1.Effect of morin on alveolar bone resorption in periodontitis mice by regulating the SIRT1/PGC-1α/Nrf2 pathway
Chunyan DING ; Ruijuan WANG ; Yijun WANG ; Liying MENG ; Guanglin FANG
China Pharmacy 2026;37(7):902-907
OBJECTIVE To investigate the effect and mechanism of morin on alveolar bone resorption in periodontitis mice based on the silent information regulator 1 (SIRT1)/peroxisome proliferator-activated receptor γ coactivator-1α (PGC-1α)/nuclear factor-erythroid 2-related factor 2 (Nrf2) pathway. METHODS The mice were randomly divided into control group, model group, morin group (40 mg/kg), SRT1720 (SIRT1 activator) group (5 mg/kg), and morin+EX527 (SIRT1 inhibitor) group (40 mg/kg morin+7.5 mg/kg EX527), with 18 mice in each group. Except for control group, mice in other groups were subjected to silk ligation to establish periodontitis model. After successful modeling, mice in each group were treated with corresponding medicinal solutions or normal saline intragastrically or intraperitoneally, once a day, for two consecutive weeks. After the last medication, serum levels of tumor necrosis factor-α (TNF-α), interleukin (IL)-1β, IL-6 and IL-10 were measured. The distance between the cementoenamel junction and alveolar bone crest was determined, and bone volume fraction and bone mineral density were calculated. Pathological changes of periodontal tissue were observed, and the number of osteoclasts was measured. mRNA expressions of receptor activator of nuclear factor-κB ligand (RANKL) and osteoprotegerin (OPG) in periodontal tissue, the levels of malondialdehyde (MDA) and superoxide dismutase (SOD) as well as protein expressions of SIRT1, PGC-1α, and Nrf2 were determined. RESULTS Compared with model group, the alveolar bone resorption and inflammatory cell infiltration in the periodontal tissues of mice were improved in morin group and SRT1720 group. The serum levels of TNF-α, IL-1β and IL-6, the distance between cementoenamel junction and alveolar bone crest, the number of osteoclasts in periodontal tissue, RANKL mRNA expression and the MDA level were decreased, shortened and reduced significantly ( P <0.05); however, serum level of IL-10, bone volume fraction and bone mineral density, OPG mRNA expression in periodontal tissue, SOD level and protein expressions of SIRT1, PGC-1α and Nrf2 were increased significantly ( P <0.05). Compared with morin group, the above pathological changes were significantly aggravated in the morin+EX527 group; and the levels of quantitative indicators were markedly reversed ( P <0.05). CONCLUSIONS Morin may inhibit alveolar bone resorption in periodontitis mice by activating the SIRT1/PGC-1α/Nrf2 pathway to reduce inflammatory reaction and oxidative stress.
2.Clinical characteristics and genetic analysis of 22 Chinese pedigrees affected with Neurofibromatosis type I.
Bingjie HU ; Xianhong DING ; Yang LU ; Hongliang CHEN ; Shuaishuai CHEN ; Mengyi XU ; Yicheng FANG ; Bo SHEN
Chinese Journal of Medical Genetics 2026;43(1):19-30
OBJECTIVE:
To explore the genetic variants and phenotypic characteristics of patients with Neurofibromatosis type I (NF1).
METHODS:
Twenty two NF1 patients who presented at Enze Medical (Center) Group in Taizhou between 2018 and 2024 were selected as the study subjects. Clinical phenotype and family history were collected for the patients. Whole exome sequencing (WES) was carried out for the 22 probands to screen the variants of NF1 gene. Candidate variants were verified by Sanger sequencing of their family members. This study was approved by the Medical Ethics Committee of the Hospital (Ethics No.: K20230902).
RESULTS:
The 22 probands were diagnosed between the age of 5 months to 47 years old, and have all shown cafe au lait spots on their skin. Seventeen patients exhibited the phenotype at birth, and 11 had various degrees of neurofibromatosis. Among them, probands 1 and 13 underwent surgical resection of the tumor but had recurred, while proband 12 had amputation due to the huge size and serious impact of the neurofibroma and had no recurrence. Five patients had various degrees of scoliosis. In total 22 germline mutations and one somatic mutation were identified among the 22 families, with 5 variants unreported previously, including 1 nonsense mutation c.1603C>T (Q535*), 3 frameshift mutations [c.7268_7269delCA (Thr2423fs), c.2293del (Arg765Alafs*26), and c.5433_5438delinsGC (Phe1812ArgfsTer50)], and 1 deletion involving exons 41-44 of the NF1 gene and adjacent introns. Proband 13 was found to harbor germline mutation c.6796C>T (Gln2266Ter) and somatic mutation c.1019_1020del (Ser340Cysfs Ter12) in the peripheral blood and tumor tissue, respectively. Among the 22 NF1 probands, 6 had received treatment due to severe illness. Proband 1 had tumor resection in the right upper limb, but was found to have malignant lung tumor and died during follow-up. Proband 12 had multiple recurrence of neurofibroma in the left ring finger. Proband 4 underwent spinal correction surgery due to severe scoliosis. Proband 11 had died due to a central nervous system disease. Among the 22 germline mutations, 6 had led to the occurrence of truncated proteins, which may have a more severe impact on the phenotype.
CONCLUSION
This study investigated the genetic variants and clinical phenotypes of 22 NF1 families and identified 5 novel variants of the NF1 gene, which has expanded the genotypic and phenotypic spectra of the NF1. Preliminary studies have identified an association between truncated mutations, young age, and severe phenotypes, which may provide important clues for prognosis evaluation. For the clinical diagnosis and treatment of NF1, it is necessary to consider the phenotypic characteristics and genetic testing in combination with genetic counseling and long-term follow-up.
Humans
;
Neurofibromatosis 1/pathology*
;
Male
;
Female
;
Pedigree
;
Adult
;
Child
;
Child, Preschool
;
Middle Aged
;
Adolescent
;
Infant
;
Young Adult
;
Neurofibromin 1/genetics*
;
Phenotype
;
Asian People/genetics*
;
Mutation
;
Exome Sequencing
;
East Asian People
3.Association between screen behaviors with overweight and obesity among children and adolescents
Chinese Journal of School Health 2026;47(4):486-489
Objective:
To investigate the prevalence of overweight and obesity among children and adolescents in Yangzhou City, and its association with screen behaviors, so as to provide scientific evidence for weight management among students.
Methods:
In May 2025, an electronic questionnaire survey was conducted among children and adolescents in Yangzhou City. A total of 3 722 participants were selected from grades 4 to 12 in 18 primary and secondary schools (108 classes) by using stratified cluster random sampling. The Chi square test was used to compare the differences in the detection rates of overweight and obesity among children and adolescents with 5 types of screen behaviors (watching TV, playing electronic games, scrolling short videos, screen based learning, electronic socializing) in different time groups each day (never, >0~<2 h, ≥2 h). Multivariate Logistic regression analysis was performed to examine the associations of five types of screen behaviors, presence of electronic devices in the bedroom, and screen use during meals on the weight status of children and adolescents.
Results:
The prevalence of overweight and obesity among children and adolescents was 37.3%. For all five types of screen behaviors, the differences in the distribution of overweight and obesity detection rates among children and adolescents across the three time spent categories were statistically significant ( χ 2=30.76- 70.78 , all P <0.01). After adjusting for confounding factors, multivariate Logistic regression analysis revealed that frequent or always using screens during meals( OR =1.63, 95% CI =1.14~2.31), playing video games ( OR =1.28, 95% CI =1.11-1.48), browsing short videos ( OR =1.29, 95% CI=1.09-1.54), and screen based learning ( OR =1.26, 95% CI =1.10-1.44) were significantly associated with overweight and obesity among children and adolescents (all P <0.05).
Conclusions
Excessive screen use is positively correlated with the incidence of overweight and obesity in children and adolescents. Targeted interventions on screen behaviors among children and adolescents are therefore warranted.
4.Effect of sacroiliac joint ankylosis on outcomes of L5/S1 transforminal lumbar interbody fusion and lumbar sagittal parameters
Yalei WANG ; Xuezhi WANG ; Tao ZHOU ; Xinxin SHEN ; Ding FANG ; Hongliang CHEN
Chinese Journal of Tissue Engineering Research 2026;30(3):634-641
BACKGROUND:The correlation between sacroiliac joint degeneration and lumbar degenerative disease has been analyzed in the literature in the past,but the clinical efficacy and imaging changes after interbody fusion with sacroiliac joint ankylosis in patients with lumbar degenerative disease have not been reported in the literature.OBJECTIVE:To investigate the effect of sacroiliac joint ankylosis on the clinical efficacy and lumbar sagittal regression after L5/S1 single-segment transforminal lumbar interbody fusion in patients with lumbar degenerative disease.METHODS:Thirty-seven patients who underwent L5/S1 segmental transforminal lumbar interbody fusion for lumbar degenerative disease with sacroiliac joint ankylosis between June 2020 and September 2023 in Affiliated Hospital of Xuzhou Medical University were retrospectively analyzed as group A.Thirty-seven patients with lumbar degenerative disease without sacroiliac joint ankylosis who were matched for general information during the same period were selected as controls in group B.Clinical efficacy was assessed using the Oswestry disability index and visual analog scale for lumbar and lower limb pain.The lumbar sagittal parameters included lumbar anterior convexity angle,lumbar partial anterior convexity angle,and lower lumbar anterior convexity angle.Pfirrmann grading was used to assess the degree of preoperative disc degeneration,postoperative endplate damage and screw loosening,and to record the fusion of the operated segments at the final postoperative follow-up visit.RESULTS AND CONCLUSION:(1)There was no statistically significant difference in age,body mass index,bone mineral density,operation time,intraoperative bleeding,preoperative primary diagnosis and postoperative follow-up time between the two groups(P>0.05).(2)The preoperative Pfirrmann grading of lumbar disc degeneration in group A patients(3.4±0.9)was significantly higher than that of group B(3.1±0.6),and the difference was statistically significant(t=2.059,P=0.044).(3)All patients showed significant improvement in postoperative lumbar sagittal parameters compared with preoperative ones(all P<0.05).During the follow-up period,there was a loss of correction in patients in group A.There was no statistical difference in the lumbar anterior convexity angle,lower lumbar anterior convexity angle,and local anterior convexity angle at the last follow-up compared with the preoperative period(P>0.05).The lumbar anterior convexity angle,lower lumbar anterior convexity angle,and local anterior convexity angle in group A were significantly lower than those of group B patients at both preoperative and final follow-up,and the differences were statistically significant(all P<0.05).(4)There was no statistically significant difference in postoperative endplate injury between the two groups(x2=0.181,P=0.670),and screw loosening was significantly higher in group A than in group B,with a statistically significant difference(x2=4.163,P=0.041).(5)At the last follow-up,the incidence of grade 3 fusion and grade 4 fusion was significantly higher in group A than in group B.The difference in the distribution of fusion grades between the two groups was statistically significant(x2=7.848,P=0.031).(6)The Oswestry disability index and lower limb visual analog scale scores at the last follow-up of both groups were significantly improved compared with the preoperative period(P<0.05).The visual analog scale scores for low back pain at 3 months after surgery and at the last follow-up of group A were significantly higher than those of group B(t=2.010,P=0.048;t=2.133,P=0.036).(7)It is concluded that regardless of whether it is accompanied by sacroiliac joint ankylosis or not,lumbar degenerative disease patients who undergo interbody fusion with foramen magnum can achieve good therapeutic effects,but lumbar degenerative disease patients with sacroiliac joint ankylosis who undergo interbody fusion with foramen magnum at the L5/S1 segments have a poorer improvement of low back pain than patients without sacroiliac joint ankylosis after the operation.Furthermore,patients with preoperative sacroiliac ankylosis who underwent L5/S1 segmental transforminal lumbar interbody fusion had a low fusion rate and were prone to loss of correction of the lumbar sagittal position.
5.Effect of sacroiliac joint ankylosis on outcomes of L5/S1 transforminal lumbar interbody fusion and lumbar sagittal parameters
Yalei WANG ; Xuezhi WANG ; Tao ZHOU ; Xinxin SHEN ; Ding FANG ; Hongliang CHEN
Chinese Journal of Tissue Engineering Research 2026;30(3):634-641
BACKGROUND:The correlation between sacroiliac joint degeneration and lumbar degenerative disease has been analyzed in the literature in the past,but the clinical efficacy and imaging changes after interbody fusion with sacroiliac joint ankylosis in patients with lumbar degenerative disease have not been reported in the literature.OBJECTIVE:To investigate the effect of sacroiliac joint ankylosis on the clinical efficacy and lumbar sagittal regression after L5/S1 single-segment transforminal lumbar interbody fusion in patients with lumbar degenerative disease.METHODS:Thirty-seven patients who underwent L5/S1 segmental transforminal lumbar interbody fusion for lumbar degenerative disease with sacroiliac joint ankylosis between June 2020 and September 2023 in Affiliated Hospital of Xuzhou Medical University were retrospectively analyzed as group A.Thirty-seven patients with lumbar degenerative disease without sacroiliac joint ankylosis who were matched for general information during the same period were selected as controls in group B.Clinical efficacy was assessed using the Oswestry disability index and visual analog scale for lumbar and lower limb pain.The lumbar sagittal parameters included lumbar anterior convexity angle,lumbar partial anterior convexity angle,and lower lumbar anterior convexity angle.Pfirrmann grading was used to assess the degree of preoperative disc degeneration,postoperative endplate damage and screw loosening,and to record the fusion of the operated segments at the final postoperative follow-up visit.RESULTS AND CONCLUSION:(1)There was no statistically significant difference in age,body mass index,bone mineral density,operation time,intraoperative bleeding,preoperative primary diagnosis and postoperative follow-up time between the two groups(P>0.05).(2)The preoperative Pfirrmann grading of lumbar disc degeneration in group A patients(3.4±0.9)was significantly higher than that of group B(3.1±0.6),and the difference was statistically significant(t=2.059,P=0.044).(3)All patients showed significant improvement in postoperative lumbar sagittal parameters compared with preoperative ones(all P<0.05).During the follow-up period,there was a loss of correction in patients in group A.There was no statistical difference in the lumbar anterior convexity angle,lower lumbar anterior convexity angle,and local anterior convexity angle at the last follow-up compared with the preoperative period(P>0.05).The lumbar anterior convexity angle,lower lumbar anterior convexity angle,and local anterior convexity angle in group A were significantly lower than those of group B patients at both preoperative and final follow-up,and the differences were statistically significant(all P<0.05).(4)There was no statistically significant difference in postoperative endplate injury between the two groups(x2=0.181,P=0.670),and screw loosening was significantly higher in group A than in group B,with a statistically significant difference(x2=4.163,P=0.041).(5)At the last follow-up,the incidence of grade 3 fusion and grade 4 fusion was significantly higher in group A than in group B.The difference in the distribution of fusion grades between the two groups was statistically significant(x2=7.848,P=0.031).(6)The Oswestry disability index and lower limb visual analog scale scores at the last follow-up of both groups were significantly improved compared with the preoperative period(P<0.05).The visual analog scale scores for low back pain at 3 months after surgery and at the last follow-up of group A were significantly higher than those of group B(t=2.010,P=0.048;t=2.133,P=0.036).(7)It is concluded that regardless of whether it is accompanied by sacroiliac joint ankylosis or not,lumbar degenerative disease patients who undergo interbody fusion with foramen magnum can achieve good therapeutic effects,but lumbar degenerative disease patients with sacroiliac joint ankylosis who undergo interbody fusion with foramen magnum at the L5/S1 segments have a poorer improvement of low back pain than patients without sacroiliac joint ankylosis after the operation.Furthermore,patients with preoperative sacroiliac ankylosis who underwent L5/S1 segmental transforminal lumbar interbody fusion had a low fusion rate and were prone to loss of correction of the lumbar sagittal position.
6.Treatment of Renal Injury in Wilson Disease Based on Pathogenesis of Latent Toxin in Kidney Collaterals
Ke DIAO ; Wenming YANG ; Xiang LI ; Yue YANG ; Yulong YANG ; Zhihong RAO ; Shuzhen FANG ; Yufeng DING
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):132-139
Hepatolenticular degeneration, also known as Wilson disease (WD), is a hereditary disease caused by mutations in the ATP7B gene, leading to copper metabolism disorders. Gene mutations result in impaired synthesis of copper-binding protein, and abnormal excretion of copper through bile leads to pathological deposition of copper in various organs, ultimately causing multi-organ damage. The insidious onset and low specificity of symptoms make it difficult to diagnose this disease. On the basis of existing studies and the theory of latent toxin, this paper proposes that latent toxin in kidney collaterals is the main pathogenesis of renal injury in WD. It is pointed out that health Qi deficiency and latent pathogen are the premises for the occurrence of this disease, and the transformation of latent pathogen into toxin is the ley pathological process. Toxin damaging kidney collaterals is the ultimate result. According to the pathogenesis, this paper proposes the treatment principle of reinforcing healthy Qi and resolving toxin and treatment based on syndrome differentiation. This review provides new ideas for the diagnosis and treatment of renal injury in WD with traditional Chinese medicine.
7.Evaluation index system of cervical cancer prevention and control literacy based on Delphi method
ZHOU Xuan ; WU Miaomiao ; HE Yiqing ; SU Fang ; DING Jinxia ; XIE Lunfang
Journal of Preventive Medicine 2025;37(4):413-416,420
Objective:
To construct an evaluation index system of cervical cancer prevention and control literacy, so as to provide an assessment tool for cervical cancer prevention and control literacy.
Methods:
The preliminary framework for cervical cancer prevention and control literacy was designed based on literature review. Twenty-one experts with both theoretical and practical experience in cervical cancer prevention and control were invited to participate in two rounds of Delphi consultation. The weights of indicators were determined by the percentage weighting method and product method, and the response rate, authority level, opinion concentration degree, and coordination degree of experts were evaluated.
Results:
Twenty-one experts participated in the consultation, including 3 males and 18 females. There were 11 experts with a doctor's degree, 7 with a master's degree and 3 with a bachelor's degree. All of them had senior professional titles and had more than 10 years of working experience. The recovery rates of the two rounds of consultations were 100.00% and 95.24%, the authority coefficients were 0.963 and 0.948, and Kendall's coefficients of concordance were 0.175 and 0.148 (both P<0.05), respectively. The final cervical cancer prevention and control literacy evaluation index system included 3 primary indicators (basic knowledge and concepts: 0.334; healthy lifestyle and behaviors: 0.338; basic skills: 0.328), 12 secondary indicators, with "capability to accurately acquire, comprehend, evaluate and apply health information" having the highest weight (0.166), and 51 tertiary indicators, with "HPV vaccination" (0.086), "consulting on relevant issues" (0.082), and "expressing personal perspectives" (0.080) having relatively higher weights.
Conclusion
The evaluation index system of cervical cancer prevention and control literacy serves as a valid assessment tool for women of appropriate age, providing the reference for developing targeted health education to enhance cervical cancer prevention and control literacy.
8.Mechanism research progress on acupuncture-moxibustion therapy for functional gastrointestinal disorders: review and prospects.
Yucheng FANG ; Jingwei ZHU ; Ziye WANG ; Kuiwu LI ; Xuechun DING ; Ning WANG ; Haoran CHU
Chinese Acupuncture & Moxibustion 2025;45(4):551-558
Acupuncture-moxibustion therapy has been known to ameliorate the symptoms of functional gastrointestinal disorders (FGIDs), although its mechanism remains unclear. The paper reviews the articles on acupuncture-moxibustion therapy for FGIDs in recent 5 years, and it is revealed that acupuncture-moxibustion therapy can alleviate FGIDs symptoms through regulating gastrointestinal motility, modulating visceral hypersensitivity, improving the impaired gastric-duodenal mucosal barrier and inflammation, balancing intestinal microbiota, and adjusting the gut-brain axis. Currently, the molecular mechanism of acupuncture-moxibustion therapy remains unknown for FGIDs, the specific disease target is not identified, and the interaction among various molecules is not elucidated adequately. The researches in the future should employ advanced technologies and methodologies to comprehensively and deeply explore and clarify the mechanism of acupuncture- moxibustion therapy for FGIDs.
Humans
;
Moxibustion
;
Acupuncture Therapy
;
Gastrointestinal Diseases/microbiology*
;
Animals
9.The SMILE study: Study of long-term methotrexate and iguratimod combination therapy in early rheumatoid arthritis.
Fang DU ; Qing DAI ; Jialin TENG ; Liangjing LU ; Shuang YE ; Ping YE ; Zhiqian LIN ; Hong DING ; Min DAI ; Chunde BAO
Chinese Medical Journal 2025;138(14):1705-1713
BACKGROUND:
Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic inflammation and joint destruction. Iguratimod (IGU) is a novel conventional synthetic disease-modifying antirheumatic drugs (csDMARD) with good efficacy and safety for the treatment of active RA in China and Japan. However, the long-term effects of IGU on the progression of bone destruction or radiographic progression in patients with active RA remain unknown. We aimed to investigate the efficacy and safety of iguratimod (IGU), a combination of methotrexate (MTX) and IGU, and IGU in patients with active rheumatoid arthritis (RA) who were naïve to MTX.
METHODS:
This multicenter, double-blind, randomized, non-inferiority clinical trial was conducted at 28 centers for over 52 weeks in China. In total, 911 patients were randomized (1:1:1) to receive MTX monotherapy (10-15 mg weekly, n = 293), IGU monotherapy (25 mg twice daily, n = 297), or IGU + MTX (10-15 mg weekly for MTX and 25 mg twice daily for IGU, n = 305) for 52 weeks. The patients' clinical characteristics, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), disease activity score in 28 joints-C-reactive protein (DAS28-CRP) level, and disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR) were assessed at baseline. The primary endpoints were the proportion of patients with ≥20% improvement according to the American College of Rheumatology (ACR20) response and changes in the van der Heijde-modified total Sharp score (vdH-mTSS) at week 52.
RESULTS:
The proportions of patients achieving an ACR20 response at week 52 were 77.44%, 77.05 %, and 65.87% for IGU monotherapy, IGU + MTX, and MTX monotherapy, respectively. The non-inferiority of IGU monotherapy to MTX monotherapy was established with the ACR20 (11.57%; 95% confidence interval [CI], 4.35-18.79%; P <0.001) and vdH-mTSS (-0.37; 95% CI, -1.22-0.47; P = 0.022). IGU monotherapy was also superior to MTX monotherapy in terms of ACR20 ( P = 0.002) but not the vdH-mTSS. The superiority of IGU + MTX over MTX monotherapy was confirmed in terms of the ACR20 (11.18%; 95% CI, 3.99-18.37%; P = 0.003), but not in the vdH-mTSS (-0.68; 95% CI, -1.46-0.11; P = 0.091). However, the difference in the incidence rates of adverse events was not statistically significant.
CONCLUSIONS:
IGU monotherapy/IGU + MTX showed a more favorable clinical response than did MTX monotherapy. IGU may have some clinical benefits over MTX in terms of radiographic progression, implying that IGU may be considered as an initial therapeutic option for patients with active RA.
TRIAL REGISTRATION
https://classic.clinicaltrials.gov/ , NCT01548001.
Adult
;
Aged
;
Female
;
Humans
;
Male
;
Middle Aged
;
Antirheumatic Agents/therapeutic use*
;
Arthritis, Rheumatoid/drug therapy*
;
Chromones/adverse effects*
;
Double-Blind Method
;
Drug Therapy, Combination
;
Methotrexate/adverse effects*
;
Treatment Outcome
;
Sulfonamides
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*


Result Analysis
Print
Save
E-mail