1.Systematic review of the relationship between dynamic changes in inflammatory markers and therapeutic efficacy in NSCLC patients during EGFR-TKIs therapy
Liying WU ; Jingyi YANG ; Yating ZENG ; Ling YONG ; Weifeng SHAO ; Wei LIU
China Pharmacy 2026;37(11):1490-1495
OBJECTIVE To systematically evaluate the correlation between dynamic changes in inflammatory markers during treatment with epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) in non-small cell lung cancer (NSCLC) patients and therapeutic efficacy, with the aim of providing evidence-based support for clinical prognosis assessment and treatment strategy adjustment. METHODS Databases including PubMed, Embase, Cochrane Library, CNKI, Wanfang Data, and CBM were searched from the inception to July 20, 2025. Following literature screening, data extraction and quality assessment, descriptive analysis was conducted on the outcomes of included studies. RESULTS A total of eight studies were included to analyze the correlation of 6 inflammatory markers before and after treatment with EGFR-TKIs with therapeutic efficacy. The risk of bias assessment identified six high-quality studies and two moderate-quality studies. Among these studies, seven studies demonstrated that lower levels of neutrophil-to-lymphocyte ratio (NLR), derived neutrophil-to-lymphocyte ratio (dNLR), platelet-to-lymphocyte ratio (PLR), and monocyte-to-lymphocyte ratio (MLR), higher lymphocyte-to-monocyte ratio (LMR) before treatment, as well as decreased NLR and MLR and increased LMR after treatment were associated with longer median progression-free survival. Five studies indicated that lower levels of NLR, dNLR, PLR, and interleukin-6 (IL-6), higher LMR before treatment as well as decreased NLR and dNLR and increased LMR were associated with longer median overall survival. Three studies indicated that lower levels of IL-6 were associated with a higher objective response rate, while the association of these markers after treatment remained controversial; another study showed that an early decline in NLR, MLR, and PLR after treatment may be associated with objective response benefit. CONCLUSIONS Lower inflammatory levels during EGFR-TKIs therapy correlate with better therapeutic efficacy in NSCLC patients.
2.Exploring Content and Distribution Patterns of 22 Ginsenosides in Stems and Leaves of Panax ginseng with Different Stem Colors by UHPLC-QqQ-MS
Tianxin ZHANG ; Yang YANG ; Jiabing ZHANG ; Lixia WANG ; Xiaoxu CHEN ; Xiaoyu ZHU ; Dade YU ; Hongwei WU ; Zhuju WANG ; Kaiyang LIU ; Liying TANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(21):198-209
ObjectiveTo systematically elucidate the accumulation characteristics of secondary metabolites in the stems and leaves of Panax ginseng with different stem colors. MethodsUltra-high-performance liquid chromatography-triple quadrupole-tandem mass spectrometry (UHPLC-QqQ-MS) was employed to determine the of 22 ginsenosides in the stems and leaves of 2- to 5-year-old P. ginseng plants with green and purple stems. Principal component analysis (PCA), orthogonal partial least squares-discriminant analysis (OPLS-DA), and one-way analysis of variance (ANOVA) were performed to explore the distribution patterns of ginsenosides from three dimensions: tissue distribution, growth duration, and stem color. Results① Tissue distribution: Leaves served as the primary organ for ginsenoside accumulation, exhibiting significantly higher total ginsenoside content than stems, which indicated distinct tissue-specific distribution of ginsenosides. ② Growth duration: Ginsenoside levels in stems generally peaked in the 2-year-old plants before stabilizing, while those in leaves displayed a declining-rebounding pattern, indicating that the 2-year-old plants (harvest stage) was a critical time point for the resurgence of leaf ginsenosides. ③ Stem color: A stage-specific correlation was observed between stem color and ginsenoside accumulation. In stems, the early-growth stage (2-year-old) of purple-stemmed plants exhibited higher content of specific ginsenosides (e.g., ginsenoside Rk1 and notoginsenoside R1), which may be associated with its stronger early-stage stress resistance. In leaves, the content of core ginsenosides (e.g., ginsenosides Re and Rd) in 5-year-old plants with green stems showed a surpassing trend, demonstrating higher potential of resource development. ConclusionThe accumulation of ginsenosides in P. ginseng stems and leaves is multidimensionally regulated by tissue type, growth duration, and stem color phenotypes. Purple-stemmed plants exhibit early-stage specific ginsenoside accumulation and stress resistance potential, whereas green-stemmed plants are more advantageous for core leaf ginsenoside development at the harvest stage. The findings confirm that aboveground stem color can serve as a biomarker for directed breeding and efficient resource utilization of P. ginseng.
3.Exploring Content and Distribution Patterns of 22 Ginsenosides in Stems and Leaves of Panax ginseng with Different Stem Colors by UHPLC-QqQ-MS
Tianxin ZHANG ; Yang YANG ; Jiabing ZHANG ; Lixia WANG ; Xiaoxu CHEN ; Xiaoyu ZHU ; Dade YU ; Hongwei WU ; Zhuju WANG ; Kaiyang LIU ; Liying TANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(21):198-209
ObjectiveTo systematically elucidate the accumulation characteristics of secondary metabolites in the stems and leaves of Panax ginseng with different stem colors. MethodsUltra-high-performance liquid chromatography-triple quadrupole-tandem mass spectrometry (UHPLC-QqQ-MS) was employed to determine the of 22 ginsenosides in the stems and leaves of 2- to 5-year-old P. ginseng plants with green and purple stems. Principal component analysis (PCA), orthogonal partial least squares-discriminant analysis (OPLS-DA), and one-way analysis of variance (ANOVA) were performed to explore the distribution patterns of ginsenosides from three dimensions: tissue distribution, growth duration, and stem color. Results① Tissue distribution: Leaves served as the primary organ for ginsenoside accumulation, exhibiting significantly higher total ginsenoside content than stems, which indicated distinct tissue-specific distribution of ginsenosides. ② Growth duration: Ginsenoside levels in stems generally peaked in the 2-year-old plants before stabilizing, while those in leaves displayed a declining-rebounding pattern, indicating that the 2-year-old plants (harvest stage) was a critical time point for the resurgence of leaf ginsenosides. ③ Stem color: A stage-specific correlation was observed between stem color and ginsenoside accumulation. In stems, the early-growth stage (2-year-old) of purple-stemmed plants exhibited higher content of specific ginsenosides (e.g., ginsenoside Rk1 and notoginsenoside R1), which may be associated with its stronger early-stage stress resistance. In leaves, the content of core ginsenosides (e.g., ginsenosides Re and Rd) in 5-year-old plants with green stems showed a surpassing trend, demonstrating higher potential of resource development. ConclusionThe accumulation of ginsenosides in P. ginseng stems and leaves is multidimensionally regulated by tissue type, growth duration, and stem color phenotypes. Purple-stemmed plants exhibit early-stage specific ginsenoside accumulation and stress resistance potential, whereas green-stemmed plants are more advantageous for core leaf ginsenoside development at the harvest stage. The findings confirm that aboveground stem color can serve as a biomarker for directed breeding and efficient resource utilization of P. ginseng.
4.Application of next-generation sequencing technology for the investigation of immunoglobulin variable region characteristics and their prognostic significance in patients with chronic lymphocytic leukemia
Zhen GUO ; Huimin JIN ; Tonglu QIU ; Liying ZHU ; Yujie WU ; Hairong QIU ; Yan WANG ; Yi MIAO ; Hui JIN ; Lei FAN ; Jianyong LI ; Yi XIA ; Chun QIAO
Chinese Journal of Hematology 2025;46(3):261-268
Objective:To elucidate the genomic characteristics of the immunoglobulin (IG) heavy-chain variable region and light-chain variable region, the expression of subclones, and the prognostic significance in patients with CLL.Methods:Blood and/or bone marrow specimens were gathered from a cohort of 36 patients with CLL diagnosed at Jiangsu Province Hospital from December 2018 to May 2023, including 12 cases of B cell receptor (BCR) stereotyped patients. IG heavy-chain (IGH) and light-chain (IG Kappa [IGK] and IG lambda [IGL]) gene rearrangements were performed using next-generation sequencing (NGS) technology to analyze the characteristics and prognostic value in CLL.Results:NGS detection of IG variable region (IGHV) demonstrated a significant correlation and superior consistency with Sanger sequencing ( r=0.957, P < 0.001). Among the 36 patients, the IGH variant (IGHV) was observed in 9 (25.0%) but not in 27 (75.0%) participants. The incidence of the MYD88 mutation was higher among patients with mutated IGHV [1/27 (3.7%) vs 4/9 (44.4%), P=0.00]. A high incidence of trisomy 12 was observed in the IGHV #8/#8B subset [4/11 (36.4%) vs 1/25 (4.0%), P=0.023], which were more likely to develop Richter transformation [8/11 (72.7%) vs 4/25 (16.0%), P=0.002]. In the patient cohort, 36 individuals (36/36, 100.0%) used the IGK variable, whereas 15 individuals (15/36, 41.7%) employed the IGL variable (IGLV). IGLV3 - 21 reported the highest utilization rate in IGLV (5/15, 33.3%). Remarkably, patients with CLL with IGLV3-21 fragments were exclusively observed in the Binet C stage and Rai Phase Ⅲ-Ⅳ, with an incidence of del (13) (q14) at 60.0% (3/5). The median time to first treatment (TTFT) of patients with or without IGLV3 - 21 fragments was 5.2 (1.1 - 41.5) and 9.9 (0.1 - 94.4) months, respectively. Using the total reads threshold of 2.5%, 4 (4/36, 11.1%) samples were detected to have two IGHV productive clones. The median TTFT and overall survival (OS) time were 2.8 (0.9-72.7) and 12.8 months in patients with one mutated clone and 57.5 (32.0-120.7) and 51.8 months in those with two mutated clones, respectively. The median TTFT and OS time were 10.9 (0.3-94.4) and 6.3 (0.1 - 12.5) months in patients with one unmutated clone and 49.9 (22.2 - 211.1) and 30.0 (9.6 - 50.3) months in those with multiple unmutated clones, respectively ( P>0.05) . Conclusions:Detection of IG gene rearrangements using NGS technology not only facilitates the analysis of the IGHV mutation status, dominant clones, and prognostic value but also contributes to the exploration of IGK/IGL gene rearrangement fragments and the utilization of subclones. Further, it provides information about the poor prognosis of IGLV3 - 21 CLL. The shortened survival of the two unmutated clone groups in the IGHV unmutated group may indicate a poor prognosis.
5.Impacts of percutaneous endoscopic interlaminar discectomy on pain and lumbar function in patients with lumbar disc herniation
Liying CAO ; Mingjing JIANG ; Binzhen LIN ; Xiaofeng YIN ; Nan ZHONG ; Chunxiang CHEN ; Qinghua WU ; Kaiming CHEN
China Journal of Endoscopy 2025;31(3):46-52
Objective To investigate the impacts of percutaneous endoscopic interlaminar discectomy(PEID)on pain level and lumbar function in patients with lumbar disc herniation(LDH).Methods From January 2022 to August 2023,84 patients were diagnosed with L4/5 LDH based on clinical data and imaging information were selected as the study subjects.And they were assigned into 42 cases in experimental group and 42 cases in traditional groups complying with treatment methods.The traditional group underwent traditional open approach treatment,while the experimental group underwent PEID.The surgical indicators(including hospitalization time,surgical time,bed rest time,and intraoperative fluoroscopy frequency),the levels of interleukin-6(IL-6)and tumor necrosis factor-α(TNF-α)were compared between the two groups,the visual analogue scale(VAS)score and Oswestry disability index(ODI)were used to quantify the pain level of waist and lower limbs and lumbar function,and the excellent and good rate of clinical satisfaction and the incidence of complications were compared.Results The hospitalization time and bed rest time of the experimental group were obviously shorter than those of the traditional group,while the fluoroscopy frequency was less than that of the traditional group,and surgical time was longer than that of the traditional group,the differences were statistically significant(P<0.05).After treatment,the pain VAS score and ODI of waist and lower limbs,the IL-6,and TNF-α in the two groups were lower than those before treatment,the experimental group was lower than the traditional group,the differences were statistically significant(P<0.05).The excellent and good rate of the experimental group and the traditional group were 88.10%and 83.33%,respectively,with no statistically significant difference(P>0.05).There was no statistically significant difference in the total incidence of complications between the two groups(P>0.05).Conclusion PEID surgery can effectively alleviate nerve compression,alleviate pain of waist and lower limbs,promote the recovering of lumbar function,and facilitate postoperative recovery in LDH patients.
6.Joint analysis of invasive margins and tumor center to evaluate the prognostic value of bystander CD8 + T cells in early-stage non-small cell lung cancer
Hao YANG ; Liying YANG ; Miaoqing ZHAO ; Li WU ; Yushan YAN ; Yimin ZHAO ; Ligang XING ; Xiaorong SUN
Chinese Journal of Oncology 2025;47(6):508-516
Objective:The impact of bystander CD8 + T cells (CD8 + Tbys) within the tumor microenvironment on the prognosis of early-stage non-small cell lung cancer (NSCLC) remains unclear, particularly concerning their infiltration differences at the invasive margin (IM) and tumor center (TC). Methods:We retrospectively collected postoperative specimens from 173 patients with primary early-stage NSCLC who underwent radical surgery at the Affiliated Tumor Hospital of Shandong First Medical University from 2014 to 2018. Tissue microarrays encompassing IM and TC regions were prepared and subjected to multicolor immunofluorescence staining (CK/CD8/CD103/DAPI). Image processing and phenotype recognition (CD8 + T cells, CK -CD8 +; CD8 + T bys, CK -CD8 +CD103 -) were performed using inFrom software, and automatic quantitative cell density analysis was conducted using R language. Differences in CD8 + T and CD8 + T bys densities at IM and TC were analyzed using the Mann-Whitney U test. The relationship between CD8 + T, CD8 + T bys and clinicopathological features was examined using the Kruskal-Wallis H test. The impact of CD8 + T and CD8 + T bys on recurrence-free survival (RFS) was evaluated using Kaplan-Meier, log-rank, and Cox proportional hazards models. Results:A total of 173 patients with stage ⅠA-ⅡA NSCLC were included, with a recurrence rate of 26.6% (46/173) and a median RFS of 62.3 months (range: 44.7-71.9 months). CD8 + T and CD8 + T bys densities (1/1 000) were significantly higher in the IM region than in the TC region [70(32, 155) vs. 37(18, 88), P<0.001; 25(11, 46) vs. 18(7, 34), P=0.002]. No significant association was found between CD8 + T, CD8 + T bys and age, gender, smoking history, histological type, or pathological stage (all P>0.05). Patients with low-density IM CD8 + T cells had lower RFS compared to those with high-density IM CD8 + T cells ( P=0.021; median RFS not reached), Further analysis revealed that patients with low-density IM CD8 + T bys cell had lower RFS compared to those with high-density IM CD8 + T bys ( P=0.047; median RFS not reached), and low-density IM CD8 + T cell was an independent risk factor for postoperative recurrence ( HR=1.836, 95% CI:1.007-3.347, P=0.048). Joint analysis of IM and TC revealed that patients with low IM CD8 + T bys and high TC CD8 + T bys had significantly lower RFS compared to the other three groups ( P=0.006), and this combination was an independent risk factor for postoperative recurrence in early-stage NSCLC ( HR=2.090, 95% CI:1.162-3.760, P=0.014). Conclusions:The spatial distribution of bystander CD8 + T cells within the primary tumor influences the prognosis of patients with early-stage NSCLC. Patients with low-density IM CD8 + T bys and high-density TC CD8 + T bys are more prone to recurrence after radical surgery.
7.Clinical characteristics and healthcare burden in patients with McCune-Albright syndrome
Huihui GAO ; Tingting ZHENG ; Xiaoqin XU ; Junwen ZHANG ; Yuchen ZHANG ; Liying SUN ; Jiansong CHEN ; Wei WU ; Guanping DONG ; Junfen FU
Chinese Journal of Pediatrics 2025;63(7):784-788
Objective:To explore the clinical characteristics and healthcare burden in patients with McCune-Albright syndrome (MAS).Methods:A cross-sectional study was conducted at the Children′s Hospital, Zhejiang University School of Medicine. Clinical and healthcare burden data were systematically collected through structured questionnaires in 164 children with MAS from February 2022 to May 2023. According to the clinical characteristics, patients were categorized into 3 groups: monosymptomatic, bisymptomatic and trisymptomatic groups. Patients were also divided into 3 groups according to the age of <7, 7-<10 and 10-18 years. Comparative analyses of clinical characteristics and healthcare burden were conducted across age, sex, and symptom categories.Results:The cohort comprised 59 males (36.0%) and 105 females (64.0%) with an age of 4.6 (2.0, 7.4) years. Age stratification revealed 117 cases (71.3%) aged 0-<7 years, 29 cases (17.7%) aged 7-<10 years, and 18 cases (11.0%) aged 10-<18 years. Among monosymptomatic (67 cases, 40.9%), the cohort comprised 32 females (47.8%) and 35 males (52.2%), predominantly presenting with fibrous dysplasia (57 cases, 85.1%). This subgroup showed peak prevalence in the 0-<7 years age range (29 cases (50.9%)). The bisymptomatic cohort (56 cases, 34.1%) consisted of 39 females (69.6%) and 17 males (30.4%), predominantly manifesting fibrous dysplasia with skin hyperpigmentation (25 cases, 44.6%). Peak prevalence occurred in the 0-<7 years subgroup(16 cases (64.0%)). The trisymptomatic cohort (41 cases, 25.0%) consisted of 34 females (82.9%) and 7 males (17.1%), with peak prevalence occurring in the 0-<7 years subgroup (36 cases (87.8%)). The diagnostic journey analysis revealed 94 cases (57.3%) required 1-3 referrals, and 34 cases (20.7%) necessitated >3 referrals from symptom onset to definitive diagnosis. Healthcare expenditure analysis revealed 69 families (42.1%) incurred direct medical costs of 10 000-100 000 CNY, with 11 families (6.7%) exceeding >100 000 CNY. Direct non-medical costs reached of 10 000-100 000 CNY for 62 families (37.8%) and >100 000 CNY for 4 families (2.4%). Productivity loss affected 58 families (35.4%) at 10 000-100 000 CNY and 8 families (4.9%) above 100 000 CNY during the study period.Conclusion:MAS requires increased attention to skeletal manifestations, especially in children aged 0-<7 years. Moreover, the significant financial burden on families necessitates a society-wide support system.
8.Analysis on the Curative Care Expenditure of Cancer Patients before and after the Comprehensive Reform of"Medical-Pharmaceutical Separation"and"Linkage of Medical Consumption"in Beijing
Yue WANG ; Ming WU ; Xiaowei MAN ; Liying ZHAO ; Yan JIANG
Chinese Health Economics 2025;44(1):72-78
Objective:To explore the changes of the Curative Care Expenditure(CCE)of outpatient and inpatient among local cancer patients and foreign cancer patients before and after the comprehensive reform of medical-pharmaceutical Separation and linkage of medical consumption in Beijing.Methods:According to A System of Health Accounts 2011(SHA 2011),multi-stage stratified sampling and multi-stage stratified sampling were used to analyze the CCE of cancer patients in Beijing from 2016 to 2019.Results:Compared with 2016,the proportion of drugs in the CCE of local residents in secondary hospitals and tertiary hospitals in 2019 decreased by 8.62 and 9.26 percentage points,respectively,and the proportion of drugs in the CCE of foreign patients in secondary hospitals and tertiary hospitals decreased by 5.60 and 5.66 percentage points,respectively.The consumption of local and nonlocal patients in tertiary hospitals decreased by 6.89 and 8.86 percentage points.In Beijing,the proportion of outpatient services in local secondary hospitals for patients increased from 30.32%to 35.09%,and the proportion of inpatient services increased from 43.25%to 52.27%.The proportion of in-patient services in tertiary hospitals for patients with external medical treatment increased to 91.91%after the comprehensive reform of linkage of medical consumption.Conclusion:The comprehensive reform on drug standard and consumption proportion are remarkable,and the flow of patients from different sources of cancer was optimized by comprehensive medical reform,but it is necessary to strengthen the role of primary medical institutions in cancer prevention and treatment and focus on the medical burden of non-local patients in Beijing.
9.A retrospective study on the impact of the number of examined lymph nodes on the survival prognosis of patients with N3b gastric cancer
Xiaodong WANG ; Zhihao YU ; Xintong SUN ; Zhishuo LI ; Xingtu QIN ; Huimin ZHANG ; Yanrui LIANG ; Jing WU ; Mansheng ZHU ; Weihong GUO ; Guoxin LI ; Yanfeng HU ; Liying ZHAO ; Xinhua CHEN
Chinese Journal of Gastrointestinal Surgery 2025;28(10):1141-1150
Objective:To investigate the impact of the number of examined lymph nodes (ELN) on survival outcomes in gastric cancer patients with postoperative pathological stage pN3b.Methods:This retrospective cohort study included 279 pN3b gastric cancer patients who underwent D2 gastrectomy at Nanfang Hospital, Southern Medical University (September 2008 to April 2023), with 35 patients receiving combination chemotherapy and anti-PD-1 therapy (immunotherapy group) and 244 receiving adjuvant chemotherapy alone (nonimmunotherapy group). Additionally, 422 patients with pN3b from the SEER database (2005 to 2020) were collected as an external validation cohort to determine the optimal cutoff value for the number of lymph nodes examined in the nonimmunotherapy group. The primary endpoints were overall survival (OS) and recurrence-free survival (RFS) in the nonimmunotherapy group of the Nanfang Hospital cohort, stratified by whether the number of examined lymph nodes was above or below the ELN optimal cutoff value. These findings were subsequently validated in the SEER cohort.Results:The optimal ELN cutoff value (34 nodes) was determined using X-tile software and by constructing an ELN-HR fitting model with inflection point identification. In the nonimmunotherapy group, patients with ELN >34 exhibited significantly prolonged survival compared to ELN ≤34 (median OS: 25.0 (95%CI:20.5-29.5) to 17.0 (95%CI:12.7-21.3) months, P=0.004; median RFS: 19.0 (95%CI:15.6-22.4) to 13.0 (95%CI:9.5-16.5) months, P=0.048). Multivariate Cox analysis also showed ELN >34 to be an independent protective factor for both OS (HR=0.576, 95%CI: 0.397-0.836) and RFS (HR=0.701, 95%CI: 0.492-0.998). In the SEER cohort, ELN >34 was associated with a 5-month OS extension (19 to 14 months, P=0.065), with multivariate analysis supporting its independent prognostic significance (HR=0.729, 95%CI: 0.580-0.915, P=0.006). Notably, in the immunotherapy group, patients with ELN >34 ( n=30) achieved a median OS of 41 months, but the median OS had not been reached in the ELN ≤34 group ( n=5) (1 death at 48 months). Conclusion:Higher ELN (>34) correlates with improved survival in nonimmunotherapy-treated pN3b gastric cancer patients. However, in pN3b gastric cancer patients treated with immunotherapy, the optimal ELN threshold requires further exploration to determine.
10.Application of next-generation sequencing technology for the investigation of immunoglobulin variable region characteristics and their prognostic significance in patients with chronic lymphocytic leukemia
Zhen GUO ; Huimin JIN ; Tonglu QIU ; Liying ZHU ; Yujie WU ; Hairong QIU ; Yan WANG ; Yi MIAO ; Hui JIN ; Lei FAN ; Jianyong LI ; Yi XIA ; Chun QIAO
Chinese Journal of Hematology 2025;46(3):261-268
Objective:To elucidate the genomic characteristics of the immunoglobulin (IG) heavy-chain variable region and light-chain variable region, the expression of subclones, and the prognostic significance in patients with CLL.Methods:Blood and/or bone marrow specimens were gathered from a cohort of 36 patients with CLL diagnosed at Jiangsu Province Hospital from December 2018 to May 2023, including 12 cases of B cell receptor (BCR) stereotyped patients. IG heavy-chain (IGH) and light-chain (IG Kappa [IGK] and IG lambda [IGL]) gene rearrangements were performed using next-generation sequencing (NGS) technology to analyze the characteristics and prognostic value in CLL.Results:NGS detection of IG variable region (IGHV) demonstrated a significant correlation and superior consistency with Sanger sequencing ( r=0.957, P < 0.001). Among the 36 patients, the IGH variant (IGHV) was observed in 9 (25.0%) but not in 27 (75.0%) participants. The incidence of the MYD88 mutation was higher among patients with mutated IGHV [1/27 (3.7%) vs 4/9 (44.4%), P=0.00]. A high incidence of trisomy 12 was observed in the IGHV #8/#8B subset [4/11 (36.4%) vs 1/25 (4.0%), P=0.023], which were more likely to develop Richter transformation [8/11 (72.7%) vs 4/25 (16.0%), P=0.002]. In the patient cohort, 36 individuals (36/36, 100.0%) used the IGK variable, whereas 15 individuals (15/36, 41.7%) employed the IGL variable (IGLV). IGLV3 - 21 reported the highest utilization rate in IGLV (5/15, 33.3%). Remarkably, patients with CLL with IGLV3-21 fragments were exclusively observed in the Binet C stage and Rai Phase Ⅲ-Ⅳ, with an incidence of del (13) (q14) at 60.0% (3/5). The median time to first treatment (TTFT) of patients with or without IGLV3 - 21 fragments was 5.2 (1.1 - 41.5) and 9.9 (0.1 - 94.4) months, respectively. Using the total reads threshold of 2.5%, 4 (4/36, 11.1%) samples were detected to have two IGHV productive clones. The median TTFT and overall survival (OS) time were 2.8 (0.9-72.7) and 12.8 months in patients with one mutated clone and 57.5 (32.0-120.7) and 51.8 months in those with two mutated clones, respectively. The median TTFT and OS time were 10.9 (0.3-94.4) and 6.3 (0.1 - 12.5) months in patients with one unmutated clone and 49.9 (22.2 - 211.1) and 30.0 (9.6 - 50.3) months in those with multiple unmutated clones, respectively ( P>0.05) . Conclusions:Detection of IG gene rearrangements using NGS technology not only facilitates the analysis of the IGHV mutation status, dominant clones, and prognostic value but also contributes to the exploration of IGK/IGL gene rearrangement fragments and the utilization of subclones. Further, it provides information about the poor prognosis of IGLV3 - 21 CLL. The shortened survival of the two unmutated clone groups in the IGHV unmutated group may indicate a poor prognosis.

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