OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs， and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization （WHO）， strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States， and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions； research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center， and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions， including topic selection， evaluation implementation， evidence evaluation， and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs， which can effectively guide the high-quality and high-efficient development of this work， enhance the standardized output and transformation application value of evaluation evidence， and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.

Objective To investigate the situation and risk factors of hypertensive retinopathy in Zhangjiakou city.Methods The residents from 19 counties and districts in Zhangjiakou were screened for hypertension and blood glucose level.Blood pressure,age,gender,course of disease,body mass index(BMI)and complications of the patients were collected by a questionnaire survey.The prevalence of hypertensive retinopathy was analyzed and the risk factors affecting the patients were analyzed.Results A total of 1 320 hypertension patients were found in 8 056 residents with prevalence rate as 16.39%(1 320/8 056)and 212 of the hypertensive patients were found to have retinopathy.The prevalence rate of retinopathy was 13.06%(212/1 320)in hypertensive patients and 2.63%in all the examined residents.The proportion of patients aged≥60 was higher than that of patients aged＜60 years old,the proportion of patients without hypertension treatment history was higher than that of patients with hypertension treatment history(P＜0.05).The disease course,systolic blood pressure,diastolic blood pressure,diabetes and smoking history in the patient group were higher than those in the control group(P＜0.05).Long hypertension course of disease,high systolic and diastolic blood pressure and diabetes history were risk factors for the occurrence of hypertensive retinopathy(P＜0.05).Conclusions The incidence hypertensive retinopathy in 19 counties and districts of Zhangjiakou city is low but is high among residents aged≥60 years.The risk factors are long course of disease,high systolic and diastolic blood pressure and diabetes history.

Objective: To explore the association between dietary inflammatory index (DII) and metabolic syndrome (MetS) and its components among children aged 6-14 years in Beijing, so as to provide a reference for preventing MetS. Methods: A cross sectional study was carried out in 2 086 records of 1 832 children from the 2017 and 2019 Nutrition and Health Surveillance in Primary and Secondary school students of Beijing (NHSPSB). Three day consecutive 24 hour dietary recalls combined with weighing household cooking oils and condiments were used to collect dietary intake and calculate DII. MetS was diagnosed according to "Definition and Suggestion on the Metabolic Syndrome of Chinese Children and Adolescent". The Generalized estimating equations (GEEs) models were used to analyze the association between DII and the presence of MetS and its components (abdominal obesity, high triglyceride, low high density lipoprotein cholesterol, hypertension, and hyperglycemia). Results: The mean DII score was (1.64±1.07) for the included children. No significant association was found between DII scores and the likelihood of MetS (per 1 point increment: OR =1.16, 95% CI =0.92-1.48, P >0.05). In terms of the components of MetS, DII scores were positively associated with the odds of high triglyceride (per 1 point increment: OR =1.17, 95% CI =1.01-1.36, P <0.05). There was no statistically significant difference in the association among different age groups ( P >0.05). No significant associations were observed between DII and other MetS components( P >0.05). Conclusion DII scores may not be correlated with the risk of MetS, but proinflammatory diet might increase the risk of high triglyceride. DII score in childhood should be emphasized to identify and prevent MetS as soon as possible.

Polymyxin B, which is a last-line antibiotic for extensively drug-resistant Gram-negative bacterial infections, became available in China in Dec. 2017. As dose adjustments are based solely on clinical experience of risk toxicity, treatment failure, and emergence of resistance, there is an urgent clinical need to perform therapeutic drug monitoring (TDM) to optimize the use of polymyxin B. It is thus necessary to standardize operating procedures to ensure the accuracy of TDM and provide evidence for their rational use. We report a consensus on TDM guidelines for polymyxin B, as endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society. The consensus panel was composed of clinicians, pharmacists, and microbiologists from different provinces in China and Australia who made recommendations regarding target concentrations, sample collection, reporting, and explanation of TDM results. The guidelines provide the first-ever consensus on conducting TDM of polymyxin B, and are intended to guide optimal clinical use.
Humans ; Anti-Bacterial Agents/therapeutic use* ; China ; Drug Monitoring/methods* ; Polymyxin B ; Practice Guidelines as Topic

OBJECTIVE To study the mechanism of Compound zaoren granule in improving insomnia. METHODS Forty-nine mice were divided into blank group， model group， positive control group 1 （Estazolam tablets 0.5 mg/kg），control group 2 （Shumian capsule 0.6 g/kg）， Compound zaoren granule low-dose， medium-dose and high-dose groups （2.5， 5， 10 g/kg）， with 7 mice in each group. The insomnia model was established by chronic unpredictable mild stress combined with 4-chloro-DL- phenylacetic acid. The behavioral changes of mice were investigated through open field test and pentobarbital sodium synergistic hypnosis experiment， as well as the pathomorphology of mice hypothalamus tissue was observed by HE staining. The metabonomics analysis and multivariate statistical analysis of serum in mice were performed by UHPLC-Q-TOF-MS/MS， and the differential metabolites were screened out； the metabolic pathway analysis was conducted based on MetaboAnalyst 5.0 database. RESULTS Compared with blank group， the total travelling distance， the number of entering the central region and the moving distance in the central region of the model group were significantly reduced （P＜0.05）， the proportion of total rest time was significantly increased （P＜0.05）， the sleep duration of mice was significantly shortened （P＜0.05）， and hypothalamic nerve cells damaged and severely vacuolated. Compared with model group， the total travelling distance of Compound zaoren granule low-dose and medium-dose groups were increased significantly and the proportions of total rest time of those groups were decreased significantly （P＜0.05）， and the sleep duration of mice in Compound zaoren granule high-dose group was prolonged significantly （P＜0.05）； the hypothalamic nerve cells of mice in each administration group recovered to varying degrees， and the hypothalamus histiocytes of mice in the Compound zaoren granules high-dose group were closer to those in the blank group. A total of 18 differential metabolites （such as phenylalanine， taurine， norvaline， methionine） and 4 important amino acid metabolic pathways （L-phenylalanine， tyrosine and tryptophan biosynthesis； taurine and hypotaurine metabolism； L-phenylalanine metabolism； cysteine and methionine metabolism） were identified through metabolomics analysis. CONCLUSIONS Compound zaoren granules can normalize the disordered metabolism in vivo by regulating differential metabolites such as phenylalanine， taurine， and four amino acid metabolic pathways， so as to improve insomnia.

OBJECTIVE To analyze the odor composition changes of two kinds of traditional Chinese medicine sachet （children type and adults type） with different placement time by using ultra-fast gasphase electronic nose technology. METHODS The change rule of sachet components at different storage times was analyzed by gas chromatography. At the same time， the qualitative results were obtained by combining electronic nose with Arochembase database. Discriminant factor analysis was used to analyze the overall odor composition differences of the two sachet samples. RESULTS A total of 10 odor compositions were identified in children-type sachet， including α-pinene and β-pinene as the functional index compositions； five odor compositions of children-type sachet disappeared after 0.25 days， and most of them disappeared after 7 days； the cumulative contribution rate of discriminant factor analysis was 99.225%. A total of 8 odor compositions were identified in adult-type sachets， including α-pinene and α-phellandrene as the functional index compositions； four odor components disappeared after the adult-type sachet was placed for 0.25 days； after 15 days of placement， the peak 6-8 disappeared， and the intensity of peak 5 decreased by 34.3% compared with 0 day of placement； the cumulative contribution rate of discriminant factor analysis was 91.965%. CONCLUSIONS With the extension of storage time， the smell and composition of the two traditional Chinese medicine sachets are decreasing. It is recommended that the use time of children-type sachet is 7 days， and that of adult-type sachet is 15 days.

Objective:To study the clinical characteristics and risk factors for hypertriglyceridemia-induced severe acute pancreatitis (HTG-SAP) complicated by acute kidney injury.Methods:The clinical data of HTG-SAP patients admitted to the Department of Critical Care Medicine of the Second Affiliated Hospital of Anhui Medical University from January 2014 to July 2022 were retrospectively collected, and divided into an AKI group and a non-AKI group according to whether AKI occurred. The general condition, laboratory data and clinical characteristics of the two groups were compared. Factors with statistically significant differences were screened for logistic regression analysis and a predictive model was constructed. We plotted the receiver operating characteristic curve and used the area under the curve (AUC) to evaluate the predictive ability of each predictor for HTG-SAP complicated with AKI.Results:A total of 91 patients were included, including 37 (40.7%) with AKI and 54 (59.3%) without AKI. The proportions of extrapancreatic infection, sepsis and multiple organ dysfunction syndrome, requiring mechanical ventilation, continuous renal replacement therapy (CRRT), retroperitoneal puncture, and surgical intervention were higher in the AKI group than in the non-AKI group (all P<0.05). The length of ICU stay, total length of hospitalization, and mortality rate in the AKI group were higher than those in the non-AKI group (all P<0.05). Multivariate logistic regression analysis showed that acute physiology and chronic health status scoreⅡ (APACHEⅡ) ( OR=2.069, 95% CI: 1.286-3.417, P=0.003), abdominal pressure ( OR=1.469, 95% CI: 1.108-1.958, P=0.007), and lactic acid ( OR=3.156, 95% CI: 1.013-9.831, P=0.047) were independent risk factors for AKI in HTG-SAP patients. The AUCs of the APACHEⅡ score, abdominal pressure, lactic acid level and combined prediction model were 0.951, 0.918, 0.837 and 0.986, respectively. Conclusions:Patients with HTG-SAP complicated with AKI were more likely to have complications related to extrapancreatic infection, sepsis and multiple organ dysfunction, and the proportion of mechanical ventilation, CRRT, retroperitoneal puncture and surgical intervention required during hospitalization was greater, the lengths of ICU stay and total hospital stay were longer, and the mortality rate was higher. APACHEⅡ score, abdominal pressure and lactic acid were independent risk factors for HTG-SAP concurrent AKI, and the prediction model established based on these three factors had higher value in predicting HGT-SAP concurrent AKI

Background and purpose:The Shanghai Municipal Center for Disease Control and Prevention provides annual updates on cancer occurrence and trends in Shanghai.This study aimed to investigate the cancer incidence and mortality in 201 7 and their trends from 2002 to 2017 in Shanghai. Methods:Data of new cancer diagnoses and deaths from 2002 to 2017 were obtained from the Shanghai Municipal Center for Disease Control and Prevention population-based cancer registry and Vital Statistics System.Cancer incidence and mortality stratified by year of diagnosis or death,gender and age group were analyzed.Number,proportion,crude rate,age-specific rate,age-standardized rate and others were calculated.The number,proportion and rates of common cancers in different groups were also calculated.Trends in age-standardized rate of incidence and death rates for all cancers combined and for the common cancer types by gender were estimated by joinpoint analysis and characterized by the annual percent change(APC)and average annual percent change(AAPC).Segi's 1960 world standard population was used for calculating age-standardized incidence and mortality. Results:The new cancer cases and deaths were 79 378 and 37 186 in Shanghai in 2017.The crude rate of incidence was 546.55/105,and the age-standardized rate was 246.31/105.The age-standardized rate of incidence was higher among females than among males.The crude rate of mortality was 256.04/1 05,and the age-standardized rate was 88.41/105.The age-standardized rate of mortality was higher among males than among females.The age-specific numbers and rates of incidence and mortality increased with age.The age-specific number and rate of incidence reached the peak at the age groups of 60-64 years and older than 85 years,and those of mortality among males reached the peak at the age groups of 60-64 years and older than 85 years,and those of mortality among females reached the peak at the age groups of older than 85 years,respectively.The sites of top 10 common cancer types sorted by the number of incidence cases among males were lung,colorectum,stomach,prostate,liver,thyroid,pancreas,bladder,kidney and oesophagus,and among females were lung,breast,thyroid,colorectum,stomach,pancreas,liver,brain,central nervous system(CNS),cervix uteri and gallbladder,the sites of those sorted by the number of deaths among males were lung,stomach,colorectum,liver,pancreas,prostate,oesophagus,bladder,lymphoma and gallbladder,among females were lung,colorectum,breast,stomach,pancreas,liver,gallbladder,brain,CNS,ovary and lymphoma.The top 10 common cancer types stratified by gender and the top 5 common cancer types stratified by common age groups merged of incidence and mortality had wide variations.Overall,the age-standardized rates of incidence were stable from 2002 to 2009,and increased 2.88％on average per year from 2009 to 201 7.The age-standardized rates of mortality were stable from 2002 to 2011,and decreased 2.66％on average per year from 2011 to 201 7.The trends differed by gender and cancer type. Conclusion:Lung cancer,colorectal cancer,pancreatic cancer,thyroid cancer,female breast cancer,cervical cancer and male prostate cancer are the most common cancers in Shanghai,the appropriate screening technical scheme should be formulated according to the current situation of malignant tumors in Shanghai,promote cancer opportunistic screening,promote appropriate technologies for intervention and management of cancer patients in the community,reduce the disease burden of malignant tumors.

Objective:To investigate the survival of cancer cases diagnosed during 2002-2013 in Shanghai. Methods:Data on new cancer cases with dead and follow-up information were obtained from the population-based cancer registry and vital statistics system of Shanghai Municipal Center for Disease Control and Prevention.Survival indicators stratified by year of diagnosis,gender,site and age were analyzed.Number of cases and proportion were calculated.The observed survival rates were calculated based on the life table.The probabilities of surviving from 0 to 99 years old were estimated according to the Elandt-Johnson model,and then the cumulative expected survival rates were calculated according to the Ederer Ⅱ method.Finally,the relative survival rates and average annual percent changes of their trends were calculated.The age-standardized relative survival rates adjusted by International Cancer Survival Standard weights were calculated. Results:Total 644 520 new cancer cases were diagnosed during 2002-2013 in Shanghai,accounting for 643 545(99.85％)cases included in the observed cohort for survival analysis.The 5-year observed survival rate increased from 37.61％to 46.47％.The 5-year relative survival rate increased from 42.1 8％to 51.11％.The 5-year age-standardized relative survival rate increased from 40.57％to 49.80％.Among the 5-year relative survival rates of cases diagnosed during 2011 to 2013,99.43％of thyroid cancer was the highest,followed by female breast cancer(88.35％)and corpus uteri cancer(85.56％);5.87％of pancreas cancer was the lowest,followed by gallbladder cancer(13.64％)and oesophagus cancer(17.72％).the rate of lung cancer with the largest number of cases was 23.59％,followed by colorectal cancer(59.82％)and stomach cancer(38.65％).The 5-year relative survival rate of total cases of all sites increased from 40.55％in 2002 to 52.77％in 2013,with an average annual percent change of 2.40％.13 cancer types showed increasing trends,such as liver cancer and lung cancer,while the trends of other cancer types were not statistically significant,such as pancreatic cancer and gallbladder cancer. Conclusion:The diagnostic levels and survival rates of cancer cases have been improved continuously in Shanghai.The trends of different cancer types were varied.

Objective:To investigate the lung cancer incidence and mortality in 2016 and their trends from 2002 to 2016 in shanghai. Methods:The data of incidence and death on lung cancer in shanghai from 2002 to 2016 were obtained from the Shanghai Municipal Center for Disease Control and Prevention population-based cancer registry and Vital Statistics System.Lung Cancer incidence and mortality stratified by age of diagnosis or death,gender and age-group were analyzed.The number of cases and deaths,proportion,crude rates,age-specific rates,age-standardized rates,corresponding truncated age-standardized rates(35-64 years)and cumulative rates were calculated.Segi's 1960 world standard population was used for calculating age-standardized rates of incidence and mortality as well as truncated age-standardized rates.Trends in age-standardized rates of incidence and death for lung cancer in Shanghai from 2002-2016 were estimated by Joinpoint analysis and characterized by the annual percent change(APC). Results:The new lung cancer cases and deaths were 14 395 and 9 170 in Shanghai in 2016.The crude rate of incidence was 99.41/105,and the age-standardized rate of incidence was 39.76/105.New cases of lung cancer accounted for 19.34％of all malignant tumors in shanghai,ranking the first in the incidence spectrum of malignant tumors.The crude rate of mortality was 63.33/105,and the age-standardized rate was 21.57/105.Deaths of lung cancer accounted for 24.78％of all malignant tumor deaths in shanghai,ranking the first in the mortality spectrum of malignant tumors.The age-standardized rates of incidence and mortality for males were higher than those for females.The age-specific numbers and rates of incidence and mortality increased with age.The age-specific number and rate of incidence reached the peak at the age group of 60-64 years and 80-84 years respectively,and those of mortality peaked at the age group of 80-84 years and older than 85 years respectively.The incidence of lung cancer increased from 33.70/105 in 2002 to 39.76/1 05 in 2016 in Shanghai.Joinpoint analyses showed that the age-standardized rate of lung cancer incidence remained stable from 2002 to 2010(APC=-0.79,t=-1.46,P=0.175)but showed a significant upward trend with an average annual increase rate of 5.12％from 2010 to 2016(APC=5.12,t=6.97,P＜0.001).The standardized mortality showed a downward trend with an average annual decrease rate of 0.87％from 2002 to 2016(APC=-0.87,t=-2.87,P=0.013). Conclusion:The incidence of lung cancer in Shanghai during 2002-2016 presented an upward trend while the mortality of lung cancer showed a gradual downward trend.There are differences in the incidence and mortality of lung cancer among different gender and age groups.