The Guidelines for Occupational Hazard Assessment and Control of Active Pharmaceutical Ingredient in the Pharmaceutical Industry (T/WSJD 60—2024) is the first guiding standard in the field of health in China that focuses on occupational health protection for active pharmaceutical ingredient (API). It covers the general principles, work procedures, assessment methods, and control strategies for API occupational hazard assessment, providing practical guidance and recommendations for pharmaceutical enterprises to eliminate or reduce occupational health risks associated with API, improve working environment, and enhance refined management practices. This article interpreted and analyzed the background of standard establishment, formulation process, fundamental basis, and main content, to provide scientific and comprehensive technical support for occupational health managers in the pharmaceutical industry to better apply this standard.

Objective To explore the effect of transcranial direct current stimulation(tDCS)based on music therapy on insomnia. Methods From July,2023 to April,2024,70 patients with insomnia in the Fourth Affiliated Hospital of Soochow Univer-sity were randomly divided into control group(n=35)and observation group(n=35).Both groups accepted mu-sic therapy;moreover,the observation group accepted tDCS,and the control group accepted sham tDCS,for four weeks.They were assessed with Pittsburgh Sleep Quality Index(PSQI)total score and sub-score,Hamilton De-pression Scale 17-item(HAMD-17),Hamilton Anxiety Scale(HAMA),Chinese version of Stress Perception Scale(CPSS);and the relative power of resting-state electroencephalography(EEG)and mean blood flow veloci-ty(Vm)of each cerebral artery with transcranial Doppler were measured before and after treatment. Results Five cases dropped down in the control group,and four in the observation group.PSQI total score and sub-score,HAMD-17 score,HAMA score and CPSS score(|t|>3.503,P<0.01)in the observation group decreased after treatment,and were less in the observation group than in the control group(|t|>2.304,P<0.05),except sleep duration,sleep efficiency and CPSS scores.The relative power of δ and θ increased in the observation group,and decreased in α,β and γ(|t|>6.468,P<0.001),and were better in the observation group than in the control group(|t|>2.395,P<0.05).The Vm of each artery increased in the observation group(|t|>4.624,P<0.001),and were more in the observation group than in the control group(|t|>2.147,P<0.05). Conclusion tDCS based on music therapy may further improve sleep quality and EEG activity,increase cerebral blood flow velocity,and reduce adverse emotions in insomnia patients.

Objective To investigate the influence and predictive value of systemic immune inflammation(SII),fibrinogen(Fib)and triglyceride glucose index(TyG)on the risk of diabetic kidney disease(DKD).Methods A total of 1073 patients with type 2 diabetes mellitus(T2DM)admitted to The Endocrinology Department of Hebei Yiling Hospital Affiliated to Hebei Medical University were enrolled in this study from January 2020 to December 2022.All the patients were divided into two groups according to the urinary protein creatinine ratio:DKD group(UACR≥30 mg/g,DKD,n=412)and simple T2DM group(UACR<30 mg/g,T2DM,n=661).Pearson correlation analysis was used to evaluat the correlation between SII,TyG,Fib and other indicators.Multiple logistic regression analysis was used to find the influencing factors for DKD.The clinical value of Fib,SII,TyG,and combined indicators in diagnosing DKD was tested by receiver operating characteristic(ROC)curve analysis.Results Compared with T2DM group,age,duration of DM,FPG,TG,TyG,cystatin C(CysC),glutamyl transpeptidase,SUA,homocysteine,SII,neutrophil count,Fib and D-D were increased(P＜0.05 or P＜0.01),while albumin(ALB)and HDL-C were decreased(P＜0.05 or P＜0.01)in DKD group.Pearson correlation analysis showed that SII was positively correlated with CysC,Scr,SUA,Fib,FDP,and D-D(P＜0.05 or P＜0.01),and negatively correlated with eGFR,ALB(P＜0.01);TyG is positively correlated with SUA(P＜0.01);Fib is positively correlated with CysC,Scr(P＜0.01),and negatively correlated with eGFR(P＜0.01).Multiple logistic regression analysis showed that TyG and Fib were the influencing factors for DKD.The ROC curve analysis showed that the area under the ROC curve for the combined index was 0.679,with a specificity of 74.2%,a sensitivity of 53.5%,and an optimal cutoff value of 0.276.Conclusion SII and Fib can directly cause renal function damage in DKD,while IR promotes DKD progression through metabolic disorders.The combined predictive value of Fib,SII,and TyG for DKD risk is superior to a single indicator.

Objective:To explore clinical value of nucleic acid detection for hepatitis B virus (HBV) screening in hospitalized patients.Methods:This cross-sectional study collected and analyzed plasma samples from patients admitted to 10 domestic medical institutions from July 2021 to December 2021. Serological immunoassay and nucleic acid screening were used to simultaneously detect hepatitis B markers such as hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B e Antigen (HBeAg), hepatitis B e antibody (HBeAb), hepatitis B core antibody (HBcAb),and HBV DNA. Statistical analysis was performed on the serology, nucleic acid test results and clinical information of the patients.Results:Of the 8 655 collected samples, HBsAg was positive in 216 (2.50%) samples,HBV DNA was positive in 238 (2.75%) samples ( P>0.05); 210 (2.43%) samples were positive for both HBsAg and HBV DNA, 28 (0.32%) were HBsAg negative and HBV DNA positive, 6 cases (0.07%) were HBsAg positive and HBV DNA negative. Conclusion:These results indicate that the HBV DNA testing is equally effective as hepatitis B virus serological detection for hepatitis B virus screening in hospitalized patients.

Objective:This multi-centre study was conducted to assess the efficacy of various preoperative/pre-transfusion screening methods for blood transmitted disease.Methods:From July 2021 to December 2021, plasma samples of patients admitted to 10 hospitals were collected for screening preoperative/pre-transfusion blood transmitted disease. Nucleic acid detection technology was used to detect hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) RNA and human immunodeficiency virus (HIV)(1+2) RNA, and the results were compared with the immuno-serological methods. χ 2 test and Kappa test were used to analyze the efficacy of these two methods. Results:A total of 8 655 valid specimens were collected from 10 hospitals. There was a statistically significant difference in the positive detection rate of HCV between the two methods ( P<0.001). There was no significant difference in the positive detection rate of HBV and HIV assessed by the two methods ( P>0.05), but the number of positive cases detected by HBV DNA and HIV RNA (218 and 4 cases) was significantly higher than the corresponding serological results (216 and 2 cases). At the same time, there were HBV, HCV and HIV immuno-serological omissions by the immuno-serological methods, among which 28 cases were HBsAg negative and HBV DNA positive, 2 cases were HCV antibody negative and HCV RNA positive, and 2 cases were HIV antigen/antibody negative and HIV RNA positive. In addition, in the 66 samples with inconsistent results from the two detection methods, 83.3% (55/66), 68.2% (45/66), 63.6% (42/66) and 62.1% (41/66) of patients aged was>45 years, tumor, surgery and male, respectively. Conclusions:Compared with immuno-serological tests, nucleic acid tests have the advantage in terms of sensitivity on detecting HBV, HCV and HIV infection and could reduce missed detection. The risk of transmission can be reduced by adding HBV, HCV, and HIV nucleic acid tests to preoperative/pre-transfusion immuno-serological tests screening for patients over 45 years of age and tumor patients.

Objective:To compare the cost-effectiveness of hospitalized Chinese patients undergoing nucleic acid screening strategies for hepatitis B and hepatitis C, immunological screening strategy, and no screening strategy under different willingness to pay (WTP). The results might aid to decision-making for the optimal strategy.Methods:In this study, nucleic acid screening, immunological screening and no screening were used as screening strategies, and China′s GDP in 2021 (80 976 yuan) was used as the threshold of WTP to construct a Markov model. After introducing parameters related to the diagnosis and treatment of hepatitis B and C in inpatients, a cohort population of 100 000 inpatients was simulated by TreeAge Pro 2021 software, the total cost, total health effects, incremental cost-effectiveness ratio and average cost-effectiveness ratio of different screening strategies were calculated, and cost-effectiveness analysis was conducted. Univariate and probabilistic sensitivity analysis were used to assess the impact of parameter uncertainty on the final results.Results:Compared with the non-screening strategy, the incremental total cost of the hepatitis B immunological screening strategy for cohort patients was 11 049 536 yuan, and the incremental cost-effectiveness ratio was 24 762 yuan/quality-adjusted life years (QALY), while the total incremental cost of nucleic acid screening was 19 208 059 yuan, and the incremental cost-effectiveness ratio was 29 873 yuan/QALY; the incremental cost-effectiveness ratio of nucleic acid screening and immunological screening was 45 834 yuan/QALY. Compared with the non-screening strategy, the incremental cost-effectiveness ratio of hepatitis C immunological screening strategy was 5 731 yuan/QALY, the incremental cost-effectiveness ratio of nucleic acid screening strategy was 8 722 yuan/QALY, the incremental cost-effectiveness ratio of nucleic acid screening and immunological screening was 45 591 yuan/QALY. The results of probabilistic sensitivity analysis showed that when the cost of nucleic acid testing exceeded 214.53 yuan, it was not cost-effective to perform hepatitis B nucleic acid screening under the WTP as 1 fold GDP. When the cost of nucleic acid testing exceeded 132.18 yuan, it was not cost-effective to conduct hepatitis C screening under the WTP as 1 fold GDP.Conclusions:Nucleic acid screening strategy can achieve more cost-effectiveness and is worthy of vigorous promotion. Compared with no screening, both the nucleic acid and immunological screening strategies are cost-effective, and hepatitis nucleic acid screening is the optimal strategy for hospitalized patients.

ObjectiveTo investigate the condom use of men who have sex with men （MSM） in Shanghai， the information motivation behavioral skills model （IMB） theory was used to introduce psychosocial factors and study the relevant factors of consistent condom use （CCU） in this population. MethodsA cross-sectional study of 547 MSM in four districts of Shanghai was conducted by snowball sampling. The structural equation model based on psychosocial optimization was constructed and validated using the data collected by structured questionnaires. ResultsAmong the 547 respondents， the proportion of CCU in the past six months was 45.5%. Comparing the fitness of the initial model with that of the adjusted model， we found that the fitness of the adjusted model was good. ConclusionThe proportion of CCU among MSM in Shanghai is relatively low； In addition， information and motivation do not directly affect the CCU of this population； Only behavioral skills have a direct effect on CCU. Finally， social psychological measures should be emphasized for this population， and comprehensive and multi-level strategies should be formulated to control the spread of HIV in this population.

Objective:To predict and analyze the number of acute pancreatitis (AP) inpatients based on time series model, and to explore the predictive efficiency of the model.Methods:Clinical data of AP inpatients in the Affiliated Hospital of Southwest Medical University from January 2014 to December 2019 were collected. R software was used to collect the time series of AP inpatients, and the trend and seasonal characteristics of AP inpatients from 2014 to 2018 were analyzed. Furthermore, the autoregressive moving average (ARIMA) model was established through stationarity test, model ordering and model testing steps, and the best selected model was used to predict the monthly number of inpatients in 2019 to verify its prediction efficiency.Results:A total of 3 939 AP patients were included in the study. The most common etiology for AP was cholestrogenic (48.2%), followed by hyperacylglyceremia (36.3%). The peak age of hospitalization was from 40 to 60 years old. Time series analysis showed that the number of AP inpatients increased year by year. The highest peak of the disease was from February to March, followed by September to November; and there was seasonal variation and the incidence was relatively small in summer. The established original training set sequence did not pass the stationarity test ( P=0.061), so the ARIMA model was established after it was transformed into a stationarity sequence by first-order difference. According to the criterion of minimum AIC value, ARIMA(2, 1, 1)(1, 1, 1) 12 was selected as the best model. The model was used to predict the number of AP inpatients in 2019, showing that it could better fit the trend of onset time and had good short-term prediction effect. The mean root error and absolute error were 6.8790 and 4.7783, respectively. Conclusions:The number of AP inpatients increases year by year with seasonal changes. ARIMA model is effective in predicting the number of AP inpatients and can be used for short-term prediction.

Background Previous studies have shown that active smoking during pregnancy can reduce the level of neonatal cord blood leptin, and thereby affect birth weight. However, few studies have studied the association of passive smoking during pregnancy with leptin in neonatal cord blood and birth weight. Objective To explore the effects of passive smoking in varied pregnancy stages and entire pregnancy on neonatal cord blood leptin level and birth weight in a certain rural area of Yunnan, and potential mediating role of cord blood leptin. Methods Based on a prospective prenatal cohort study conducted in Xuanwei County, Yunnan Province, a total of 545 mother-infant pairs were included in this study from early pregnancy enrollment to delivery. The demographic information and reproductive history of the subjects were collected by questionnaire. The urine samples of pregnant women in the first, second, and third trimesters of pregnancy were collected during regular prenatal examinations. Umbilical cord blood samples were collected from newborns at birth. The concentration of urine cotinine (UC) was measured by ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS). According to the results of UC level during pregnancy, the study subjects were divided into three groups: negative group (M), and high exposure group(>M). The level of leptin in cord blood was detected by ELISA. Multiple linear regression was used to analyze the effect of passive smoking on umbilical cord blood leptin in newborns during pregnancy. Path analysis was used to explore the relationship among passive smoking during pregnancy, neonatal cord blood leptin, and birth weight. Results The average exposure rate of passive smoking during pregnancy was 87.28%, and the exposure rate for entire pregnancy was 76.88%. The median concentration of leptin in neonatal cord blood was 4.17 μg·L⁻¹. After adjusting for maternal age, ethnicity, educational level, pre-pregnancy body mass index (BMI), gestational weight gain, parity, annual household income, infant sex, and birth weight, we found that low level (b=−3.388, P=0.001) and high level (b=−2.738, P=0.006) of passive smoking in the first trimester of pregnancy had negative associations with leptin concentration of cord blood by multiple linear model. The path analysis results showed that passive smoking in the first trimester and pre-pregnancy BMI directly affected leptin levels, and the sizes of direct effects were −0.073 and −0.087 (both P<0.05) respectively. Passive smoking in late pregnancy, gestational weight gain, premature, newborn girls, parity, and pre-pregnancy BMI directly affected birth weight, and the sizes of direct effects were −0.063, 0.191, −0.301, −0.128, −0.121, and 0.167 (all P<0.05), respectively. No mediating role of leptin was found in the effect of passive smoking on neonatal birth weight. Conclusion Passive smoking exposure during pregnancy is common among rural women in Yunnan Province. Passive smoking in the first trimester may be key in decreasing the leptin level of neonatal cord blood. Passive smoking in third trimester may lead to a decrease in birth weight. No evidence shows that leptin mediates the relationship between passive smoking and birth weight.

Objective:To investigate the expression of coronavirus disease 2019 (COVID-19) transmission-related receptors angiotensin-converting enzyme 2 (ACE2) and transmembrane serine protease 2 (TMPRSS2) in human conjunctival tissue and its clinical significance.Methods:Fifty human conjunctival tissue specimens from 50 patients including 10 normal conjunctival tissues, 15 conjunctival papilloma tissues, 15 conjunctival nevus tissues and 10 conjunctival cyst tissues were collected from June 2019 to June 2020 at Xi'an People's Hospital.Ten corneal tissue samples from 10 patients with eyes removed due to trauma were collected as control.The distribution of ACE2 and TMPRSS2 in different corneal tissues was detected by the immunohistochemistry.The expression of ACE2 and TMPRSS2 was scored and compared.Reuse of the human samples and the research protocol was approved by an Ethics Committee of Xi'an People's Hospital (No.20190022). Written informed consent was obtained from each patient.Results:ACE2 and TMPRSS2 were both expressed in normal conjunctival epithelium, epithelial cells in conjunctiva papilloma and conjunctival nevus, and cells in conjunctiva cyst wall.ACE2 was mainly distributed in the superficial and intermediate cells of conjunctival epithelium, but not in the basal cells and goblet cells.TMPRSS2 was found in different layers of cells.The positive expression rates of ACE2 and TMPRSS2 in conjunctiva were both 100%.There was no significant difference in the expression intensity of ACE2 and TMPRSS2 among normal conjunctival tissue, conjunctival papilloma, conjunctival nevus and conjunctival cyst (all at P>0.05). Weakly expressed in corneal tissues, ACE2 and TMPRSS2 were more moderately and strongly expressed in conjunctival tissues.There were significant differences in the number of differently graded ACE2 and TMPRSS2 expression between normal conjunctival tissues, conjunctival papilloma, conjunctival nevus, conjunctival cyst and corneal tissues (ACE2: Z=-3.473, -4.183, -3.970, -3.873, all at P<0.01; TMPRSS2: Z=-4.119, -4.472, -4.443, -4.147, all at P<0.001). Conclusions:COVID-19 transmission-related receptors ACE2 and TMPRSS2 are expressed in human conjunctival tissue, which provides organological evidence for ocular surface transmission of COVID-19.