OBJECTIVE To provide a reference for standardizing the conduct of positron-emitting radiopharmaceuticals'phase 0 clinical trials(hereinafter referred to as"phase 0 clinical trials")and advancing the development of innovative drug by medical institutions.METHODS Initiated by the First Affiliated Hospital of Jinan University,a panel of experts consisting of pharmacy,clinical medicine and medical ethics from multiple institutions was established to investigate the current landscape,and discuss the necessary conditions,procedures,and other aspects for conducting phase 0 clinical trials in medical institutions by integrating relevant national policies,regulations and expert consensus.Finally,an agreement was reached to formulate this consensus.RESULTS&CONCLUSIONS Currently,most medical institutions have deficiencies in pharmaceutical care during the management of radiopharmaceuticals and the phase 0 clinical trials.In conjunction with the Expert Consensus on the Establishment of Nuclear Pharmacist Positions,this consensus explicitly defines the responsibilities of nuclear pharmacists in the phase 0 clinical trials on the basis of the Expert Consensus for the Application of Positron Emission Tomography Radioligands for Translational Study in the Phase 0 Clinical Trials(2020 edition),providing a guidance for high-quality participation of nuclear pharmacists from medical institutions in China in phase 0 clinical research.Additionally,in consideration of some constraints imposed by current relevant regulations,this consensus also proposes strategic recommendations,such as encouraging medical institutions to form a consortium,leading to the establishment of dedicated bases or industrial parks,holding significant implications to strengthen institutional capacity for advancing radiopharmaceutical innovation through phase 0 clinical trials.

OBJECTIVE To provide references for improving the satisfaction of patients with chronic kidney disease(CKD)on the quality of pharmaceutical care.METHODS CKD patients from six tertiary hospitals in Jiangsu Province were selected as subjects of the investigation by stratified sampling and random sampling.Based on the modified SERVQUAL model,the evaluation of pharmaceutical care quality for CKD patients in Jiangsu Province was investigated from the dimensions of reliability,responsiveness,empathy,assurance,continuity and tangibility,then the influence of six dimensions on overall satisfaction was analyzed.RESULTS A total of 205 questionnaires were distributed and 199 valid questionnaires were recovered,with an effective rate of 97.07％.The overall satisfaction on the CKD pharmaceutical care quality among the interviewed patients was not high,with 60.30％of patients stating"barely satisfied"and 28.65％stating"dissatisfied"or"very dissatisfied".The service quality values(SQ)of the six dimensions were all less than 0,and the quality of the six dimensions was positively correlated with the overall satisfaction of patients.Among them,the reliability and responsiveness service quality evaluation were the highest(the average SQ was-1.01),and the assurance service quality evaluation was the lowest(the average SQ was-1.10).CONCLUSIONS The patients with CKD in Jiangsu Province have poor evaluation and overall satisfaction on the quality of pharmaceutical care.It is suggested that relevant medical institutions should focus on the dimensions of assurance,tangibility,empathy and continuity,further strengthen the professional skills training of pharmacists,pay attention to the follow-up of patients and timely improve the hardware facilities.

The Vaccine Adverse Event Reporting System (VAERS) in the United States is the earliest vaccine safety surveillance system in the world, established in 1990. The VAERS database can be used to detect new, unusual, or rare adverse events following vaccine to identify potential safety issues with marketed vaccines. This paper introduces the basic situation and data acquisition methods of VAERS database, summarizes the format, content, relevance and practical application methods of VAERS data packet, and reviews the research on vaccine safety data analysis and signal mining by foreign scholars using VAERS data in recent years, so as to provide reference for Chinese scholars in use of VAERS database and the data opening of surveillance data of suspected adverse event following immunization in China.

The Vaccine Adverse Event Reporting System (VAERS) in the United States is the earliest vaccine safety surveillance system in the world, established in 1990. The VAERS database can be used to detect new, unusual, or rare adverse events following vaccine to identify potential safety issues with marketed vaccines. This paper introduces the basic situation and data acquisition methods of VAERS database, summarizes the format, content, relevance and practical application methods of VAERS data packet, and reviews the research on vaccine safety data analysis and signal mining by foreign scholars using VAERS data in recent years, so as to provide reference for Chinese scholars in use of VAERS database and the data opening of surveillance data of suspected adverse event following immunization in China.

Objective To investigate the correlation between body mass index (BMI) and features of tongue manifestation.Methods A total of 1 655 physical examination individuals were selected,and height and body weight were measured to calculate BMI.Traditional Chinese Medicine tongue inspection was performed,and map of tongue manifestation was photographed by a digital camera.Results Among the 1 655 physical examination individuals,prevalences of normal weight,overweight/obesity and low weight were 50.94％,43.74％ and 5.32％,respectively.The prevalences of individuals had dark red tongue (37.98％ vs.24.56％;x2=40.883,P＜0.001),purplish tongue (5.94％ vs.3.44％;x2=8.133,P=0.017),dark purplish tongue (2.35％ vs.0.59％;x2=10.398,P=0.006),yellow fur (63.95％ vs.58.84％;x2=9.570,P=0.008),thick greasy fur (24.86％ vs.17.20％;x2=18.698,P＜0.001) in the overweight/obesity group were significantly higher than those in the normal weight group,and the prevalence of individuals had exfoliative fur/little fur/less fur in the overweight/obesity group was significantly higher than that in the normal weight group (1.93％ vs.3.91％;x2=6.454,P=0.040).The prevalences of individuals had red or deep red tongue (48.86％ vs.24.72％;x2=24.608,P＜0.001),red dot tongue (7.95％ vs.1.93％;x2=12.254,P=0.002),thin whitish fur (22.73％ vs.9.53％;x2=14.030,P=0.001) in the low weight group were significantly higher than those in the normal weight group.Binary logistic regression analysis showed positive correlation between dark red tongue (OR 1.830,95％ CI 1.515-2.211;P＜0.001),purplish tongue (OR 1.874,95％ CI 1.211-2.901;P=0.005),dark purplish tongue (OR 4.259,95％ CI 1.610-11.266;P=0.003),yellow fur (OR 1.294,95％ CI 1.093-1.531;P=0.003),gray-black fur (OR 6.147,95％ CI 1.816-20.811;P=0.004),thick greasy fur (OR 1.597,95％ CI 1.289-1.978;P＜0.001) and BMI,and negative correlation between pink tongue (OR 0.766,95％ CI 0.637-0.920;P=0.004),red or deep red tongue (OR 0.659,95％ CI 0.549-0.789;P＜0.001),red dot tongue (OR 0.548,95％ CI 0.326-0.921;P=0.023),thin whitish fur (OR 0.695,95％ CI 0.536-0.900;P=0.006),whitish fur (OR 0.821,95％ CI 0.683-0.986;P=0.035) and BMI.Conclusions There is some correlation between BMI and features of tongue manifestation.Abnormal tongue color is mainly dark red tongue in the overweight/obesity individuals,and red or deep red tongue in low weight individuals.Abnormal tongue fur is mainly thick yellow fur.The tongue shape is normal in different body weight groups.

Objective To study the metabolic parameters in health checkup people with dark red tongue and light red tongue,with different coating nature,coating color or liguliform,to understand the relationship between dark red tongue and human metabolic state.Methods Clinical data of 2 891 individuals who underwent health checkup in our center between Dec.2013 and Aug.2014 were collected,including body mass index,blood pressure,blood glucose,lipid and uric acid.Tongue diagnosis was made by Chinese Medicine practitioners.Results The dark red tongue was more common in males,it was found in 61.58％ males and 38.42％ females in the dark red tongue group.The average level including body mass index,systolic blood pressure,diastolic blood pressure,blood glucose,total cholesterol,triglyceride,low-density lipoprotein cholesterol and blood uric acid in dark red tongue group were higher than those in light red tongue group (P＜0.01).When the dark red tongue had yellow fur-like or thick and greasy coat,the average level of body mass index,blood glucose,total cholesterol,low-density lipoprotein cholesterol and blood uric acid were higher than those of the normal dark red tongue group,the level of high-density lipoprotein cholesterol was lower than that of the normal dark red tongue group.Conclusions Dark red tongue has homogeneous relations with abnormal metabolic parameters,it may be the external expression of metabolic abnormalities;tongue is the external macro manifestation of human body health state.

Objective To measure the chromatic differences of the tongue tip and tongue side and provide quantitative evidence for tongue color diagnosis. Methods Totally 683 healthy people were recruited, and their tongue photos were taken. Then ICC specific documents were used for the correction of all tongue photos, and chromatic values (L*, a*, b*, C*and h°) of tongue tip and tongue side were obtained for further statistical analysis. CIEDE2000 was used for calculating the color differences. Results The average color difference of tongue tip and tongue side in normal pink tongue was 5.4. When pink tongue has abnormal red tongue tip, the average color difference of tongue tip and tongue side was 10.85. Compared with normal tongue tip, the average color difference of tongue tip and tongue side in abnormal color tongue with abnormal red tongue tip increased from 5.4-7.0 to 11.23. Conclusion Red tongue tip is a sensitive sign indicating abnormal heat in the body. Tongue tip quantitative diagnosis is valuable in the determination of heat sign in TCM preventive treatment of disease, and reveal the diagnosis meaning and scientific connotation of red tongue tip.

This study was aimed to discuss the diagnosis significance of the diseased tongue demonstration in Shanghuo (heatiness) people. Based on 303Shanghuo cases, the relevance of diseased tongue demonstration and inquiry data were analyzed. The results showed that 53.14%Shanghuo cases had at least more than 2Shanghuo inducing causes. The most common inducing cause combinations were pathogenic factors neither endogenous nor exogenous (unbalanced diet, overworked) and internal factors (over stressed, emotional). When there were several Shanghuo causes occurred at the same time, the probability of appearing diseased tongue demonstration increased significantly. There were 29.95%Shanghuo cases occurredShanghuo experience frequently. And in these cases, the probability of appearing diseased tongue demonstration increased significantly. It was concluded that when Shanghuo people had diseased tongue demonstration appeared, it was not merely just“is going to get ill”, but was already suffering from heat syndrome. In traditional Chinese medicine (TCM) physical examination, to effectively differentiate“is going to get ill” and“being ill” was initially important. And the diseased tongue demonstration was a crucial diagnostic basis.

This study was aimed to discuss the connotation of congenital constitution in medical books before Qing dynasty. By searching the character Bing as a keyword in the Encyclopedia of Traditional Chinese Medicine (TCM), 6 480 articles were retrieved. Through reading each of the articles, 9 congenital constitution terms were con-cluded. A total of 1 041 valid entries involved in 165 medical books were retrieved. The results showed that congen-ital constitution was affected by parent heredity and region factors. Parent heredity factor includes the influence of both parents and the influence of mother during pregnancy where the influence of both parents includes both parents' habits and conditions when having sex; the influence from the mother includes habits and medication during her pregnancy. Congenital constitution embodiment includes the body's growth and development, body structure and vis-cera, qi and blood, pulse and forefinger blood vessels (of young children), mental state and life span. In three other factors of congenital constitution (i.e. qi and blood, body structure and life span), both body structure and life span depend on the endowment of qi and blood. It was concluded that TCM practitioners before Qing dynasty judged one's congenital constitution through observing the speed of its growth and development, appearance, mental state, strength of visceral functions, condition of its mind, forefinger blood vessels, pulse, susceptible to types of disease and etc. Therefore, body structure is an important factor of congenital constitution judgment. TCM practitioners before Qing dynasty paid attention to the effect on mother to her offspring's health.

This study was aimed to investigate the congenital constitution terms consist of Bing and connotation in medical books before Qing dynasty. By searching the character Bing as a keyword in the Encyclopedia of Tradi-tional Chinese Medicine (TCM), 6480 articles were retrieved. Through reading each of the articles, 9 congenital con-stitution terms were concluded. The results showed that Sui dynasty recorded the earliest congenital constitution term. And till the end of Ming dynasty, altogether 9 terms, which were Bing Qi, Bing Zhi, Bing Shou, Bing Fu, Suo Bing, Fu Bing, Qi Bing, Bing Ti and Su Bing, appeared in sequence. The terms appeared with high frequency were Bing Shou ( 33 . 27%) and Bing Fu ( 32 . 99%) . There were 5 congenital constitution relat-ed factors altogether , which were physique , parental heredity , life span , qi and blood as well as region , ap-peared in sequence . And the term appeared with high frequency was physique ( 32.11%) . It was concluded that before Qing dynasty, all congenital constitution terms occurred with the character of Bing (endowment). The usage of different terms to state congenital constitution was intended to describe different associated factors . It reflected the understanding of congenital constitution process. The first known congenital constitution factor was not parental heredity but physique . Qi and blood was the second most appeared factor . This indicated that con-genital constitution does not only involve the structure of the body ( physique ) , but also the function of the body (qi and blood). The investigation about congenital constitution of ancient TCM brings a positive practical signifi-cance for the modern health cognition and health maintenance .