further explore the differences in volatile components between Xihuangwan samples prepared with natural musk and artificial musk. ResultsNon-targeted metabolomics identified 291 volatile compounds in Xihuangwan, including alkanes, esters, alkanes, alcohols, ketones, naphthalenes and others. OPLS-DA analysis revealed distinct separation between Xihuangwan samples containing artificial musk(A1, C1, D1, E1, F1, G1, I1) and those containing natural musk(H1, H3). A total of 30 differential metabolites were identified. The relative contents of these 30 differential metabolites were visualized using a radar chart, revealing significant differences in the levels of octanol, borneol acetate and muscone. Cluster analysis and PCA results from targeted metabolomics indicated that Xihuangwan could be classified into two distinct groups:one composed of natural musk(H1, H3) and the other of artificial musk, sample H2. PLS-DA identified muscone, octyl acetate, and dehydroepiandrosterone as key differential volatile components. Although no significant difference was observed in the content of octyl acetate between the two groups, statistically significant differences were found for muscone and dehydroepiandrosterone(P<0.05). ConclusionMuscone and dehydroepiandrosterone can be used for the differentiation of Xihuangwan samples containing natural musk from those containing artificial musk. This study systematically and comprehensively analyzed the differences in the types and contents of major volatile components in Xihuangwan prepared with natural musk and artificial musk, providing a scientific basis for quality evaluation and control of Xihuangwan.
3.Effect of Modified Tuoli Xiaodusan on Patients After Perianal Abscess Surgery on STAT3/VEGF Pathway
Haoyang DU ; Yuan GAO ; Haiqi FU ; Jinling HE ; Jing ZHANG ; Yangyang YU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):187-195
ObjectiveTo explore the clinical efficacy of oral administration of modified Tuoli Xiaodusan on postoperative patients with perianal abscess, and its effects on related inflammatory factors and signal transducers and activators of transcription protein 3 (STAT3)/vascular endothelial growth factor (VEGF) signaling pathways. MethodsFrom January 2023 to December 2023 in Inner Mongolia hospital of traditional Chinese medicine, 60 postoperative patients with perianal abscess who met the inclusion criteria were selected. They were divided into a treatment group and a control group using the random number table method, with 30 cases in each group. The control group received conventional treatment, while the treatment group received additional treatment with modified Tuoli Xiaodusan on the basis of the control group. The course of treatment in both groups was three weeks. On the day of operation and on the 7th, 14th and 21st day after operation, enzyme-linked immunosorbent assay (ELISA) was used to measure the expression levels of serum interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α). Hematoxylin eosin (HE) staining was used to observe the pathological morphology of pathological tissue. Western blot was used to measure the levels of phosphorylated STAT3 (p-STAT3) and vascular endothelial growth factor (VEGF) proteins, and real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was used to determine the expression level of VEGF mRNA. The clinical efficacy of the two groups was compared according to the wound pain, secretion volume score, and healing rate of patients on the 3rd, 7th, 14th, and 21st day after operation. ResultsThe total effective rate of the treatment group was higher than that of the control group (P<0.05). For intra-group comparison, the pain score of the control group decreased at each time period (P<0.05), and the healing rate increased (P<0.05). The secretion volume score decreased on the 14th and 21st days after operation (P<0.05). The pain score and secretion volume score of the treatment group decreased at each time period (P<0.05), and the healing rate increased (P<0.05). The levels of various inflammatory factors decreased in both groups (P<0.05). Compared with those on the surgical day, the levels of p-STAT3 and VEGF proteins in the wound tissue of the two groups were different on the 7th and 21st days after operation (P<0.05). There were significant differences in VEGF mRNA levels in wound tissue between the two groups at each time period (P<0.01). For inter-group comparison, on the 7th and 14th days after operation, the pain score in the treatment group was lower than that in the control group. On the 7th, 14th and 21st days after operation, the secretion volume scores and healing rate of the treatment group were better than those of the control group (P<0.05). The levels of various inflammatory factors in the treatment group were lower than those in the control group (P<0.05), and the decline rate was faster (P<0.05). On the 7th day after operation, the levels of p-STAT3, VEGF protein, and VEGF mRNA in the wound tissue of the treatment group were higher than those in the control group (P<0.05). HE staining showed that the inflammatory cell infiltration in the treatment group decreased faster. The cell arrangement was more orderly, and new blood vessel lumens were visible. There were no abnormalities in the safety observation indexes of all patients during the study period. ConclusionModified Tuoli Xiaodusan can relieve wound pain after perianal abscess surgery, reduce secretions, and improve wound healing rate. The mechanism may be reducing the levels of serum IL-1β, IL-6, and TNF-α, reducing the inflammatory response of the wound, upregulating the expression of p-STAT3 and VEGF proteins, and stimulating the STAT3/VEGF signaling pathway, thereby accelerating angiogenesis and promoting wound healing.
4.Analysis of related factors for the comorbidity of allergic rhinitis and obesity among primary and secondary school students in Inner Mongolia
Chinese Journal of School Health 2026;47(1):27-31
Objective:
To investigate the factors influencing the co-prevalence of allergic rhinitis and obesity among primary and secondary school students in Inner Mongolia, so as to provide a data foundation and theoretical basis for developing targeted intervention measures.
Methods:
In September and October 2024, a stratified cluster random sampling method was employed to select 139 102 students from 539 schools across 12 leagues/cities and 103 banners/counties in Inner Mongolia Autonomous Region. Participants who were diagnosed with allergic rhinitis by a doctor at least once within one year and had a body mass index ≥ 28 kg/m 2 were considered to have comorbid conditions.
Results:
The coprevalence rate of allergic rhinitis and obesity among primary and secondary school students in Inner Mongolia was 6.4% (8 931 cases). Lasso-Logistic regression revealed that nonboarding status, higher maternal education, consuming high protein foods ≥1 time daily, occasionally or never eating breakfast, engaging in moderate to vigorous physical activity for ≥60 minutes on fewer than half of holidays, and having been exposed to second hand smoke in person within the past seven days were associated with higher odds ratios for co-prevalence of allergic rhinitis and obesity( OR = 1.23 , 1.22-1.63, 1.20, 1.19, 1.38, 1.35); being female, higher grade level, residence in flag/county/district areas, non only child status, never having consumed a full glass of alcohol, non hypertensive status, and households without pets were associated with lower co-prevalence risks ( OR =0.65, 0.67-0.77, 0.81, 0.87, 0.73, 0.41, 0.68) (all P <0.05). The ROC curve indicated an area under the curve of 0.64 for the predictive model, demonstrating satisfactory discriminatory ability. The calibration curve showed consistency between predicted and actual occurrence probabilities.
Conclusions
The co-prevalence of allergic rhinitis and obesity among primary and secondary school students in Inner Mongolia is closely associated with demographic characteristics, dietary behaviours, and lifestyle habits. Future prevention and control strategies should prioritize these factors to implement targeted interventions.
5.Trends and influencing factors in China's life expectancy from a Global Perspective
Jiayan GAO ; Yueyun ZENG ; Jing WANG ; Chuanhua YU
Journal of Public Health and Preventive Medicine 2026;37(3):1-7
Objective To systematically analyze the trends in life expectancy and healthy life expectancy in China from 1990 to 2023, identify the factors influencing changes in life expectancy, and provide scientific evidence for the Healthy China Strategy. Methods Based on the most recent authoritative data from the Global Burden of Disease Study 2023 (GBD 2023), the United Nations Population Division, the World Bank, and Our World in Data, complete life tables and cause-deleted life tables were constructed. Analytical methods including Joinpoint regression and ARIMA forecasting were comprehensively applied to systematically evaluate life expectancy, survival probability, and the burden of diseases and risk factors. Results From 1990 to 2023, life expectancy at birth in China exhibited sustained and rapid growth (average annual percentage change, AAPC = 0.63%), with a growth rate significantly higher than those observed in the United States, Japan, and the global average (AAPC = 0.12%, 0.21%, and 0.45%, respectively). Survival probability improved across all age groups, with particularly notable gains in children and the oldest-old. Interprovincial and sex-based disparities persisted. Cause-deleted analysis revealed that cardiovascular disease (CVD) accounted for the greatest loss in life expectancy at birth. From 2004 to 2020, years of life lost due to CVD increased annually, reaching 8.70 years in 2020 for the zero-age group in China. Neoplasm ranked second in causing life expectancy loss, which remained relatively stable at approximately 3 years over the study period. Among risk factors, tobacco use, hypertension, air pollution, dietary risks, and high fasting plasma glucose were identified as prominent contributors to life expectancy loss. Strong positive correlations were observed between health resources, economic growth, and life expectancy. Conclusion China has made remarkable progress in extending lifespan and improving quality of life, but it still faces challenges such as chronic diseases limiting lifespan and life quality, diverse health risks, and disparities in health levels and life expectancy across regions and populations.
6.Efficacy of Zishen Huoxue Formula in treatment of molecular-targeted therapy-associated proteinuria in patients with primary liver cancer
Jing JING ; Aozhe ZHANG ; Simiao YU ; Xin WANG ; Yongqiang SUN ; Yiling WANG ; Ruixin GAO ; Yinying LU ; Xiaohe XIAO ; Ruilin WANG
Journal of Clinical Hepatology 2026;42(4):874-881
ObjectiveTo investigate the effect of Zishen Huoxue Formula (ZSXHF) on molecular-targeted therapy-associated proteinuria in patients with primary liver cancer (PLC), to assess the efficacy of ZSXHF in the treatment of molecular-targeted therapy-associated proteinuria, and to provide a basis for clinical medication. MethodsA retrospective cohort study was conducted among the PLC patients with molecular-targeted therapy-associated proteinuria who were diagnosed and treated in The Department of Hepatology of Chinese PLA General Hospital, from January 1, 2022 to July 1, 2025. With ZSXHF treatment as the exposure factor, the patients with a cumulative treatment duration of ≥9 weeks were enrolled as traditional Chinese medicine (TCM) group, while those without TCM treatment were enrolled as control group. Propensity score matching was performed for the two groups at a ratio of 1∶1 based on sex, age, 24-hour urinary protein, blood urea nitrogen, and serum creatinine. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test was used for comparison of categorical data between groups. Univariate and multivariate Logistic regression analyses were used to investigate the influencing factors for promoting the improvement of targeted-therapy-associated proteinuria. ResultsA total of 137 PLC patients with targeted-therapy-associated proteinuria were enrolled, with 34 patients in the TCM group and 103 in the control group. After follow-up for 6 months, the TCM group had a significant improvement in urinary protein grade compared with the control group (χ2=9.261, P=0.016). There were 25 patients in each group after propensity score matching, and after follow-up for 6 months, there were significant differences between the two groups in urinary protein grade (χ2=15.689, P<0.001) and 24-hour urinary protein (Z=-3.075, P=0.002). After cumulative treatment with ZSXHF for ≥9 weeks, the TCM group had a significantly greater change in 24-hour urinary protein from baseline compared with the control group (t=-2.514, P=0.016), while there were no significant differences in the changes in liver and renal function after ZSXHF intervention between the two groups (all P>0.05). The multivariate Logistic regression analysis showed that ZSXHF treatment (odds ratio=2.901, 95% confidence interval: 1.135 — 7.417, P=0.026) was an independent influencing factor for improvement in molecular-targeted therapy-associated proteinuria. ConclusionZSHXF can effectively alleviate molecular-targeted therapy-associated proteinuria in PLC patients with a favorable safety profile, which provides a new reference for TCM prevention and treatment of molecular-targeted therapy-associated adverse reactions in PLC patients.
7.Targeting farnesoid X receptor as aging intervention therapy.
Lijun ZHANG ; Jing YU ; Xiaoyan GAO ; Yingxuan YAN ; Xinyi WANG ; Hang SHI ; Minglv FANG ; Ying LIU ; Young-Bum KIM ; Huanhu ZHU ; Xiaojun WU ; Cheng HUANG ; Shengjie FAN
Acta Pharmaceutica Sinica B 2025;15(3):1359-1382
Environmental toxicants have been linked to aging and age-related diseases. The emerging evidence has shown that the enhancement of detoxification gene expression is a common transcriptome marker of long-lived mice, Drosophila melanogaster, and Caenorhabditis elegans. Meanwhile, the resistance to toxicants was increased in long-lived animals. Here, we show that farnesoid X receptor (FXR) agonist obeticholic acid (OCA), a marketed drug for the treatment of cholestasis, may extend the lifespan and healthspan both in C. elegans and chemical-induced early senescent mice. Furthermore, OCA increased the resistance of worms to toxicants and activated the expression of detoxification genes in both mice and C. elegans. The longevity effects of OCA were attenuated in Fxr -/- mice and Fxr homologous nhr-8 and daf-12 mutant C. elegans. In addition, metabolome analysis revealed that OCA increased the endogenous agonist levels of the pregnane X receptor (PXR), a major nuclear receptor for detoxification regulation, in the liver of mice. Together, our findings suggest that OCA has the potential to lengthen lifespan and healthspan by activating nuclear receptor-mediated detoxification functions, thus, targeting FXR may offer to promote longevity.
8.Carvedilol to prevent hepatic decompensation of cirrhosis in patients with clinically significant portal hypertension stratified by new non-invasive model (CHESS2306)
Chuan LIU ; Hong YOU ; Qing-Lei ZENG ; Yu Jun WONG ; Bingqiong WANG ; Ivica GRGUREVIC ; Chenghai LIU ; Hyung Joon YIM ; Wei GOU ; Bingtian DONG ; Shenghong JU ; Yanan GUO ; Qian YU ; Masashi HIROOKA ; Hirayuki ENOMOTO ; Amr Shaaban HANAFY ; Zhujun CAO ; Xiemin DONG ; Jing LV ; Tae Hyung KIM ; Yohei KOIZUMI ; Yoichi HIASA ; Takashi NISHIMURA ; Hiroko IIJIMA ; Chuanjun XU ; Erhei DAI ; Xiaoling LAN ; Changxiang LAI ; Shirong LIU ; Fang WANG ; Ying GUO ; Jiaojian LV ; Liting ZHANG ; Yuqing WANG ; Qing XIE ; Chuxiao SHAO ; Zhensheng LIU ; Federico RAVAIOLI ; Antonio COLECCHIA ; Jie LI ; Gao-Jun TENG ; Xiaolong QI
Clinical and Molecular Hepatology 2025;31(1):105-118
Background:
s/Aims: Non-invasive models stratifying clinically significant portal hypertension (CSPH) are limited. Herein, we developed a new non-invasive model for predicting CSPH in patients with compensated cirrhosis and investigated whether carvedilol can prevent hepatic decompensation in patients with high-risk CSPH stratified using the new model.
Methods:
Non-invasive risk factors of CSPH were identified via systematic review and meta-analysis of studies involving patients with hepatic venous pressure gradient (HVPG). A new non-invasive model was validated for various performance aspects in three cohorts, i.e., a multicenter HVPG cohort, a follow-up cohort, and a carvediloltreating cohort.
Results:
In the meta-analysis with six studies (n=819), liver stiffness measurement and platelet count were identified as independent risk factors for CSPH and were used to develop the new “CSPH risk” model. In the HVPG cohort (n=151), the new model accurately predicted CSPH with cutoff values of 0 and –0.68 for ruling in and out CSPH, respectively. In the follow-up cohort (n=1,102), the cumulative incidences of decompensation events significantly differed using the cutoff values of <–0.68 (low-risk), –0.68 to 0 (medium-risk), and >0 (high-risk). In the carvediloltreated cohort, patients with high-risk CSPH treated with carvedilol (n=81) had lower rates of decompensation events than non-selective beta-blockers untreated patients with high-risk CSPH (n=613 before propensity score matching [PSM], n=162 after PSM).
Conclusions
Treatment with carvedilol significantly reduces the risk of hepatic decompensation in patients with high-risk CSPH stratified by the new model.
9.Percutaneous coronary intervention vs . medical therapy in patients on dialysis with coronary artery disease in China.
Enmin XIE ; Yaxin WU ; Zixiang YE ; Yong HE ; Hesong ZENG ; Jianfang LUO ; Mulei CHEN ; Wenyue PANG ; Yanmin XU ; Chuanyu GAO ; Xiaogang GUO ; Lin CAI ; Qingwei JI ; Yining YANG ; Di WU ; Yiqiang YUAN ; Jing WAN ; Yuliang MA ; Jun ZHANG ; Zhimin DU ; Qing YANG ; Jinsong CHENG ; Chunhua DING ; Xiang MA ; Chunlin YIN ; Zeyuan FAN ; Qiang TANG ; Yue LI ; Lihua SUN ; Chengzhi LU ; Jufang CHI ; Zhuhua YAO ; Yanxiang GAO ; Changan YU ; Jingyi REN ; Jingang ZHENG
Chinese Medical Journal 2025;138(3):301-310
BACKGROUND:
The available evidence regarding the benefits of percutaneous coronary intervention (PCI) on patients receiving dialysis with coronary artery disease (CAD) is limited and inconsistent. This study aimed to evaluate the association between PCI and clinical outcomes as compared with medical therapy alone in patients undergoing dialysis with CAD in China.
METHODS:
This multicenter, retrospective study was conducted in 30 tertiary medical centers across 12 provinces in China from January 2015 to June 2021 to include patients on dialysis with CAD. The primary outcome was major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. Secondary outcomes included all-cause death, the individual components of MACE, and Bleeding Academic Research Consortium criteria types 2, 3, or 5 bleeding. Multivariable Cox proportional hazard models were used to assess the association between PCI and outcomes. Inverse probability of treatment weighting (IPTW) and propensity score matching (PSM) were performed to account for potential between-group differences.
RESULTS:
Of the 1146 patients on dialysis with significant CAD, 821 (71.6%) underwent PCI. After a median follow-up of 23.0 months, PCI was associated with a 43.0% significantly lower risk for MACE (33.9% [ n = 278] vs . 43.7% [ n = 142]; adjusted hazards ratio 0.57, 95% confidence interval 0.45-0.71), along with a slightly increased risk for bleeding outcomes that did not reach statistical significance (11.1% vs . 8.3%; adjusted hazards ratio 1.31, 95% confidence interval, 0.82-2.11). Furthermore, PCI was associated with a significant reduction in all-cause and cardiovascular mortalities. Subgroup analysis did not modify the association of PCI with patient outcomes. These primary findings were consistent across IPTW, PSM, and competing risk analyses.
CONCLUSION
This study indicated that PCI in patients on dialysis with CAD was significantly associated with lower MACE and mortality when comparing with those with medical therapy alone, albeit with a slightly increased risk for bleeding events that did not reach statistical significance.
Humans
;
Percutaneous Coronary Intervention/methods*
;
Male
;
Female
;
Coronary Artery Disease/drug therapy*
;
Retrospective Studies
;
Renal Dialysis/methods*
;
Middle Aged
;
Aged
;
China
;
Proportional Hazards Models
;
Treatment Outcome
10.Programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in patients with advanced non-small cell lung cancer: A retrospective, multicenter, observational study.
Yuequan SHI ; Xiaoyan LIU ; Anwen LIU ; Jian FANG ; Qingwei MENG ; Cuimin DING ; Bin AI ; Yangchun GU ; Cuiying ZHANG ; Chengzhi ZHOU ; Yan WANG ; Yongjie SHUI ; Siyuan YU ; Dongming ZHANG ; Jia LIU ; Haoran ZHANG ; Qing ZHOU ; Xiaoxing GAO ; Minjiang CHEN ; Jing ZHAO ; Wei ZHONG ; Yan XU ; Mengzhao WANG
Chinese Medical Journal 2025;138(14):1730-1740
BACKGROUND:
This study aimed to investigate programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in treating patients with advanced non-small cell lung cancer (NSCLC) in a real-world setting.
METHODS:
This retrospective, multicenter, observational study enrolled adult patients who received PD-1/PD-L1 antibody-based therapy in China and met the following criteria: (1) had pathologically confirmed, unresectable stage III-IV NSCLC; (2) had a baseline PD-L1 tumor proportion score (TPS); and (3) had confirmed efficacy evaluation results after PD-1/PD-L1 treatment. Logistic regression, Kaplan-Meier analysis, and Cox regression were used to assess the progression-free survival (PFS), overall survival (OS), and immune-related adverse events (irAEs) as appropriate.
RESULTS:
A total of 409 patients, 65.0% ( n = 266) with a positive PD-L1 TPS (≥1%) and 32.8% ( n = 134) with PD-L1 TPS ≥50%, were included in this study. Cox regression confirmed that patients with a PD-L1 TPS ≥1% had significantly improved PFS (hazard ratio [HR] 0.747, 95% confidence interval [CI] 0.573-0.975, P = 0.032). A total of 160 (39.1%) patients experienced 206 irAEs, and 27 (6.6%) patients experienced 31 grade 3-5 irAEs. The organs most frequently associated with irAEs were the skin (52/409, 12.7%), thyroid (40/409, 9.8%), and lung (34/409, 8.3%). Multivariate logistic regression revealed that a PD-L1 TPS ≥1% (odds ratio [OR] 1.713, 95% CI 1.054-2.784, P = 0.030) was an independent risk factor for irAEs. Other risk factors for irAEs included pretreatment absolute lymphocyte count >2.5 × 10 9 /L (OR 3.772, 95% CI 1.377-10.329, P = 0.010) and pretreatment absolute eosinophil count >0.2 × 10 9 /L (OR 2.006, 95% CI 1.219-3.302, P = 0.006). Moreover, patients who developed irAEs demonstrated improved PFS (13.7 months vs. 8.4 months, P <0.001) and OS (28.0 months vs. 18.0 months, P = 0.007) compared with patients without irAEs.
CONCLUSIONS
A positive PD-L1 TPS (≥1%) was associated with improved PFS and an increased risk of irAEs in a real-world setting. The onset of irAEs was associated with improved PFS and OS in patients with advanced NSCLC receiving PD-1/PD-L1-based therapy.
Humans
;
Carcinoma, Non-Small-Cell Lung/metabolism*
;
Male
;
Female
;
Retrospective Studies
;
Middle Aged
;
Lung Neoplasms/metabolism*
;
Aged
;
B7-H1 Antigen/metabolism*
;
Programmed Cell Death 1 Receptor/metabolism*
;
Adult
;
Aged, 80 and over
;
Immune Checkpoint Inhibitors/therapeutic use*


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