1.Analysis of Anti-tumor Innovative Drug Policy Text Based on Policy Tools in China
Xiaofang ZHONG ; Ya LI ; Hong ZHU ; Zhiyuan SUN ; Shuyang ZHAO
Herald of Medicine 2024;43(4):654-660
Objective By analyzing the anti-tumor innovative drug policies text in China,this study aimed to explore the focus and shortcomings of policies related to anti-tumor innovative drugs,and provide the reference for future policy formula-tion and optimization in the field of anti-tumor innovative drug.Methods By accessing the official websites of relevant minis-tries and subordinate institutions such as the Central Committee of the Communist Party of China,the State Council of the People's Republic of China,the National Health Commission of the People's Republic of China,and National Medical Products Administra-tion,and using the keywords"cancer","tumor","anti-tumor drug",and"innovative drug",etc,the national level policies related to the anti-tumor innovative drugs from January 1,2005,to December 31,2022,were collected.Based on a two-dimensional analy-sis framework of policy tools and stakeholders,the collected policy texts were classified,encoded,and statistically analyzed.Results A total of 30 policy texts were involved,and a total of 90 policy codes were generated.There were 24,43,and 23 codes for demand-based policy tools,environmental policy tools,and supply-based policy tools,accounting for 26.67%,47.78%,and 25.56%,respectively.Based on policy tools and stakeholders,a total of 183 codes were generated,with government departments,pharmaceutical enterprises,medical institutions,and patients having 70,36,54,and 23 codes respectively,accounting for 38.25%,19.67%,29.51%,and 12.57%.Conclusions China had the highest proportion of environmental policy tools in the application of innovative anti-tumor drug policies,while supply-oriented and demand-oriented policy tools were underutilized,resulting in an overall imbalance in application;The distribution pattern of stakeholders was not coordinated,with government departments and medical institutions having higher attention than pharmaceutical enterprises and patients..It was necessary to reasonably promote the collaborative application of anti-tumor innovative drug policy tools,scientifically plan the layout of anti-tumor innovative drug policy sub-tools,and balance the interests of all stakeholders to ensure the efficient implementation of the policies.
2.Expert consensus on surgical treatment of oropharyngeal cancer
China Anti-Cancer Association Head and Neck Oncology Committee ; China Anti-Cancer Association Holistic Integrative Oral Cancer on Preventing and Screen-ing Committee ; Min RUAN ; Nannan HAN ; Changming AN ; Chao CHEN ; Chuanjun CHEN ; Minjun DONG ; Wei HAN ; Jinsong HOU ; Jun HOU ; Zhiquan HUANG ; Chao LI ; Siyi LI ; Bing LIU ; Fayu LIU ; Xiaozhi LV ; Zheng-Hua LV ; Guoxin REN ; Xiaofeng SHAN ; Zhengjun SHANG ; Shuyang SUN ; Tong JI ; Chuanzheng SUN ; Guowen SUN ; Hao TIAN ; Yuanyin WANG ; Yueping WANG ; Shuxin WEN ; Wei WU ; Jinhai YE ; Di YU ; Chunye ZHANG ; Kai ZHANG ; Ming ZHANG ; Sheng ZHANG ; Jiawei ZHENG ; Xuan ZHOU ; Yu ZHOU ; Guopei ZHU ; Ling ZHU ; Susheng MIAO ; Yue HE ; Jugao FANG ; Chenping ZHANG ; Zhiyuan ZHANG
Journal of Prevention and Treatment for Stomatological Diseases 2024;32(11):821-833
With the increasing proportion of human papilloma virus(HPV)infection in the pathogenic factors of oro-pharyngeal cancer,a series of changes have occurred in the surgical treatment.While the treatment mode has been im-proved,there are still many problems,including the inconsistency between diagnosis and treatment modes,the lack of popularization of reconstruction technology,the imperfect post-treatment rehabilitation system,and the lack of effective preventive measures.Especially in terms of treatment mode for early oropharyngeal cancer,there is no unified conclu-sion whether it is surgery alone or radiotherapy alone,and whether robotic minimally invasive surgery has better func-tional protection than radiotherapy.For advanced oropharyngeal cancer,there is greater controversy over the treatment mode.It is still unclear whether to adopt a non-surgical treatment mode of synchronous chemoradiotherapy or induction chemotherapy combined with synchronous chemoradiotherapy,or a treatment mode of surgery combined with postopera-tive chemoradiotherapy.In order to standardize the surgical treatment of oropharyngeal cancer in China and clarify the indications for surgical treatment of oropharyngeal cancer,this expert consensus,based on the characteristics and treat-ment status of oropharyngeal cancer in China and combined with the international latest theories and practices,forms consensus opinions in multiple aspects of preoperative evaluation,surgical indication determination,primary tumor re-section,neck lymph node dissection,postoperative defect repair,postoperative complication management prognosis and follow-up of oropharyngeal cancer patients.The key points include:① Before the treatment of oropharyngeal cancer,the expression of P16 protein should be detected to clarify HPV status;② Perform enhanced magnetic resonance imaging of the maxillofacial region before surgery to evaluate the invasion of oropharyngeal cancer and guide precise surgical resec-tion of oropharyngeal cancer.Evaluating mouth opening and airway status is crucial for surgical approach decisions and postoperative risk prediction;③ For oropharyngeal cancer patients who have to undergo major surgery and cannot eat for one to two months,it is recommended to undergo percutaneous endoscopic gastrostomy before surgery to effectively improve their nutritional intake during treatment;④ Early-stage oropharyngeal cancer patients may opt for either sur-gery alone or radiation therapy alone.For intermediate and advanced stages,HPV-related oropharyngeal cancer general-ly prioritizes radiation therapy,with concurrent chemotherapy considered based on tumor staging.Surgical treatment is recommended as the first choice for HPV unrelated oropharyngeal squamous cell carcinoma(including primary and re-current)and recurrent HPV related oropharyngeal squamous cell carcinoma after radiotherapy and chemotherapy;⑤ For primary exogenous T1-2 oropharyngeal cancer,direct surgery through the oral approach or da Vinci robotic sur-gery is preferred.For T3-4 patients with advanced oropharyngeal cancer,it is recommended to use temporary mandibu-lectomy approach and lateral pharyngotomy approach for surgery as appropriate;⑥ For cT1-2N0 oropharyngeal cancer patients with tumor invasion depth>3 mm and cT3-4N0 HPV unrelated oropharyngeal cancer patients,selective neck dissection of levels ⅠB to Ⅳ is recommended.For cN+HPV unrelated oropharyngeal cancer patients,therapeutic neck dissection in regions Ⅰ-Ⅴ is advised;⑦ If PET-CT scan at 12 or more weeks after completion of radiation shows intense FDG uptake in any node,or imaging suggests continuous enlargement of lymph nodes,the patient should undergo neck dissection;⑧ For patients with suspected extracapsular invasion preoperatively,lymph node dissection should include removal of surrounding muscle and adipose connective tissue;⑨ The reconstruction of oropharyngeal cancer defects should follow the principle of reconstruction steps,with priority given to adjacent flaps,followed by distal pedicled flaps,and finally free flaps.The anterolateral thigh flap with abundant tissue can be used as the preferred flap for large-scale postoperative defects.
3.Core competency of doctors at tertiary public hospitals in regions of different income levels in China: a cross-sectional survey
Zitang HE ; Yue LI ; Yaoda HU ; Guojie ZHANG ; Li LI ; Jialin SUN ; Linzhi LUO ; Zhenlong WU ; Guangliang SHAN ; Shuyang ZHANG
Chinese Journal of Hospital Administration 2023;39(6):442-448
Objective:To explore the core competency of doctors in tertiary public hospitals in regions of different income levels in China, and provide reference for promoting such competency and related policy formulation.Methods:Using multi-stage stratified cluster sampling method, 195 tertiary public hospitals in 16 provinces of China were selected from November 2021 to March 2022. 200 doctors were sampled from each hospital. A self-designed questionnaire was used to investigate the status of doctors′ core competencies, as well as the status of their postgraduate medical education and continuing medical education. According to the per capita gross regional product of each province in China Statistical Yearbook 2022, each province was divided into high, middle and low income regions, and the questionnaire data were descriptively analyzed, while χ2 test was used to compare the differences between groups. Results:A total of 32 673 valid questionnaires were collected. There were 12 135 doctors (37.14%) in China who had received comprehensive education and training of core competency in all dimensions. Among the dimensions of self-rated core competency of the surveyed doctors, there were 10 019 doctors (30.66%) with insufficient teaching ability and 438 (1.34%) with insufficient professional quality, and there was no significant difference between regions ( P>0.05). There were 2 385 (27.08%), 2 528 (27.55%) and 3 646 (24.82%) doctors in high-, middle- and low-income regions with insufficient lifelong learning ability, respectively. The proportion of doctors in middle- and high-income regions was higher than that in low-income ones ( P<0.05). There were 1 317 (15.57%), 1 290 (14.06%) and 2 719 (18.51%) doctors with insufficient knowledge and skills in high-, middle- and low-income areas, respectively. The proportion of doctors in low-income regions was higher than that in middle- and high-income regions ( P<0.05). The proportion of doctors who did not receive any kind of postgraduate medical education or continuing medical education in low-income regions was 7.33% (1 077 people), higher than that in high-income and middle- income ones ( P<0.05); 50.44% (4 442 people) of surveyed doctors in high-income regions believed that for standardized training of resident physicians (hereinafter referred to as residential training), the clinical teachers were " overworked to take this job", which was higher than that in middle- and low-income regions ( P<0.001); In middle-income regions, 46.16% (4 235 people) and 43.46% (3 987 people) believed that the salary residents and specialized physicians in standardized training (hereinafter referred to as specialized training) was too low, while 42.47% (3 897 people) and 30.44% (2 793 people) believed that the clinical practice opportunities of students were limited, both of which were higher than those in high-income and low-income regions ( P<0.001); 34.91% (5 128 people) of surveyed doctors in low-income regions believed that the investment was insufficient for training bases of residential training, 27.81% (4 085 people) of those held that training bases for specialized training were unevenly distributed, and 33.19% (4 876 people) of those held that continuing medical education was plagued by " insufficient promotion coverage, and insufficient opportunities for primary doctors", all of which being higher than those in high- and middle-income regions ( P<0.001). Conclusions:There is an obvious need to improve the core competence of doctors in the teaching ability dimension of tertiary public hospitals in China, especially in middle- and high-income regions for lifelong learning, and in low-income regions for knowledge and skills; There are differences between postgraduate medical education and continuing medical education systems in regions of different income levels in China. It is necessary to improve the competency oriented postgraduate medical education and continuing medical education systems.
4.A biomimetic nanoplatform for customized photothermal therapy of HNSCC evaluated on patient-derived xenograft models.
Qi WU ; Lan CHEN ; Xiaojuan HUANG ; Jiayi LIN ; Jiamin GAO ; Guizhu YANG ; Yaping WU ; Chong WANG ; Xindan KANG ; Yanli YAO ; Yujue WANG ; Mengzhu XUE ; Xin LUAN ; Xin CHEN ; Zhiyuan ZHANG ; Shuyang SUN
International Journal of Oral Science 2023;15(1):9-9
Cancer cell membrane (CCM) derived nanotechnology functionalizes nanoparticles (NPs) to recognize homologous cells, exhibiting translational potential in accurate tumor therapy. However, these nanoplatforms are majorly generated from fixed cell lines and are typically evaluated in cell line-derived subcutaneous-xenografts (CDX), ignoring the tumor heterogeneity and differentiation from inter- and intra- individuals and microenvironments between heterotopic- and orthotopic-tumors, limiting the therapeutic efficiency of such nanoplatforms. Herein, various biomimetic nanoplatforms (CCM-modified gold@Carbon, i.e., Au@C-CCM) were fabricated by coating CCMs of head and neck squamous cell carcinoma (HNSCC) cell lines and patient-derived cells on the surface of Au@C NP. The generated Au@C-CCMs were evaluated on corresponding CDX, tongue orthotopic xenograft (TOX), immune-competent primary and distant tumor models, and patient-derived xenograft (PDX) models. The Au@C-CCM generates a photothermal conversion efficiency up to 44.2% for primary HNSCC therapy and induced immunotherapy to inhibit metastasis via photothermal therapy-induced immunogenic cell death. The homologous CCM endowed the nanoplatforms with optimal targeting properties for the highest therapeutic efficiency, far above those with mismatched CCMs, resulting in distinct tumor ablation and tumor growth inhibition in all four models. This work reinforces the feasibility of biomimetic NPs combining modular designed CMs and functional cores for customized treatment of HNSCC, can be further extended to other malignant tumors therapy.
Animals
;
Humans
;
Squamous Cell Carcinoma of Head and Neck/therapy*
;
Heterografts
;
Photothermal Therapy
;
Biomimetics
;
Disease Models, Animal
;
Head and Neck Neoplasms/therapy*
;
Cell Line, Tumor
;
Tumor Microenvironment
5.Correction To: A biomimetic nanoplatform for customized photothermal therapy of HNSCC evaluated on patient-derived xenograft models.
Qi WU ; Lan CHEN ; Xiaojuan HUANG ; Jiayi LIN ; Jiamin GAO ; Guizhu YANG ; Yaping WU ; Chong WANG ; Xindan KANG ; Yanli YAO ; Yujue WANG ; Mengzhu XUE ; Xin LUAN ; Xin CHEN ; Zhiyuan ZHANG ; Shuyang SUN
International Journal of Oral Science 2023;15(1):12-12
6.Research prospect of preclinical model construction and precision therapy in ameloblastoma
Xindan KANG ; Lulu SUN ; Zhiyuan ZHANG ; Shuyang SUN
Chinese Journal of Stomatology 2023;58(8):844-851
Ameloblastoma (AM) is a benign odontogenic tumor with unknown etiology. It is prone to recurrence and has a potential for malignant transformation. Patients often show high rates of relapse after curettage, or suffer from structural and functional damage of jaw after partial resection. Whole-genome sequencing data revealed that BRAF mutations and SMO mutations were common and likely to be mutually exclusive in AM. It was also reported that BRAF inhibitors were effective in several patients carrying BRAF V600E mutation. However, reliable preclinical models are urgently needed for exploring targeted therapy as it′s so difficult to conduct large clinical trials in this tumor. Patient-derived cell models in vitro and xenograft models in vivo are frequently used preclinical models. In fact, benign tumor cells generally showed a finite proliferative capacity in two-dimensional culture, and most likely, they could exhibit altered cellular phenotype after immortalization. Moreover, this benign tumor presented low chances of subcutaneous engraftment in nude mice. Accordingly, humanized mouse xenograft model needs more exploration. Yet, it is worth mentioning that a three-dimensional organoid model presents a high potential in culturing stem-cell-like epithelial cells in AM, and it would further be used in recapitulating corresponding tumors and developing targeted medicines. In this paper, we review research progress in preclinical models and the genetic variations of AM, and raise drug screening prospect of the current organoid models, which may pave the way for the possible personalized medicine in AM.
7.Correlation between curative effect and 5-HTTLPR polymorphism in treatment of diarrhea-predominant irritable bowel syndrome with acupuncture for regulating
Jing GUO ; Jian-Hua SUN ; Lu CHEN ; Hao GENG ; Xiao-Liang WU ; Ya-Fang SONG ; Guo-Hui YANG ; Rong-Rong SHEN ; Min DING ; Jin LU ; Lian LIU ; Xiang-Dong FANG ; Li-Xia PEI
Chinese Acupuncture & Moxibustion 2021;41(4):365-370
OBJECTIVE:
To compare the curative effect on diarrhea-predominant irritable bowel syndrome (IBS-D) between acupuncture for regulating
METHODS:
A total of 231 patients with IBS-D were randomized into an acupuncture group (154 cases) and a western medication group (77 cases) at the ratio of 2 to 1. In the acupuncture group, acupuncture was applied to acupoint regimen for regulating
RESULTS:
After treatment and in follow-up, the total scores of IBS-SSS in the patients of the two groups were all reduced as compared with those before treatment (
CONCLUSION
Acupuncture for regulating
Acupuncture Therapy
;
Diarrhea/therapy*
;
Humans
;
Irritable Bowel Syndrome/therapy*
;
Quality of Life
;
Serotonin Plasma Membrane Transport Proteins/genetics*
;
Spleen
;
Treatment Outcome
8.Clinical Recommendations for Perioperative Immunotherapy-induced Adverse Events in Patients with Non-small Cell Lung Cancer.
Jun NI ; Miao HUANG ; Li ZHANG ; Nan WU ; Chunxue BAI ; Liang'an CHEN ; Jun LIANG ; Qian LIU ; Jie WANG ; Yilong WU ; Fengchun ZHANG ; Shuyang ZHANG ; Chun CHEN ; Jun CHEN ; Wentao FANG ; Shugeng GAO ; Jian HU ; Tao JIANG ; Shanqing LI ; Hecheng LI ; Yongde LIAO ; Yang LIU ; Deruo LIU ; Hongxu LIU ; Jianyang LIU ; Lunxu LIU ; Mengzhao WANG ; Changli WANG ; Fan YANG ; Yue YANG ; Lanjun ZHANG ; Xiuyi ZHI ; Wenzhao ZHONG ; Yuzhou GUAN ; Xiaoxiao GUO ; Chunxia HE ; Shaolei LI ; Yue LI ; Naixin LIANG ; Fangliang LU ; Chao LV ; Wei LV ; Xiaoyan SI ; Fengwei TAN ; Hanping WANG ; Jiangshan WANG ; Shi YAN ; Huaxia YANG ; Huijuan ZHU ; Junling ZHUANG ; Minglei ZHUO
Chinese Journal of Lung Cancer 2021;24(3):141-160
BACKGROUND:
Perioperative treatment has become an increasingly important aspect of the management of patients with non-small cell lung cancer (NSCLC). Small-scale clinical studies performed in recent years have shown improvements in the major pathological remission rate after neoadjuvant therapy, suggesting that it will soon become an important part of NSCLC treatment. Nevertheless, neoadjuvant immunotherapy may be accompanied by serious adverse reactions that lead to delay or cancelation of surgery, additional illness, and even death, and have therefore attracted much attention. The purpose of the clinical recommendations is to form a diagnosis and treatment plan suitable for the current domestic medical situation for the immune-related adverse event (irAE).
METHODS:
This recommendation is composed of experts in thoracic surgery, oncologists, thoracic medicine and irAE related departments (gastroenterology, respirology, cardiology, infectious medicine, hematology, endocrinology, rheumatology, neurology, dermatology, emergency section) to jointly complete the formulation. Experts make full reference to the irAE guidelines, large-scale clinical research data published by thoracic surgery, and the clinical experience of domestic doctors and publicly published cases, and repeated discussions in multiple disciplines to form this recommendation for perioperative irAE.
RESULTS:
This clinical recommendation covers the whole process of prevention, evaluation, examination, treatment and monitoring related to irAE, so as to guide the clinical work comprehensively and effectively.
CONCLUSIONS
Perioperative irAE management is an important part of immune perioperative treatment of lung cancer. With the continuous development of immune perioperative treatment, more research is needed in the future to optimize the diagnosis and treatment of perioperative irAE.
9.Pregnancy combined with acute Stanford type A aortic dissection: single center experience and literature review
Shuyang LU ; Wangchao YAO ; Ben HUANG ; Hao LAI ; Jun LI ; Jiawei GU ; Yongxin SUN ; Chunsheng WANG
Chinese Journal of Thoracic and Cardiovascular Surgery 2021;37(1):14-17
Objective:To summarize the clinical characteristics and surgical treatment experience of pregnant women with acute Stanford type A aortic dissection.Methods:From January 2005 to December 2018, a total of 12 patients with acute Stanford type A aortic dissection were treated in Zhongshan Hospital affiliated to Fudan University. Two patients died of sudden aortic dissection rupture during emergency CTA examination. The other 10 patients underwent surgical treatment, the age was 22-40 years[mean(30.7±5.8) years], the pregnancy was 15-39 weeks[mean(28.8±6.5) weeks], two cases in the second trimester of pregnancy, seven cases in the third trimester of pregnancy and one case in puerperium. Among them, seven cases were Marfan syndrome, one case was bicuspid aortic valve malformation, two cases were complicated with pregnancy hypertension.Results:One case died during perioperative period and died of rupture of abdominal aortic dissection in twelfth day after operation. One fetus was diagnosed as stillborn before operation. Before December 2013, six patients underwent surgeries, the mean cardiopulmonary bypass time was(96.8±16.5)min, aortic occlusion time was(70.8±19.3)min, intensive care unit time was(3.4±2.3) days, ventilator-assisted mechanical ventilation time was(21.6±15.6)h. After January 2014, four patients underwent surgeries, the mean cardiopulmonary bypass time was(202.3±6.4)min, the aortic cross-blocking time was(137.5±10.3)min, circulatory arrest time was(27.3±8.8)min, intensive care unit time was(12.0±5.7) days, and the ventilator-assisted mechanical ventilation time was(40.3±24.4)h. The postoperative complications included tracheotomy in two cases, hemodialysis in one case, poor wound healing in one case. One patient who had been treated with Bentall was followed up to sixth year and died of progressive rupture of descending arch dissection. One patient was followed up to seventh year after Bentall surgery, redo Bentall and Sun’s procedure were performed because of artificial valve infection, and was discharged uneventful. No adverse cardiovascular events occurred in other patients.Conclusion:Surgical treatment should be actively considered in pregnancy complicated with acute Stanford type A aortic dissection. Multi-disciplinary team cooperation can effectively improve the safety and effect of operation.
10.Bidirectional regulation of acupuncture: a subgroup analysis of multicenter randomized controlled trial of acupuncture with
Jing GUO ; Jian-Hua SUN ; Lu CHEN ; Hao GENG ; Guo-Hui YANG ; Rong-Rong SHEN ; Min DING ; Jin LU ; Lian LIU ; Xiang-Dong FANG ; Li-Xia PEI
Chinese Acupuncture & Moxibustion 2021;41(8):845-850
OBJECTIVE:
To explore the bidirectional regulation of acupuncture based on a subgroup analysis of multicenter randomized controlled trial of acupuncture with
METHODS:
A total of 519 patients were included in the analysis, including 137 patients with constipation type irritable bowel syndrome (IBS-C) (92 cases in the acupuncture group and 45 cases in the polyethylene glycol [PEG] group), and 382 patients with diarrhea type irritable bowel syndrome (IBS-D) (252 cases in the acupuncture group and 130 cases in the pinaverium group). The patients in the acupuncture group were given acupuncture at Baihui (GV 20), Yintang (GV 29), Tianshu (ST 25), Shangjuxu (ST 37), Zusanli (ST 36), Sanyinjiao (SP 6) and Taichong (LR 3) once every other day, 3 times a week. The patients in the PEG group received polyethylene glycol 4000 powder orally, and the pinaverium group received pinaverium bromide tablets orally. All were treated for 6 weeks. The IBS symptom severity score (IBS-SSS) was assessed at baseline, treatment period (2, 4, 6 weeks of treatment) and 12 weeks of follow-up, and the IBS quality of life (IBS-QOL) score was evaluated at the baseline period, 6 weeks of treatment and 12 weeks of follow-up.
RESULTS:
The total IBS-SSS scores of the two groups of IBS-C patients at 2, 4, 6 weeks of treatment and follow-up of 12 weeks were lower than those in the baseline period (
CONCLUSION
Acupuncture with
Acupuncture Points
;
Acupuncture Therapy
;
Diarrhea
;
Humans
;
Irritable Bowel Syndrome/therapy*
;
Quality of Life
;
Treatment Outcome


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