OBJECTIVE To explore the risk signals of Fluocinolone acetonide intravitreal implants and promote safe and rational drug use for patients. METHODS Based on the data from the Hainan Province Franchised Drug Adverse Reaction Monitoring Subsystem （hereinafter referred to as the “Franchised Drug Monitoring System”） and the FDA Adverse Event Reporting System （FAERS）， the adverse drug reaction （ADR）/adverse drug event （ADE） reports of Fluocinolone acetonide intravitreal implants were coded by using system organ classification and preferred terminology， and relevant patient information was collected. Risk signal mining was carried out by using the reporting odds ratio （ROR） method and the comprehensive standards method of the UK Medicines and Healthcare Products Regulatory Agency （hereinafter referred to as the “MHRA method”）. RESULTS Among the 72 reports of Fluocinolone acetonide intravitreal implants received by the Franchised Drug Monitoring System， the ratio of male to female was 1∶1.4， the patient’s age was mainly distributed between 18 and 64 years old； ADR/ADE affected 5 systemic organs， with eye organ diseases accounting for 87.7%； among them， there were 9 new and general ADR reports （12.5%） and 4 severe ADR reports （5.6%）； ROR method and MHRA method both identified three risk signals： cataracts， glaucoma， and high intraocular pressure. Among the 244 reports received by the FAERS database， the ratio of male to female was 1∶1.5； ADR/ADE damage affected 10 systemic organs， with 46.1% suffering from various injuries， poisoning， and operational complications， and 32.0% suffering from product problems； there were 20 severe ADR reports （8.2%）； ROR method and MHRA method both identified 19 risk signals， including implantation complications， medication system issues， etc. CONCLUSIONS When using Fluocinolone acetonide intravitreal implants in clinical practice， in addition to paying attention to eye ADR/ADE such as high intraocular pressure， cataracts， and glaucoma， attention should also be paid to the potential risks caused by ADE due to product quality and unreasonable use.

ObjectiveTo explore the effect of occupational stress on work-related musculoskeletal disorders (WMSDs) in electronics manufacturing workers. Methods A total of 392 front-line workers in two electronic manufacturing enterprises in Guangdong Province were selected as the research subjects using the judgment sampling method. The prevalence of WMSDs and the level of occupational stress of the research subjects were investigated using the Musculoskeletal Disorders Questionnaire and the Core Occupational Stress Scale. Results The total WMSDs detection rate was 39.5%, and the multi-site WMSDs detection rate was 30.6%. The detection rate of occupational stress was 14.8%. The total WMSDs detection rate and multi-site WMSDs detection rate in the occupational stress group were higher than those in the non-occupational stress group (65.5% vs 35.0%, 56.9% vs 26.0%, both P<0.01). Binary logistic regression analysis result showed that the risk of WMSDs in the occupational stress group was higher than that in the non-occupational stress group after adjusting the effect of confounding factors such as age, gender, job type and work days per week (P<0.01). Conclusion The occupational stress may increase the risk of WMSDs in electronics manufacturing workers. Reducing the level of occupational stress among workers in electronic manufacturing enterprises is beneficial for reducing the risk of WMSDs.

Objective:This study aims to analyze the clinical characteristics of elderly patients with lung adenocarcinoma and to construct a predictive model for assessing their survival.Methods:We conducted a retrospective analysis of clinical data sourced from the SEER database for patients aged 60 years or older who were diagnosed with lung adenocarcinoma between 2013 and 2018.Cox regression analysis was employed to identify independent prognostic factors affecting the survival of elderly lung adenocarcinoma patients, leading to the development of a nomogram model.The discriminative ability and calibration of the nomogram were assessed using the C-index and calibration curve.Each patient's total risk score was calculated based on the predictive model, and patients were stratified according to the quartiles of their total risk scores.The Kaplan-Meier method and Log-rank test were utilized to evaluate survival differences among the identified risk groups.Results:Among 38, 852 lung adenocarcinoma patients, 17, 200 were males and 21, 652 were females.Significant differences in survival rates were observed among lung adenocarcinoma patients based on age, gender, marital status, histological grade, TNM stage, tumor size, and the presence of bone, brain, or liver metastases, as well as the type of treatment received, including surgical treatment, radiation therapy, and chemotherapy(all P<0.001).The C-index of the training model was 0.815(95% CI: 0.811-0.819), while the validation model yielded a C-index of 0.810(95% CI: 0.804-0.816).The prediction model demonstrated higher Area Under Curve(AUC)values of 0.746, 0.768, and 0.775 for 1-year, 3-year, and 5-year survival in the modeling dataset, respectively, and 0.747, 0.770, and 0.777 in the validation dataset.Furthermore, the risk stratification model effectively distinguished patients at varying levels of risk( P<0.001). Conclusions:Age, gender, marital status, histological grade, TNM stage, tumor size, and the presence of bone, brain, and liver metastases, along with treatment modalities such as surgery, radiotherapy, and chemotherapy, were identified as independent prognostic factors for elderly patients with lung adenocarcinoma.The risk prediction model developed in this study effectively differentiates between patients at varying levels of risk, which holds significant implications for predicting treatment responses in elderly lung adenocarcinoma patients and advancing the practice of precision medicine.

Background The high-quality development of manufacturing in China has spurred industrial transformation and upgrading, placing higher demands on the skills of employees in the electronic manufacturing industry. This situation may induce psychological health problems such as job burnout and depressive symptoms in the employees, and also lead to insomnia, which has become a public health problem that urgently needs attention and solution. Objective To investigate the relationship between job burnout, depressive symptoms, and insomnia among employees in the electronic manufacturing industry. Methods A total of 3034 employees from four electronic manufacturing companies in Beijing City, Shanghai City, and Guangdong Province were selected using judgment sampling from September to November 2019. The Maslach Burnout Inventory-General Survey, Patient Health Questionnaire-9, and Self-Administered Sleep Questionnaire were used to collect data. The correlation between job burnout, depressive symptoms, and insomnia was evaluated by hierarchical regression. Results A total of 3034 survey questionnaires were distributed, and 2614 valid questionnaires were collected, with a response effectiveness rate of 86.2%. The reporting rates of job burnout, depressive symptoms, and insomnia among employees in the electronic manufacturing industry were 47.2%, 19.5%, and 29.1%, respectively. The reporting rates of insomnia of employees in the job burnout group and depressive symptoms group were higher than those in the non-job burnout group and non-depressive symptoms group (35.3% vs. 23.6%, 47.2% vs. 24.7%, P＜0.001). The results of hierarchical regression showed that job burnout explained 2.8% of the variation of insomnia (P<0.001), and the inclusion of depressive symptoms explained 1.2% of the variation of insomnia (P<0.001). Conclusion Job burnout and depressive symptoms could both affect insomnia of employees in the electronic manufacturing industry.

Objective:To explore the demand and actual supply of community-based care services for the elderly residents and the factors that affecting care mode for them in the context of rapid urbanization and population aging in China.Methods:Based on the cross-sectional data of the seventh China Longitudinal Survey on Health and Longevity(CLHLS)(2018), 15 854 elderly residents aged 60 and above were selected as the research population.Logistic regression method was used to analyze the patterns of community-based care services and their influencing factors.Results:Among 15 854 elderly residents, 6 912(43.60%)were male and 8 942(56.40%)were female.The results of activities of daily living(ADL)evaluation showed that 11 109 elderly residents could take care of themselves completely, and 3 889 elderly residents were disabled.The disability rate was 25.93%.The proportion of social services that elderly town dwellers expect the community to provide is higher than those living in cities and rural areas in terms of daily care, spiritual care, providing health care knowledge, and dealing with neighborhood disputes.From the perspective of social services actually provided by the community, in addition to providing home-based care, the proportion of community services available to the elderly living in towns and rural areas are similar, but significantly lower than the proportion of social services provided for elderly city dwellers.Age, marital status, residence, cultural differences, health status, source of life and living preference had significant impacts on the choice of care demand patterns.Those of older age( OR=2.29, 95% CI: 1.04-5.03 for 70-79 years old; OR=2.94, 95% CI: 1.38-6.25 for elderly 80 years old or above), having no spouse( OR=3.50, 95% CI: 2.49-4.92), and with higher levels of disability( OR=4.24, 95% CI: 3.12-5.77 for mild disability; OR=7.54, 95% CI: 5.19-10.95 for moderate disability; OR=10.50, 95% CI: 7.59-14.53 for severe disability)are more inclined to choose socialized care. Conclusions:In the process of rapid urbanization in China, the demands for care services of elderly living in towns has increased, but the actual care services provided for them by the communities are yet to be improved.Moreover, elderly town dwellers are still inclined to family care, the same as those of elderly rural dwellers.

Objective:To explore the correlation between Traditional Chinese Medicine (TCM) excessive patterns and clinical characteristics of acute exacerbation of chronic obstructive pulmonary disease (COPD) complicated with chronic pulmonary heart disease (CPHD) in high altitude environment.Methods:Patients with acute exacerbation of COPD complicated with CPHD admitted to the Pulmonology Department of Qinghai Provincial Hospital of Traditional Chinese Medicine from December 2016 to November 2017 were selected. Demographic data and clinical medical characteristics data of the patients were collected, and TCM patterns differentiation was conducted. The correlation between each pattern type and clinical characteristics and all collected laboratory indexes were analyzed by multivariate logistic regression.Results:Phlegm obstructing lung pattern showed a negative correlation relationship with mMRC score [ OR=0.419, 95% CI (0.219-0.802), P=0.009], PCT [ OR=8.132×10 -11, 95% CI (1.632×10 -16-4.1×10 -5), P<0.001], Hb [ OR=0.971, 95% CI (0.952-0.989), P=0.002] and PaCO 2[ OR=0.914, 95% CI (0.853-0.980), P=0.011]; turbid phlegm obstructing lung pattern showed a negative correlation relationship with gender(0 male, 1 female) [ OR=0.427, 95% CI (0.204-0.892), P=0.024], Hb [ OR=0.960, 95% CI (0.945-0.975), P<0.001], and there was a positive correlation relationship with LVEF [ OR=1.061, 95% CI (1.006-1.118), P=0.028]; phlegm-heat obstructing lung pattern showed a negative correlation relationship with Hb [ OR=0.950, 95% CI (0.927-0.974), P<0.001]and cardiac function grade [ OR=0.468, 95% CI (0.248,0.881), P=0.019], and there was a positive correlation relationship with PCT [ OR=1.118×10 8, 95% CI (1.466×10 4-8.523×10 11), P<0.001] and D-D [ OR=2.283, 95% CI (1.300-4.010), P=0.004]; there was a negative correlation between phlegm and stasis blocking lung pattern with cardiac function grade[ OR=0.309, 95% CI (0.167-0.570), P<0.001], and there was a positive correlation relationship with Hb[ OR=1.060, 95% CI (1.042-1.078), P<0.001]; there was a negative correlation between wet phlegm and blood stasis heat pattern with PCT [ OR=1.266×10 -13, 95% CI (1.658×10 -21-0.1×10 -4), P<0.001], SaO 2 [ OR=0.934, 95% CI (0.892-0.979), P=0.004], LVEF [ OR=0.896, 95% CI (0.826-0.971), P=0.008], D-D [ OR=0.030, 95% CI (0.002-0.508), P=0.015], and there was a positive correlation relationship with CRP [ OR=1.042, 95% CI (1.018-1.067), P<0.001], RBC [ OR=3.411, 95% CI (1.684-6.910), P<0.001], cardiac function grade [ OR=8.573, 95% CI (2.410-30.504), P<0.001], pulmonary arterial pressure difference [ OR=2.091, 95% CI (1.243-3.516), P=0.005]. Conclusions:Male patients are more prone to phlegm and turbidities than female patients. PCT and D-D were the main risk factors of phlegm-heat obstruction syndrome. Elevated hemoglobin is a risk factor for patients with phlegm stasis and lung syndrome. Heart function classification is the main risk factor of phlegm-dampness-stasis heat syndrome.

Objective:To analyze whether the sample of elderly subjects in clinical trials of prostate cancer drugs is representative.Methods:From the level of trial design, the age distribution of subjects in clinical trials of prostate cancer drugs for elderly patients from January 2019 to December 2021 was inquired on the platform of drug clinical trial registration and information disclosure.From the actual enrollment level, the prostate cancer drug clinical trials initiated and completed by a hospital from January 2010 to June 2022 were collected.The age information of subjects in all centers was collected for multicenter trials with a summary report, and the age data of subjects in the center was collected for trials without a summary report or single-center trials.The average age of prostate cancer onset and the incidence of prostate cancer in different age groups were compared with the Chinese Cancer Registry System, so as to compare whether the two were consistent.Results:Most of the trials(72.1%、44/61)did not set upper age limit at the protocol design level.Phase Ⅲ and phase Ⅳ trials did not set an upper age limit for enrolled subjects in the protocol.From the actual enrollment level, a total of 19 studies were included in this study, with 1 402 subjects, and the average age of subjects was 67.1±8.6 years old, which was significantly different from the average age of prostate cancer in China and Beijing(all P<0.001). The age group with the largest number of participants was 60-64 years old(34.2%、479/1 402). The population aged ≥75 years was the least(21.5%, 301/1 402), which was different from the high incidence age group of prostate cancer in China in 2017(421.77/100 000). Conclusions:Clinical trials of prostate cancer drugs are designed to cover all age groups of elderly patients, but the actual sample representation of the enrolled elderly subjects is insufficient.Under the premise of protecting the safety of subjects, the trial population who are matched for the average age of prostate cancer onset and the incidence of prostate cancer in age groups, should be gradually increased.

Objective:To explore the effects and mechanism of apigenin on lung ischemia-reperfusion (I/R) injury in mice.Methods:A total of 40 male C57/B6 mice were randomized into 4 groups of sham, I/R, low-dose apigenin and high-dose apigenin (n=10 each). Lung I/R injury model was established by clipping left hilum for 1h and reperfusion for 2 h. Low/high-dose apigenin group received a gavage of apigenin (10/50 mg·kg -1·d -1) for 7 days before lung I/R.After 2-hour reperfusion, lung tissue was collected and lung injury status evaluated and scored by hematoxylin-eosin (H&E) stain; mRNA expression levels of interleukin-1β (IL-1β), tumor necrosis factor-alpha (TNF-α), high mobility group box 1 (HMGB1), prostaglandin-endoperoxide synthase 2 (PTGS2) and glutathione peroxidase 4 (GPX4) were detected by reverse transcription-polymerase chain reaction (RT-PCR); Western blot was utilized for detecting the protein expressions of Bax, Bcl-2 and HIF-1α.Finally, after morinostat activated Hif-1α, the effect of apigenin (50 μmol/L) on hypoxia-reoxygenation (H/R)-induced ferroptosis was further observed in A549 lung epithelial cells. Results:As compared with sham group, lung injury score spiked markedly in I/R group (7.05±0.6 vs.1.25±0.42), pulmonary edema worsened obviously (8.65±1.12 vs.4.17±0.54), the percentage of Tunel positive cells rose significantly (58.22±4.92 vs.8.23±1.22) and mRNA expression levels of IL-1β, TNF-α and HMGB1 increased (7.82±0.16 vs.1.00±0.14, 4.24±0.12 vs.1.00±0.19, 6.24±0.19 vs.1.00±0.11) ( P<0.05); Compared with I/R group, lung injury score declined markedly in low/high-dose apigenin group (4.88±0.31/2.11±0.29 vs.7.05±0.66)( P<0.05), pulmonary edema lessened markedly (6.42±1.03/4.88±1.62 vs.8.65±1.12)( P<0.05) and the percentage of Tunel positive cells (41.46±6.73/16.02±5.31 vs.58.22±4.92) and the mRNA expression levels of IL-1β, TNF-α and HMGB1 became obviously suppressed (5.88±0.13/3.21±0.19 vs.7.82±0.16, 3.56±0.11/2.12±0.09 vs.4.24±0.12, 4.12±0.14/3.12±0.09 vs.6.24±0.19)( P<0.05); protein expressions of HIF-1α and PTGS2 dropped sharply in low/high-dose apigenin group (2.00±0.10/0.93±0.11 vs.2.99±0.06, 4.12±0.14/2.51±0.18 vs.6.11±0.12) while GPX4 protein rose obviously (0.55±0.02/0.83±0.02 vs.0.38±0.04)( P<0.05). In vitro experiments further showed that apigenin could significantly suppress the H/R-induced protein expression of PTGS2 in A549 lung epithelial cells (1.11±0.0 vs.4.55±0.12)( P<0.05) while up-regulating the protein expression of GPX4 (0.93±0.11 vs.0.32±0.04)( P<0.05). The inhibition of PTGS2 protein (4.01±0.12 vs.1.11±0.05) and the up-regulation of GPX4 were significantly blocked (0.52±0.05 vs.0.93±0.11)( P<0.05). Conclusions:Through an inhibition of HIF-1α/ferroptosis axis, apigenin can alleviate lung injury, apoptosis and inflammatory response associated with lung I/R in mice.

Objective:To analyze the time cost in the start-up stages of clinical trials and to investigate the influencing factors of the initiation efficiency.Methods:We retrospectively analyzed time-cost of the review and approval of drug clinical trials initiated in Beijing Hospital from January 2020 to June 2021.The contract signing time and trial starting time of drug clinical trials in different situations were compared.Results:The mean time to sign the contract in our hospital was 19(11~26) days, and the mean time to start experiment was 235(175~317) days. There was no significant difference in the contract signature time between clinical trials with different stages, different sponsors, different types of drugs and whether to be the leading site ( P>0.05). Compared with other phases, phase Ⅲ drug trials took the longest time to start, and the mean initiation time of clinical trials initiated by foreign pharmaceutical companies was 136 days longer than that initiated by domestic pharmaceutical companies ( P<0.05). Conclusions:Clinical trial institutions should optimize the project management process, better organize the contract review and ethics review, encourage the sponsor to use our template document. Every department may set up a GCP contact to be responsible for clinical trials; The sponsor should improve the efficiency of internal circulation and communication, submit the review materials as soon as possible according to the requirements of the institution, and establish a good communication and feedback mechanism between both sides, may shorten the start-up time of clinical trials and improve the initiation efficiency.

Objective:The Clinical Research Coordinator (CRC) is responsible for transcribing and verifying clinical trial data, and making recommendations to research institutions and sponsors on clinical trial data through analyzing and discussing data problems found in CRC work assessment, thereby improving the quality of clinical trials.Methods:Based on the ALOCA+ Principle, this study analyzed the data problems found in CRC assessment based on clinical trial quality conducted in a grade A tertiary hospital in Beijing from November 2018 to December 2021, and discussed improvement measures for clinical trial data problems.Results:Among the clinical trial data problems, data integrity is the most prominent, followed by accuracy.Conclusions:Research institutions and sponsors should improve the data management system and SOP, strengthen the training for clinical trial participants, optimize a trial plan and process design, strengthen supervision and inspection, and establish a risk-based quality control system, etc., so as to make clinical trial data conform to the international ALOCA+ principle and make clinical trial results accurate and reliable.