1.Clinical efficacy and safety of vortioxetine as an adjuvant drug for patients with bipolar depression.
Chunxiao DAI ; Yaoyang FU ; Xuanwei LI ; Meihua LIN ; Yinbo LI ; Xiao LI ; Keke HUANG ; Chengcheng ZHOU ; Jian XIE ; Qingwei ZHAO ; Shaohua HU
Journal of Zhejiang University. Science. B 2025;26(1):26-38
OBJECTIVES:
Whether vortioxetine has a utility as an adjuvant drug in the treatment of bipolar depression remains controversial. This study aimed to validate the efficacy and safety of vortioxetine in bipolar depression.
METHODS:
Patients with bipolar Ⅱ depression were enrolled in this prospective, two-center, randomized, 12-week pilot trial. The main indicator for assessing treatment effectiveness was a Montgomery-Asberg Depression Rating Scale (MADRS) of ≥50%. All eligible patients initially received four weeks of lurasidone monotherapy. Patients who responded well continued to receive this kind of monotherapy. However, no-response patients were randomly assigned to either valproate or vortioxetine treatment for eight weeks. By comprehensively comparing the results of MADRS over a period of 4‒12 weeks, a systematic analysis was conducted to determine whether vortioxetine could be used as an adjuvant drug for treating bipolar depression.
RESULTS:
Thirty-seven patients responded to lurasidone monotherapy, and 60 patients were randomly assigned to the valproate or vortioxetine group for eight weeks. After two weeks of combined valproate or vortioxetine treatment, the MADRS score in the vortioxetine group was significantly lower than that in the valproate group. There was no difference in the MADRS scores between the two groups at 8 and 12 weeks. The incidence of side effects did not significantly differ between the valproate and vortioxetine groups. Importantly, three patients in the vortioxetine group appeared to switch to mania or hypomania.
CONCLUSIONS
This study suggested that lurasidone combination with vortioxetine might have potential benefits to bipolar II depression in the early stage, while disease progression should be monitored closely for the risk of switching to mania.
Humans
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Bipolar Disorder/drug therapy*
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Vortioxetine/therapeutic use*
;
Male
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Female
;
Middle Aged
;
Adult
;
Valproic Acid/administration & dosage*
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Lurasidone Hydrochloride/administration & dosage*
;
Prospective Studies
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Treatment Outcome
;
Pilot Projects
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Drug Therapy, Combination
;
Sulfides/therapeutic use*
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Antidepressive Agents/therapeutic use*
2.Nanomedicine strategies for cuproptosis: Metabolic reprogramming and tumor immunotherapy.
Ruixuan ZHANG ; Yunfei LI ; Hui FU ; Chengcheng ZHAO ; Xiuyan LI ; Yuming WANG ; Yujiao SUN ; Yingpeng LI
Acta Pharmaceutica Sinica B 2025;15(9):4582-4613
Cuproptosis, a recently discovered form of regulated cell death involving copper ion metabolism, has emerged as a promising approach for tumor therapy. This pathway not only directly eliminates tumor cells but also promotes immunogenic cell death (ICD), reshaping the tumor microenvironment (TME) and initiating robust anti-tumor immune responses. However, translating cuproptosis-based therapies into clinical applications is hindered by challenges, including complex metabolic regulation, TME heterogeneity, and the precision required for effective drug delivery. To address these limitations, nanoparticles offer transformative solutions by providing precise delivery of cuproptosis-inducing agents, controlled drug release, and enhanced therapeutic efficacy through simultaneous modulation of metabolic pathways and immune responses. This review systematically discusses recent advancements in nanoparticle-based cuproptosis delivery systems, highlighting nanoparticle design principles and their synergistic effects when integrated with other therapeutic modalities such as ICB, PTT, and CDT. Furthermore, we explore the potential of cuproptosis-based nanomedicine for personalized cancer treatment by emphasizing strategies for TME stratification and therapeutic optimization tailored to patient profiles. By integrating current insights from metabolic reprogramming, tumor immunotherapy, and nanotechnology, this review aims to facilitate the clinical translation of cuproptosis nanomedicine and significantly contribute to the advancement of precision oncology.
3.Meta-analysis of the diagnostic value of 18F-FDG PET/CT in postoperative recurrence or metastasis of ovarian cancer patients with elevated CA125 levels
Chunyan MIAO ; Dapai LIU ; Fu GAO ; Chengcheng YU ; MANFEIDA·MAIMAITI ; Wutao PU ; Luhua XIA
China Medical Equipment 2025;22(5):33-37
Objective:To systematically review the diagnostic value of 18F-fluorodeoxyglucose positron emission tomography/computed tomography(18F-FDG PET/CT)on recurrence or metastasis of patients with ovarian cancer whose postoperative serum carbohydrate antigen 125(CA125)occurred abnormal elevation.Methods:A systematic search was conducted in foreign databases,including PubMed,Embase,Cochrane Library(Central)and Web of Science(SCI-Expanded),as well as Chinese databases,such as China National Knowledge Infrastructure(CNKI),VIP Network,Wanfang Database,and China Biology Medicine(CBM),for the studies that were published between January 2010 and January 2023 on the diagnostic value of 18F-FDG PET/CT on recurrence or metastasis of patients with ovarian cancer whose postoperative serum CA125 levels occurred abnormal elevation.The quality of the included studies was assessed by using the QUADAS-2 quality evaluation tool in Review Manager 5.4 software.The effective data were extracted,and effect quantities were merged,and heterogeneity test was conducted through Meta-Disc 1.4 software.Publication bias of the included studies was tested by using Stata 14.0 software.Results:A total of seven literatures were involved in this research,and 290 patients with ovarian cancer were included to conduct heterogeneity test,which revealed I2 values all were greater than 50%.Therefore,the a fixed-effect model was used to merge effect quantity.The results demonstrated that the diagnostic accuracy was higher,and the sensitivity,specificity,positive likelihood ratio,negative likelihood ratio,and diagnostic odds ratio(DOR)of the mergement were respectively 0.95(95%CI:0.91-0.98),0.83(95%CI:0.70-0.92),4.84(95%CI:2.82-8.31),0.07(95%CI:0.04-0.13)and 73.53(95%CI:28.00-187.90).The area under curve(AUC)value of receiver operating characteristic curve(AUC)was 0.9527,and the diagnostic accuracy of 18F-FDG PET/CT for metastasis or recurrence in patients with ovarian cancer,whose postoperative serum CA125 levels occurred elevation,reached to 95.27%.Publication bias testing showed there was no evidence of publication bias.Conclusion:18F-FDG PET/CT exhibits higher accuracy in diagnosing recurrence or metastasis in patients with ovarian cancer whose postoperative serum CA125 levels occurred elevation,which can sensitively and accurately confirmed postoperative recurrence or metastasis of patients with ovarian cancer,and early find the lesions of metastasis or recurrence of ovarian cancer.
4.Renal response and prognosis of newly diagnosed patients with multiple myeloma with renal impairment applying VRD and autologous hematopoietic stem cell transplantation
Xingyue WU ; Yue HUANG ; Hongmiao SHEN ; Hongying YOU ; Zhi YAN ; Yan XIE ; Weiqin YAO ; Shuang YAN ; Jing WANG ; Yingying ZHAI ; Xiaolan SHI ; Jingjing SHANG ; Song JIN ; Lingzhi YAN ; Depei WU ; Chengcheng FU
Chinese Journal of Hematology 2025;46(9):839-847
Objective:To investigate the feasibility of the bortezomib, lenalidomide, and dexamethasone (VRD) regimen combined with autologous hematopoietic stem cell transplantation (auto-HSCT) in patients with multiple myeloma (MM) and renal impairment, analyze treatment efficacy and renal responses stratified based on renal dysfunction severity, and explore the prognostic significance of early renal response and its affecting factors.Methods:This retrospective study, conducted at the First Affiliated Hospital of Soochow University, categorized 316 patients with newly diagnosed MM (NDMM) from August 2018 to October 2022 based on renal function for analysis of clinical characteristics, treatment response, and prognosis. Continuous variables were compared using t-tests or Mann-Whitney U tests, categorical variables utilizing Chi-square tests, survival outcomes employing Kaplan-Meier and Log-rank tests, and renal response predictors with logistic regression.Results:Patients were stratified based on baseline estimated glomerular filtration rate (eGFR) : normal [≥90 ml·min -1· (1.73 m 2) -1, n=160], mild [≥60 ml·min -1· (1.73 m 2) -1 to <90 ml·min -1· (1.73 m 2) -1, n=55], moderate [≥30 ml·min -1· (1.73 m 2) -1 to <60 ml·min -1· (1.73 m 2) -1, n=39], and severe impairment [<30 ml·min -1· (1.73 m 2) -1, n=62]. Moderate and severe renal impairment correlated with advanced International Staging System/Revised International Staging System classification, lower hemoglobin levels, frailty, and higher light-chain/IgD subtype prevalence ( P<0.05). Despite younger age ( P=0.001) and higher transplant rates ( P=0.041) in severe cases, overall response rates ( ORR: 93.7% ; ≥VGPR: 82.9% ) were comparable across groups ( P>0.05). Among 24 dialysis-dependent patients at diagnosis, 11 (45.8% ) achieved dialysis independence after induction [median: 3.0 (0.5–4.0) months], including 10 undergoing auto-HSCT. In 89 evaluable patients [baseline eGFR <50 ml·min -1· (1.73 m 2) -1], renal ORR (RORR) was 70.8% [rapid complete response: 31.5% ; rapid partial response: 11.2% ; rapid minimal response (RMR) : 28.1% ]. Renal response predicted better survival (overall survival: HR=0.36, 95% CI: 0.13–0.99, P=0.049). Moderate-to-severe renal impairment was associated with increased transplant-related adverse events and delayed engraftment ( P<0.05) ; however, auto-HSCT significantly improved outcomes after 33.5-month median follow-up (range: 2–65 months). Multivariate analysis identified 1q21+ ( OR=3.58, 95% CI: 1.17–11.02, P=0.026) and light-chain subtype ( OR=2.86, 95% CI: 1.08–7.69, P=0.036) as independent predictors of poor renal response. Conclusion:VRD regimen plus auto-HSCT demonstrates robust efficacy in NDMM, including patients with renal impairment, with a 70.8% RORR and manageable toxicity. Achieving ≥RMR correlates with superior prognosis, whereas 1q21+ and light-chain subtype independently predict inferior renal response.
5.Development, reliability, and validity of a treatment-related quality of life scale for Chinese patients with multiple myeloma
Chunyan SUN ; Zhen CAI ; Bing CHEN ; Lijuan CHEN ; Wenming CHEN ; Kaiyang DING ; Juan DU ; Rong FU ; Chengcheng FU ; Da GAO ; Guangxun GAO ; Yanjuan HE ; Jian HOU ; Ming JIANG ; Fei LI ; Jian LI ; Juan LI ; Zhenyu LI ; Aijun LIAO ; Jing LIU ; Jun LUO ; Jianmin LUO ; Yanping MA ; Jianqing MI ; Ting NIU ; Hongling PENG ; Yongping SONG ; Luqun WANG ; Rong ZHAN ; Xi ZHANG ; Yu HU
Chinese Journal of Hematology 2025;46(8):713-721
Objective:To develop a treatment-related quality of life scale for Chinese patients with multiple myeloma (MM) and to test its reliability and validity.Methods:The initial scale was constructed through a literature search, Delphi expert correspondence, and cognitive testing. This study conducted a preliminary survey of 379 patients with MM and a formal survey of 865 patients from the hematology departments of 155 hospitals nationwide from February 2024 to March 2024. The final scale was obtained after conducting item analysis and reliability and validity tests on the initial scale.Results:The constructed scale contains 36 items covering six domains: physiological, psychological, social, treatment side effects, general health, and others. In the preliminary survey, the Cronbach’s alpha coefficient of each item ranged from 0.597 to 0.939, and the test-retest reliability was 0.747 ( P<0.001). Exploratory factor analysis extracted eight common factors with a cumulative variance contribution of 60.058%. In the formal survey, the Cronbach’s alpha coefficient of each item ranged from 0.484 to 0.930, and the test-retest reliability was 0.835 ( P<0.001). Confirmatory factor analysis revealed a comparative fit index of 0.750, a root-mean-square error of approximation of 0.090, and a root-mean-square residual of 0.067. Conclusion:The treatment-related quality of life scale for Chinese patients with MM designed in this study exhibited good reliability and validity, reflecting the impact of treatment on the quality of life of patients. This scale can provide a reference to clinicians for assessing the disease status of patients.
6.Impact of donor characteristics on prognosis for myelodysplastic syndromes after haplo-identical transplantation: a retrospective study
Hong WANG ; Xueqian LI ; Qingyuan WANG ; Jiaqian QI ; Huiying QIU ; Chengcheng FU ; Xiaowen TANG ; Miao MIAO ; Ying WANG ; Suning CHEN ; Changgeng RUAN ; Depei WU ; Yue HAN
Chinese Journal of Hematology 2025;46(11):1026-1031
Objective:To evaluate the impact of donor characteristics on the prognosis of myelodysplastic syndrome (MDS) patients undergoing haplo-identical transplantation (HIDT) .Methods:A retrospective analysis of 203 MDS patients who received HIDT was conducted to evaluate how donor factors influenced transplant outcomes.Results:In MDS patients undergoing haploidentical transplantation, donors over 50 years were associated with higher EBV reactivation (2-year cumulative incidence 42.9% vs 22.0% for <50 years old; P=0.010). Female donors were linked to increased severe chronic GVHD compared with male donors (2-year incidence 11.9% vs 4.0% ; P=0.017). Additionally, 2-year overall survival (OS) was slightly lower with female donors than male donors (56.6% vs 69.7% ), but the difference was not statistically significant ( P=0.073). Donor-recipient blood type did not affect post-transplant OS or cumulative relapse rates. Donor-recipient kinship analysis revealed that child donors, compared to haploidentical sibling or parent donors, had lower rates of grade Ⅱ–Ⅳ acute GVHD (27.2% vs 45.7% vs 53.5%, P=0.007) and 2-year EBV reactivation (13.9% vs 29.3% vs 38.9%, P=0.001). For donors under 20 years, donor gender did not significantly affect 2-year OS ( P=0.913), relapse-free survival ( P=0.716), or 100-day incidence of grade Ⅱ–Ⅳ acute GVHD ( P=0.359) . Conclusion:For MDS patients undergoing HIDT, donors over 50 should be avoided. Male and child donors are preferred, while donor gender does not significantly affect outcomes if the donor is under 20 years old.
7.Redefining multiple myeloma treatment: Advances, challenges, and future directions in immunotherapy.
Chengcheng FU ; Yingying ZHAI ; Lingzhi YAN ; Song JIN ; Jingjing SHANG ; Xiaolan SHI ; Depei WU
Chinese Medical Journal 2025;138(19):2399-2410
Multiple myeloma (MM) is a hematological malignancy that poses significant treatment challenges due to its heterogeneity and propensity for relapse and progression. In the last two decades, the therapeutic landscape of MM has changed dramatically, but the disease remains largely incurable, with many patients facing treatment resistance. This review evaluates the current status of MM treatments, emphasizing the limitations of traditional therapies and the emerging role of immunotherapy in improving patient outcomes. It highlights the importance of achieving and maintaining minimal residual disease negativity and a balanced immune response as key treatment goals. Furthermore, it discusses the advancements in immunotherapies that are improving the prospects for patients, particularly those with relapsed or refractory disease. Innovative strategies, such as chimeric antigen receptor T-cell therapy, bispecific antibodies, and bispecific T cell engagers, have shown significant promise by targeting the malignant cells and the bone marrow microenvironment, which are essential for disease persistence and resistance to therapy. Future research should focus on refining MM treatment strategies, including the integration of immunotherapy into earlier treatment lines and the development of predictive biomarkers for personalized treatment approaches, ultimately enhancing patient outcomes.
8.Research progress in immunotherapy for resectable non-small cell lung cancer
Hao YANG ; Chengcheng ZHANG ; Yue ZHANG ; Liwen ZHANG ; Maoyong FU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(11):1664-1671
Resectable non-small cell lung cancer (NSCLC) is prone to recurrence and metastasis after simple surgery. Although patients can benefit from preoperative neoadjuvant chemotherapy and postoperative adjuvant chemotherapy, the 5-year survival rate is not significantly improved. In recent years, with the rise of immunotherapy, NSCLC immunotherapy has gradually received attention. Many explorations have been made on resectable NSCLC immunotherapy, and satisfactory results have been obtained. With the release of multiple phase 3 research results, a new chapter in resectable NSCLC immunotherapy has officially opened. However, there are still many problems in the immunotherapy of resectable NSCLC. This article reviews the current relevant research and provides reference for clinical application.
9.Dynamic changes and prognostic significance of immunoparesis in newly diagnosed multiple myeloma patients
Zhi YAN ; Xingyue WU ; Weiqin YAO ; Lingzhi YAN ; Song JIN ; Jingjing SHANG ; Xiaolan SHI ; Depei WU ; Chengcheng FU
Journal of Shanghai Jiaotong University(Medical Science) 2025;45(7):807-814
Objective·To detect immunoglobulin(Ig)expression levels in newly diagnosed multiple myeloma(MM)patients before and after induction therapy,and to explore the clinical significance of Ig expression levels and their dynamic changes in relation to treatment efficacy,infection occurrence,and prognosis.Methods·Clinical data from 142 MM patients treated at the Department of Hematology,The First Affiliated Hospital of Soochow University between August 2018 and September 2020 were analyzed.Baseline Ig expression levels and post-induction changes following bortezomib-lenalidomide-dexamethasone(VRD)regimen were assessed.Immunoparesis was defined as uninvolved Igs below the laboratory lower limit of normal.Patients were stratified by immunoparesis severity(mild,moderate,severe,extremely severe).ANOVA,rank-sum tests,and x2 tests were used to analyze correlations with baseline characteristics.The relationship between the improvement in immunoparesis and the induction efficacy,infection occurrence,and prognosis was analyzed based on the dynamic changes in immunoparesis.Results·Normal Igs were severely reduced in newly diagnosed MM patients.Immunoparesis was present in 128 patients(90.1%),with severe or extremely severe immunoparesis accounting for 76.1%.Patients with extensive immunoparesis(all uninvolved Ig levels below the lower normal limit)were more likely to have severe immunoparesis(P<0.05).There were no statistically significant differences in age,gender,presence of severe renal insufficiency,and high-risk cytogenetics among MM patients with different degrees of immunoparesis(P>0.05),but there were statistically significant differences in MM staging(P=0.008)and typing(P=0.010).Most patients with severe immunoparesis were at stage Ⅱ/Ⅲ based on the Revised International Staging System(R-ISS)and were of the IgG type.At diagnosis,the levels of the involved Ig or light chain were negatively correlated with normal Ig levels(P<0.05).Improvement in immunoparesis after induction therapy was positively correlated with treatment response(P=0.006).The infection rate was high(26.8%),but no significant correlation was found between immunoparesis and infection occurrence(P>0.05).After induction therapy,patients showing improvement in immunoparesis had significantly longer progression-free survival(PFS)(median PFS:not reached vs 38 months,P=0.025),but no significant impact on overall survival(OS)was observed(P=0.450).Conclusion·Immunoparesis is common and severe in newly diagnosed MM patients,with severity correlating with disease stage and subtype.VRD therapy can partially reverse immunoparesis,and improvement is positively associated with treatment response and PFS benefit.Infection risk appears unrelated to immunoparesis severity and warrants comprehensive prevention strategies.Humoral immune deficiency may serve as a prognostic indicator in MM,but its impact on OS requires further investigation.
10.Chinese version of the Attitude Tool of Delirium Scale and its reliability and validity test
Yanfei SUN ; Mengxin XUE ; Sijiao HU ; Chengcheng FU ; Wenli JIANG ; Mengyao CAO ; Huajuan HOU
Chinese Journal of Practical Nursing 2025;41(3):191-197
Objective:To translate the English version of the Attitude Tool of Delirium (ATOD) into Chinese and test the reliability and validity of its application in Chinese nurses, and to provide an assessment tool for assessing nurses ′ attitudes towards delirium patients. Methods:After obtaining authorization from the source scale developer, the English version of the ATOD scale was translated, back-translated, expert-consulte, pre-surveyed and cross-culturally adapted according to the Brislin translation model. A questionnaire survey was conducted among 298 nurses with experience in caring for patients with delirium in three tertiary hospitals in Jiangsu Province using a convenience sampling method. The critical ratio value and correlation coefficient were used to analyze the scale items. Exploratory factor analysis was used to evaluate the structural validity of the scale, and experts were invited to evaluate the content validity of the scale. Cronbach α coefficient and test-retest reliability were used to evaluate the reliability of the scale. Results:The Chinese version of the ATOD scale contains 3 dimensions of cognitive attitudes, behavioral attitudes, and emotional attitudes toward patients with delirium, with a total of 23 entries. The Cronbach α coefficient for the entire scale was 0.896, with each dimension′s Cronbach α coefficient ranging from 0.614 to 0.912. The retest reliability of the scale was 0.868, with each dimension ′s retest reliability ranging from 0.603 to 0.927. Exploratory factor analysis extracted three eigenvalues with common factors greater than 1, and the cumulative variance contribution rate was 63.812%. Conclusions:The Chinese version of the ATOD scale has good reliability and validity, and can be used as an evaluation tool for evaluating nurses ′ attitudes towards delirium patients in China, so as to provide an effective basis for the formulation of corresponding interventions.

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