1.Research the effect of 4℃ refrigerated stored apheresis platelets based on platelet metabolomics
Xiaoye XIA ; Xuejing LI ; Aihua SU ; Xiao HAO ; Hongyan YE
Chinese Journal of Blood Transfusion 2025;38(4):514-521
[Objective] To investigate the differences in metabolomics between apheresis platelets stored at 4℃ and at 22℃ with agitation, aiming to provide a theoretical basis for the cold storage of apheresis platelets. [Methods] Samples were collected at four time points (d1, d5, d10, d15) for platelets stored at 4℃ (experimental group) and two time points (d1, d5) for platelets stored at 22℃ with agitation (control group). Liquid chromatography-tandem mass spectrometry (LC-MS/MS) technology was used to detect changes in platelet metabolome levels under different storage conditions. Platelet functional activity was assessed by thromboelastography (TEG) for maximum amplitude (MA) values and flow cytometry for CD62P activation rates. [Results] Metabolites in the glycolytic pathway, key metabolites in the tricarboxylic acid cycle (citrate, α-ketoglutarate), metabolites in the purine metabolism pathway (adenine, inosine monophosphate, guanine, etc.) and amino acid metabolites significantly decreased by d5 in the control group, whereas they remained stable in the experimental group. The content of fatty acid metabolites, such as prostaglandin G2, 13(S)-HOTrE, and linoleic acid, significantly increased in the control group. Statistically significant differences in MA values were observed between the two groups at d1 and d5 (P<0.05). However, in the experimental group, as the storage time extended, the MA values at d10 and d15 showed no significant difference compared to the control group at d5 (P>0.05). The CD62P activation rate between the two groups was statistically significant (P<0.05). Additionally, the CD62P activation rate of platelets in the 22℃ group increased rapidly from d1, while it rose gradually in the 4 ℃ group. [Conclusion] Platelets stored at 4 ℃ exhibit more stable metabolic activity and slower functional deterioration, which is beneficial for extending the effective storage period of platelets.
2.Factors influencing the prognosis of patients with laryngeal cancer combined with simultaneous lung cancer based on the SEER database
Hongyan SU ; Hongwei LI ; Shangming YANG
Cancer Research and Clinic 2024;36(1):41-46
Objective:To explore the prognostic factors and the relationship between the disease type at initial diagnosis and the disease type causing death in patients with laryngeal cancer combined with simultaneous lung cancer.Methods:The clinicopathological data of 240 patients diagnosed with laryngeal cancer combined with simultaneous lung cancer between January 2004 and December 2015 in the Surveillance, Epidemiology and End Results (SEER) database were retrospectively analyzed. Chi-square test was used to evaluate the relationship between the disease type at initial diagnosis and the disease type causing death in patients with laryngeal cancer combined with simultaneous lung cancer. Kaplan-Meier method was used for survival analysis, and Cox proportional risk model was used to make univariate and multivariate analysis of the factors influencing the overall survival of patients.Results:A total of 240 cases with laryngeal cancer combined with simultaneous lung cancer included 222 males and 18 females, and there were 141 cases aged over 65 years. The disease type at initial diagnosis was not correlated with the disease type causing death of patients ( χ2 = 3.31, P = 0.191). The 1-year, 3-year, and 5-year overall survival rates of these patients were 62.1%, 31.5%, and 16.4%, respectively. Univariate analysis showed that the primary location of laryngeal cancer, primary location of lung cancer, histological grade of lung cancer, pathological type, clinical staging, surgical condition, and radiotherapy influenced the overall survival of patients (all P < 0.05); multivariate analysis showed that the primary location of laryngeal cancer, primary location of lung cancer, histological grade of lung cancer, pathological type, clinical stage, and surgical condition were independent influencing factors for overall survival of patients with laryngeal cancer combined with simultaneous lung cancer (all P < 0.05). Conclusions:The independent factors influencing the prognosis of laryngeal cancer with simultaneous lung cancer patients include the primary focus of laryngeal cancer, the primary focus of lung cancer, the histological grade of lung cancer, the pathological type, the clinical stage, and the surgical condition. And there is no correlation between the disease type at initial diagnosis and the disease type causing death.
3.Predictive value of LAR on in-hospital death of patients with intra-abdominal infection sepsis in ICU
Xin JIN ; Hongyan ZHAO ; Shandao SU
Chongqing Medicine 2024;53(14):2159-2162,2167
Objective To investigate the predictive value of lactic acid to albumin ratio in the in-hospital mortality of the patients with intra-abdominal infection sepsis in ICU.Methods The clinical data in 175 pa-tients with sepsis caused by intra-abdominal infection admitted and treated in the intensive care medicine de-partment of this hospital from January 2018 to December 2021 were retrospectively analyzed.The patients were divided into the survival group (n=94) and death group (n=81) according to whether or not having in-hospital death.The general data,blood lactic acid and albumin levels of the patients at admission were collect-ed,and the LAR value was calculated.The receiver operating characteristic (ROC) curve was used to evaluate the predictive value of LAR for the in-hospital mortality of sepsis patients in ICU.The Cox regression analysis and Kaplan-Meier curves were used to analyze the independent correlation between LAR and ICU mortality. Results There were statistically significant differences in the acute physiology and chronic health scoring sys-tem Ⅱ (APACHⅡ) score,sequential organ failure assessment (SOFA) score,mean arterial pressure,oxygen-ation index,PCT,lactic acid,albumin,LAR and the proportion of surgical patients between the two groups (P<0.05).The area under the curve (AUC) of LAR for predicting the prognosis in the patients with ICU sepsis was 0.765 (95%CI:0.695-0.835),which was higher than that of the APACHEⅡscore,SOFA score,lactic acid and PCT.With LAR=1.295 as the cutoff value,the sensitivity and specificity for its prediction were 0.679 and 0.707,respectively.The Kaplan-Meier curve showed that the ICU motality rate in high LAR (LAR≥1.29) was higher than that in low LAR,and the difference was statistically significant(63.2% vs. 41.5%,P<0.05).The Cox regression analysis results showed that the mortality in sepsis showed the increas-ing trend with the LAR level increase (P<0.05).Conclusion LAR is an influencing factor of the death in the intra-abdominal infection sepsis in ICU,which could effectively predict the risk of in-hospital death of the patients.
4.Expression level of serum UBE2C and TRIM27 in patients with endometrial cancer and their correlation with pathological parameters
Fei CHAI ; Zhenwen CHEN ; Hongyan LIU ; Su LI ; Yuanyuan GONG ; Yingying ZHAO
The Journal of Practical Medicine 2024;40(13):1808-1813
Objective To investigate the expression level of serum ubiquitin-conjugating enzyme 2C(UBE2C)and tripartite motif-containing protein 27(TRIM27)in patients with endometrial cancer(EC)and their correlation with pathological parameters.Methods A total of 96 EC patients from March 2020 to March 2023 were selected as EC group;65 patients with endometrial atypical hyperplasia(EAH)as EAH group,and 80 healthy subjects as the control group.Enzyme linked immunosorbent assay was applied to analyze the expression level of serum UBE2C and TRIM27.The relationship between serum UBE2C,TRIM27,and pathological data was analyzed;receiver operating characteristic was applied to evaluate the predictive value of serum UBE2C and TRIM27 level for EC.Results The level of serum UBE2C and TRIM27 of EC patients was obviously higher than that in healthy subjects(P<0.05),and was correlated with tumor diameter,tumor differentiation,lymph node metastasis,FIGO stage,muscle layer invasion depth,cervical involvement,estrogen receptor expression,and progestogen receptor expression(P<0.05).There was positive correlation between serum UBE2C and TRIM27(r=0.475,P<0.001);and the level of serum UBE2C and TRIM27 was positively correlated with tumor diameter,lymph node metastasis,FIGO stage,and depth of musclular invasion,but negatively with tumor differentiation,estrogen receptor expression,and progestogen receptor expression(P<0.05).The combination of UBE2C and TRIM27 had obviously higher AUC in evaluating EC than single detection(ZUBE2C-combination=3.406,P<0.001,ZTRIM27-combination=3.285,P=0.001).Conclusion The expression level of UBE2C and TRIM27 in serum of EC patients is up-regulated,which is closely related to pathological parameters.The level of serum UBE2C and TRIM27 can provide reference for early diagnosis of EC.
5.Abnormal Karyotypes Distribution Characteristics and Pregnancy Outcomes of Fetal Sex Chromosome Aneuploidy in 101 Cases
Xin WU ; Ting QIN ; Xigui LONG ; Hongyan ZHANG ; Linhong SU ; Xiuqun ZHANG
Journal of Modern Laboratory Medicine 2024;39(4):40-44,62
Objective To analyze the distribution characteristics of abnormal karyotypes of fetal sex chromosome aneuploidy(SCA)and pregnancy outcomes in 101 fetal cases.Methods A retrospective study was conducted among 7 821 pregnant women who underwent successfully prenatal karyotyping diagnosis at Guangxi Zhuang Autonomous Region People's Hospital from January 2016 to December 2021.All women received amniotic fluid cell culture karyotype analysis and copy number variation sequencing(CNV-seq)detection and 101 cases of SCA detected were analyzed.Results A total of 101 cases were detected by SCA,with a detection rate of 1.29%.Among them,Klinefelter syndrome accounted for 33.66%,superestrogenism syndrome accounted for 17.82%,superandrogenic syndrome accounted for 12.87%,turner syndrome accounted for 10.89%,other aneuploidy abnormalities[including 48,XXXY:1 case;69,XXY(80%)/68,XXY,-22(20%):1 case]accounted for 1.98%,and chimerism accounted for 22.77%.The prenatal indications for 101 cases of SCA were as follows:age ≥ 35 years,high/critical risk of serum biochemical screening,fetal ultrasound abnormalities,abnormalities in non-invasive prenatal testing(NIPT),history of adverse pregnancy and childbirth and other reasons(1 case of cerebral palsy in pregnant women and 4 cases of bilateral thalassemia)accounted for 53.47%(54/101),4.95%(5/101),17.82%(18/101),51.49%(52/101),12.87%(13/101),4.95%(5/101),respectively.Partial cases had multiple prenatal diagnostic indications.Meanwhile,23 fetuses diagnosed with sex chromosome chimerism,of which 22 cases were validated by karyotype and CNV seq,11 pregnant women chose to terminate their pregnancy,with the rest chose to continue pregnancy.Conclusion The combination of prenatal karyotype diagnosis,serological testing,prenatal ultrasound and other prenatal screening methods can help improve the detection rate of SCA,while CNV-seq can provide more clinical evidence for genetic counseling of pregnant women with sex chromosome chimerism.
6.Changing resistance profiles of Proteus,Morganella and Providencia in hospitals across China:results from the CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Yunmin XU ; Xiaoxue DONG ; Bin SHAN ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Ping JI ; Fengbo ZHANG ; Yi XIE ; Mei KANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Hongyan ZHENG ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Wenhui HUANG ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WEN ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2024;24(4):410-417
Objective To understand the changing distribution and antimicrobial resistance profiles of Proteus,Morganella and Providencia in hospitals across China from January 1,2015 to December 31,2021 in the CHINET Antimicrobial Resistance Surveillance Program.Methods Antimicrobial susceptibility testing was carried out following the unified CHINET protocol.The results were interpreted in accordance with the breakpoints in the 2021 Clinical & Laboratory Standards Institute(CLSI)M100(31 st Edition).Results A total of 32 433 Enterobacterales strains were isolated during the 7-year period,including 24 160 strains of Proteus,6 704 strains of Morganella,and 1 569 strains of Providencia.The overall number of these Enterobacterales isolates increased significantly over the 7-year period.The top 3 specimen source of these strains were urine,lower respiratory tract specimens,and wound secretions.Proteus,Morganella,and Providencia isolates showed lower resistance rates to amikacin,meropenem,cefoxitin,cefepime,cefoperazone-sulbactam,and piperacillin-tazobactam.For most of the antibiotics tested,less than 10%of the Proteus and Morganella strains were resistant,while less than 20%of the Providencia strains were resistant.The prevalence of carbapenem-resistant Enterobacterales(CRE)was 1.4%in Proteus isolates,1.9%in Morganella isolates,and 15.6%in Providencia isolates.Conclusions The overall number of clinical isolates of Proteus,Morganella and Providencia increased significantly in the 7-year period from 2015 to 2021.The prevalence of CRE strains also increased.More attention should be paid to antimicrobial resistance surveillance and rational antibiotic use so as to prevent the emergence and increase of antimicrobial resistance.
7.Therapeutic effects of high monounsaturated fatty acid and low carbohydrate formula on blood glucose levels and diarrhea in critically ill neurological patients
Xiaochang HUANG ; Rong LAI ; Qiuliang YANG ; Jiezhen FENG ; Yongjing SU ; Huiyu FENG ; Hongyan ZHOU
Chinese Critical Care Medicine 2024;36(9):980-984
Objective:To investigate the effects of using a high monounsaturated fatty acid (MUFA) and low carbohydrate formula on blood glucose levels and diarrhea treatment effects in critically ill neurological patients.Methods:A self-controlled before-and-after study design was employed, with 13 patients admitted to the neurology intensive care unit (ICU) of the First Affiliated Hospital of Sun Yat-sen University from November to December 2023, who were treated with a high MUFA and low carbohydrate formula [Glucerna enteral nutrition (EN) preparation]. Changes in blood glucose parameters within 7 days before and after the use of Glucerna EN preparation were analyzed, including standard deviation ( SD) of blood glucose, mean blood glucose (MG), median blood glucose, mean amplitude of glycemic excursions (MAGE), largest amplitude of glycemic excursions (LAGE), coefficient of variation ( CV) of blood glucose, the incidence of hyperglycemia (> 7.8 mmol/L) and severe hyperglycemia (> 13.9 mmol/L), and daily insulin dose. Changes in total protein (TP), albumin (ALB), hemoglobin (Hb), C-reactive protein (CRP), and white blood cell count (WBC) were observed before and after intervention. Improvement in diarrhea symptoms, Hart diarrhea score, Bristol Stool classification score, and incontinence dermatitis classification were also analyzed before and after the use of Glucerna EN preparation. Results:A total of 13 critically ill neurological patients were enrolled, among whom 9 patients had a history of hyperglycemia and 8 patients had diarrhea symptoms. After intervention with Glucerna, the patients' SD of blood glucose, MG, median blood glucose, MAGE, LAGE, CV of blood glucose, incidence of hyperglycemia, incidence of severe hyperglycemia, and daily insulin dose were all lower than those before the intervention [ SD of blood glucose (mmol/L): 1.83±1.11 vs. 2.10±1.13, MG (mmol/L): 8.87±2.03 vs. 9.75±1.37, median blood glucose (mmol/L): 9.12±1.67 vs. 10.17±0.48, MAGE (mmol/L): 0.66±0.31 vs. 0.78±0.32, LAGE (mmol/L): 4.95±3.64 vs. 5.58±3.10, CV of blood glucose: 16.00% (11.00%, 28.50%) vs. 18.00% (12.50%, 27.50%), hyperglycemia incidence: 47.31% vs. 74.66%, severe hyperglycemia incidence: 6.08% vs. 6.71%, daily insulin dose (U): 5.25 (0.00, 32.59) vs. 20.76 (0.00, 66.88)], with a significant decrease in daily insulin dose after the intervention ( P < 0.05); TP, ALB, Hb, CRP and WBC showed no significant changes before and after the intervention with Glucerna EN preparation. The improvement time of diarrhea symptoms after intervention was (3.50±1.41) days, and the Hart diarrhea score on the seventh day after intervention (4.88±3.48 vs. 10.00±3.38) and the Bristol Stool classification score on the third and seventh days after intervention (5.87±0.35, 5.50±0.53 vs. 6.50±0.53) were significantly lower than before the intervention (all P < 0.05). Before the intervention with Glucerna EN preparation, the classification of incontinence dermatitis was mainly classified as Grade 2 severity (71.43%); after the intervention, it significantly improved by the seventh day, with Grade 1 being the main classification (57.14%). Conclusion:The high MUFA and low carbohydrate formula has a positive effect on blood glucose control and diarrhea treatment in critically ill neurological patients.
8.Effects of perioperative use of renin-angiotensin system inhibitor on renal function and clinical outcomes in patients undergoing coronary artery bypass grafting surgery
Hongyan ZHOU ; Xiaoting SU ; Heng ZHANG ; Zhongchen LI ; Nan CHENG ; Bei ZHANG ; Su YUAN ; Juan DU
Chinese Critical Care Medicine 2024;36(10):1056-1062
Objective:To analyze the effects of preoperative renin-angiotensin system inhibitor (RASi) use on postoperative renal function and short-term and long-term prognosis in patients undergoing coronary artery bypass grafting (CABG).Methods:A retrospective cohort analysis was conducted. Based on the registration study data of CABG patients at Fuwai Hospital, Chinese Academy of Medical Sciences, the clinical data of adult patients who underwent CABG from January 2013 to December 2022 were analyzed. Preoperative use of RASi (PreRASi) was defined as receiving RASi treatment within 48 hours before surgery. Postoperative acute kidney injury (AKI) was defined using the diagnostic criteria of Kidney Disease: Improving Global Outcomes (KDIGO). Demographic characteristics, past medical history, comorbidities, preoperative medication, preoperative laboratory test results, specific information on surgical procedures, and postoperative treatment related data were extracted. The primary endpoint was the incidence of postoperative AKI. Secondary endpoints included in-hospital all-cause mortality and all-cause mortality within the longest follow-up period. According to whether RASi was used before surgery, the patients were divided into PreRASi group and No-PreRASi group. The baseline data of the two groups were balanced by propensity score matching (PSM). Logistic regression model and Cox proportional hazards model were used to assess the correlation between PreRASi and postoperative AKI and clinical outcomes, and analyze the subgroups of hypertension and heart failure with preserved ejection fraction (HFpEF) in the cohort.Results:A total of 33?884 patients who underwent CABG were included, with a mean follow-up duration of (3.0±2.4) years and the longest follow-up duration up to 8.5 years. There were 9?128 cases (26.94%) in the PreRASi group and 24?756 cases (73.06%) in the No-PreRASi group. The incidence of postoperative AKI in the PreRASi group was 47.61% (4?346 cases), compared to 52.37% (12?964 cases) in the No-PreRASi group. Two groups were matched with 5?094 patients each. Compared to the No-PreRASi group, both before and after PSM, PreRASi was associated with a reduction of risk of postoperative AKI [before PSM: odds ratio ( OR) = 0.834, 95% confidence interval (95% CI) was 0.793-0.877, P < 0.001; after PSM: OR = 0.875, 95% CI was 0.808-0.948, P = 0.001]. Subgroup analysis of hypertensive and HFpEF patients showed that PreRASi was associated with a decreased risk of postoperative AKI before and after PSM. The in-hospital mortality for the PreRASi and No-PreRASi groups were 0.61% (56 cases) and 0.49% (121 cases), respectively. Analysis of the overall cohort and subgroups with hypertension and HFpEF showed no correlation between PreRASi and in-hospital mortality or longest follow-up mortality. Conclusion:The perioperative use of RASi can reduce the risk of postoperative AKI in patients undergoing CABG, has a certain renal protective effect, but is not associated with short-term or long-term death risk after surgery.
9.Comparison of four early warning scores in predicting the prognosis of critically ill patients in secondary hospitals.
Xiaoqin SU ; Hongyan ZHANG ; Wenjun YUAN ; Meng YI ; Chenghao FU ; Jiawei JIANG ; Hongmei GAO
Chinese Critical Care Medicine 2023;35(10):1093-1098
OBJECTIVE:
To explore the predictive value of acute physiology and chronic health evaluation II (APACHE II), sequential organ failure assessment (SOFA), quick sequential organ failure assessment (qSOFA) and modified early warning score (MEWS) in evaluating the prognosis of patients in intensive care unit (ICU) of secondary hospitals, and to provide guidance for clinical application.
METHODS:
The clinical data of adult critical patients admitted to the ICU of Wanzhou District First People's Hospital from October 2022 to April 2023 were retrospectively analyzed. According to the clinical outcome of ICU, the patients were divided into improvement group and death group. The general information, blood routine, heart, liver and kidney function indicators, coagulation indicators, blood gas analysis, APACHE II score, SOFA score, qSOFA score, MEWS score at the time of admission to the ICU, the number of cases of invasive mechanical ventilation (IMV) and continuous blood purification (CBP) were compared between the two groups. Univariate analysis was performed, and multivariate Logistic regression analysis was used to analyze the related factors of death. Receiver operator characteristic curve (ROC curve) was used to analyze the predictive value of the four scores in ICU patients.
RESULTS:
A total of 126 patients were included, of which 45 patients died in the ICU and 81 patients improved and transferred out. Univariate analysis of death-related critically ill patients showed that procalcitonin (PCT), serum creatinine (SCr), blood urea nitrogen (BUN), albumin (ALB), prothrombin time (PT), activated partial prothrombin time (APTT), D-dimer, pH value, HCO3-, blood lactic acid (Lac), number of patients treated with IMV and CBP, APACHE II score, SOFA score, qSOFA score and MEWS score were significantly different between the two groups (all P < 0.05). Multivariate Logistic regression analysis showed that the APACHE II score [odds ratio (OR) = 1.115, 95% confidence interval (95%CI) was 1.025-1.213, P = 0.011], SOFA score (OR = 1.204, 95%CI was 1.037-1.398, P = 0.015), MEWS score (OR = 1.464, 95%CI was 1.102-1.946, P = 0.009), and APTT (OR = 1.081, 95%CI was 1.015-1.152, P = 0.016) were independent risk factors affecting the mortality of critically ill patients in the ICU. ROC curve analysis showed that APACHE II, SOFA, qSOFA, and MEWS scores could predict the prognosis of critically ill ICU patients, among which SOFA score had the strongest predictive effect, and the area under the curve (AUC) was 0.808. There was a statistically significant difference in the time required for the four scores (F = 117.333, P < 0.001), among which the MEWS scoring required the shortest time [(1.03±0.39) minutes], and the APACHE II scoring required the longest time [(2.81±1.04) minutes].
CONCLUSIONS
APACHE II, SOFA, qSOFA, and MEWS scores can be used to assess the severity of critically ill patients and predict in-hospital mortality. The SOFA score is superior to other scores in predicting severity. The MEWS is preferred because its assessment time is shortest. Early warning score can help secondary hospitals to detect potentially critical patients early and provide help for clinical rapid urgent emergency decision-making.
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Early Warning Score
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Organ Dysfunction Scores
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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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