1.Combination Therapy of Pyrotinib and Metronomic Vinorelbine in HER2+ Advanced Breast Cancer after Trastuzumab Failure (PROVE): A Prospective Phase 2 Study
Chunfang HAO ; Xu WANG ; Yehui SHI ; Zhongsheng TONG ; Shufen LI ; Xiaodong LIU ; Lan ZHANG ; Jie ZHANG ; Wenjing MENG ; Li ZHANG
Cancer Research and Treatment 2025;57(2):434-442
Purpose:
Approximately 50%-74% of patients with metastatic human epidermal growth factor receptor 2 (HER2)–positive breast cancer do not respond to trastuzumab, with 75% of treated patients experiencing disease progression within a year. The combination of pyrotinib and capecitabine has showed efficacy in these patients. This study evaluates the efficacy and safety of pyrotinib combined with metronomic vinorelbine for trastuzumab-pretreated HER2-positive advanced breast cancer patients.
Materials and Methods:
In this phase 2 trial, patients aged 18-75 years with HER2-positive advanced breast cancer who had previously failed trastuzumab treatment were enrolled to receive pyrotinib 400 mg daily in combination with vinorelbine 40mg thrice weekly. The primary endpoint was progression-free survival (PFS), while secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
Results:
From October 21, 2019, to January 21, 2022, 36 patients were enrolled and received at least one dose of study treatment. At the cutoff date, 20 experienced disease progression or death. With a median follow-up duration of 35 months, the median PFS was 13.5 months (95% confidence interval [CI], 8.3 to 18.5). With all patients evaluated, an ORR of 38.9% (95% CI, 23.1 to 56.5) and a DCR of 83.3% (95% CI, 67.2 to 93.6) were achieved. The median OS was not reached. Grade 3 adverse events (AEs) were observed in 17 patients, with diarrhea being the most common (27.8%), followed by vomiting (8.3%) and stomachache (5.6%). There were no grade 4/5 AEs.
Conclusion
Pyrotinib combined with metronomic vinorelbine showed promising efficacy and an acceptable safety profile in HER2-positive advanced breast cancer patients after trastuzumab failure.
2.Long-term efficacy of CMV/EBV bivirus-specific T cells for viral co-reactivation after stem cell transplantation.
Xuying PEI ; Meng LV ; Xiaodong MO ; Yuqian SUN ; Yuhong CHEN ; Chenhua YAN ; Yuanyuan ZHANG ; Lanping XU ; Yu WANG ; Xiaohui ZHANG ; Xiaojun HUANG ; Xiangyu ZHAO
Chinese Medical Journal 2025;138(5):607-609
3.Preemptive immunotherapy for KMT2A rearranged acute leukemias post-allogeneic stem cell transplantation.
Jing LIU ; Shuang FAN ; Xiaohui ZHANG ; Lanping XU ; Yu WANG ; Yifei CHENG ; Chenhua YAN ; Yuhong CHEN ; Yuanyuan ZHANG ; Meng LV ; Yazhen QIN ; Xiaosu ZHAO ; Xiaojun HUANG ; Xiaodong MO
Chinese Medical Journal 2025;138(22):3034-3036
4.Expert consensus on clinical protocol for treating herpes zoster with fire needling.
Xiaodong WU ; Bin LI ; Baoyan LIU ; Lin HE ; Zhishun LIU ; Shixi HUANG ; Keyi HUI ; Hongxia LIU ; Yuxia CAO ; Shuxin WANG ; Zhe XU ; Cang ZHANG ; Jingsheng ZHAO ; Yali LIU ; Nanqi ZHAO ; Nan DING ; Jing HU
Chinese Acupuncture & Moxibustion 2025;45(12):1825-1832
The expert consensus on the clinical treatment of herpes zoster with fire needling was developed, and the commonly used fire needling treatment scheme verified by clinical research was selected to form a standardized diagnosis and treatment scheme for acute herpes zoster and postherpetic neuralgia (PHN), so as to answer the core problems in clinical application. The consensus focuses on patients with herpes zoster, and forms recommendations for 9 key clinical issues, covering simple fire needling and TCM comprehensive therapy based on fire needling, including fire needling combined with cupping, fire needling combined with Chinese herb, fire needling combined with cupping and Chinese herb, fire needling combined with filiform needling, fire needling combined with moxibustion, and provides specific recommendations and operational guidelines for various therapies.
Humans
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Herpes Zoster/therapy*
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Acupuncture Therapy/instrumentation*
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Consensus
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Clinical Protocols
5.Exploring Immune Mechanism of Alveolar Epithelial Homeostasis in Idiopathic Pulmonary Fibrosis Based on Principle of "Spleen being in Charge of Defensive Function"
Jie CHEN ; Lijian PANG ; Ningzi ZANG ; Jingyu WANG ; Siyu LI ; Yuanyu LIANG ; XU XINZHU ; Ping LEI ; Xiaodong LYU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):259-264
Idiopathic pulmonary fibrosis (IPF) can be classified as pulmonary collateral disease,and its pathogenesis is mainly characterized by the loss of Qi meridian nourishment,the loss of Yin meridian nourishment,and the formation of blood stasis in the blood vessels. Qi Yin deficiency is the pathological basis that runs through IPF,and obstruction of meridians and collaterals is a key element in the development of the disease. The dysfunction of "spleen being in charge of the defensive function" is closely related to the formation of the pathological pattern of "lung deficiency and collateral stasis" in IPF. The term "spleen being in charge of the defensive function" originated from the Yellow Emperor's Inner Canon. If the spleen is healthy,the Qi will be filled with vitality. Positive energy is stored inside,evil cannot be dried up. Its concept is quite similar to the immune defense function in modern medicine. If the principle of "spleen being in charge of the defensive function" is lost,the key structure and function of the IPF alveolar epithelial barrier may be abnormal,and it can interact with various innate immune cells to promote inflammation and fibrosis processes. Therefore,this article explains the imbalance of immune homeostasis in IPF alveolar epithelium from two aspects:the barrier function of alveolar epithelial cells(AECs) and their interaction with innate immune cells. And based on the theory of "spleen being in charge of the defensive function",using traditional Chinese medicine for strengthening the spleen and nourishing Qi to treat IPF from the perspective of the spleen. This not only strengthens the scientific connotation of "spleen being in charge of the defensive function" in the pathogenesis of IPF,but also provides new research directions and ideas for its future clinical prevention and treatment.
6.Predictive value of contrast-enhanced ultrasound in evaluating delayed graft function in kidneys from donation after brain death
Jing SUN ; Yue WANG ; Jianlei JI ; Jinquan LIU ; Xiaodong WU ; Chuanshen XU ; Jianhong WANG
Organ Transplantation 2025;16(3):460-466
Objective To investigate the predictive value of quantitative parameters of contrast-enhanced ultrasound (CEUS) in evaluating kidneys from donation after brain death (DBD) for the occurrence of delayed graft function (DGF) in recipients. Methods The clinical data of 134 DBD donors and 202 corresponding kidneys and recipients were retrospective analyzed. The recipients were divided into DGF group (n=39) and non-DGF group (n=163) according to the renal function after kidney transplantation. Conventional ultrasound, CEUS parameters, and clinical data were compared between the two groups. Receiver operating characteristic (ROC) curves were used to determine the optimal cut-off values for predicting DGF using CEUS parameters, clinical parameters, and their combination, based on the highest Youden index. The predictive ability of different parameters for DGF was evaluated. Results There were statistically significant differences in cortical peak intensity (PIc), medullary peak intensity (PIm), donor albumin (ALB), serum creatinine (Scr) after admission, and the Na+ concentration of recipients between the two groups (all P<0.05). The area under the curve (AUC) for predicting DGF using the combination of CEUS parameters PIc and PIm was 0.711, with an optimal cut-off value of 0.193 and a Youden index of 0.382. The AUC for predicting DGF using the combination of CEUS parameters PIc, PIm and clinical parameters was 0.808, with an optimal cut-off value of 0.191 and a Youden index of 0.517. The sensitivity and specificity were 0.769 and 0.613 for the former, and 0.769 and 0.748 for the latter, respectively. The AUC for predicting DGF using CEUS parameters PIc and PIm combined with clinical parameters was significantly higher than that using CEUS parameters PIc and PIm (P<0.05). Conclusions The CEUS quantitative parameters PIc and PIm have good predictive value in assessing kidneys from DBD donors for DGF in recipients, and the diagnostic efficacy is better when combined with clinical parameters.
7.Causal relationship between periodontal disease and prostate cancer:A two-sample bidirectional Mendelian randomization analysis in two races
Xiaoxu JIN ; Jing LIU ; Xiaodong ZHAO ; Wenyi HUANG ; Ning DONG ; Shihao WANG ; Mengfei MA ; Yulin ZHOU ; Yuhao CHEN ; Jinlu SUN ; Jie DONG ; Jun HU ; Song XU
National Journal of Andrology 2025;31(10):885-890
Objective The aim of this study is to discuss the causal relationship between periodontal disease(PD)and prostate cancer(PCa).Methods A two-sample bidirectional Mendelian randomization(MR)analysis based on publicly statistical data from genome-wide association studies(GWAS)was conducted.MR Egger,weighted medium,simple mode and weighted mode were supplemented,while inverse variance weighted analysis(IVW)was the main method of analysis.Heterogeneity testing,pleiotropy testing and leave-one-out testing were used to assess the sensitivity and stabili-ty.Results The results of MR analysis showed that PD had no significant impact on the occurrence of PCa:East Asian(IVW,PD:OR=1.07,P=0.48);European(IVW,PD:OR=1.00,P=0.37,periodontitis:OR=1.03,P=0.14,chronic gingivitis:OR=0.99,P=0.37,chronic periodontitis:OR=1.03,P=0.22).The reverse MR analysis also did not show a causal relationship between PCa and PD:East Asian(IVW,PD:OR=0.97,P=0.22);European(IVW,PD:OR=0.84,P=0.44,periodontitis:OR=1.01,P=0.75,chronic gingivitis:OR=0.93,P=0.23,chronic periodontitis:OR=0.99,P=0.80).The results of other analysis were consistent with those of IVW analysis.Conclusions The results of our two-sample bidirectional MR analysis do not support a causal relationship between PD and PCa.
8.Clinical analysis of donor-purified CD34 + stem cell boost in 11 patients with poor hematopoietic reconstruction after haploid hematopoietic stem cell transplantation for aplastic anemia
Yun HE ; Zhengli XU ; Huan CHEN ; Yao CHEN ; Tingting HAN ; Yuanyuan ZHANG ; Meng LYU ; Xiaodong MO ; Chenhua YAN ; Yu WANG ; Yuqian SUN ; Xiaohui ZHANG ; Xiaojun HUANG ; Lanping XU
Chinese Journal of Hematology 2025;46(7):618-624
Objective:To evaluate the safety and efficacy of donor-purified CD34 + stem cell boosts in patients with poor hematopoietic reconstruction (PHR) after haploid hematopoietic stem cell transplantation (haplo-HSCT) for aplastic anemia (AA) . Method:A retrospective analysis was conducted on 11 patients with AA and PHR who underwent haplo-HSCT and received donor-purified CD34 + stem cell boosts at Peking University People’s Hospital. Recovery of blood cell counts, incidence of graft-versus-host disease (GVHD), and overall survival (OS) were assessed. Results:Of the 11 patients with PHR, two were diagnosed with prolonged isolated thrombocytopenia (PT), one was primary poor graft function (PGF), and eight were diagnosed with secondary PGF. The median time to PHR diagnosis was 110 days (range: 60-330 days), and the median interval from transplantation to purified CD34 + hematopoietic stem cell infusion was 194 days (range: 125-456 days). The two patients with PT achieved complete platelet recovery at 22 and 13 days after CD34 + stem cell infusion, respectively. Among the remaining nine patients with PGF, six achieved complete hematopoietic recovery, with a median absolute neutrophil count recovery time of 19 days (8-158 days), HGB recovery time of 32.5 days (range: 13-158 days), and platelet recovery time of 31.5 days (range: 7-171 days). The incidence of chronic GVHD after infusion was 18.2%, with no cases of acute GVHD observed. The OS rate was 90.9% (10/11) in the 11 patients, with a median follow-up of 614 days (range: 153-1 765 days) . Conclusion:Donor-purified CD34 + stem cell boost may be an effective therapeutic strategy for PHR in patients with AA after haplo-HSCT.
9.Clinicopathological features and surgery-related outcomes of duodenal adenocarcinoma: a multicenter retrospective study
Qifeng XIAO ; Xin WU ; Chunhui YUAN ; Zongting GU ; Xiaolong TANG ; Fanbin MENG ; Dong WANG ; Ren LANG ; Gang ZHAI ; Xiaodong TIAN ; Yu ZHANG ; Enhong ZHAO ; Xiaodong ZHAO ; Feng CAO ; Jingyong XU ; Ying XING ; Jishu WEI ; Shanmiao GOU ; Chengfeng WANG ; Jianwei ZHANG
Chinese Journal of Oncology 2025;47(10):1026-1038
Objective:This multicenter retrospective study aimed to analyze the clinicopathological features of duodenal adenocarcinoma (DA) and identify prognostic factors for postoperative survival.Methods:Demographic characteristics, clinicopathological features, treatment outcomes and survival of DA patients undergoing surgical treatment at 18 Chinese medical centers from January 2012 to December 2023 were retrospectively analyzed.Results:Among the 2 056 DA patients included, 46.8% (963) had extra-ampullary DA (EA-DA), and 53.2% (1 093) had peri-ampullary DA (PA-DA). The 1-, 3-, and 5-year overall survival (OS) rates for patients who underwent radical surgery were 93.2%, 71.0%, and 57.2%, respectively. The median overall survival was 76 months, and the median progression-free survival (PFS) was 65 months. No differences in survival were observed between the laparotomy group and minimally invasive surgery (MIS) group either before or after propensity score matching (OS: 76 vs. 75 months before PSM, P=0.986; OS: 75 vs. 75 months after PSM, P=0.602). Furthermore, there were no significant differences between-group in operation time and postoperative complications ( P>0.05). The MIS group experienced less intraoperative blood loss and shorter hospital stays. The multivariate Cox regression analysis revealed that advanced age ( HR=1.43,95% CI:1.18-1.73), elevated carbohydrate antigen 19-9 levels ( HR=1.24,95% CI:1.02-1.51), perineural invasion ( HR=1.44,95% CI:1.14-1.81), vascular invasion ( HR=1.35,95% CI:1.07-1.71), advanced T stage (T3-4 vs. T1-2: HR=1.86,95% CI:1.49-2.31), regional lymph node metastasis ( HR=1.93,95% CI:1.58-2.36), preoperative biliary drainage ( HR=1.26,95% CI:1.04-1.53), intraoperative blood loss ( HR=1.34,95% CI:1.11-1.62), clinically significant postoperative pancreatic fistulas ( HR=1.53,95% CI:1.12-2.09), and postoperative hemorrhage ( HR=1.62,95% CI:1.14-2.29) were independent risk factors for poor prognosis after surgery (all P<0.05). Conclusions:Radical surgery is associated with favorable overall survival among DA patients, and no difference in survival is observed between EA-DA and PA-DA patients. MIS is a reliable alternative for DA treatment.
10.Efficacy and safety of an antioxidant gel containing tea polyphenols combined with narrow-band ultraviolet B in the treatment of vitiligo: a single-center randomized controlled trial
Miaoni ZHOU ; Anqi SHENG ; Lifang FU ; Rong JIN ; Wen XU ; Xiaodong WEI ; Ai′e XU
Chinese Journal of Dermatology 2025;58(9):834-838
Objective:To evaluate the clinical efficacy and safety of an antioxidant gel containing tea polyphenols combined with narrow-band ultraviolet B in the treatment of vitiligo.Methods:A single-center, randomized controlled clinical trial was conducted. From April 25 to June 27, 2024, patients with vitiligo were selected from the Department of Dermatology, Hangzhou Third People's Hospital. An open-label and researcher-blinded design was used. The patients were divided into 3 groups: a phototherapy group receiving phototherapy alone, a tea polyphenols combined group treated with an antioxidant gel containing tea polyphenols combined with phototherapy, and a positive control group treated with an antioxidant gel containing superoxide dismutase combined with phototherapy, with the treatment duration being 3 months. The efficacy was evaluated using the Vitiligo Area Scoring Index (VASI), and when the VASI was improved by ≥ 10%, the treatment would be considered effective. Changes in skin aging and skin barrier function indicators before and after treatment were assessed for 72 vitiligo lesions in the tea polyphenols combined group and for 72 lesions in the phototherapy group. Comparisons between the groups were performed using one-way analysis of variance, Fisher's exact test, chi-square test, or t test. Results:A total of 171 vitiligo patients with 307 target lesions were successfully followed up in this study, including 74 males and 97 females, and their ages ranged from 1 to 64 years. Among the 307 lesions, 95 were treated with phototherapy alone, of which 35 showed improvement, resulting in a total response rate of 36.8% and an average VASI improvement rate of 10.9%; adverse reactions occurred in 29 lesions (30.5%). Of 138 lesions treated with the antioxidant gel containing tea polyphenols combined with phototherapy, 73 showed improvement, resulting in a total response rate of 52.9% and an average VASI improvement rate of 24.0%; adverse reactions occurred in 10 lesions (7.2%). In the positive control group, 74 lesions were treated, and 40 showed improvement, resulting in a total response rate of 54.1% and an average VASI improvement rate of 18.3%; adverse reactions occurred in 5 lesions (6.8%). Compared with the phototherapy group, the tea polyphenols combined group showed a significantly increased total response rate and a VASI improvement rate (both P < 0.01), but a significantly decreased incidence rate of adverse reactions ( P < 0.001). No significant differences in the above indicators were observed between the tea polyphenols combined group and the positive control group (all P > 0.05). In addition, the changes in skin barrier function and skin aging indicators (except for wrinkle depth) before and after treatment were significantly reduced in the tea polyphenols combined group compared to the phototherapy group (all P < 0.05). After the phototherapy alone, the transepidermal water loss significantly increased ( P = 0.004), and the water content of the stratum corneum significantly decreased ( P = 0.012). However, no significant differences in skin barrier function or skin aging indicators were found between pre- and post-treatment in the tea polyphenols combined group ( P > 0.05) . Conclusion:The antioxidant gel containing tea polyphenols could effectively improve the efficacy of narrow-band ultraviolet B in the treatment of vitiligo, and alleviate skin aging and barrier damage caused by phototherapy.

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