1.Pozelimab,a new generation of C5 complement inhibitors for CHAPLE disease
Xuan-Ling ZHANG ; Chao-Yang CHEN ; Ran WEI ; Ying ZHOU
The Chinese Journal of Clinical Pharmacology 2024;40(2):276-278
		                        		
		                        			
		                        			On August 18,2023,the U.S.Food and Drug Administration(FDA)officially approved Regeneron's Pozelimab-bbfg(Veopoz?)for the treatment of complement factor H-related protein 5 deficiency type protein-losing enteropathy(CHAPLE)disease in children aged 1 and above,as well as adult patients.CHAPLE disease is a rare condition.Pazelimab monoclonal antibody is a recombinant monoclonal antibody(immunoglobulin G4 isotype).This antibody works by binding to the terminal complement protein C5,thereby preventing the cleavage of C5 into C5a(an anaphylatoxin)and C5b,and inhibit the activation of the terminal complement pathway.This article provides an overview of Pozelimab-bbfg,including its pharmacological research,pharmacokinetics,clinical studies,safety profile,and more,to introduce the current state of research and the achievements made with this drug.
		                        		
		                        		
		                        		
		                        	
2.Palovarotene:A new drug for fibrodysplasia ossificans progressive
Ran WEI ; Chao-Yang CHEN ; Xuan-Ling ZHANG ; Ying ZHOU
The Chinese Journal of Clinical Pharmacology 2024;40(5):745-748
		                        		
		                        			
		                        			Progressive ossifying fibrous dysplasia(FOP)is a rare,hereditary,and progressive connective tissue disease characterized by heterotopic ossification(HO)formation in muscles,joints,tendons,and ligaments,leading to major joint stiffness,limited movement,deformity,and severe disability in patients.In August 2023,Palovarotene was approved by the US Food and Drug Administration(FDA)to reduce the formation of HO in adults and children aged 8 years and above for females and 10 years and above for males with FOP.It is currently the only approved curable drug worldwide.Palovarotene is a selective retinoic acid receptor γ(RAR-γ)agonist that reduces the formation of HO by inhibiting bone morphogenetic protein and SMAD 1/5/8 signaling.The pharmacological study,pharmacokinetics,clinical research,and safety are reviewed to comprehensively introduce Palovarotene.
		                        		
		                        		
		                        		
		                        	
3.68 Ga-DOTATOC,a new diagnostic agent for localization of somatostatin receptor positive neuroendocrine tumors
Si-Miao ZHAO ; Chao-Yang CHEN ; Ran WEI ; Xuan-Ling ZHANG ; Ying ZHOU
The Chinese Journal of Clinical Pharmacology 2024;40(11):1654-1657
		                        		
		                        			
		                        			68Ga-DOTATOC injection is a radiopharmaceutical agent for positron emission tomography localization of somatostatin receptor positive neuroendocrine tumors(NETs)in adult and pediatric patients.68 Ga-DOTATOC binds to cells that express somatostatin receptors(SSTRs),including malignant neuroendocrine cells that overexpress SSTR2 receptor.Gallium-68 is a radionuclide used in positron emission tomography for tumor diagnosis.This paper introduces its the mechanism of action,pharmacokinetics,usage and dosage,clinical evaluation,safety and use in specific populations.
		                        		
		                        		
		                        		
		                        	
4.Pafolacianine,optical imaging agents for intraoperative tumor detection
Zhao WANG ; Chao-Yang CHEN ; Ran WEI ; Xuan-Ling ZHANG ; Xiao-Juan HU ; Ying ZHOU
The Chinese Journal of Clinical Pharmacology 2024;40(11):1658-1660
		                        		
		                        			
		                        			Pafolacianine is a fluorescent agent that specifically targets folate receptors,employed in the treatment of adult ovarian cancer patients to support the detection of malignant growths during surgical interventions.Pafolacianine binds to cancer cells expressing folate receptors,accumulating within folate-receptor-positive tumor tissue through receptor-mediated endocytosis.It can be excited by near-infrared fluorescence imaging,facilitating the surgical removal of tumors during procedures.This article gives an introduction to the mechanism of action,pharmacokinetics,clinical studies,and safety aspects of Pafolacianine.
		                        		
		                        		
		                        		
		                        	
5.Gadopiclenol,a new radiological diagnostic drug used in magnetic resonance imaging
Lu ZHENG ; Ting YANG ; Chao-Yang CHEN ; Ran WEI ; Xuan-Ling ZHANG ; Jing-Zhong DENG ; Ying ZHOU
The Chinese Journal of Clinical Pharmacology 2024;40(11):1661-1664
		                        		
		                        			
		                        			Gadopiclenol was used in adults and pediatric patients 2 years of age and older during magnetic resonance imaging(MRI)to detect and view lesions of the central nervous system(brain,spine,and associated tissues)and body(head and neck,chest,abdomen,pelvis,and musculoskeletal system)with abnormal vascular properties.Gadopiclenol is a new type of macrocyclic gadolinium-based contrast agent(GBCA).In this article,the molecular structure,principle of action,pharmacodynamics,pharmacokinetics,clinical studies,safety and other aspects of Gadopiclenol were reviewed,in order to introduce the current research status and existing achievements of Gadopiclenol.
		                        		
		                        		
		                        		
		                        	
6.Copper Cu 64 dotatate,a new diagnostic agent for somatostatin receptor-positive neuroendocrine tumors
Ming-Zhu XU ; Chao-Yang CHEN ; Ran WEI ; Xuan-Ling ZHANG ; Ying ZHOU
The Chinese Journal of Clinical Pharmacology 2024;40(12):1832-1834
		                        		
		                        			
		                        			On September 3,2020,the U.S.Food and Drug Administration(FDA)granted formal approval to Copper Cu 64 dotatate(commercially known as Detectnet),for its pivotal role in diagnosing somatostatin receptor(SSTR)positive neuroendocrine tumors(NETs)in adult patients.This innovative diagnostic agent,Copper Cu 64 dotatate,is a sophisticated radionuclide that selectively targets somatostatin receptors,facilitating the emission of positron(β+)radionuclides in a quantity conducive for high-resolution positron emission tomography(PET)imaging.This review delves into the intricate mechanisms of action,the dynamic pharmacokinetics,comprehensive clinical studies,and the safety profile of Copper Cu 64 dotatate,highlighting its significance in the realm of medical diagnostics.
		                        		
		                        		
		                        		
		                        	
7.Piflufolastat F 18 for PSMA PET imaging in prostate cancer
Jing-Tian SHI ; Ting YANG ; Chao-Yang CHEN ; Ran WEI ; Xuan-Ling ZHANG ; Xiao-Juan HU ; Ying ZHOU
The Chinese Journal of Clinical Pharmacology 2024;40(12):1835-1838
		                        		
		                        			
		                        			On May 27,2021,the U.S.Food and Drug Administration(FDA)officially approved Lantheus'PYLARIFY?(Piflufolastat F 18,18 F-labeled imaging agent),which can be used for positron emission computed tomography(PET)of prostate-specific membrane antigen(PSMA)-positive lesions in prostate cancer patients to accurately identify prostate cancer with suspected metastasis or recurrence.Piflufolastat F 18 is approved by FDA for two indications.The first is the initial staging for suspected metastatic lesions in men with newly diagnosed prostate cancer.The second is restaging,with the goal of identifying lesions in the setting of biochem ical recurrence.
		                        		
		                        		
		                        		
		                        	
8.Expert consensus on late stage of critical care management.
Bo TANG ; Wen Jin CHEN ; Li Dan JIANG ; Shi Hong ZHU ; Bin SONG ; Yan Gong CHAO ; Tian Jiao SONG ; Wei HE ; Yang LIU ; Hong Min ZHANG ; Wen Zhao CHAI ; Man hong YIN ; Ran ZHU ; Li Xia LIU ; Jun WU ; Xin DING ; Xiu Ling SHANG ; Jun DUAN ; Qiang Hong XU ; Heng ZHANG ; Xiao Meng WANG ; Qi Bing HUANG ; Rui Chen GONG ; Zun Zhu LI ; Mei Shan LU ; Xiao Ting WANG
Chinese Journal of Internal Medicine 2023;62(5):480-493
		                        		
		                        			
		                        			We wished to establish an expert consensus on late stage of critical care (CC) management. The panel comprised 13 experts in CC medicine. Each statement was assessed based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) principle. Then, the Delphi method was adopted by 17 experts to reassess the following 28 statements. (1) ESCAPE has evolved from a strategy of delirium management to a strategy of late stage of CC management. (2) The new version of ESCAPE is a strategy for optimizing treatment and comprehensive care of critically ill patients (CIPs) after the rescue period, including early mobilization, early rehabilitation, nutritional support, sleep management, mental assessment, cognitive-function training, emotional support, and optimizing sedation and analgesia. (3) Disease assessment to determine the starting point of early mobilization, early rehabilitation, and early enteral nutrition. (4) Early mobilization has synergistic effects upon the recovery of organ function. (5) Early functional exercise and rehabilitation are important means to promote CIP recovery, and gives them a sense of future prospects. (6) Timely start of enteral nutrition is conducive to early mobilization and early rehabilitation. (7) The spontaneous breathing test should be started as soon as possible, and a weaning plan should be selected step-by-step. (8) The waking process of CIPs should be realized in a planned and purposeful way. (9) Establishment of a sleep-wake rhythm is the key to sleep management in post-CC management. (10) The spontaneous awakening trial, spontaneous breathing trial, and sleep management should be carried out together. (11) The depth of sedation should be adjusted dynamically in the late stage of CC period. (12) Standardized sedation assessment is the premise of rational sedation. (13) Appropriate sedative drugs should be selected according to the objectives of sedation and drug characteristics. (14) A goal-directed minimization strategy for sedation should be implemented. (15) The principle of analgesia must be mastered first. (16) Subjective assessment is preferred for analgesia assessment. (17) Opioid-based analgesic strategies should be selected step-by-step according to the characteristics of different drugs. (18) There must be rational use of non-opioid analgesics and non-drug-based analgesic measures. (19) Pay attention to evaluation of the psychological status of CIPs. (20) Cognitive function in CIPs cannot be ignored. (21) Delirium management should be based on non-drug-based measures and rational use of drugs. (22) Reset treatment can be considered for severe delirium. (23) Psychological assessment should be conducted as early as possible to screen-out high-risk groups with post-traumatic stress disorder. (24) Emotional support, flexible visiting, and environment management are important components of humanistic management in the intensive care unit (ICU). (25) Emotional support from medical teams and families should be promoted through"ICU diaries"and other forms. (26) Environmental management should be carried out by enriching environmental content, limiting environmental interference, and optimizing the environmental atmosphere. (27) Reasonable promotion of flexible visitation should be done on the basis of prevention of nosocomial infection. (28) ESCAPE is an excellent project for late stage of CC management.
		                        		
		                        		
		                        		
		                        			Humans
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		                        			Consensus
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		                        			Critical Care/methods*
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		                        			Intensive Care Units
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		                        			Pain/drug therapy*
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		                        			Analgesics/therapeutic use*
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		                        			Delirium/therapy*
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		                        			Critical Illness
		                        			
		                        		
		                        	
9.Multi-component comprehensive quality evaluation of Tongjing ointment
Ling-Chao RAN ; Jin-Ying FENG ; Zhi-Ming LI ; Kang-Kang JI
China Pharmacist 2023;26(11):319-331
		                        		
		                        			
		                        			Objective To establish a method for comprehensive quality evaluation of Tongjing ointment by multi-component quantification combined with chemometrics and grey correlation analysis(GRA).Methods With curcumin as the internal reference substance,HPLC-QAMS method was used to simultaneously determine the contents of limonin,evodiamine,rutaecarpine,bisdemethoxycurcumin,demethoxycurcumin,curcumin,6-gingerol,8-gingerol,10-gingerol,tetrahydropalmatine,dehydrocorydalin,dorydaline in Tongjing ointment.The quality of Tongjing ointment was evaluated by cluster analysis,principal component analysis,orthogonal partial least square discriminant analysis and GRA.Results The determination of 12 components manifested a good linear relationship in the range of mass concentration(r≥0.999 1).The average recovery was between 96.58%and 100.19%(RSD<2.0%,n=9).There were no significant difference between the measured value of external standard method and the calculated value of HPLC-QAMS(P>0.05).Tongjing ointment samples were classified into three eategories by chemometrics and it showed that curcumin,6-gingerol,bisdemethoxycurcumin,demethoxycurcumin,limonin and tetrahydropalmatine were the main potential markers affecting the quality of Tongjing ointment.GRA showed that the relative correlation degree was in the range of 0.317 3-0.624 8,and there were some differences in the quality of Tongjing ointment.Conclusion The established method can comprehensively evaluate the quality of Tongjing ointment.
		                        		
		                        		
		                        		
		                        	
10.Study on the equity of resource allocation for health education in China from 2015-2019 based on Gini coefficient and Lorenz curve
Sirong ZHANG ; Ling ZHANG ; LI RAN ; Xiaoan DU ; Longjiang ZHANG ; Chao SUN ; Xiaodong TAN
Journal of Public Health and Preventive Medicine 2022;33(1):12-16
		                        		
		                        			
		                        			Objective  Health education resource allocation is one of the basic indicators for evaluating health equity. At present, the research on the equity of health education resource allocation in China is mostly limited to a single year or regional data. This study was aimed to understand the equity of health education resources in the whole China from 2015-2019, and to provide a corresponding basis for further rational allocation of health education resources.  Methods  The data was obtained based on the number of health education training work, health education publicity work, distribution of health education publicity materials and the annual use of funds carried out mainly by the CDC or health education centers in each province according to the 2016-2020 China Health Statistics Yearbook. The inequality coefficient (Gini coefficient) and Lorenz curve were applied to study the selected data. Results  The total number of health education resources in China from 2015-2019 was 1 789 735 and 1 933 336, respectively. The Gini coefficients of health education resource allocation by population distribution were all below the warning line of 0.4, which were in an equitable state.  Conclusion  The equity of health education resources in China is good according to demographic indicators, and there is no significant inequity. Especially, the aspects of health education services, such as technical consultation and media cooperation, are relatively good, but there is still much room for improvement in the construction of websites.
		                        		
		                        		
		                        		
		                        	
            

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