OBJECTIVE To evaluate the characteristics of adverse drug event （ADE） associated with five therapeutic agents for Gaucher disease（imiglucerase， velaglucerase alfa， taliglucerase alfa， eliglustat，and miglustat）. METHODS ADE reports related to the above five drugs were retrieved from the FDA Adverse Event Reporting System （FAERS） database from January 2004 to September 2025. The reporting odds ratio （ROR） and proportional reporting ratio （PRR） methods were applied for data mining. system organ class （SOC） and preferred term （PT） from the Medical Dictionary for Regulatory Activities （MedDRA， version 26.0） drug ADE terminology were used for classification and statistical analysis of ADE. RESULTS A total of 4 329， 1 740， 500， 1 329 and 998 ADE reports were retrieved for the aforementioned five drugs， respectively， generating 4 612， 2 605， 776， 1 157 and 2 185 ADE signals. These signals involved 26 SOC， affecting 25， 26， 16， 19， and 19 SOC， respectively. The predominant SOCs were various injuries， poisoning and procedural complications， as well as infections and infestations. The top one PTs of each drug were as follows： bone infarction， zinc deficiency， failure to perform drug monitoring steps， ichthyosis， abnormal nerve conduction examination. New suspected PTs included weight gain and spontaneous abortion for imiglucerase and velaglucerase alfa， weight gain for taliglucerase alfa and eliglustat， and neuropsychiatric manifestations such as dementia and apathy for miglustat. In terms of severe ADEs， other serious medical events were predominant for imiglucerase and taliglucerase alfa； prolonged hospital stays were the main severe ADE for velaglucerase alfa and eliglustat； and death was the leading severe ADE for miglustat. CONCLUSIONS In clinical medication， apart from common ADE，for imiglucerase， clinicians should be alert to bone infarction， weight gain and spontaneous abortion， and strengthen monitoring related to bones， metabolism and pregnancy. For velaglucerase alfa， attention should be paid to zinc deficiency， bone infarction， weight gain and spontaneous abortion， with focused monitoring of nutritional status and pregnancy risks. For taliglucerase alfa， failure to perform drug monitoring steps and weight gain require vigilance， and medication procedures should be standardized along with regular weight monitoring. For eliglustat， clinicians need to watch out for ichthyosis and weight gain and pay close attention to skin conditions. For miglustat， bone infarction， abnormal nerve conduction examination and dementia should be closely monitored， with enhanced surveillance on nervous system function， infections and prognosis of critically ill patients，to ensure patient medication safety.

Objective:To investigate the correlation between long-term statin use and Helicobacter pylori( Hp)infection in the elderly, and to compare the effects of rosuvastatin combined with bismuth-containing quadruple therapy for Hp eradication on lipid levels in elderly patients with mixed hyperlipidemia. Methods:A retrospective analysis was conducted on 1 181 elderly patients with hyperlipidemia, cardiovascular and cerebrovascular diseases, and peripheral arterial disease who were treated at the First Hospital of Lanzhou University between March 2019 and December 2023.According to the results of carbon 14 urea breath test(C 14-UBT), the subjects were divided into the Hp infection group and the non- Hp infection group.Multivariate logistic regression methods were used to analyze the correlation between Hp infection and statin use.A prospective case-control analysis was conducted on 109 patients with mixed hyperlipidemia and Hp infection treated during the same period, they were treated with rosuvastatin combined with bismuth-containing quadruple therapy for Hp eradication.The successful eradication people were selected as the eradication group (n=95). Patients with hyperlipidemia and Hp infection unwilling eradication was selected as the control group (n=109), and treated with rosuvastatin.Changes in lipid levels were compared over a consecutive 6-month period. Results:The overall Hp infection rate was 53.94%(637/1 181). Univariate analysis showed that the infection rate in women was higher than in men.Body mass index(BMI), low-density lipoprotein cholesterol(LDL-C), fasting blood glucose(FBG)levels in the Hp(+ )group were higher than in the Hp(-)group.Long-term low-dose aspirin users had a higher infection rate than non-users.The infection rate was lower in statin users than in non-users[42.65%(374/877) vs.55.59%(169/304), χ2=15.234, P<0.001]. Multivariate analysis showed that women had a higher infection risk than men ( OR=1.441, 95% CI: 1.102-1.729, P=0.011). Higher FBG and LDL-C levels increased the risk of Hp infection ( OR=1.406, 95% CI: 1.271-2.286, P<0.001, OR=1.118, 95% CI: 1.017-1.387, P=0.010). Aspirin use increased the risk of Hp infection( OR=1.162, 95% CI: 1.034-1.294, P=0.021), while statin use reduced the risk of Hp infection ( OR=0.177, 95% CI: 0.018-0.311, P<0.001). The Hp eradication rate was 87.16%(95/109). At 1-and 2-months post-eradication, statistically significant differences were observed between the eradication and control groups in LDL-C, total cholesterol(TC), changes from baseline, and target achievement rates(all P<0.05). At 1-month post-eradication, a statistically significant difference was observed in high-density lipoprotein cholesterol(HDL-C) levels between the two groups.Additionally, at both 1-and 2-months post-eradication, significant differences were found in the changes in HDL-C levels from baseline between the eradication group and the control group(all P<0.05). Conclusions:Long-term statin use in the elderly may reduce the risk of Hp infection.Rosuvastatin combined with a standard quadruple therapy does not improve the Hp eradication rates in elderly patients with mixed hyperlipidemia, but it facilitates short-term achievement of cholesterol targets.

Objective To investigate the adverse pregnancy outcomes of fetuses with increased nuchal translucency(NT).Methods A total of 376 pregnant women at the Third Affiliated Hospital of Zhengzhou University from May 2023 to January 2024 were selected as research subjects,who had a diagnosis of fetal NT ≥ the 95th percentile and complete pregnancy outcomes for singleton pregnancies.The fetuses were divided into simple thickening group(n=320)and thickening with structural abnormalities group(n=56)based on NT ultrasound results.The interventional prenatal diagnosis outcomes and pregnancy outcomes of two groups were compared.Results The rate of chromosomal abnormalities and the incidence of adverse pregnancy outcomes were higher in thickening with structural abnormalities group compared to simple thickening group with statistically significant differences(P＜0.05).The overall incidence of adverse pregnancy outcomes in NT thickened fetuses was 31.65％,but after excluding chromosomal abnormalities and structural malformations,the good pregnancy outcome rate in NT thickened fetuses was 98.09％.Conclusion NT thickening is associated with adverse pregnancy outcomes in fetuses,and the risk of poor fetal outcome is further increased when NT thickening combined with structural abnormalities in early pregnancy,but the pregnancy outcome is better in fetuses with NT thickening after excluding chromosomal abnormalities and structural malformations.

Objective To investigate the adverse pregnancy outcomes of fetuses with increased nuchal translucency(NT).Methods A total of 376 pregnant women at the Third Affiliated Hospital of Zhengzhou University from May 2023 to January 2024 were selected as research subjects,who had a diagnosis of fetal NT ≥ the 95th percentile and complete pregnancy outcomes for singleton pregnancies.The fetuses were divided into simple thickening group(n=320)and thickening with structural abnormalities group(n=56)based on NT ultrasound results.The interventional prenatal diagnosis outcomes and pregnancy outcomes of two groups were compared.Results The rate of chromosomal abnormalities and the incidence of adverse pregnancy outcomes were higher in thickening with structural abnormalities group compared to simple thickening group with statistically significant differences(P＜0.05).The overall incidence of adverse pregnancy outcomes in NT thickened fetuses was 31.65％,but after excluding chromosomal abnormalities and structural malformations,the good pregnancy outcome rate in NT thickened fetuses was 98.09％.Conclusion NT thickening is associated with adverse pregnancy outcomes in fetuses,and the risk of poor fetal outcome is further increased when NT thickening combined with structural abnormalities in early pregnancy,but the pregnancy outcome is better in fetuses with NT thickening after excluding chromosomal abnormalities and structural malformations.

Objective:To investigate the correlation between long-term statin use and Helicobacter pylori( Hp)infection in the elderly, and to compare the effects of rosuvastatin combined with bismuth-containing quadruple therapy for Hp eradication on lipid levels in elderly patients with mixed hyperlipidemia. Methods:A retrospective analysis was conducted on 1 181 elderly patients with hyperlipidemia, cardiovascular and cerebrovascular diseases, and peripheral arterial disease who were treated at the First Hospital of Lanzhou University between March 2019 and December 2023.According to the results of carbon 14 urea breath test(C 14-UBT), the subjects were divided into the Hp infection group and the non- Hp infection group.Multivariate logistic regression methods were used to analyze the correlation between Hp infection and statin use.A prospective case-control analysis was conducted on 109 patients with mixed hyperlipidemia and Hp infection treated during the same period, they were treated with rosuvastatin combined with bismuth-containing quadruple therapy for Hp eradication.The successful eradication people were selected as the eradication group (n=95). Patients with hyperlipidemia and Hp infection unwilling eradication was selected as the control group (n=109), and treated with rosuvastatin.Changes in lipid levels were compared over a consecutive 6-month period. Results:The overall Hp infection rate was 53.94%(637/1 181). Univariate analysis showed that the infection rate in women was higher than in men.Body mass index(BMI), low-density lipoprotein cholesterol(LDL-C), fasting blood glucose(FBG)levels in the Hp(+ )group were higher than in the Hp(-)group.Long-term low-dose aspirin users had a higher infection rate than non-users.The infection rate was lower in statin users than in non-users[42.65%(374/877) vs.55.59%(169/304), χ2=15.234, P<0.001]. Multivariate analysis showed that women had a higher infection risk than men ( OR=1.441, 95% CI: 1.102-1.729, P=0.011). Higher FBG and LDL-C levels increased the risk of Hp infection ( OR=1.406, 95% CI: 1.271-2.286, P<0.001, OR=1.118, 95% CI: 1.017-1.387, P=0.010). Aspirin use increased the risk of Hp infection( OR=1.162, 95% CI: 1.034-1.294, P=0.021), while statin use reduced the risk of Hp infection ( OR=0.177, 95% CI: 0.018-0.311, P<0.001). The Hp eradication rate was 87.16%(95/109). At 1-and 2-months post-eradication, statistically significant differences were observed between the eradication and control groups in LDL-C, total cholesterol(TC), changes from baseline, and target achievement rates(all P<0.05). At 1-month post-eradication, a statistically significant difference was observed in high-density lipoprotein cholesterol(HDL-C) levels between the two groups.Additionally, at both 1-and 2-months post-eradication, significant differences were found in the changes in HDL-C levels from baseline between the eradication group and the control group(all P<0.05). Conclusions:Long-term statin use in the elderly may reduce the risk of Hp infection.Rosuvastatin combined with a standard quadruple therapy does not improve the Hp eradication rates in elderly patients with mixed hyperlipidemia, but it facilitates short-term achievement of cholesterol targets.

OBJECTIVE To establish a liquid chromatography-tandem mass spectrometry （LC-MS/MS） method for the simultaneous determination of bepotastine and hydroxychloroquine concentrations in human breast milk and apply it in clinical practice. METHODS The milk samples （50 μL） were precipitated with 200 μL methanol containing the internal standard （100 ng/mL chloroquine）， and the supernatant was taken for analysis after vortexing and centrifugation. The separation was performed on a Waters ACQUITY UPLC HSS T3 column with mobile phase consisted of 0.1% formic acid-10 mmol/L ammonium acetate solution （phase A） and methanol （phase B） at gradient elution of 0.35 mL/min. The injection volume was 2 μL， and the analysis time was 4 min. The detection of the analytes was performed by electrospray ionization in positive mode by multiple reaction monitoring with the transition of m/z 388.9→201.9 （bepotastine）， m/z 336.3→247.1 （hydroxychloroquine）， and m/z 320.2→247.2 （chloroquine）. The established LC-MS/MS method was researched in methodology and used to determine the drug concentrations in the breast milk of 1 case of lactating patient. RESULTS The linear range of bepotastine was 2-200 ng/mL（ r＝0.999）， and hydroxychloroquine was 50-1 000 ng/mL （r＝0.998）. The intra-assay and inter-assay precisions were both ≤15%， and the accuracy， extraction recovery， matrix effect， and stability all met the acceptance criteria for bioanalytical method validation. The concentration result of bepotastine and hydroxychloroquine in the breast milk of the lactating patient showed， after 2 h and 14 h， the concentrations of bepotastine in the breast milk of the patient were 34.95 ng/mL and 5.72 ng/mL； those of hydroxychloroquine were 211.92 ng/mL and 104.18 ng/mL， respectively. The relative infant doses were 1.83% and 0.56%， respectively. CONCLUSIONS The established method is simple， rapid， and sensitive. It is suitable for simultaneous determination of bepotastine and hydroxychloroquine concentrations in human milk and can provide reference for safe drug use during lactation.

OBJECTIVE To establish a liquid chromatography-tandem mass spectrometry （LC-MS/MS） method for the simultaneous determination of bepotastine and hydroxychloroquine concentrations in human breast milk and apply it in clinical practice. METHODS The milk samples （50 μL） were precipitated with 200 μL methanol containing the internal standard （100 ng/mL chloroquine）， and the supernatant was taken for analysis after vortexing and centrifugation. The separation was performed on a Waters ACQUITY UPLC HSS T3 column with mobile phase consisted of 0.1% formic acid-10 mmol/L ammonium acetate solution （phase A） and methanol （phase B） at gradient elution of 0.35 mL/min. The injection volume was 2 μL， and the analysis time was 4 min. The detection of the analytes was performed by electrospray ionization in positive mode by multiple reaction monitoring with the transition of m/z 388.9→201.9 （bepotastine）， m/z 336.3→247.1 （hydroxychloroquine）， and m/z 320.2→247.2 （chloroquine）. The established LC-MS/MS method was researched in methodology and used to determine the drug concentrations in the breast milk of 1 case of lactating patient. RESULTS The linear range of bepotastine was 2-200 ng/mL（ r＝0.999）， and hydroxychloroquine was 50-1 000 ng/mL （r＝0.998）. The intra-assay and inter-assay precisions were both ≤15%， and the accuracy， extraction recovery， matrix effect， and stability all met the acceptance criteria for bioanalytical method validation. The concentration result of bepotastine and hydroxychloroquine in the breast milk of the lactating patient showed， after 2 h and 14 h， the concentrations of bepotastine in the breast milk of the patient were 34.95 ng/mL and 5.72 ng/mL； those of hydroxychloroquine were 211.92 ng/mL and 104.18 ng/mL， respectively. The relative infant doses were 1.83% and 0.56%， respectively. CONCLUSIONS The established method is simple， rapid， and sensitive. It is suitable for simultaneous determination of bepotastine and hydroxychloroquine concentrations in human milk and can provide reference for safe drug use during lactation.