1.Sufei Pingchuan Formula (肃肺平喘方) for the Treatment of Bronchiectasis Patients Combined with Airflow Limitation of Phlegm-Heat Obstructing the Lung and Lung-Spleen Qi Deficiency Syndrome: A Randomised Controlled Trial
Shasha YUAN ; Haiyan ZHANG ; Xia SHI ; Bing WANG ; Xiaodong CONG ; Qing MIAO
Journal of Traditional Chinese Medicine 2025;66(6):581-587
ObjectiveTo evaluate the effectiveness and safety of Sufei Pingchuan Formula (肃肺平喘方) in the treatment of bronchiectasis with airflow limitation, phlegm-heat obstructing the lung, and lung-spleen qi deficiency syndrome. MethodsA randomized, double-blind, placebo-controlled trial was conducted. A total of 72 patients with stable bronchiectasis with airflow limitation of phlegm-heat obstructing the lung and lung-spleen qi deficiency syndrome were randomly divided into treatment group and control group, with 36 cases in each group. On the basis of regular inhalation of tiotropium bromide inhalation spray, the treatment group was given Sufei Pingchuan Formula granules, and the control group was given Sufei Pingchuan Formula granule simulant. The course of treatment in both groups was 12 weeks. The pulmonary function of both groups before and after treatment was observed, specifically focusing on forced expiratory volume in one second (FEV1); the modified British Medical Research Council (mMRC) dyspnea scale, 24-hour sputum volume, COPD assessment test (CAT), and traditional Chinese medicine (TCM) syndrome scores were assessed before treatment and after 4, 8, and 12 weeks of treatment; acute exacerbations were recorded at weeks 4, 8, and 12; additionally, changes in routine blood tests, urinalysis, liver and kidney function, and adverse events were monitored before and after treatment. ResultsAfter treatment, 4 patients in the treatment group and 6 in the control group dropped out. After 12 weeks of treatment, FEV1 increased in both groups compared to pre-treatment levels (P<0.05), but the difference between groups was not statistically significant (P>0.05). Compared to before treatment, the treatment group showed a reduction in mMRC scores after 12 weeks (P<0.05) and a decrease in 24-hour sputum volume, CAT scores, and TCM syndrome scores at weeks 4, 8, and 12 (P<0.05). In the control group, 24-hour sputum volume decreased after 12 weeks (P<0.05), and TCM syndrome scores decreased at weeks 8 and 12 (P<0.05). Compared to the control group, the treatment group showed a greater reduction in mMRC scores at week 12 (P<0.05), a decrease in 24-hour sputum volume and TCM syndrome scores at weeks 4, 8, and 12 (P<0.05), and lower CAT scores at weeks 8 and 12 (P<0.05). The frequency and number of acute exacerbations in the treatment group were significantly lower than those in the control group at week 12 (P<0.05). No severe adverse events occurred in either group. ConclusionSufei Pingchuan Formula can improve the pulmonary function FEV1, the severity of dyspnea, reduce 24-hour sputum volume and frequent acute exacerbations, and improve the quality of life in patients with bronchiectasis and airflow limitation, with good safety.
2.The core issue of the management of occupational health technical service institutions in China under new circumstances
Xiaodong SHI ; Shijie HU ; Han ZHAO ; Dongshan LIU
China Occupational Medicine 2025;52(1):82-88
Occupational health technical service (OHTS) is one of the core contents in the technical support system of occupational disease prevention and control, and efficient management of OHTS institutions is necessary for improving the service ability. At present, OHTS institutions in China face several issues, such as uneven distribution in terms of quantity, function, unclear area coverage and roles and overlapping responsibilities among different types of institutions, and insufficient service capabilities with inconsistent service levels in some institutions. With the implementation of the national reform like the “separating permits from business license” and “delegate power, streamline administration and optimize government services"”policies, the management mode and operational approach of OHTS institutions have been profoundly changed. In light of this, five key recommendations are proposed to improve the management of OHTS institutions and enhance their management effectiveness, ensuring the sustainable development of national OHTS services. Firstly, it is necessary to clarify the relationship between national and provincial administrative levels in managing OHTS institutions to ensure their healthy and orderly development. Secondly, multiple measurements are taken to strengthen OHTS institutional capacity building to address regional disparities in technical capabilities and service quality. Thirdly, both technical capabilities and service quality should be focused on strengthening the supervision and management of OHTS institutions, preventing the decline of key conditions such as staffing, laboratories, equipment, and quality management after obtaining qualifications. Fourthly, “dual randomized- inspections and one open” and “internet+supervision” methods are used as basic tools for managing OHTS institutions operating across multiple provincial regions and enforcing cross-regional law. Fifthly, professional integrity of radiological health service institutions should be restored to effectively apply their technical advantages in their specialized fields.
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.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.
5.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.
6.Advances on Exercise-mediated Regulation of Programmed Cell Death in the Management of Sarcopenia
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(5):737-746
With the acceleration of global population aging, sarcopenia, characterized by a progressive loss of skeletal muscle mass, strength, and physical function, has become a major public health issue that seriously threatens the health and quality of life in older adults. The development and progression of sarcopenia involve complex, multi-level, and cross-system cellular and molecular mechanisms. Recent studies have highlighted the central role of programmed cell death (PCD) in maintaining skeletal muscle homeostasis, regulating metabolism, and mediating tissue repair. The classic forms of PCD-apoptosis, autophagy, pyroptosis, and ferroptosis-interact through critical nodes such as reactive oxygen species(ROS) accumulation, mitochondrial dysfunction, and iron homeostasis disruption, ultimately driving muscle fiber loss, functional decline, and chronic inflammation. These processes underpin the pathology of sarcopenia. Exercise, the most effective non-pharmacological intervention to date, has been shown to precisely regulate multiple PCD pathways. It improves muscle mass, strength, and metabolic stability, and delays the progression of sarcopenia. Specifically, appropriate exercise could inhibit excessive apoptosis, activate protective autophagy, alleviate NLRP3 inflammasome-mediated pyroptosis, and suppress ferroptosis by enhancing antioxidant defenses and maintaining iron homeostasis. This review systematically summarizes the roles and mechanisms of apoptosis, autophagy, pyroptosis, and ferroptosis in sarcopenia. It particularly focuses on the molecular targets and physiological effects of exercise-mediated PCD regulation. The aim is to provide theoretical and practical support for developing personalized and precision exercise interventions targeting PCD pathways for the prevention and management of sarcopenia.
7.Biological Activities of Sesquiterpenoids: A Review
Liyuan YANG ; Ju CHENG ; Jianjun CHEN ; Xiaozheng CHEN ; Xiaoyi SHI ; Rasheed AMNA ; Wenjing SHI ; Xiuzhu LIU ; Xiaodong XIE
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(5):289-298
Sesquiterpenoids are natural compounds composed of 15 carbon atoms, which can be divided into sesquiterpene alcohols, ketones, lactones, aldehydes, and carboxylic acids according to oxygen groups. These compounds are widely distributed in nature, and their physiological activities are diverse. For example, many sesquiterpenes with potential anticancer effects have been found for anti-tumor effects, including cytotoxicity, antioxidant, immune regulation, cell proliferation, and so on. In addition, some sesquiterpenoids have good application prospects in antibacterial, anti-inflammatory, and anti-cardiovascular diseases. Malignant tumors, inflammation, bacterial diseases, and cardiovascular diseases are the main diseases that cause human death, and natural products have unique advantages in the treatment of these diseases. Therefore, the development of new drugs that are easy to promote has become a new research hotspot. In this paper, the sesquiterpenes extracted from the natural components of Chinese herbs and plants with anti-tumor, anti-inflammatory, antibacterial, and anti-cardiovascular activities, such as Xanthium, Atractylodes, Convolvulus, Acanthium, Ligularia, Artemisia, Ligularia, Ligularia, Labiaceae Mint, Acanthophyllum, Turmeria, Ginger, and other Chinese herbs and plants, were discussed. The biological activities and related mechanisms of this compound were reviewed, which provided a reference for further research and clinical application of sesquiterpenes.
8.3D printing process of gelatin/oxidized nanocellulose skin scaffold with high elastic modulus and high porosity
Xiaodong XU ; Jiping ZHOU ; Qi ZHANG ; Chen FENG ; Mianshun ZHU ; Hongcan SHI
Chinese Journal of Tissue Engineering Research 2024;28(3):398-403
BACKGROUND:In the treatment of skin trauma with active repair,tissue engineering techniques are needed to generate new tissue to replace necrotic tissue.Skin scaffolds have a good application prospect in the field of wound repair.Skin scaffolds need to present three-dimensional porous structures with certain mechanical strength to meet the needs of cell proliferation and division.However,the mechanical strength of the currently used gelatin-based biomaterials is weak and cannot meet the requirements of the use of skin scaffolds. OBJECTIVE:To study the 3D printing process used in the preparation of tissue engineering skin scaffolds by gelatin/oxidized nanocellulose composites,and focus on the relationship between the porosity and mechanical strength of the scaffolds prepared under different process parameters. METHODS:Oxidized nanocellulose whiskers at 10%concentration were extracted from Humulus scandens and then compounded with 5%gelatin to obtain gelatin/oxidized nanocellulose composites.The elastic modulus of gelatin and gelatin/oxidized nanocellulose composite was determined.Skin scaffolds were prepared by 3D printing extrusion molding using gelatin/oxidized nanocellulose composite as the base material.Mechanical and rheological properties of the composite were tested to determine extrusion molding parameters(filling gap 1.5-2.5 mm,uniform distribution of 0.1 mm;air pressure of 160-200 kPa),and the skin scaffold with a three-dimensional porous structure was prepared.The compressive performance of the skin scaffold was tested and compared with the finite element analysis results.The relationship between the filling gap and the porosity and mechanical strength of the scaffold was demonstrated. RESULTS AND CONCLUSION:(1)The elastic modulus of 5%gelatin was increased by 8.84 times by adding 10%oxidized nanocellulose whisker.A gel filament with a diameter of 1 mm was obtained by extrusion at the air pressure of 160 kPa.When the filling gap increased from 1.5 mm to 2.5 mm,the theoretical porosity of the scaffold increased from 33%to 60%,but the compressive strength decreased from 230 000 Pa to 95 000 Pa.(2)These findings showed that the skin scaffold with theoretical porosity of 50%and elastic modulus of 160 000 Pa was prepared by using 2 mm filling gap.The scaffold had a clear three-dimensional porous structure.
9.Immunostimulatory gene therapy combined with checkpoint blockade reshapes tumor microenvironment and enhances ovarian cancer immunotherapy.
Yunzhu LIN ; Xiang WANG ; Shi HE ; Zhongxin DUAN ; Yunchu ZHANG ; Xiaodong SUN ; Yuzhu HU ; Yuanyuan ZHANG ; Zhiyong QIAN ; Xiang GAO ; Zhirong ZHANG
Acta Pharmaceutica Sinica B 2024;14(2):854-868
Immune evasion has made ovarian cancer notorious for its refractory features, making the development of immunotherapy highly appealing to ovarian cancer treatment. The immune-stimulating cytokine IL-12 exhibits excellent antitumor activities. However, IL-12 can induce IFN-γ release and subsequently upregulate PDL-1 expression on tumor cells. Therefore, the tumor-targeting folate-modified delivery system F-DPC is constructed for concurrent delivery of IL-12 encoding gene and small molecular PDL-1 inhibitor (iPDL-1) to reduce immune escape and boost anti-tumor immunity. The physicochemical characteristics, gene transfection efficiency of the F-DPC nanoparticles in ovarian cancer cells are analyzed. The immune-modulation effects of combination therapy on different immune cells are also studied. Results show that compared with non-folate-modified vector, folate-modified F-DPC can improve the targeting of ovarian cancer and enhance the transfection efficiency of pIL-12. The underlying anti-tumor mechanisms include the regulation of T cells proliferation and activation, NK activation, macrophage polarization and DC maturation. The F-DPC/pIL-12/iPDL-1 complexes have shown outstanding antitumor effects and low toxicity in peritoneal model of ovarian cancer in mice. Taken together, our work provides new insights into ovarian cancer immunotherapy. Novel F-DPC/pIL-12/iPDL-1 complexes are revealed to exert prominent anti-tumor effect by modulating tumor immune microenvironment and preventing immune escape and might be a promising treatment option for ovarian cancer treatment.
10.Review of research on competency of nosocomial infection control personnel in China
Qingfeng SHI ; Bijie HU ; Xiaodong GAO ; Yanting WANG ; Wei SUN
Shanghai Journal of Preventive Medicine 2024;36(5):511-515
Nosocomial infection control personnel are crucial in ensuring the nosocomial infection management and the implementation of prevention and control measures. The level of their job competency directly determines the quality and standard of nosocomial infection management. This article reviews the research progress of competency requirements and evaluation indicators of nosocomial infection personnel domestically and internationally. It also summarizes the current gaps and primary reasons behind these gaps in China’s research, so as to offer insights for the future development and improvement of the comprehensive capabilities of these professionals.

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