To analyze potential adverse drug events(ADEs) associated with ustekinumab and upadacitinib in the treatment of inflammatory bowel disease(IBD) based on an international authoritative database, thereby providing evidence for clinical medication safety.

OBJECTIVE To analyze the medication needs of parents of pediatric children in our hospital regarding drug instructions， and explore improvement strategies， thereby providing a basis for clinically guiding the rational use of drugs in pediatric patients. METHODS A self-designed questionnaire was used to randomly select the parents of pediatric patients in the pediatric outpatient and emergency departments of our hospital from July 1st to September 30th， 2024. A randomized face-to-face survey was conducted regarding their willingness to read drug instructions， their current understanding status， and their needs. The survey results were then statistically analyzed. RESULTS A total of 300 questionnaires were distributed in this survey， and 299 valid questionnaires were recovered， with an effective recovery rate of 99.7%. Before medication， the parents who “always” and “often” read the drug instructions in detail accounted for 39.1% （117 respondents） and 35.1% （105 respondents）， respectively. Statistically significant differences were observed in the willingness to read drug instructions among respondents with varying educational levels and occupations （P＜0.05）. Among the 299 respondents， only 48 people （16.1%）“ fully understood” the drug instructions， and the average understanding score of all the respondents was （3.77±0.83） points. The stronger the respondents’ willingness to read drug instructions， the higher their understanding scores of drug instructions （P＜0.05）. A total of 256 respondents thought that drug instructions were of great help to themselves， and the average helpfulness rating score of all the respondents was （4.28±0.78） points. Under the conditions of varying ages， educational levels， occupations， and willingness to read drug instructions， statistically significant differences were observed in the scores representing the degree of helpfulness of drug instructions to the respondents （P＜0.05）. Respondents paid the most attention to content in drug instructions such as “dosage and administration method”，“ adverse reactions”， and “indications and therapeutic categories”. The most difficult sections for them to understand included “chemical structure and properties”， “pharmacological and toxicological effects” ， and “pharmacokinetics”， etc. The demographic characteristics of the respondents were not significantly associated with the content areas of drug instructions they most desired to see improved （P＞0.05）. Most respondents （86.0%） hoped to improve the instructions mainly by “simplifying professional terms to make them more accessible”. Others included “highlighting key information” （60.5%） and “providing more detailed medication guidance” （49.2%）， etc. CONCLUSIONS Parents of pediatric patients in our hospital have a high demand for drug instructions but low comprehension. The pharmacy department should make targeted improvements to drug instructions based on parents’ actual needs， helping them accurately obtain medication knowledge and reduce potential medication safety risks.

Objective:To observe and analyze the adverse drug reactions (ADRs) caused by adalimumab in patients with inflammatory bowel disease (IBD) and its influencing factors.Methods:A retrospective study was conducted on 106 patients with inflammatory bowel disease treated with adalimumab at Tianjin Medical University General Hospital from November 2019 to November 2023. Among them, 31 patients who experienced adverse reactions were included in the ADR group (case group), while 75 patients who did not experience adverse reactions were included in the non-ADR group (control group). Patients' basic information, laboratory tests, adverse drug reactions, etc were collected. Measurement data with normal distribution were expressed as xˉ± s and means between two groups were compared using independent samples t-test. The percentage of count data was calculated, and the rate between groups was compared by χ2 test. The risk factors of adverse drug reactions caused by adalimumab in patients with inflammatory bowel disease were analyzed by single factor screening and multivariable Logistic regression model. Results:ADR occurred in 31 of 106 patients, accounting for 29.25% (31/106), among those patients which infection was the most common,accounting for 18.87%(20/106). The number of combined drugs (≥3 kinds), drug allergy history, drug duration (≥3 months), blood concentration (>12 μg/mL) in ADR group were higher than those in non-ADR group ( χ2-values were 5.90, 5.78, 6.94 and 10.07, respectively,t-values were 8.55 and 0.97 respectively; all P<0.05). Multivariate Logistic regression results showed that the number of combined drugs ≥3, drug allergy history, drug duration >3 months, blood concentration >12 ng/L, creatinine and total bilirubin levels were all risk factors for adverse drug reactions of adalimumab in IBD patients (O R values were 2.680, 2.394, 3.228, 4.415, 3.673 and 4.646, respectively;95% CI:1.563~3.798, 1.434-3.354, 2.070-4.387, 3.803-5.027, 2.364-4.982 and 3.449-5.843, respectively; all P<0.05). Conclusion:The number of combined drugs ≥3, drug allergy history, drug duration >3 months, blood concentration >12 ng/L, creatinine and total bilirubin levels are all risk factors for adverse drug reactions in IBD patients with adalimumab. In clinical practice, it is necessary to strengthen monitoring and take timely preventive measures for IBD patients with the above-mentioned factors, in order to reduce the incidence of ADR.

Objectives:To analyze the disease burden and trends of ischemic stroke attributable to major metabolic risk factors in China from 1990 to 2021,and provide a basis for disease prevention and management.Methods:Based on the Global Burden of Disease(GBD)2021 data,we compared the age-standardized mortality rate(ASMR)and age-standardized disability-adjusted life year rate(ASDR)of ischemic stroke attributable to major metabolic risk factors(including overweight/obesity,hypertension,elevated low-density lipoprotein cholesterol,low bone density,hyperglycemia,and impaired renal function)in China and globally,and estimated their time trends through estimated annual percentage change(EAPC).We also analyzed the number of deaths,mortality rate,disability adjusted life year(DALY),and DALY rate of ischemic stroke attributable to major metabolic risk factors in China from 1990 to 2021,and compared the epidemiological differences among different gender and age groups.Results:From 1990 to 2021,the disease burden of ischemic stroke attributable to major metabolic risk factors in China showed a slight upward trend(1990 to 2005)and then gradually decreased,with a relatively small overall decline.,while the global disease burden showed a decreasing trend.In 2021,the ASMR and ASDR of ischemic stroke attributable to major metabolic risk factors in China were 48.11/100 000 and 898.35/100 000(EAPC[95%CI]were-0.24%[-1.13%to 0.66%]and-0.25%[-1.00%to 0.51%]),respectively,both higher than the global average levels(33.96/100 000 and 651.46/100 000,EAPC[95%CI]were-1.75%[-2.03%to 1.47%]and-1.49%[-1.74%to-1.23%],respectively).Compared with 1990,the actual mortality rate and DALY rate of ischemic stroke attributable to major metabolic risk factors in China increased by 139.60%and 110.53%respectively in 2021.There are gender differences in the disease burden of ischemic stroke attributable to major metabolic risk factors in China,with significantly higher death numbers,mortality rates,DALY,and DALY rates in males compared to females.At the age level,DALY and DALY rates were both higher in individuals aged 15-49,DALY increased but DALY rates decreased in individuals aged 50-69.DALY surged in individuals aged 70 and above,male DALY rates showed increasing trend and female DALY rates showed slightly decreasing trend.Conclusions:The disease burden of ischemic stroke in China is significantly affected by metabolic risk factors.Although prevention and control have achieved certain positive results,the overall disease burden in China is higher than that of the world,and precise intervention strategies need to be developed for different genders and ages in China.

A 12-year-old male child with severe pneumonia received anti-infection therapy with cefoperazone sodium and sulbactam sodium (3 g by intravenous infusion, once every 8 hours) and minocycline (100 mg twice daily orally). After 8 days, the child experienced severe headache, accompanied by blurred vision and nausea. The head magnetic resonance imaging and 4-hour video electroencephalogram showed no abnormalities in the child. Cerebrospinal fluid pressure measured by lumbar puncture was 220 mmH 2O, and cerebrospinal fluid biochemistry and routine examination showed no abnormalities. After excluding intracranial infection, toxic encephalopathy, intracranial hemorrhage, and space-occupying lesions, it was considered that the increase of intracranial pressure was caused by minocycline. After discontinuing minocycline and administering symptomatic treatments such as mannitol, nonsteroidal anti-inflammatory drugs for 3 days, his headache was relieved. At 1-week and 1-month follow-up, no abnormal symptoms such as headache recurred in the child.

A 12-year-old male child with severe pneumonia received anti-infection therapy with cefoperazone sodium and sulbactam sodium (3 g by intravenous infusion, once every 8 hours) and minocycline (100 mg twice daily orally). After 8 days, the child experienced severe headache, accompanied by blurred vision and nausea. The head magnetic resonance imaging and 4-hour video electroencephalogram showed no abnormalities in the child. Cerebrospinal fluid pressure measured by lumbar puncture was 220 mmH 2O, and cerebrospinal fluid biochemistry and routine examination showed no abnormalities. After excluding intracranial infection, toxic encephalopathy, intracranial hemorrhage, and space-occupying lesions, it was considered that the increase of intracranial pressure was caused by minocycline. After discontinuing minocycline and administering symptomatic treatments such as mannitol, nonsteroidal anti-inflammatory drugs for 3 days, his headache was relieved. At 1-week and 1-month follow-up, no abnormal symptoms such as headache recurred in the child.

Objective:To analyze the occurrence and influencing factors of adverse reactions in patients with inflammatory bowel disease (IBD) during the long-term treatment with vedolizumab (VDZ).Methods:The study was a retrospective observational design. The study subjects were selected from patients who long-termly used VDZ to treat moderate-to-severe active IBD in Tianjin Medical University General Hospital from February 1, 2021 to December 31, 2023. Clinical data of patients were collected through the hospital system of clinical pharmacy management, including general information, IBD condition, VDZ maintenance treatment plan, combination of drugs, laboratory test results, etc. The adverse reactions of VDZ were screened and their clinical manifestations, severity, intervention and outcomes were analyzed descriptively. The patients were divided into 2 groups according to whether VDZ adverse reactions occurred, and the differences in clinical data between them were compared; the influencing factors of adverse reactions were analyzed by multivariate logistic regression method.Results:A total of 142 patients were included in the study, including 81 males and 61 females, aged (37.6±6.4) years with a range from 18 to 57 years. There were 103 patients (72.5%) developed VDZ adverse reactions, which mainly involved skin (52 patients, account for 50.5%), digestive system (33 patients, account for 32.0%) and respiratory system (18 patients, account for 17.5%). All 103 patients did not stop VDZ treatment, and the adverse reaction symptoms disappeared or were relieved after symptomatic treatments. Compared with patients without VDZ adverse reactions, the age of patients with VDZ adverse reactions were higher [(39.5±5.4) years vs. (32.4±6.7) years], and the proportions of patients with chronic relapsing clinical type [65.0%(67/103) vs. 41.0%(16/39)], severe disease activity [60.2%(62/103) vs. 33.3%(13/39)], combined drug use [67.0%(69/103) vs. 46.2%(18/39)], and injecting VDZ once every 4 weeks during maintenance treatment [27.2%(28/103) vs. 10.3%(4/39)] in the group were larger, with statistical significance (all P<0.05). Multivariate logistic regression analysis showed that the chronic relapsing clinical type [odds ratio ( OR)=1.012, 95% confidence interval ( CI): 1.001-1.028, P=0.002], severe disease activity ( OR=1.096, 95% CI: 1.010-1.158, P=0.040), combination drugs ( OR=1.035, 95% CI: 1.003-1.122, P=0.041), VDZ maintenance therapy injection interval of 4 weeks ( OR=1.014, 95% CI: 1.002-1.113, P=0.005) were the risk factors for VDZ adverse reactions. Conclusions:Among IBD patients receiving long-term treatment of VDZ, the incidence of adverse reactions of VDZ was 72.5%, mainly involving skin, digestive system and respiratory system. Symptomatic treatments could be given, and the prognosis was good. Patients with chronic relapsing clinical type, severe disease activity, combination therapy, and shorter VDZ maintenance injection interval were at higher risk of adverse reactions.

Objective:To observe and analyze the adverse drug reactions (ADRs) caused by adalimumab in patients with inflammatory bowel disease (IBD) and its influencing factors.Methods:A retrospective study was conducted on 106 patients with inflammatory bowel disease treated with adalimumab at Tianjin Medical University General Hospital from November 2019 to November 2023. Among them, 31 patients who experienced adverse reactions were included in the ADR group (case group), while 75 patients who did not experience adverse reactions were included in the non-ADR group (control group). Patients' basic information, laboratory tests, adverse drug reactions, etc were collected. Measurement data with normal distribution were expressed as xˉ± s and means between two groups were compared using independent samples t-test. The percentage of count data was calculated, and the rate between groups was compared by χ2 test. The risk factors of adverse drug reactions caused by adalimumab in patients with inflammatory bowel disease were analyzed by single factor screening and multivariable Logistic regression model. Results:ADR occurred in 31 of 106 patients, accounting for 29.25% (31/106), among those patients which infection was the most common,accounting for 18.87%(20/106). The number of combined drugs (≥3 kinds), drug allergy history, drug duration (≥3 months), blood concentration (>12 μg/mL) in ADR group were higher than those in non-ADR group ( χ2-values were 5.90, 5.78, 6.94 and 10.07, respectively,t-values were 8.55 and 0.97 respectively; all P<0.05). Multivariate Logistic regression results showed that the number of combined drugs ≥3, drug allergy history, drug duration >3 months, blood concentration >12 ng/L, creatinine and total bilirubin levels were all risk factors for adverse drug reactions of adalimumab in IBD patients (O R values were 2.680, 2.394, 3.228, 4.415, 3.673 and 4.646, respectively;95% CI:1.563~3.798, 1.434-3.354, 2.070-4.387, 3.803-5.027, 2.364-4.982 and 3.449-5.843, respectively; all P<0.05). Conclusion:The number of combined drugs ≥3, drug allergy history, drug duration >3 months, blood concentration >12 ng/L, creatinine and total bilirubin levels are all risk factors for adverse drug reactions in IBD patients with adalimumab. In clinical practice, it is necessary to strengthen monitoring and take timely preventive measures for IBD patients with the above-mentioned factors, in order to reduce the incidence of ADR.

Objectives:To analyze the disease burden and trends of ischemic stroke attributable to major metabolic risk factors in China from 1990 to 2021,and provide a basis for disease prevention and management.Methods:Based on the Global Burden of Disease(GBD)2021 data,we compared the age-standardized mortality rate(ASMR)and age-standardized disability-adjusted life year rate(ASDR)of ischemic stroke attributable to major metabolic risk factors(including overweight/obesity,hypertension,elevated low-density lipoprotein cholesterol,low bone density,hyperglycemia,and impaired renal function)in China and globally,and estimated their time trends through estimated annual percentage change(EAPC).We also analyzed the number of deaths,mortality rate,disability adjusted life year(DALY),and DALY rate of ischemic stroke attributable to major metabolic risk factors in China from 1990 to 2021,and compared the epidemiological differences among different gender and age groups.Results:From 1990 to 2021,the disease burden of ischemic stroke attributable to major metabolic risk factors in China showed a slight upward trend(1990 to 2005)and then gradually decreased,with a relatively small overall decline.,while the global disease burden showed a decreasing trend.In 2021,the ASMR and ASDR of ischemic stroke attributable to major metabolic risk factors in China were 48.11/100 000 and 898.35/100 000(EAPC[95%CI]were-0.24%[-1.13%to 0.66%]and-0.25%[-1.00%to 0.51%]),respectively,both higher than the global average levels(33.96/100 000 and 651.46/100 000,EAPC[95%CI]were-1.75%[-2.03%to 1.47%]and-1.49%[-1.74%to-1.23%],respectively).Compared with 1990,the actual mortality rate and DALY rate of ischemic stroke attributable to major metabolic risk factors in China increased by 139.60%and 110.53%respectively in 2021.There are gender differences in the disease burden of ischemic stroke attributable to major metabolic risk factors in China,with significantly higher death numbers,mortality rates,DALY,and DALY rates in males compared to females.At the age level,DALY and DALY rates were both higher in individuals aged 15-49,DALY increased but DALY rates decreased in individuals aged 50-69.DALY surged in individuals aged 70 and above,male DALY rates showed increasing trend and female DALY rates showed slightly decreasing trend.Conclusions:The disease burden of ischemic stroke in China is significantly affected by metabolic risk factors.Although prevention and control have achieved certain positive results,the overall disease burden in China is higher than that of the world,and precise intervention strategies need to be developed for different genders and ages in China.

Objective:To analyze the occurrence and influencing factors of adverse reactions in patients with inflammatory bowel disease (IBD) during the long-term treatment with vedolizumab (VDZ).Methods:The study was a retrospective observational design. The study subjects were selected from patients who long-termly used VDZ to treat moderate-to-severe active IBD in Tianjin Medical University General Hospital from February 1, 2021 to December 31, 2023. Clinical data of patients were collected through the hospital system of clinical pharmacy management, including general information, IBD condition, VDZ maintenance treatment plan, combination of drugs, laboratory test results, etc. The adverse reactions of VDZ were screened and their clinical manifestations, severity, intervention and outcomes were analyzed descriptively. The patients were divided into 2 groups according to whether VDZ adverse reactions occurred, and the differences in clinical data between them were compared; the influencing factors of adverse reactions were analyzed by multivariate logistic regression method.Results:A total of 142 patients were included in the study, including 81 males and 61 females, aged (37.6±6.4) years with a range from 18 to 57 years. There were 103 patients (72.5%) developed VDZ adverse reactions, which mainly involved skin (52 patients, account for 50.5%), digestive system (33 patients, account for 32.0%) and respiratory system (18 patients, account for 17.5%). All 103 patients did not stop VDZ treatment, and the adverse reaction symptoms disappeared or were relieved after symptomatic treatments. Compared with patients without VDZ adverse reactions, the age of patients with VDZ adverse reactions were higher [(39.5±5.4) years vs. (32.4±6.7) years], and the proportions of patients with chronic relapsing clinical type [65.0%(67/103) vs. 41.0%(16/39)], severe disease activity [60.2%(62/103) vs. 33.3%(13/39)], combined drug use [67.0%(69/103) vs. 46.2%(18/39)], and injecting VDZ once every 4 weeks during maintenance treatment [27.2%(28/103) vs. 10.3%(4/39)] in the group were larger, with statistical significance (all P<0.05). Multivariate logistic regression analysis showed that the chronic relapsing clinical type [odds ratio ( OR)=1.012, 95% confidence interval ( CI): 1.001-1.028, P=0.002], severe disease activity ( OR=1.096, 95% CI: 1.010-1.158, P=0.040), combination drugs ( OR=1.035, 95% CI: 1.003-1.122, P=0.041), VDZ maintenance therapy injection interval of 4 weeks ( OR=1.014, 95% CI: 1.002-1.113, P=0.005) were the risk factors for VDZ adverse reactions. Conclusions:Among IBD patients receiving long-term treatment of VDZ, the incidence of adverse reactions of VDZ was 72.5%, mainly involving skin, digestive system and respiratory system. Symptomatic treatments could be given, and the prognosis was good. Patients with chronic relapsing clinical type, severe disease activity, combination therapy, and shorter VDZ maintenance injection interval were at higher risk of adverse reactions.