1.Impact of radiation-induced lymphopenia on prognosis in patients with limited-stage small cell lung cancer:a cohort study
Yihua WANG ; Yaqi LI ; Yulei PEI ; Kailiang WU ; Xingwen FAN
China Oncology 2025;35(9):867-873
Background and purpose:Despite Radiation-induced lymphopenia has been associated with poor survival outcomes in certain solid tumors,there is limited evidence for small cell lung cancer(SCLC).The purpose of this study was to investigate whether the absolute lymphocyte count before and after radiotherapy could predict the clinical outcomes for limited-stage SCLC(LS-SCLC)patients.Methods:This was a single-center,retrospective cohort study.A retrospective analysis of patients evaluated at Fudan University Shanghai Cancer Center from January 2007 to December 2017 was conducted.Inclusion criteria:⑴ pathologically confirmed small-cell lung cancer;⑵ limited-stage disease defined by positron emission tomography and computed tomography(PET/CT)and contrast-enhanced brain magnetic resonance imaging(MRI)[American Joint Committee on Cancer(AJCC)8th edition TNM stage M0];⑶ receipt of definitive chemoradiotherapy;⑷ availability of complete blood counts before,during and within 1 month after radiotherapy;⑸ complete survival,relapse,and last-follow-up information retrievable.Exclusion criteria:⑴ distant metastasis at baseline(AJCC 8th edition TNM stage M1,including any distant nodal,visceral,or bone-marrow involvement);⑵ total radiotherapy dose<50 Gy[calculated as an equivalent biological dose at 2 Gy/fraction,i.e.,a biological effective dose(BED)<40 Gy];⑶ incomplete laboratory data at any scheduled time point;⑷ inability to ascertain survival or relapse status or insufficient follow-up records.The study protocol was approved by the ethics committee of Fudan University Shanghai Cancer Center(approval number:2303271-15),and the requirement for informed consent was waived.Clinical data extracted comprised age,sex,Eastern Cooperative Oncology Group performance status(ECOG PS)score,smoking history,TNM stage,chemotherapy regimen and number of cycles,radiotherapy dose and fractionation schedule,use of concurrent chemoradiotherapy and administration of prophylactic cranial irradiation(PCI).Laboratory data comprised serial absolute lymphocyte counts obtained within 1 month before,during and after radiotherapy;lymphopenia was graded according to the Common Terminology Criteria for Adverse Events(CTCAE)version 4.0.Progression-free survival(PFS)and overall survival(OS)were estimated using the Kaplan-Meier method and compared with the log-rank test.Results:A total of 170 patients were included.The median age of the patients was 57 years,with 77.6%being male.The median radiation therapy dose was 60 Gy(range:45-66 Gy).For the entire cohort,the median PFS was 22.0 months,the 5-year PFS rate was 31.3%,and the 10-year PFS rate was 19.8%.The median OS was 38.0 months,the 5-year OS rate was 37.5%,and the 10-year OS rate was 24.2%.Before radiation therapy,14 patients(8.2%)had grade 1-2 lymphocytopenia.During radiation therapy,the number of patients with grade 1,2,3 and 4 lymphocytopenia was 7(4.1%),22(12.9%),111(65.3%),and 24(14.1%),respectively.One month after radiation therapy,the number of patients with grade 1,2,3 and 4 lymphocytopenia was 36(21.2%),36(21.2%),11(6.5%)and 1(0.6%),respectively.There were no significant differences in PFS and OS among patients with different grades of lymphocytopenia before,during,or after radiation therapy.Conclusion:Before immunotherapy,radiotherapy-induced lymphopenia did not appear to affect the prognosis of patients with LS-SCLC.
2.Impact of radiation-induced lymphopenia on prognosis in patients with limited-stage small cell lung cancer:a cohort study
Yihua WANG ; Yaqi LI ; Yulei PEI ; Kailiang WU ; Xingwen FAN
China Oncology 2025;35(9):867-873
Background and purpose:Despite Radiation-induced lymphopenia has been associated with poor survival outcomes in certain solid tumors,there is limited evidence for small cell lung cancer(SCLC).The purpose of this study was to investigate whether the absolute lymphocyte count before and after radiotherapy could predict the clinical outcomes for limited-stage SCLC(LS-SCLC)patients.Methods:This was a single-center,retrospective cohort study.A retrospective analysis of patients evaluated at Fudan University Shanghai Cancer Center from January 2007 to December 2017 was conducted.Inclusion criteria:⑴ pathologically confirmed small-cell lung cancer;⑵ limited-stage disease defined by positron emission tomography and computed tomography(PET/CT)and contrast-enhanced brain magnetic resonance imaging(MRI)[American Joint Committee on Cancer(AJCC)8th edition TNM stage M0];⑶ receipt of definitive chemoradiotherapy;⑷ availability of complete blood counts before,during and within 1 month after radiotherapy;⑸ complete survival,relapse,and last-follow-up information retrievable.Exclusion criteria:⑴ distant metastasis at baseline(AJCC 8th edition TNM stage M1,including any distant nodal,visceral,or bone-marrow involvement);⑵ total radiotherapy dose<50 Gy[calculated as an equivalent biological dose at 2 Gy/fraction,i.e.,a biological effective dose(BED)<40 Gy];⑶ incomplete laboratory data at any scheduled time point;⑷ inability to ascertain survival or relapse status or insufficient follow-up records.The study protocol was approved by the ethics committee of Fudan University Shanghai Cancer Center(approval number:2303271-15),and the requirement for informed consent was waived.Clinical data extracted comprised age,sex,Eastern Cooperative Oncology Group performance status(ECOG PS)score,smoking history,TNM stage,chemotherapy regimen and number of cycles,radiotherapy dose and fractionation schedule,use of concurrent chemoradiotherapy and administration of prophylactic cranial irradiation(PCI).Laboratory data comprised serial absolute lymphocyte counts obtained within 1 month before,during and after radiotherapy;lymphopenia was graded according to the Common Terminology Criteria for Adverse Events(CTCAE)version 4.0.Progression-free survival(PFS)and overall survival(OS)were estimated using the Kaplan-Meier method and compared with the log-rank test.Results:A total of 170 patients were included.The median age of the patients was 57 years,with 77.6%being male.The median radiation therapy dose was 60 Gy(range:45-66 Gy).For the entire cohort,the median PFS was 22.0 months,the 5-year PFS rate was 31.3%,and the 10-year PFS rate was 19.8%.The median OS was 38.0 months,the 5-year OS rate was 37.5%,and the 10-year OS rate was 24.2%.Before radiation therapy,14 patients(8.2%)had grade 1-2 lymphocytopenia.During radiation therapy,the number of patients with grade 1,2,3 and 4 lymphocytopenia was 7(4.1%),22(12.9%),111(65.3%),and 24(14.1%),respectively.One month after radiation therapy,the number of patients with grade 1,2,3 and 4 lymphocytopenia was 36(21.2%),36(21.2%),11(6.5%)and 1(0.6%),respectively.There were no significant differences in PFS and OS among patients with different grades of lymphocytopenia before,during,or after radiation therapy.Conclusion:Before immunotherapy,radiotherapy-induced lymphopenia did not appear to affect the prognosis of patients with LS-SCLC.
3.Ligation of the intersphincteric fistula tract (LIFT) for high transsphincteric fistulas: a double-center retrospective study with long-term follow-up
Leichang ZHANG ; Chuanyu ZHAN ; Lu LI ; Wanjin SHAO ; Guidong SUN ; Yugen CHEN ; Guanghua CHEN ; Yulei LANG ; Zenghua XIAO ; Xiao XIAO
Annals of Coloproctology 2025;41(1):77-83
Purpose:
This study aimed to evaluate the long-term efficacy of the ligation of the intersphincteric fistula tract (LIFT) procedure in treating high transsphincteric fistulas.
Methods:
We conducted a retrospective study to evaluate the success rate of LIFT treatment in 82 patients with high transsphincteric fistulas involving at least one-third of the external sphincter. This study was carried out across 2 centers from November 2009 to February 2023.
Results:
All patients underwent successful surgery with a median operative time of 48.9 minutes (range, 20–80 minutes), and no intraoperative or postoperative complications were reported. The median follow-up duration was 85.5 months (range, 4–120 months), with 5 patients (6.1%) lost to follow-up. Treatment was successful in 62 patients, whose symptoms disappeared and both the external opening and the intersphincteric incision completely healed, yielding an overall efficiency rate of 80.5%. There were 15 cases (19.5%) of treatment failure, including 6 (7.8%) that converted to intersphincteric anal fistula and 9 (11.7%) that experienced persistent or recurrent fistulas. Only 1 patient reported minor overflow during the postoperative follow-up, but no other patients reported any significant discomfort. There were no statistically significant differences between patients with surgical success and those with treatment failure in terms of fistula length, history of previous abscess or anal fistula surgery, number of external orifices or fistulas, and location of fistulas (all P>0.05).
Conclusion
LIFT is a safe and effective sphincter-preserving procedure that yields satisfactory healing outcomes and has minimal impact on anal function.
4.Ligation of the intersphincteric fistula tract (LIFT) for high transsphincteric fistulas: a double-center retrospective study with long-term follow-up
Leichang ZHANG ; Chuanyu ZHAN ; Lu LI ; Wanjin SHAO ; Guidong SUN ; Yugen CHEN ; Guanghua CHEN ; Yulei LANG ; Zenghua XIAO ; Xiao XIAO
Annals of Coloproctology 2025;41(1):77-83
Purpose:
This study aimed to evaluate the long-term efficacy of the ligation of the intersphincteric fistula tract (LIFT) procedure in treating high transsphincteric fistulas.
Methods:
We conducted a retrospective study to evaluate the success rate of LIFT treatment in 82 patients with high transsphincteric fistulas involving at least one-third of the external sphincter. This study was carried out across 2 centers from November 2009 to February 2023.
Results:
All patients underwent successful surgery with a median operative time of 48.9 minutes (range, 20–80 minutes), and no intraoperative or postoperative complications were reported. The median follow-up duration was 85.5 months (range, 4–120 months), with 5 patients (6.1%) lost to follow-up. Treatment was successful in 62 patients, whose symptoms disappeared and both the external opening and the intersphincteric incision completely healed, yielding an overall efficiency rate of 80.5%. There were 15 cases (19.5%) of treatment failure, including 6 (7.8%) that converted to intersphincteric anal fistula and 9 (11.7%) that experienced persistent or recurrent fistulas. Only 1 patient reported minor overflow during the postoperative follow-up, but no other patients reported any significant discomfort. There were no statistically significant differences between patients with surgical success and those with treatment failure in terms of fistula length, history of previous abscess or anal fistula surgery, number of external orifices or fistulas, and location of fistulas (all P>0.05).
Conclusion
LIFT is a safe and effective sphincter-preserving procedure that yields satisfactory healing outcomes and has minimal impact on anal function.
5.Ligation of the intersphincteric fistula tract (LIFT) for high transsphincteric fistulas: a double-center retrospective study with long-term follow-up
Leichang ZHANG ; Chuanyu ZHAN ; Lu LI ; Wanjin SHAO ; Guidong SUN ; Yugen CHEN ; Guanghua CHEN ; Yulei LANG ; Zenghua XIAO ; Xiao XIAO
Annals of Coloproctology 2025;41(1):77-83
Purpose:
This study aimed to evaluate the long-term efficacy of the ligation of the intersphincteric fistula tract (LIFT) procedure in treating high transsphincteric fistulas.
Methods:
We conducted a retrospective study to evaluate the success rate of LIFT treatment in 82 patients with high transsphincteric fistulas involving at least one-third of the external sphincter. This study was carried out across 2 centers from November 2009 to February 2023.
Results:
All patients underwent successful surgery with a median operative time of 48.9 minutes (range, 20–80 minutes), and no intraoperative or postoperative complications were reported. The median follow-up duration was 85.5 months (range, 4–120 months), with 5 patients (6.1%) lost to follow-up. Treatment was successful in 62 patients, whose symptoms disappeared and both the external opening and the intersphincteric incision completely healed, yielding an overall efficiency rate of 80.5%. There were 15 cases (19.5%) of treatment failure, including 6 (7.8%) that converted to intersphincteric anal fistula and 9 (11.7%) that experienced persistent or recurrent fistulas. Only 1 patient reported minor overflow during the postoperative follow-up, but no other patients reported any significant discomfort. There were no statistically significant differences between patients with surgical success and those with treatment failure in terms of fistula length, history of previous abscess or anal fistula surgery, number of external orifices or fistulas, and location of fistulas (all P>0.05).
Conclusion
LIFT is a safe and effective sphincter-preserving procedure that yields satisfactory healing outcomes and has minimal impact on anal function.
6.Ligation of the intersphincteric fistula tract (LIFT) for high transsphincteric fistulas: a double-center retrospective study with long-term follow-up
Leichang ZHANG ; Chuanyu ZHAN ; Lu LI ; Wanjin SHAO ; Guidong SUN ; Yugen CHEN ; Guanghua CHEN ; Yulei LANG ; Zenghua XIAO ; Xiao XIAO
Annals of Coloproctology 2025;41(1):77-83
Purpose:
This study aimed to evaluate the long-term efficacy of the ligation of the intersphincteric fistula tract (LIFT) procedure in treating high transsphincteric fistulas.
Methods:
We conducted a retrospective study to evaluate the success rate of LIFT treatment in 82 patients with high transsphincteric fistulas involving at least one-third of the external sphincter. This study was carried out across 2 centers from November 2009 to February 2023.
Results:
All patients underwent successful surgery with a median operative time of 48.9 minutes (range, 20–80 minutes), and no intraoperative or postoperative complications were reported. The median follow-up duration was 85.5 months (range, 4–120 months), with 5 patients (6.1%) lost to follow-up. Treatment was successful in 62 patients, whose symptoms disappeared and both the external opening and the intersphincteric incision completely healed, yielding an overall efficiency rate of 80.5%. There were 15 cases (19.5%) of treatment failure, including 6 (7.8%) that converted to intersphincteric anal fistula and 9 (11.7%) that experienced persistent or recurrent fistulas. Only 1 patient reported minor overflow during the postoperative follow-up, but no other patients reported any significant discomfort. There were no statistically significant differences between patients with surgical success and those with treatment failure in terms of fistula length, history of previous abscess or anal fistula surgery, number of external orifices or fistulas, and location of fistulas (all P>0.05).
Conclusion
LIFT is a safe and effective sphincter-preserving procedure that yields satisfactory healing outcomes and has minimal impact on anal function.
7.Ligation of the intersphincteric fistula tract (LIFT) for high transsphincteric fistulas: a double-center retrospective study with long-term follow-up
Leichang ZHANG ; Chuanyu ZHAN ; Lu LI ; Wanjin SHAO ; Guidong SUN ; Yugen CHEN ; Guanghua CHEN ; Yulei LANG ; Zenghua XIAO ; Xiao XIAO
Annals of Coloproctology 2025;41(1):77-83
Purpose:
This study aimed to evaluate the long-term efficacy of the ligation of the intersphincteric fistula tract (LIFT) procedure in treating high transsphincteric fistulas.
Methods:
We conducted a retrospective study to evaluate the success rate of LIFT treatment in 82 patients with high transsphincteric fistulas involving at least one-third of the external sphincter. This study was carried out across 2 centers from November 2009 to February 2023.
Results:
All patients underwent successful surgery with a median operative time of 48.9 minutes (range, 20–80 minutes), and no intraoperative or postoperative complications were reported. The median follow-up duration was 85.5 months (range, 4–120 months), with 5 patients (6.1%) lost to follow-up. Treatment was successful in 62 patients, whose symptoms disappeared and both the external opening and the intersphincteric incision completely healed, yielding an overall efficiency rate of 80.5%. There were 15 cases (19.5%) of treatment failure, including 6 (7.8%) that converted to intersphincteric anal fistula and 9 (11.7%) that experienced persistent or recurrent fistulas. Only 1 patient reported minor overflow during the postoperative follow-up, but no other patients reported any significant discomfort. There were no statistically significant differences between patients with surgical success and those with treatment failure in terms of fistula length, history of previous abscess or anal fistula surgery, number of external orifices or fistulas, and location of fistulas (all P>0.05).
Conclusion
LIFT is a safe and effective sphincter-preserving procedure that yields satisfactory healing outcomes and has minimal impact on anal function.
8.Effects of dual vascularized tissue-engineered bone constructed by vascular bundles and endothelial progenitor cells on repair of large radius defects and vascular regeneration
Yulei WANG ; Fanzhe FENG ; Junhong SHEN ; Zhongzheng YU ; Jingyuan LI ; Nengqi SHAO ; Wenhao XU ; Yi LUO ; Yi CUI
Chinese Journal of Orthopaedic Trauma 2025;27(4):348-357
Objective:To investigate the effects of dual vascularized tissue-engineered bone constructed by vascular bundles and endothelial progenitor cells (EPCs) on repair of large bone defects and vascular regeneration.Methods:EPCs were seeded on the demineralized bone matrix (DBM) scaffolds and cultured for 6 days. The attachment and morphology of EPCs on DBM scaffolds were observed by electron microscopy. Next, the radial artery was implanted into a vascular groove opened inside the DBM-EPCs composite scaffolds. Finally, models of a large segmental bone defect were constructed using the radii from 18 New Zealand white rabbits. The rabbits were randomly divided into 4 groups using a simple random sampling method: DBM group, DBM+EPCs group, DBM+vascular bundle group, and DBM+EPCs+vascular bundle group. The DBM group and DBM+EPCs group shared the same rabbits so that transplantations were conducted into the left and right forearms respectively; the DBM+vascular bundle group and DBM+EPCs+vascular bundle group also shared the same rabbits so that transplantations were conducted into the left and right forearms respectively. Consequently, there were 9 experimental sites in each group. X-ray examination and gross morphological observation were performed to evaluate the bone regeneration in the experimental rabbits in each group at 4, 8, and 12 weeks after surgery, and CD31 immunofluorescence staining was used to evaluate the vascular regeneration. Micro-CT was used to analyze bone tissue parameters and reconstruct the three-dimensional structures of the defects site at 12 weeks after surgery.Results:Compared with the DBM, DBM+EPCs and DBM+vascular bundle groups, the DBM+EPCs+vascular bundle group showed new bone tissue crawling on the scaffold surface at 4 weeks after surgery, almost complete healing of the bone defect area at 8 weeks, and forming of a complete and dense bone bridge and appearance of a bone marrow cavity at 12 weeks. Micro-CT data at 12 weeks after surgery showed regular arrangement of the trabeculae, significantly improved mineralization, and increased thickness of the bone cortex in the DBM+EPCs+vascular bundle group. Additionally, in the DBM+EPCs+vascular bundle group, the number of microvessels was significantly higher than that in the other groups at 4, 8, 12 weeks after surgery ( P<0.05), and the angiogenesis and bone tissue regeneration were particularly prominent at 12 weeks after surgery. The number of CD31 cells in the DBM+EPCs+vascular bundle group increased significantly more than that in the DBM, DBM+EPCs and DBM+vascular bundle groups ( P<0.05). Conclusion:As the dual vascularized tissue-engineered bone constructed by vascular bundles and EPCs can significantly promote bone tissue regeneration and angiogenesis, it may be a potential therapeutic strategy for repair of large bone defects.
9.A phase Ⅲ clinical study to evaluate the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of adults with chronic hepatitis C
Lai WEI ; Jia SHANG ; Xuan AN ; Guoqiang ZHANG ; Yujuan GUAN ; Hongxin PIAO ; Jinglan JIN ; Lang BAI ; Xingxiang YANG ; Daokun YANG ; Xinhua LUO ; Shufang YUAN ; Yingren ZHAO ; Yingjie MA ; Guangming LI ; Feng LIN ; Xiaoping WU ; Jiawei GENG ; Guizhou ZOU ; Jiabao CHANG ; Zuojiong GONG ; Xiaorong MAO ; Jing ZHU ; Wentao GUO ; Qingwei HE ; Lin LUO ; Yulei ZHUANG ; Hongming XIE ; Yingjun ZHANG
Chinese Journal of Hepatology 2025;33(6):560-569
Objective:To assess the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of chronic hepatitis C (CHC) of various genotypes, without cirrhosis or with compensated cirrhosis.Methods:394 cases with CHC from 22 centers were collected from October 2021 to April 2023. They were randomly assigned to receive either the experimental drugs (antaitasvir phosphate 100 mg+yiqibuvir 600 mg) or placebo treatment in a 3∶1 ratio. The patients were administered drugs once a day for 12 consecutive weeks, and then followed up for 24 weeks after treatment cessation. All subjects were unblinded at the four-week follow-up following drug discontinuation, with the experimental drug group continuing to complete subsequent post-discontinuation follow-up. The placebo group was switched to receive the experimental drugs for a repeated 12-week treatment period and followed up for another 24 weeks after discontinuation of the drug (placebo delayed treatment phase).The sustained virologic response rate (SVR12) was observed for subjects in the double-blind phase and the placebo delayed-treatment phase at 12 weeks after treatment cessation.Virological resistance analysis was performed on subjects who failed treatment. The primary efficacy endpoint was SVR12. The number and percentage of subjects who achieved "HCV RNA
10.Efficacy and safety of intravenous thrombolysis with tenecteplase in acute ischemic stroke across different time windows: a Meta-analysis
Yejun SHI ; Yulei JING ; Xin NIE ; Le YAO ; Mengjie FAN ; Chaosheng LI
Chinese Journal of Neuromedicine 2025;24(8):806-816
Objective:To systematically evaluate the efficacy and safety of intravenous thrombolysis with tenecteplase (TNK) in acute ischemic stroke (AIS) across different time windows.Methods:Randomized controlled trials investigating TNK in AIS were retrieved from PubMed, Embase, Web of Science, Cochrane Library, CNKI, and Wanfang databases, with data collected up to May 2025. Experimental group received intravenous thrombolysis with 0.25 mg/kg TNK, either alone or in combination with mechanical thrombectomy (MT). Control group received alteplase, placebo, standard medication (containing butylphthalide), MT, or above-mentioned drugs combined with MT. These patients were within 4.5 hours of onset (within-time window) or within 4.5-24 hours of onset (extended-time window). Efficacy indexes included functional outcome excellent rate (modified Rankin scale [mRS] score of 0-1 at 3 months after treatment), early neurological improvement rate (National Institutes of Health Stroke Scale [NIHSS] score improvement≥4 or NIHSS score ranged 0-1 within 72 of treatment), and recanalization rate 24 h after treatment. Safety indexes comprised symptomatic intracranial hemorrhage (sICH) rate within 48 h of treatment, and mortality rate and rate of serious adverse events (SAEs) within 90 d of treatment. Quality of the trials was assessed according to Cochrane handbook for systematic reviews of interventions (version 5.1). Meta-analysis was conducted using Stata software, with pooling data as risk difference ( RD). Results:Sixteen articles (11 were within-time window ones, and 5 were extended-time window ones), involving 9,430 AIS patients, were included. Quality grade of these articles is B-level. (1) In articles of within-time window: the experimental group had a significantly higher functional outcome excellent rate compared with the control group ( RD=0.031, 95% CI: 0.009-0.052, P=0.005); no significant difference was observed in early neurological improvement rate ( RD=0.016, 95% CI: -0.012-0.043, P=0.260), recanalization rate ( RD=0.040, 95% CI: 0.000-0.081, P=0.053), sICH rate ( RD=0.005, 95% CI: -0.002-0.012, P=0.198), mortality rate ( RD=0.000, 95% CI: -0.012-0.013, P=0.950), or SAE rate ( RD=0.003, 95% CI: -0.028-0.033, P=0.870) between the two groups. (2) In articles of extended-time window: the experimental group exhibited significantly higher functional outcome excellent rate ( RD=0.064, 95% CI: 0.016-0.113, P=0.009), early neurological improvement rate ( RD=0.101, 95% CI: 0.023-0.180, P=0.012), and recanalization rate ( RD=0.131, 95% CI: 0.059-0.203, P<0.001) compared with the control group; no significant difference was found in sICH rate ( RD=0.014, 95% CI: -0.003-0.032, P=0.097), mortality rate ( RD=0.006, 95% CI: -0.030-0.041, P=0.752), or SAE rate ( RD=0.030, 95% CI: -0.037-0.097, P=0.385) between the two groups. Conclusion:Intravenous thrombolysis with TNK is safe and effective in AIS patients at both within-time window and extended-time window.

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