1.Some thoughts on compulsory licensing of pharmaceutical patents in emergency situations
Yonghe FEI ; Lijun CUI ; Jing CHEN
Journal of Pharmaceutical Practice and Service 2024;42(7):310-314
Objective To explore the conditions for compulsory licensing of pharmaceutical patents and the steps for implementing compulsory licensing of pharmaceutical patents.Methods The current situation and problem of compulsory licensing of pharmaceutical patents in China were analyzed by collecting the relevant laws and regulations in China,United States,India,and the World Trade Organization.The feasible practices of compulsory licensing of pharmaceutical patents among the other countries and organizations were compared.Results China needs to improve the system of compulsory licensing of pharmaceutical patents,clarify the implementation details,strengthen policy guidance,and encourage cooperation between government and enterprises to ensure the smooth implementation in emergency situations.Conclusion Compulsory licensing system and implementation rules in China for pharmaceutical patents should be supplemented and improved by absorbing the useful provisions of international organizations and relevant countries,so as to achieve the pharmaceutical supply in emergency situations and meet the needs of public health.
2.Comparative study on pharmaceutical emergency approval systems in China and other countries
Lijun CUI ; Yanting CHEN ; Yonghe FEI ; Jing CHEN
Journal of Pharmaceutical Practice and Service 2024;42(8):359-364
Objective To explore the ideas and measures to further optimize China's drug emergency approval system by comparing the drug emergency approval systems in China and other countries.Methods The current situation of China's drug emergency approval system was analyzed and compared with the relevant systems of the United States,the European Union and Japan.Results The goal of drug emergency approval in other countries is clearly positioned to accelerate the review and listing of urgently needed clinical drugs for the purpose of clinical needs,forming a multi-channel,multi-mode and multi-mechanism priority review system covering the whole process,and the regulatory system is clear,complete,and operable.The corresponding approval system in China started late and is in the stage of continuous improvement,which needs to be improved in terms of system construction,government functions,personnel optimization,and post-market supervision.Conclusion Drug regulatory authorities in China should summarize their past work experience and draw on some feasible approval models and regulatory approaches in foreign countries,further improve the system and process of the drug emergency approval system and enhance the efficiency of drug approval and the ability to protect drugs in response to emergencies.
3.Clinical application of natural orifice transluminal endoscopic surgery in autopsy:a case report
Xiao CHEN ; Zhiqiang WANG ; Huaiyin SHI ; Jing LIU ; Zhanbo WANG ; Qing ZHOU ; Yonghe FU ; Shiping XU ; Hui SHI
Chinese Journal of Forensic Medicine 2024;39(5):572-576,583
Objective To explore the feasibility of minimally invasive autopsy by natural orifice transluminal endoscopic surgery.Methods Autopsy was performed on a deceased patient with COVID-19 via transesophageal,transtrachea,and transgastric natural orifice transluminal endoscopic surgery.The white light endoscopic manifestations of the corresponding organs were observed,and organ tissue specimens were obtained for routine pathological examination.Results All four pathways reached the corresponding organs successfully.Diffuse congestion and submucous bleeding were seen in the trachea,bronchus and bronchus of the pulmonary lobes.The bronchus of the left lower lobe was filled with dark red sputum;the surface of the left lung was congested obviously.Four thrombi and plaque rupture were seen on the aortic wall.The gastric mucosa was congested,eroded,and had active ulcers.The surface of heart and liver was smooth.Small lamellar panniculitis was seen in the omentum.Routine pathology showed chronic inflammation with acute inflammation of the bronchial mucosa and inflammatory exudation,and partial squamous metaplasia of the epithelium.In lung tissue,some alveolar epithelial hyperplasia,a little fibrin-like exudation,widened alveolar septa,and infiltration of acute and chronic inflammatory cells were seen.The columnar epithelial mucosa of the gastric mucosa showed chronic inflammation with acute inflammation and exudates and fungal masses.Conclusion Natural orifice transluminal endoscopic surgery is feasible for autopsy,and covid-19 virus can cause multi-system and multi-organ damage.
4.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
5.PD-1 inhibitors plus chemotherapy for refractory EBV-positive DLBCL:a retrospective analysis
Youli LI ; Yonghe WU ; Sufen CAO ; Baohua YU ; Qunling ZHANG ; Zuguang XIA ; Junning CAO ; Fangfang LV ; Guang‑Liang CHEN
Blood Research 2024;59():36-
Background:
Immunochemotherapy has demonstrated a promising efficacy for a variety of B-cell lymphoma but has limited efficacy for Epstein–Barr virus-positive (EBV +) diffuse large B-cell lymphoma (DLBCL) that is refractory or relapsed to conventional chemotherapy regimens. Considering higher programmed death-ligand 1 (PD-L1) expres‑ sion in the subset of patients with DLBCL with positive EBV, we speculated that PD-1 inhibitors plus chemotherapy may be an alternative regimen in patients with refractory/relapsed EBV + DLBCL.
Methods:
This retrospective study included six adult patients diagnosed with refractory EBV + DLBCL resistant to first-line immunochemotherapy regimens (R-CHOP). These patients received PD-1 inhibitors plus chemotherapy as second-line treatment.
Results:
The final analysis included six patients (four men and two women (median age, 50 years; range, 39–83 years)). Four patients were diagnosed with Epstein–Barr virus (EBV) + DLBCL, and two had DLBCL associated with chronic inflammation. Over a median follow-up of 20 months (range, 2–31 months), the objective response rate was 83% (5/6) and the complete remission rate was 67% (4/6). No severe immune-related adverse reactions occurred, and only a mild rash was reported, which did not necessitate the discontinuation of therapy.
Conclusion
The combination of PD-1 inhibitors and chemotherapy offers promising results as a second-line treat‑ ment for patients with refractory EBV + DLBCL that is resistant to first-line immunochemotherapy regimens. These preliminary findings warrant further investigation in larger clinical trials to validate the efficacy and safety of this therapeutic approach.
6.PD-1 inhibitors plus chemotherapy for refractory EBV-positive DLBCL:a retrospective analysis
Youli LI ; Yonghe WU ; Sufen CAO ; Baohua YU ; Qunling ZHANG ; Zuguang XIA ; Junning CAO ; Fangfang LV ; Guang‑Liang CHEN
Blood Research 2024;59():36-
Background:
Immunochemotherapy has demonstrated a promising efficacy for a variety of B-cell lymphoma but has limited efficacy for Epstein–Barr virus-positive (EBV +) diffuse large B-cell lymphoma (DLBCL) that is refractory or relapsed to conventional chemotherapy regimens. Considering higher programmed death-ligand 1 (PD-L1) expres‑ sion in the subset of patients with DLBCL with positive EBV, we speculated that PD-1 inhibitors plus chemotherapy may be an alternative regimen in patients with refractory/relapsed EBV + DLBCL.
Methods:
This retrospective study included six adult patients diagnosed with refractory EBV + DLBCL resistant to first-line immunochemotherapy regimens (R-CHOP). These patients received PD-1 inhibitors plus chemotherapy as second-line treatment.
Results:
The final analysis included six patients (four men and two women (median age, 50 years; range, 39–83 years)). Four patients were diagnosed with Epstein–Barr virus (EBV) + DLBCL, and two had DLBCL associated with chronic inflammation. Over a median follow-up of 20 months (range, 2–31 months), the objective response rate was 83% (5/6) and the complete remission rate was 67% (4/6). No severe immune-related adverse reactions occurred, and only a mild rash was reported, which did not necessitate the discontinuation of therapy.
Conclusion
The combination of PD-1 inhibitors and chemotherapy offers promising results as a second-line treat‑ ment for patients with refractory EBV + DLBCL that is resistant to first-line immunochemotherapy regimens. These preliminary findings warrant further investigation in larger clinical trials to validate the efficacy and safety of this therapeutic approach.
7.PD-1 inhibitors plus chemotherapy for refractory EBV-positive DLBCL:a retrospective analysis
Youli LI ; Yonghe WU ; Sufen CAO ; Baohua YU ; Qunling ZHANG ; Zuguang XIA ; Junning CAO ; Fangfang LV ; Guang‑Liang CHEN
Blood Research 2024;59():36-
Background:
Immunochemotherapy has demonstrated a promising efficacy for a variety of B-cell lymphoma but has limited efficacy for Epstein–Barr virus-positive (EBV +) diffuse large B-cell lymphoma (DLBCL) that is refractory or relapsed to conventional chemotherapy regimens. Considering higher programmed death-ligand 1 (PD-L1) expres‑ sion in the subset of patients with DLBCL with positive EBV, we speculated that PD-1 inhibitors plus chemotherapy may be an alternative regimen in patients with refractory/relapsed EBV + DLBCL.
Methods:
This retrospective study included six adult patients diagnosed with refractory EBV + DLBCL resistant to first-line immunochemotherapy regimens (R-CHOP). These patients received PD-1 inhibitors plus chemotherapy as second-line treatment.
Results:
The final analysis included six patients (four men and two women (median age, 50 years; range, 39–83 years)). Four patients were diagnosed with Epstein–Barr virus (EBV) + DLBCL, and two had DLBCL associated with chronic inflammation. Over a median follow-up of 20 months (range, 2–31 months), the objective response rate was 83% (5/6) and the complete remission rate was 67% (4/6). No severe immune-related adverse reactions occurred, and only a mild rash was reported, which did not necessitate the discontinuation of therapy.
Conclusion
The combination of PD-1 inhibitors and chemotherapy offers promising results as a second-line treat‑ ment for patients with refractory EBV + DLBCL that is resistant to first-line immunochemotherapy regimens. These preliminary findings warrant further investigation in larger clinical trials to validate the efficacy and safety of this therapeutic approach.
8.Analysis on the funding of pharmacy administration from National Natural Science Foundation in China from 2010 to 2021
Yonghe FEI ; Lijun CUI ; Jing CHEN
Journal of Pharmaceutical Practice 2023;41(9):572-575
Objective To summarize the project and fund of Pharmacy Administration from the NSFC during 2010 to 2021 and to provide references for the funding application. Methods The data and relevant documents which related to the projects status of Pharmacy Administration on the website of NSFC were collected and analyzed by Excel. Results There were more paths which were suitable to the Pharmacy Administration in NSFC. The direction and measure were expanded. There were more interdisciplinary researchers involved in Pharmacy Administration projects, while the funded organizations and regional distribution were concentrated. Conclusion The funding situation, research hotspots and basic information of applicants in recent years were summarized through statistical data of NSFC from 2010 to 2021, which suggest that the advantage, regional characteristics, cross-discipline and the policies should be concerned by the applicants .
9. Treatment strategy for gastrointestinal tumor under the outbreak of novel coronavirus pneumonia in China
Chinese Journal of Gastrointestinal Surgery 2020;23(2):I-IV
The outbreak of the novel coronavirus pneumonia (NCP) has become a public health emergency in China. Chinese authorities and health agencies had devoted great efforts to control this disease. As surgeons specialized in the treatment of gastrointestinal tumors, we should always be aware of the prevention for NCP and incorporate this awareness into every detail of clinical practice. For the patients with gastrointestinal tumors, pre-admission screening should be done in order to rule out NCP. Real-time RT-PCR panel and chest CT scan should be conducted for patients with fever (>37.3℃), travel history to Hubei Province within 14 days, or contact history with residents from Wuhan district within 14 days. Prevention measures for both medical staffs and the screen-negative admitted patients should also be enhanced because false negative is possible. Medical instruments should be properly discarded or disinfected according to standardized procedures established by the local center for disease control and prevention (CDC). Surgical operation should be reduced at a minimal level to prevent cross infection in this special period.Surgical intervention for benign tumor should be postponed. For malignant tumor, multidisciplinary therapy (MDT) is recommended and non-surgical anti-tumor therapy should be selected with higher priority. Neoadjuvant therapy is highly recommended for gastrointestinal cancer at advanced stages that meet the indications of NCCN guideline (gastric cancer T stage ≥ 2/rectal cancer T stage ≥ 3/unresectable colon cancer). Gastric or esophagogastricjunction (EGJ) malignant tumor with obstruction can be managed with gastric tube decompression or stent placement to relieve the symptoms. Transnasal enteral feeding tube intubation/percutaneous endoscopic gastrostomy could be adopted to ensure enteral nutrition supply. For colorectal malignancy with simple intestinal obstruction, stent placement can achieve a high success rate, which not only helps avoid emergency surgery, but also creates a better condition for subsequent surgery. Transcatheter arterial embolization for hemostasis is an alternative choice for gastrointestinal tumor with bleeding. However, emergency operation still must be performed for patients with acute uncontrolled bleeding, obstruction or after other alternative treatment measures fail. All cases with suspicious or confirmed with NCP must be reported to the local CDC department. All invasive intervention must be performed in a designated isolation area. Tertiary prevention measure must be adopted for all anesthetists with additional face mask or medical goggle protection to prevent respiratory droplet transmission. Preventive enterostomy is preferable in lower digestive tract surgery. Thoroughly disinfecting the operating room after surgery is necessary. Fever after surgery must be carefully differentiated whether it's caused by post-surgery abdominal infection/inflammation or NCP. Single-room isolation and related examinations should be performed according to the standard procedures. We believe that with the unprecedentedly joint efforts of doctors and patients, we will eventually win this war against NCP.
10.Diagnostic value of P2X7 receptor and its role in inflammatory reaction in rheumatoid arthritis.
Yonghe CHEN ; Baochang SU ; Mengqiao SHANG
Journal of Southern Medical University 2018;38(12):1453-1458
OBJECTIVE:
To study the diagnostic value of P2X7 receptor for rheumatoid arthritis (RA) and its role in the inflammatory response.
METHODS:
With the synovial tissues from 25 patients with bone and joint replacement as the control,the synovial tissues of 25 RA patients were examined for the relative expression of P2X7 receptor mRNA using qRT-PCR.In an immortalized RA synovial cell line (MH7A),the effect of P2X7 receptor knockdown via a small interfering RNA were examined on the productions of the inflammatory cytokines including interleukin-1β(IL-1β),IL-6,and IL-8 using ELISA.
RESULTS:
The RA patients showed significantly higher levels of P2X7 receptor mRNA expression in the synovial tissue than the control patients.P2X7 receptor had a good diagnostic value for RA.The expression levels of IL-1β,IL-6,and IL-8 were positively correlated with the levels of P2X7 receptor in the synovial tissues of RA patients (<0.001).In MH7A cells,P2X7 receptor knockdown obviously reduced the secretion of IL-1β and IL-6.
CONCLUSIONS
RA patients show elevated P2X7 receptor level in the synovial tissue, which has a good diagnostic value for RA.Blocking P2X7 receptor can inhibit inflammatory factor secretion and suppress inflammatory reactions.
Arthritis, Rheumatoid
;
diagnosis
;
physiopathology
;
Case-Control Studies
;
Cell Line
;
Gene Knockdown Techniques
;
Humans
;
Inflammation
;
metabolism
;
Interleukin-1beta
;
metabolism
;
Interleukin-6
;
metabolism
;
Interleukin-8
;
metabolism
;
Purinergic P2X Receptor Antagonists
;
RNA, Messenger
;
metabolism
;
Receptors, Purinergic P2X7
;
physiology
;
Synovial Membrane
;
metabolism

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