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 bioaccessibility of the main metal components in welding fume welding fume in simulated lung fluid, and to evaluate the exposure level of each metal component in combination with the EPA inhalation exposure risk assessment model.Methods:In November 2022, the microscopic morphology characteristics of welding fumes were analyzed by scanning electron microscopy, the bioaccessibility of each metal component in lung fluid simulated normal and lung inflammatory states was analyzed by in vitro simulation method, and the exposure level of each metal component was calculated in combination with the EPA inhalation exposure risk assessment model.Results:The main metal components in carbon dioxide gas shielded welding fumes were Fe, Mn, Zn, Ti, Al, Cu, Cr, Cd, Ni and As, and the bioaccessibility in simulated normal lung interstitial fluid was 0.82%-1.84%, 5.07%-9.41%, 4.52%-7.23%, 5.10%-8.67%, 20.48%-29.60%, 5.27%-9.83%, 4.80%-7.56%, 0.07%-1.08%, 6.48%-13.84% and 33.02%-42.81%. The bioaccessibility of the above metal components in the lung fluid under simulated lung inflammation was 14.79%-27.45%, 34.53%-46.11%, 35.31%-59.13%, 16.45%-22.51%, 60.78%-76.51%, 26.58%-34.12%, 15.32%-25.87%, 2.0%-5.7%, 34.77%-43.33% and 71.34%-88.36%, respectively. Compared with the simulated lurg interstitial fluid, the bioaccessibility of metal components in the lung fluid under the simulated inflammatory state was increased, and the difference was statistically significant ( P<0.05). The average daily exposure dose Mn in the two simulated lung fluids exceeded the inhalation reference limit (>50 times), and the average daily exposure dose Ti and Cr in the simulated lung inflammation exceeded the reference limit (>1.3 times) . Conclusion:Attention should be paid to the bioaccessibility characteristics of metal components in the exposure level and hazard assessment of welding fumes.

Objective:To explore the bioaccessibility of the main metal components in welding fume welding fume in simulated lung fluid, and to evaluate the exposure level of each metal component in combination with the EPA inhalation exposure risk assessment model.Methods:In November 2022, the microscopic morphology characteristics of welding fumes were analyzed by scanning electron microscopy, the bioaccessibility of each metal component in lung fluid simulated normal and lung inflammatory states was analyzed by in vitro simulation method, and the exposure level of each metal component was calculated in combination with the EPA inhalation exposure risk assessment model.Results:The main metal components in carbon dioxide gas shielded welding fumes were Fe, Mn, Zn, Ti, Al, Cu, Cr, Cd, Ni and As, and the bioaccessibility in simulated normal lung interstitial fluid was 0.82%-1.84%, 5.07%-9.41%, 4.52%-7.23%, 5.10%-8.67%, 20.48%-29.60%, 5.27%-9.83%, 4.80%-7.56%, 0.07%-1.08%, 6.48%-13.84% and 33.02%-42.81%. The bioaccessibility of the above metal components in the lung fluid under simulated lung inflammation was 14.79%-27.45%, 34.53%-46.11%, 35.31%-59.13%, 16.45%-22.51%, 60.78%-76.51%, 26.58%-34.12%, 15.32%-25.87%, 2.0%-5.7%, 34.77%-43.33% and 71.34%-88.36%, respectively. Compared with the simulated lurg interstitial fluid, the bioaccessibility of metal components in the lung fluid under the simulated inflammatory state was increased, and the difference was statistically significant ( P<0.05). The average daily exposure dose Mn in the two simulated lung fluids exceeded the inhalation reference limit (>50 times), and the average daily exposure dose Ti and Cr in the simulated lung inflammation exceeded the reference limit (>1.3 times) . Conclusion:Attention should be paid to the bioaccessibility characteristics of metal components in the exposure level and hazard assessment of welding fumes.

Background: It is well known that a large number of patients with diabetes also have dyslipidemia, which significantly increases the risk of cardiovascular disease (CVD). This study aimed to evaluate the efficacy and safety of combination drugs consisting of metformin and atorvastatin, widely used as therapeutic agents for diabetes and dyslipidemia. Methods: This randomized, double-blind, placebo-controlled, parallel-group and phase III multicenter study included adults with glycosylated hemoglobin (HbA1c) levels >7.0% and <10.0%, low-density lipoprotein cholesterol (LDL-C) >100 and <250 mg/dL. One hundred eighty-five eligible subjects were randomized to the combination group (metformin+atorvastatin), metformin group (metformin+atorvastatin placebo), and atorvastatin group (atorvastatin+metformin placebo). The primary efficacy endpoints were the percent changes in HbA1c and LDL-C levels from baseline at the end of the treatment. Results: After 16 weeks of treatment compared to baseline, HbA1c showed a significant difference of 0.94% compared to the atorvastatin group in the combination group (0.35% vs. −0.58%, respectively; P<0.0001), whereas the proportion of patients with increased HbA1c was also 62% and 15%, respectively, showing a significant difference (P<0.001). The combination group also showed a significant decrease in LDL-C levels compared to the metformin group (−55.20% vs. −7.69%, P<0.001) without previously unknown adverse drug events. Conclusion The addition of atorvastatin to metformin improved HbA1c and LDL-C levels to a significant extent compared to metformin or atorvastatin alone in diabetes and dyslipidemia patients. This study also suggested metformin’s preventive effect on the glucose-elevating potential of atorvastatin in patients with type 2 diabetes mellitus and dyslipidemia, insufficiently controlled with exercise and diet. Metformin and atorvastatin combination might be an effective treatment in reducing the CVD risk in patients with both diabetes and dyslipidemia because of its lowering effect on LDL-C and glucose.

Viral load and the duration of viral shedding of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are important determinants of the transmission of coronavirus disease 2019.In this study, we examined the effects of viral doses on the lung and spleen of K18-hACE2 transgenic mice by temporal histological and transcriptional analyses. Approximately, 1×105 plaque-forming units (PFU) of SARS-CoV-2 induced strong host responses in the lungs from 2 days post inoculation (dpi) which did not recover until the mice died, whereas responses to the virus were obvious at 5 days, recovering to the basal state by 14 dpi at 1×102 PFU. Further, flow cytometry showed that number of CD8+ T cells continuously increased in 1×102 PFU-virusinfected lungs from 2 dpi, but not in 1×105 PFU-virus-infected lungs. In spleens, responses to the virus were prominent from 2 dpi, and number of B cells was significantly decreased at 1×105PFU; however, 1×102 PFU of virus induced very weak responses from 2 dpi which recovered by 10 dpi. Although the defense responses returned to normal and the mice survived, lung histology showed evidence of fibrosis, suggesting sequelae of SARS-CoV-2 infection. Our findings indicate that specific effectors of the immune response in the lung and spleen were either increased or depleted in response to doses of SARS-CoV-2. This study demonstrated that the response of local and systemic immune effectors to a viral infection varies with viral dose, which either exacerbates the severity of the infection or accelerates its elimination.

Purpose: Intrahepatic biliary cysts (IBCs) after Kasai portoenterostomy (KPE) are associated with intractable recurrent cholangitis. This study aimed to investigate the feasibility of its use as well as indication for surgical management of IBCs in pediatric patients. Methods: We retrospectively reviewed the medical records and imaging studies of patients who underwent KPE for biliary atresia from 2010 to 2020. Results: An imaging study identified IBCs in 28 of 129 patients who underwent KPE with biliary atresia (21.7%). Among them, 5 patients were subjected to surgical treatment for intractable cholangitis. The median time from KPE to the development of IBCs was 1.7 years. Four out of 5 patients had IBCs confined to the left lateral lobe, and in one patient, the IBCs were in the hepatic hilum. All 5 patients experienced more than one cholangitis. Although they received intravenous antibiotic treatment and percutaneous transhepatic cholangiodrainage as treatment, they were intractable. Three patients underwent hepatectomy, and 2 underwent cystojejunostomy. There was no recurrence of cholangitis during the median follow-up period of 2.9 years. Conclusion Surgical treatment for IBCs after KPE could be considered a safe and effective surgical procedure for children if appropriate indications are applied.

Purpose: Intrahepatic biliary cysts (IBCs) after Kasai portoenterostomy (KPE) are associated with intractable recurrent cholangitis. This study aimed to investigate the feasibility of its use as well as indication for surgical management of IBCs in pediatric patients. Methods: We retrospectively reviewed the medical records and imaging studies of patients who underwent KPE for biliary atresia from 2010 to 2020. Results: An imaging study identified IBCs in 28 of 129 patients who underwent KPE with biliary atresia (21.7%). Among them, 5 patients were subjected to surgical treatment for intractable cholangitis. The median time from KPE to the development of IBCs was 1.7 years. Four out of 5 patients had IBCs confined to the left lateral lobe, and in one patient, the IBCs were in the hepatic hilum. All 5 patients experienced more than one cholangitis. Although they received intravenous antibiotic treatment and percutaneous transhepatic cholangiodrainage as treatment, they were intractable. Three patients underwent hepatectomy, and 2 underwent cystojejunostomy. There was no recurrence of cholangitis during the median follow-up period of 2.9 years. Conclusion Surgical treatment for IBCs after KPE could be considered a safe and effective surgical procedure for children if appropriate indications are applied.