1.Clinical application of single-balloon and double-balloon enteroscopy in pediatric small bowel diseases: a retrospective study of 576 cases.
Can-Lin LI ; Jie-Yu YOU ; Yan-Hong LUO ; Hong-Juan OU-YANG ; Li LIU ; Wen-Ting ZHANG ; Jia-Qi DUAN ; Na JIANG ; Mei-Zheng ZHAN ; Chen-Xi LIU ; Juan ZHOU ; Ling-Zhi YUAN ; Hong-Mei ZHAO
Chinese Journal of Contemporary Pediatrics 2025;27(7):822-828
OBJECTIVES:
To evaluate the effectiveness of single-balloon and double-balloon enteroscopy in diagnosing pediatric small bowel diseases and assess the diagnostic efficacy of computed tomography enterography (CTE) for small bowel diseases using enteroscopy as the reference standard.
METHODS:
Clinical data from 576 children who underwent enteroscopy at Hunan Children's Hospital between January 2017 and December 2023 were retrospectively collected. The children were categorized based on enteroscopy type into the single-balloon enteroscopy (SBE) group (n=457) and double-balloon enteroscopy (DBE) group (n=119), and the clinical data were compared between the two groups. The sensitivity and specificity of CTE for diagnosing small bowel diseases were evaluated using enteroscopy results as the standard.
RESULTS:
Among the 576 children, small bowel lesions were detected by enteroscopy in 274 children (47.6%).There was no significant difference in lesion detection rates or complication rates between the SBE and DBE groups (P>0.05), but the DBE group had deeper insertion, longer procedure time, and higher complete small bowel examination rate (P<0.05). The complication rate during enteroscopy was 4.3% (25/576), with 18 cases (3.1%) of mild complications and 7 cases (1.2%) of severe complications, which improved with symptomatic treatment, surgical, or endoscopic intervention. Among the 412 children who underwent CTE, the sensitivity and specificity for diagnosing small bowel diseases were 44.4% and 71.3%, respectively.
CONCLUSIONS
SBE and DBE have similar diagnostic efficacy for pediatric small bowel diseases, but DBE is preferred for suspected deep small bowel lesions and comprehensive small bowel examination. Enteroscopy in children demonstrates relatively good overall safety. CTE demonstrates relatively low sensitivity but comparatively high specificity for diagnosing small bowel diseases.
Retrospective Studies
;
Treatment Outcome
;
Double-Balloon Enteroscopy/statistics & numerical data*
;
Single-Balloon Enteroscopy/statistics & numerical data*
;
Humans
;
Male
;
Female
;
Child
;
Operative Time
;
Tomography, X-Ray Computed/statistics & numerical data*
;
Sensitivity and Specificity
;
Intestine, Small/surgery*
;
Intestinal Diseases/surgery*
2.Preparation of Monoclonal Antibody to Vasorin in Tree Shrew and Exploration of Its Application
Meizhen OU ; Yongfeng LI ; Sha WEN ; Zhouxiang LIAO ; Xuejing HUANG ; Lichao YANG ; Min HE
Laboratory Animal and Comparative Medicine 2025;45(5):611-622
Objective To obtain tree shrew Vasorin(VASN)recombinant protein through prokaryotic expression and purification,prepare monoclonal antibody against tree shrew VASN by immunizing mice with this protein,and preliminarily evaluate its application value.Methods Reverse transcription-polymerase chain reaction(RT-PCR)was used to amplify the full-length sequence of tree shrew VASN gene in vitro.The tree shrew VASN gene fragment was inserted into pET-30a vector to construct pET-30a-VASN recombinant plasmid.The recombinant plasmid was subjected to double digestion with BamH Ⅰ and Sal Ⅰfor identification,and its correctness was further verified by sequencing.The recombinant plasmid with correct sequencing was transformed into BL21(DE3)competent cells,and isopropyl β-D-thiogalactoside(IPTG)was used to induce expression of VASN recombinant protein.Proteins were separated by sodium dodecyl sulfate polyacrylamide gel electrophoresis(SDS-PAGE),and the VASN recombinant protein was purified by KCI.Purified recombinant protein was used to immunize BALB/c mice for four times,and serum antibody titer was detected by enzyme-linked immunosorbent assay(ELISA).Splenocytes from mice with serum antibody titer above 1:10 000 were used for cell fusion with myeloma cells.Hypoxanthine-aminopterin-thymidine(HAT)culture medium was first used to screen hybridoma cells.ELISA was used to screen positive hybridoma cell lines that could secrete specific antibodies,and monoclonal hybridoma cell lines were obtained by limiting dilution method.VASN monoclonal antibodies were prepared in large quantities by ascites induction method,purified using rProtein G,and the affinity and in vitro reaction specificity of the monoclonal antibodies were detected by ELISA and Western blotting.Results The full-length sequence of the tree shrew VASN gene was successfully amplified and the recombinant plasmid vector of tree shrew pET-30a-VASN was constructed.The sequence obtained by sequencing of the recombinant plasmid vector was identical to the tree shrew VASN target gene sequence.Recombinant protein VASN mainly existed in the form of inclusion bodies,and the purity after purification reached 90%,meeting the requirements of subsequent immunization experiments.After four immunizations with recombinant protein VASN,mouse serum antibody titer reached 1:729 000.Monoclonal positive hybridoma cell lines were obtained through ascites induction and purification,and the constant affinity value of monoclonal antibodies measured by ELISA reached 2.59x107 L/mol.Western blotting results showed that the tree shrew VASN monoclonal antibody could bind to tree shrew VASN recombinant protein,but it showed no binding reaction with porcine retinol-binding protein 4 recombinant protein,human VASN-leucine rich repeat recombinant protein,or bovine serum albumin.Anti-tree shrew VASN monoclonal antibody could specifically recognize VASN protein in tree shrew heart,liver,spleen,lung,kidney and muscle,with clear bands and clean background.Immunohistochemical detection results showed that this monoclonal antibody could recognize VASN protein in tree shrew spleen,lung,and tree shrew immortalized fibroblasts with high VASN mRNA expression levels,and the detection results were positive.Conclusion Monoclonal antibody against tree shrew VASN is successfully prepared.This antibody can be used for immunohistochemical detection of tree shrew immortalized fibroblasts,spleen tissue,and lung tissue,providing an important tool for further research on the function of VASN in tree shrew models.
3.Clinical effects of Supplemented Buyang Huanwu Decoction on postoperative patients with lumbar vertebral fracture complicated with spinal cord injury due to Qi Deficiency and Blood Stasis Pattern
Jia-man YANG ; Tong LIU ; De-hui FAN ; Mei-yi SU ; Ying LIN ; Man-guang LIANG ; Zhi-wen OU ; Shun-cong ZHANG
Chinese Traditional Patent Medicine 2025;47(11):3630-3634
AIM To explore the clinical effects of Supplemented Buyang Huanwu Decoction on postoperative patients with lumbar vertebral fracture complicated with spinal cord injury due to Qi Deficiency and Blood Stasis Pattern.METHODS One hundred and twenty patients were randomly assigned into control group(60 cases)for 6-week intervention of conventional treatment,and observation group(60 cases)for 6-week intervention of both Supplemented Buyang Huanwu Decoction and conventional treatment.The changes in clinical effects,TCM syndrome scores,spinal cord conduction signals(SEP amplitude,MEP amplitude),serum neurotrophic factors(NGF,IGF-1,BDNF),coagulation and inflammatory indices(PT,APTT,TNF-α,IL-1 β)and incidence of adverse reactions were detected.RESULTS The observation group demonstrated higher total effective rate than the control group(P<0.05).After the treatment,the two groups displayed decreased TCM syndrome scores,TNF-α,IL-1β(P<0.05),increased spinal cord conduction signals,coagulation and inflammatory indices(P<0.05),and shortened PT,APTT(P<0.05),especially for the observation group(P<0.05).No significant difference in incidence of adverse reactions was found between the two groups(P>0.05).CONCLUSION For the patients with lumbar vertebral fracture complicated with spinal cord injury due to Qi Deficiency and Blood Stasis Pattern,Supplemented Buyang Huanwu Decoction can safely and effectively promote neurological function recovery.
4.Causal relationship between insomnia and erectile dysfunction based on heart-kidney intersection theory:A two-sample Mendelian randomization study
Ze-rui QIU ; Guang-yang OU ; Heng-jie LIU ; Wen-tao MA ; Man-jie HUANG ; Neng WANG ; Jun ZHOU ; Qing ZHOU
National Journal of Andrology 2025;31(7):597-602
Objective:Previous studies have shown that insomnia is closely related to erectile dysfunction(ED).However,the causal relationship between them is still unclear.Mendelian randomization(MR)provides a new method for studying the relationship between the two,and the theory of heart-kidney interaction in TCM provides a new idea for exploring the causal relationship between them.Methods:Based on the statistical data collected by genome-wide association studies(GWAS),the causal relationship be-tween insomnia and ED was discussed by MR.Inverse variance weighted(IVW)is the main analysis method,and weighted median(WME),simple mode(SM),weighted mode(WM)and MR Egger method were the supplementary analysis to evaluate the causal effect.MR-Egger intercept test,Cochran Q test and leave-one-out method were used in sensitivity analysis to verify the reliability of MR results.Results:Thirty-nine SNPs significantly related to insomnia were finally included for MR analysis.The results of IVW method in MR analysis showed that insomnia had a significant causal relationship with the increased risk of ED(OR=3.111,95%CI=1.566-6.181,P=1.193 × 10-3).The results obtained by MR-Egger method,WME method,WM method and SM method were consistent with IVW method in the direction of effect.The sensitivity results suggested that the results of this study were robust.Conclusion:Our study reveals the causal relationship between insomnia and ED,which provides a new basis for future clinical practice and prevention and treatment of ED.
5.Preparation of Monoclonal Antibody to Vasorin in Tree Shrew and Exploration of Its Application
Meizhen OU ; Yongfeng LI ; Sha WEN ; Zhouxiang LIAO ; Xuejing HUANG ; Lichao YANG ; Min HE
Laboratory Animal and Comparative Medicine 2025;45(5):611-622
Objective To obtain tree shrew Vasorin(VASN)recombinant protein through prokaryotic expression and purification,prepare monoclonal antibody against tree shrew VASN by immunizing mice with this protein,and preliminarily evaluate its application value.Methods Reverse transcription-polymerase chain reaction(RT-PCR)was used to amplify the full-length sequence of tree shrew VASN gene in vitro.The tree shrew VASN gene fragment was inserted into pET-30a vector to construct pET-30a-VASN recombinant plasmid.The recombinant plasmid was subjected to double digestion with BamH Ⅰ and Sal Ⅰfor identification,and its correctness was further verified by sequencing.The recombinant plasmid with correct sequencing was transformed into BL21(DE3)competent cells,and isopropyl β-D-thiogalactoside(IPTG)was used to induce expression of VASN recombinant protein.Proteins were separated by sodium dodecyl sulfate polyacrylamide gel electrophoresis(SDS-PAGE),and the VASN recombinant protein was purified by KCI.Purified recombinant protein was used to immunize BALB/c mice for four times,and serum antibody titer was detected by enzyme-linked immunosorbent assay(ELISA).Splenocytes from mice with serum antibody titer above 1:10 000 were used for cell fusion with myeloma cells.Hypoxanthine-aminopterin-thymidine(HAT)culture medium was first used to screen hybridoma cells.ELISA was used to screen positive hybridoma cell lines that could secrete specific antibodies,and monoclonal hybridoma cell lines were obtained by limiting dilution method.VASN monoclonal antibodies were prepared in large quantities by ascites induction method,purified using rProtein G,and the affinity and in vitro reaction specificity of the monoclonal antibodies were detected by ELISA and Western blotting.Results The full-length sequence of the tree shrew VASN gene was successfully amplified and the recombinant plasmid vector of tree shrew pET-30a-VASN was constructed.The sequence obtained by sequencing of the recombinant plasmid vector was identical to the tree shrew VASN target gene sequence.Recombinant protein VASN mainly existed in the form of inclusion bodies,and the purity after purification reached 90%,meeting the requirements of subsequent immunization experiments.After four immunizations with recombinant protein VASN,mouse serum antibody titer reached 1:729 000.Monoclonal positive hybridoma cell lines were obtained through ascites induction and purification,and the constant affinity value of monoclonal antibodies measured by ELISA reached 2.59x107 L/mol.Western blotting results showed that the tree shrew VASN monoclonal antibody could bind to tree shrew VASN recombinant protein,but it showed no binding reaction with porcine retinol-binding protein 4 recombinant protein,human VASN-leucine rich repeat recombinant protein,or bovine serum albumin.Anti-tree shrew VASN monoclonal antibody could specifically recognize VASN protein in tree shrew heart,liver,spleen,lung,kidney and muscle,with clear bands and clean background.Immunohistochemical detection results showed that this monoclonal antibody could recognize VASN protein in tree shrew spleen,lung,and tree shrew immortalized fibroblasts with high VASN mRNA expression levels,and the detection results were positive.Conclusion Monoclonal antibody against tree shrew VASN is successfully prepared.This antibody can be used for immunohistochemical detection of tree shrew immortalized fibroblasts,spleen tissue,and lung tissue,providing an important tool for further research on the function of VASN in tree shrew models.
6.Clinical effects of Supplemented Buyang Huanwu Decoction on postoperative patients with lumbar vertebral fracture complicated with spinal cord injury due to Qi Deficiency and Blood Stasis Pattern
Jia-man YANG ; Tong LIU ; De-hui FAN ; Mei-yi SU ; Ying LIN ; Man-guang LIANG ; Zhi-wen OU ; Shun-cong ZHANG
Chinese Traditional Patent Medicine 2025;47(11):3630-3634
AIM To explore the clinical effects of Supplemented Buyang Huanwu Decoction on postoperative patients with lumbar vertebral fracture complicated with spinal cord injury due to Qi Deficiency and Blood Stasis Pattern.METHODS One hundred and twenty patients were randomly assigned into control group(60 cases)for 6-week intervention of conventional treatment,and observation group(60 cases)for 6-week intervention of both Supplemented Buyang Huanwu Decoction and conventional treatment.The changes in clinical effects,TCM syndrome scores,spinal cord conduction signals(SEP amplitude,MEP amplitude),serum neurotrophic factors(NGF,IGF-1,BDNF),coagulation and inflammatory indices(PT,APTT,TNF-α,IL-1 β)and incidence of adverse reactions were detected.RESULTS The observation group demonstrated higher total effective rate than the control group(P<0.05).After the treatment,the two groups displayed decreased TCM syndrome scores,TNF-α,IL-1β(P<0.05),increased spinal cord conduction signals,coagulation and inflammatory indices(P<0.05),and shortened PT,APTT(P<0.05),especially for the observation group(P<0.05).No significant difference in incidence of adverse reactions was found between the two groups(P>0.05).CONCLUSION For the patients with lumbar vertebral fracture complicated with spinal cord injury due to Qi Deficiency and Blood Stasis Pattern,Supplemented Buyang Huanwu Decoction can safely and effectively promote neurological function recovery.
7.Effects of Huang'e Capsules on type IIIA prostatitis and inflammatory cytokines in the expressed prostatic secretion of the patient.
Yang-Fan OU ; Yu-Ru LIANG ; Pan XU ; Wen-Bin HUANG ; Zuo-Gang XIE
National Journal of Andrology 2024;30(12):1135-1140
OBJECTIVE:
To investigate the clinical efficacy of Huang'e Capsules in the treatment of type ⅢA chronic prostatitis, and its effects on the levels of the inflammatory cytokines neutrophil elastase (NE), IL-8 and TGF-β1 in the expressed prostatic secretion (EPS) of the patients.
METHODS:
We selected 120 patients with type ⅢA chronic prostatitis and randomly assigned them to medication with Huang'e Capsules (the trial group, n = 60) or Levofloxacin and Tamsulosin (the control group, n = 60), both for a course of 4 weeks. We obtained the NIH-CPSI scores and the levels of NE, IL-8 and TGF-β1 in the EPS, and compared them between the two groups before and after treatment.
RESULTS:
Totally, 116 of the patients completed the study, 59 in the trial and 57 in the control group. The overall clinical effectiveness was significantly higher in the trial group than in the control (89.8% vs 77.2%, P<0.05). Compared with the baseline, the patients of the trial group showed significant decreases after treatment in the total NIH-CPSI scores (32.5±7.4 vs 13.2±5.1), pain symptom scores (13.7±3.9 vs 4.2±2.3), urination symptom scores (6.9±2.4 vs 5.1±3.2) and quality of life (QOL) scores (8.3±2.7 vs 3.7±1.5) (all P< 0.05), and so did the controls in the total NIH-CPSI scores (30.8±7.8 vs 13.7±3.9), pain symptom scores (14.2±4.1 vs 7.8±2.9), urination symptom scores (7.1±2.7 vs 4.9±3.4) and quality of life (QOL) scores (8.1±2.4 vs 5.6±1.9) (all P< 0.05), and the decreases were even more significant in the trial than in the control group in the pain symptom and QOL scores ( P< 0.05). The patients of the trial group also exhibited a marked reduction after treatment in the contents of NE ([1135.4±321.5] vs [347.6±207.3] ng/L, P< 0.05) and IL-8 ([974.9±231.6] vs [ 431.3±207.2] ng/L, P< 0.05) but an elevation in that of TGF-β1 ([591.0±172.1] vs [1 402.1 ± 221.5] ng/L, P< 0.05) in the EPS, and so did the controls in the levels of NE ([1052.8±280.3] vs [761.1±225.1] ng/L, P<0.05), ([1007.5±287.7] vs [775.7±182.5] ng/L, P< 0.05), ([607.8±201.3] vs [871.3±192.5] ng/L, P< 0.05), with even more significant improvement in the trial than in the control group (P< 0.05).
CONCLUSION
Huang'e Capsules has a significant clinical efficacy and safety in the treatment of type IIIA prostatitis, which can effectively relieve the pain and urination symptoms and improve the levels of the inflammatory cytokines NE, IL-8 and TGF-β1 in the patients.
Humans
;
Male
;
Prostatitis/metabolism*
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Interleukin-8/metabolism*
;
Drugs, Chinese Herbal/therapeutic use*
;
Transforming Growth Factor beta1/metabolism*
;
Prostate/metabolism*
;
Leukocyte Elastase/metabolism*
;
Tamsulosin
;
Treatment Outcome
;
Capsules
;
Middle Aged
;
Phytotherapy
;
Cytokines/metabolism*
;
Adult
;
Levofloxacin
8.Inferring Mycobacterium Tuberculosis Drug Resistance and Transmission using Whole-genome Sequencing in a High TB-burden Setting in China
Feng Yu FAN ; Xin Dong LIU ; Wang Yi CHEN ; Chao Xi OU ; Zhi Qi MAO ; Ting Ting YANG ; Jiang Xi WANG ; Cong Wen HE ; Bing ZHAO ; Jiang Zhen LIU ; Maiweilanjiang ABULIMITI ; Maimaitiaili AIHEMUTI ; Qian GAO ; Lin Yan ZHAO
Biomedical and Environmental Sciences 2024;37(2):157-169
Objective China is among the 30 countries with a high burden of tuberculosis(TB)worldwide,and TB remains a public health concern.Kashgar Prefecture in the southern Xinjiang Autonomous Region is considered as one of the highest TB burden regions in China.However,molecular epidemiological studies of Kashgar are lacking. Methods A population-based retrospective study was conducted using whole-genome sequencing(WGS)to determine the characteristics of drug resistance and the transmission patterns. Results A total of 1,668 isolates collected in 2020 were classified into lineages 2(46.0%),3(27.5%),and 4(26.5%).The drug resistance rates revealed by WGS showed that the top three drugs in terms of the resistance rate were isoniazid(7.4%,124/1,668),streptomycin(6.0%,100/1,668),and rifampicin(3.3%,55/1,668).The rate of rifampicin resistance was 1.8%(23/1,290)in the new cases and 9.4%(32/340)in the previously treated cases.Known resistance mutations were detected more frequently in lineage 2 strains than in lineage 3 or 4 strains,respectively:18.6%vs.8.7 or 9%,P<0.001.The estimated proportion of recent transmissions was 25.9%(432/1,668).Multivariate logistic analyses indicated that sex,age,occupation,lineage,and drug resistance were the risk factors for recent transmission.Despite the low rate of drug resistance,drug-resistant strains had a higher risk of recent transmission than the susceptible strains(adjusted odds ratio,1.414;95%CI,1.023-1.954;P = 0.036).Among all patients with drug-resistant tuberculosis(DR-TB),78.4%(171/218)were attributed to the transmission of DR-TB strains. Conclusion Our results suggest that drug-resistant strains are more transmissible than susceptible strains and that transmission is the major driving force of the current DR-TB epidemic in Kashgar.
9.Grey correlation analysis on influencing factors of Yang deficiency constitution
LUO Yue ; JIANG Luxia ; YANG Shengwen ; SU Biliang ; OU Jintao ; WEN Chuanbiao
Digital Chinese Medicine 2023;6(2):151-159
【Objective 】 To explore the influencing factors of Yang deficiency constitution in traditional Chinese medicine (TCM) from the perspective of mathematics with the use of calculation formulas, so as to protect patients from getting diseases caused by Yang deficiency constitution and provide suggestions for TCM disease prevention.
【Methods】 Based on the classification and determination criteria of TCM constitution implemented by China Association of Chinese Medicine, data for 24 solar terms from May 5, 2020(Start of Summer) to April 20, 2021 (Grain Rain) for the identification of Yang deficiency were collected by mobile constitution identification system. The grey correlation analysis method was used to determine the grey correlation degree of the factors influencing Yang deficiency constitution. In addition, a random forest model was constructed for the verification of the results from the grey correlation analysis, and for the evaluation of correlation degree between Yang deficiency constitution and its influencing factors.
【Results】 A total of 16 259 sets of data were collected from healthy or sub-healthy individuals aged from 18 to 60 years living in the central and northeastern parts of Sichuan Province(China) for the identification of TCM constitutions. After screening and preprocessing, a total of 544 sets of data for the identification of Yang deficiency constitution, involving 18 aspects of factors influencing Yang deficiency constitution. The results of the grey correlation analysis showed that there were 12 influencing factors whose grey correlation degree with Yang deficiency constitution was greater than 0.6. The accuracy of these 12 influencing factors with the training set and validation set of the Yang deficiency constitution random forest model were 98.39% and 93.12%, respectively.
【Conclusion】 In the sample data selected in this paper, grey correlation analysis is the appropriate technology to analyze the influencing factors of Yang deficiency constitution. It provides a new idea and a new methodological reference for the research and analysis of the influencing factors of TCM constitution.
10.Efficacy and safety of mitoxantrone hydrochloride liposome injection in treatment of peripheral T-cell lymphomas: a multicenter, non-interventional, ambispective cohort, real-world study (MOMENT)
Huiqiang HUANG ; Zhiming LI ; Lihong LIU ; Liang HUANG ; Jie JIN ; Hongyan TONG ; Hui ZHOU ; Zengjun LI ; Zhenqian HUANG ; Wenbin QIAN ; Kaiyang DING ; Quande LIN ; Ming HOU ; Yunhong HUANG ; Jingbo WANG ; Pengcheng HE ; Xiuhua SUN ; Xiaobo WANG ; Zunmin ZHU ; Yao LIU ; Jinhai REN ; Huijing WU ; Liling ZHANG ; Hao ZHANG ; Liangquan GENG ; Jian GE ; Ou BAI ; Liping SU ; Guangxun GAO ; Xin LI ; Yanli YANG ; Yijian CHEN ; Aichun LIU ; Xin WANG ; Yi WANG ; Liqun ZOU ; Xiaobing HUANG ; Dongping HUANG ; Shujuan WEN ; Donglu ZHAO ; Jun MA
Journal of Leukemia & Lymphoma 2023;32(8):457-464
Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.

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