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.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.
3.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.
4.Clinical Study on Guhong Injection in the Treatment of Coronary Microvascular Dysfunction
Haobo ZHANG ; Qihua WU ; Ting LAI ; Shufen WANG ; Hairong CAI ; Li CHEN ; Bojun CHEN ; Qingmin LI
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(1):44-50
Objective To investigate the clinical efficacy of Guhong Injection for the treatment of patients with coronary microvascular dysfunction(CMD)of qi stagnation and blood stasis syndrome.Methods Sixty cases of patients with CMD of qi stagnation and blood stasis syndrome who were admitted to Guangdong Provincial Hospital of Chinese Medicine from June 2021 to August 2022 were randomly divided into the control group and the trial group according to the random number table method,with 30 cases in each group.The control group was treated with conventional western medicine,and the trial group was treated with Guhong Injection on the basis of treatment for the control group.The course of treatment for the two groups covered 10 days.The changes in traditional Chinese medicine(TCM)syndrome scores,and levels of lipid indicators,serum inflammatory factors and endothelial factors in the two groups were observed before and after treatment.After treatment,the clinical efficacy of the two groups was evaluated.Results(1)During the trial,three cases in the control group and two cases in the trial group fell off and a total of 55 cases were finally included in the statistical analysis of efficacy,including 27 cases in the control group and 28 cases in the trial group.(2)After 10 days of treatment,the total effective rate of the trial group was 89.29%(25/28),and that of the control group was 40.74%(11/27),and the intergroup comparison(tested by chi-square test)showed that the therapeutic efficacy of the trial group was significantly superior to that of the control group(P<0.01).(3)After treatment,the TCM syndrome scores of patients in both groups were decreased compared with those before treatment(P<0.05),and the decrease in the trial group was significantly superior to that in the control group(P<0.01).(4)After treatment,the levels of lipid indicators triglyceride(TG),total cholesterol(TC),and low-density lipoprotein cholesterol(LDL-C)in the two groups of patients were decreased compared with those before treatment(P<0.05),and the level of high-density lipoprotein cholesterol(HDL-C)was increased compared with that before treatment(P<0.05).The intergroup comparison showed that the decrease of TG,TC,and LDL-C levels as well as the increase of HDL-C level in the trial group was significantly superior to that in the control group(P<0.05 or P<0.01).(5)After treatment,the serum levels of inflammatory factors high-sensitivity C-reactive protein(hs-CRP),interleukin 6(IL-6)and tumor necrosis factor α(TNF-α)in the two groups of patients were decreased compared with those before treatment(P<0.05),and the decrease in the trial group was significantly superior to that in the control group(P<0.01).(6)After treatment,the serum level of endothelial factor nitric oxide(NO)in the two groups of patients was increased(P<0.05)and the serum endothelin 1(ET-1)level was decreased compared with that before treatment(P<0.05),and the increase of serum NO level,as well as the decrease of serum ET-1 level in the trial group was significantly superior to that in the control group(P<0.05 or P<0.01).Conclusion Based on the conventional treatment in western medicine,the application of Guhong Injection in the treatment of patients with CMD of qi stagnation and blood stasis syndrome exerts remarkable efficacy,which can effectively alleviate the symptoms,regulate the levels of blood lipids,reduce the inflammatory response,and improve the endothelial function.
5.Application of PDCA cycle and TBL embedded teaching method in clinical training program of gynecologic oncology
Shufen TAN ; Qian WANG ; Lei ZHANG ; Yi ZHANG ; Shuqing LI
Basic & Clinical Medicine 2025;45(11):1532-1535
Objective To explore a new training strategy suitable for clinical education and talent cultivation in gy-necologic oncology.Methods Ninety undergraduates from each of the two grades of clinical medicine curriculum at Kunming Medical University were randomly divided into control group(n=40)and research group(n=50).The"4+3"teaching model of plan-do-check-action(PDCA)cycle integrated with TBL were adopted,whereas the control group was educated with classic methods.Two groups of students were evaluated with quantitative assessments and anonymous questionnaire surveys.Results Multidimensional questionnaire surveys indicated that the teaching model of the test group provided a better learning experience than classic teaching methods as proved by significant improvements in educational reform(58%),learning interest(64%),skill development(72%),capacity building of learning(66%)and satisfaction with the new model of training(70%)(P<0.05,<0.01).Further-more,the PDCA cycle can address the short-comings of the previous teaching iteration.In written exams,the class-room quiz scores,regular grades,and comprehensive scores of the research group were(18.38±5.81),(29.09±0.29),and(82.38±4.03)points respectively all higher than those of the control group(P<0.01).Conclusions The PDCA cycle and the TBL-embedded teaching model promote the standardization of gynecologic oncology teach-ing procedures,thereby enhancing teaching quality and achieving precise alignment between student satisfaction and assessment performance.
6.Clinical study on reducing false alarms in ICU by using four-lead ECG synchronization technique and multi-parameter fusion technique
Shufen CHEN ; Jinfang ZHENG ; Zhenyu LIU ; Jielin ZHONG ; Xiaoli FANG ; Aimei WU ; Qiufang WANG ; Haiyan WU ; Youjian CHEN ; Ruoxi HUANG ; Houyuan HUANG
China Medical Equipment 2025;22(8):17-21
Objective:To assess the effects of recognition function of four-lead electrocardiogram(ECG)synchronization technique and multi-parameter fusion technique in reducing the number of false alarms and improving the quality of alarms in intensive care units(ICU).Methods:Four-lead ECG synchronization technique and multi-parameter fusion technique were used to strengthen the monitoring and assessment for the alarm of clinical monitors,and reduce the false alarm rate of monitors.The clinical alarm data of bed units corresponding to 48 monitors in clinical use of ICU,cardiovascular intensive care unit(CCU)and neurosurgery intensive care unit(NICU)of Hainan General Hospital from October 14 to December 27,2024 were selected.According to the opening and close of the four-lead ECG synchronization and multi-parameter fusion technique algorithm of the monitors,they were divided into group A(opened four-lead ECG synchronization and multi-parameter fusion),group B(opened four-lead ECG synchronization,but closed multi-parameter fusion),group C(closed four-lead ECG synchronization,but opened multi-parameter fusion)and group D(closed four-lead ECG synchronization and multi-parameter fusion),with 12 units in each group.The numbers of total alarms and false alarms generated by monitor of each bed unit among different optimization strategies were compared.Results:The numbers of average daily alarm of the monitors in groups A,B and C were respectively(134.2±32.4)cases,(392.5±68.2)cases and(583.4±126.5)cases,which were lower than those in group D(1 073.2±168.6),with statistically significant differences(Z=3.45,2.94,2.52,P<0.05).The optimization rates of the alarm numbers in groups A,B and C were increased by 87.51%,63.47%and 45.67%,respectively.The rates of average false alarm of the monitors in groups A,B and C were respectively(1.04±0.15)%,(1.73±0.12)%and(2.07±0.08)%,which were lower than(3.76±0.2)%in group D,with statistically significant differences(Z=3.45,2.94,2.52,P<0.05).Conclusion:Four-lead ECG synchronization technique and multi-parameter fusion technique can effectively optimize the number of alarms in ICU,and reduce the proportion of false alarms of monitors in department,and decrease fatigue of medical staffs for alarm.
7.Clinical study on reducing false alarms in ICU by using four-lead ECG synchronization technique and multi-parameter fusion technique
Shufen CHEN ; Jinfang ZHENG ; Zhenyu LIU ; Jielin ZHONG ; Xiaoli FANG ; Aimei WU ; Qiufang WANG ; Haiyan WU ; Youjian CHEN ; Ruoxi HUANG ; Houyuan HUANG
China Medical Equipment 2025;22(8):17-21
Objective:To assess the effects of recognition function of four-lead electrocardiogram(ECG)synchronization technique and multi-parameter fusion technique in reducing the number of false alarms and improving the quality of alarms in intensive care units(ICU).Methods:Four-lead ECG synchronization technique and multi-parameter fusion technique were used to strengthen the monitoring and assessment for the alarm of clinical monitors,and reduce the false alarm rate of monitors.The clinical alarm data of bed units corresponding to 48 monitors in clinical use of ICU,cardiovascular intensive care unit(CCU)and neurosurgery intensive care unit(NICU)of Hainan General Hospital from October 14 to December 27,2024 were selected.According to the opening and close of the four-lead ECG synchronization and multi-parameter fusion technique algorithm of the monitors,they were divided into group A(opened four-lead ECG synchronization and multi-parameter fusion),group B(opened four-lead ECG synchronization,but closed multi-parameter fusion),group C(closed four-lead ECG synchronization,but opened multi-parameter fusion)and group D(closed four-lead ECG synchronization and multi-parameter fusion),with 12 units in each group.The numbers of total alarms and false alarms generated by monitor of each bed unit among different optimization strategies were compared.Results:The numbers of average daily alarm of the monitors in groups A,B and C were respectively(134.2±32.4)cases,(392.5±68.2)cases and(583.4±126.5)cases,which were lower than those in group D(1 073.2±168.6),with statistically significant differences(Z=3.45,2.94,2.52,P<0.05).The optimization rates of the alarm numbers in groups A,B and C were increased by 87.51%,63.47%and 45.67%,respectively.The rates of average false alarm of the monitors in groups A,B and C were respectively(1.04±0.15)%,(1.73±0.12)%and(2.07±0.08)%,which were lower than(3.76±0.2)%in group D,with statistically significant differences(Z=3.45,2.94,2.52,P<0.05).Conclusion:Four-lead ECG synchronization technique and multi-parameter fusion technique can effectively optimize the number of alarms in ICU,and reduce the proportion of false alarms of monitors in department,and decrease fatigue of medical staffs for alarm.
8.Factors Influencing the Incidence of Complications After Thoracoscopic Pulmonary Resection in Elderly Patients
Huiling ZHANG ; Zhibo ZHENG ; Naixin LIANG ; Xiaoyi ZHAO ; Shufen LIU ; Riwang WANG ; Lunxu LIU ; Lixia CHEN ; Lu ZHANG
Medical Journal of Peking Union Medical College Hospital 2025;17(3):805-812
To investigate the influencing factors of postoperative complications following thoracoscopic lung resection in elderly patients and to provide a scientific basis for developing preoperative prehabilitation strategies for high-risk elderly populations. This retrospective study enrolled elderly patients who underwent video-assisted thoracoscopic surgery(VATS) lung resection at the Department of Thoracic Surgery, Peking Union Medical College Hospital between April 2019 and July 2023. General clinical data, pulmonary function testing(PFT) parameters[including forced expiratory volume in 1 second(FEV1%pred), forced vital capacity(FVC%pred), and peak expiratory flow(PEF%pred)], cardiopulmonary exercise testing(CPET) parameters[peak oxygen uptake(peak VO2) and resting arterial oxygen saturation(SpO2), etc.], and postoperative complications were collected. Univariate analysis and multivariate Logistic regression were performed to identify independent risk factors for postoperative complications. Among 219 eligible patients, 44 developed postoperative complications(complication group), while 175 did not(non-complication group). Univariate analysis revealed that the complication group had higher body mass index(BMI), smoking rates, lobectomy rates, and prevalence of preexisting arrhythmias, along with lower FEV1%pred, FVC%pred, PEF%pred, peak VO2, and resting SpO2(all Lobectomy, preexisting arrhythmias, decreased FVC%pred, and reduced peak VO2 are significantly associated with an elevated risk of postoperative complications in elderly patients undergoing VATS lung resection. These findings underscore the importance of preoperative risk stratification and tailored prehabilitation strategies to optimize outcomes in this population.
9.Longitudinal extrauterine growth restriction in extremely preterm infants: current status and prediction model
Xiaofang HUANG ; Qi FENG ; Shuaijun LI ; Xiuying TIAN ; Yong JI ; Ying ZHOU ; Bo TIAN ; Yuemei LI ; Wei GUO ; Shufen ZHAI ; Haiying HE ; Xia LIU ; Rongxiu ZHENG ; Shasha FAN ; Li MA ; Hongyun WANG ; Xiaoying WANG ; Shanyamei HUANG ; Jinyu LI ; Hua XIE ; Xiaoxiang LI ; Pingping ZHANG ; Hua MEI ; Yanju HU ; Ming YANG ; Lu CHEN ; Yajing LI ; Xiaohong GU ; Shengshun QUE ; Xiaoxian YAN ; Haijuan WANG ; Lixia SUN ; Liang ZHANG ; Jiuye GUO
Chinese Journal of Neonatology 2024;39(3):136-144
Objective:To study the current status of longitudinal extrauterine growth restriction (EUGR) in extremely preterm infants (EPIs) and to develop a prediction model based on clinical data from multiple NICUs.Methods:From January 2017 to December 2018, EPIs admitted to 32 NICUs in North China were retrospectively studied. Their general conditions, nutritional support, complications during hospitalization and weight changes were reviewed. Weight loss between birth and discharge > 1SD was defined as longitudinal EUGR. The EPIs were assigned into longitudinal EUGR group and non-EUGR group and their nutritional support and weight changes were compared. The EPIs were randomly assigned into the training dataset and the validation dataset with a ratio of 7∶3. Univariate Cox regression analysis and multiple regression analysis were used in the training dataset to select the independent predictive factors. The best-fitting Nomogram model predicting longitudinal EUGR was established based on Akaike Information Criterion. The model was evaluated for discrimination efficacy, calibration and clinical decision curve analysis.Results:A total of 436 EPIs were included in this study, with a mean gestational age of (26.9±0.9) weeks and a birth weight of (989±171) g. The incidence of longitudinal EUGR was 82.3%(359/436). Seven variables (birth weight Z-score, weight loss, weight growth velocity, the proportion of breast milk ≥75% within 3 d before discharge, invasive mechanical ventilation ≥7 d, maternal antenatal corticosteroids use and bronchopulmonary dysplasia) were selected to establish the prediction model. The area under the receiver operating characteristic curve of the training dataset and the validation dataset were 0.870 (95% CI 0.820-0.920) and 0.879 (95% CI 0.815-0.942), suggesting good discrimination efficacy. The calibration curve indicated a good fit of the model ( P>0.05). The decision curve analysis showed positive net benefits at all thresholds. Conclusions:Currently, EPIs have a high incidence of longitudinal EUGR. The prediction model is helpful for early identification and intervention for EPIs with higher risks of longitudinal EUGR. It is necessary to expand the sample size and conduct prospective studies to optimize and validate the prediction model in the future.
10.Relationship between perceived stress and suicide ideation in adolescent inpatients with depression: the pathway of psychological capital
Yan WU ; Yongna WANG ; Dawei ZHANG ; Jingjing HAO ; Chuan YU ; Ya'nan WANG ; Shufen WANG
Sichuan Mental Health 2024;37(6):515-519
BackgroundSuicide ideation in adolescent inpatients with depression is a multi-factorial problem, and perceived stress is considered to be closely related to suicide ideation, while its mediating role in suicide ideation among adolescent inpatients with depression remains unclear. ObjectiveTo explore the mediating effect of psychological capital on the relationship between perceived stress and suicide ideation among adolescent inpatients with depression, so as to provide references for preventing the onset of suicide ideation in adolescent inpatients with depression. MethodsA sample of 585 adolescent patients who were hospitalized in Beijing Huilongguan Hospital from June 2021 to March 2023 and fulfilling the International Classification of Diseases, 10th edition (ICD-10) diagnostic criteria for depression were enrolled. All patients were evaluated using self-designed questionnaire, Chinese Perceived Stress Scale (CPSS), Positive Psychological Capital Questionnaire (PPQ) and Beck Scale for Suicide Ideation-Chinese Version (BSI-CV). Pearson correlation was used to assess the correlation among the scores of the above scales. Bootstrap method was employed to verify the mediating effect of psychological capital on the relationship between perceived stress and suicide ideation. ResultsCPSS score in adolescent inpatients with depression was positively correlated with BSI-CV score (r=0.375, P<0.01), and CPSS score and BSI-CV score were negatively correlated with PPQ score (r=-0.481, -0.436, P<0.01). Psychological capital played a significant yet a partial role in mediating the link between perceived stress and suicide ideation, with an indirect mediating effect value of 0.160 (95% CI: 0.178~0.373), accounting for 30.42% of the total effect. ConclusionThe perceived stress of adolescent inpatients with depression can affect the onset of suicide ideation both directly and indirectly through psychological capital.

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